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MEDS eNews 3

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Vol. 3 No. 45

FDA approval of romosozumab called
good news for osteoporosis patients

SOUTHBURY, CONN.U.S. Food and Drug Administration (FDA) approval this year of romosozumab to treat osteoporosis in menopausal women at high-fracture risk is “very good news” for that patient population, says an expert on the disease.

The April approval of romosozumab (brand name, Evenity) “is a definite option for this subset of people at high-fracture risk,” says Southbury, Conn., resident Rick Pope, (PA-C), Department of Rheumatology, Western Connecticut Medical Group, Danbury, Conn.

Romosozumab, according to the FDA, is a monoclonal antibody that blocks the effects of the protein sclerostin, working mainly by increasing new bone formation. One dose consists of two injections by a health-care professional, one right after the other, once a month.

Its bone-forming effect wanes after 12 doses; if osteoporosis therapy is needed after those dozen doses, patients should follow up on treatment to decrease bone breakdown.

The FDA states that the target population for the medication consists of women with histories of osteoporotic fractures or multiple-risk factors for fractures, or those who have failed or are intolerant to other osteoporosis therapies.

Pope, founder and past president of the Society of Physician Assistants in Rheumatology (SPAR), and faculty member of the Metabolic & Endocrine Disease Summit (MEDS), notes that the approval especially impacts “Medicare-patients who have had fractures while on bisphosphonate therapy.”

These patients, Pope adds, who choose romosozumab, will receive injections in their medical-practitioners’ offices over a 12-month period---so long as they have not suffered heart attacks or strokes over the past year. A boxed warning appears on the drug’s packaging, noting that the drug can increase the risk of heart attack, stroke, and cardiovascular death.

This warning, Pope asserts, “may limit acceptance; for those in this subset who have had these events over the past year, they would not have romosozumab prescribed.”

Pope also points to a 2017 study published in Lancet and including 436 female patients aged 55-to-90, indicating that in patients at high risk of fracture transitioning from bisphosphonates, romosozumab increased hip-and-spine bone-mineral density (BMD) and estimated hip strength compared to teriparatide through a dual effect---increasing bone formation and decreasing bone resorption.

That randomized, phase 3, open-label, active-controlled study was conducted at 46 sites in North America, Latin America, and Europe; 218 patients were randomly-assigned to romosozumab, the same number to teriparatide.

That study indicates that integral BMD at the hip and estimated hip-bone strength declined with teriparatide use at six months in the targeted-patient population. Study results suggest that romosozumab might offer a “unique” benefit to patients with post-menopausal osteoporosis who are transitioning from bisphosphonate therapy.

“Most patients with osteoporosis who are post-menopausal women in this country are on oral-bisphosphonate therapy,” Pope notes. “Fractures while on these therapies are not uncommon.”

Pope adds that “from past experience, teriparatide doesn’t work as well in the first year after taking oral bisphosphonates. It improves in the second year, and, in the 2017 study (also called a STRUCTURE trial), with romosozumab, the gain in BMD is rapid, and significant.”

In assessing whether patients are candidates for romosozumab, Pope says practitioners must “tell patients about the boxed warning, and that those with histories of heart attacks and strokes would not be likely candidates.”

Still, as the 2017 study (partly funded by Amgen, which produces romosozumab) notes, patients who don’t respond sufficiently with these medications---including those who have persistently low BMD or who develop fractures on therapy---are often switched to bone-forming agents.

“Romosozumab,” Pope concludes, “hasn’t been used yet. It will be interesting to see how it plays out. This is a new market, and the uptake will likely be slow. This is now a more-crowded field (of treatments). There are a number of options in the race.”

CITATION: Langdahl BL, Libanati C, et. al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep. 30; 390(10102):1585-1594.  FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture. April 9, 2019. FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture.  New treatment for osteoporosis in postmenopausal women with high fracture risk. APhA. June 24, 2019.


Assessment of veterans shows RYGB
offers sustained, long-term weight loss

SAN FRANCISCO – Roux-en-Y gastric bypass (RYGB), according to a recent study, offers sustained, long-term weight loss with significant resolution of major comorbidities in older veterans, with acceptably low morbidity and mortality.

The study was published in July in The American Journal of Surgery. Authors include Victoria Lyo and Anne L. Schafer, who are affiliated with the San Francisco VA Health Care System, San Francisco.

The researchers note that while more than one-third of veterans suffer from obesity and its associated comorbidities, bariatric surgery is less-commonly offered than in other populations.

They reviewed surgical outcomes using CPRS/Vista data of 315 RYGB cases performed at a major Veterans Administration medical center from 1995-to-2017.

Patients were 69% male, with an average age of 52 (65% over 50), and were followed for an average of eight years; 158 underwent laparoscopic surgery, and the remaining open.

Outcomes were: 30-day mortality---open: 1.3%, laparoscopic, 0%; anatomic leak---open: 0.3%, laparoscopic: 0%.

At five and 15 years, average body mass index (BMI) decreased from 47 pre-operatively to 33.3 and 31 respectively, while excess body-weight loss was 68%, and 80%, respectively.

Co-morbidity resolution rates were between 70% and 80% diabetes, sleep apnea, hyperlipidemia, gastroesophageal reflux disease (GERD), and non-alcoholic steatohepatitis (NASH).

CITATION: Victoria Lyo, Anne L. Schafer, et. al. Roux-en-Y Gastric Bypass is a Safe and Effective Option that Improves Major Co-Morbidities Associated with Obesity in an Older, Veteran Population. The American Journal of Surgery. Published online: July 20, 2019 Accepted: July 17, 2019. Received in revised form: April 30, 2019. Received: March 1, 2019.


Research: Sub-clinical atherosclerosis burden
predicts CVEs for diabetes patients with CKD

BARCELONA – The burden of sub-clinical atherosclerosis is the strongest predictor of future cardiovascular events (CVEs) in diabetic patients with chronic kidney disease (CKD), according to research indicating that early detection of sub-clinical atherosclerotic burden by multi-territorial vascular ultrasound could improve CVE prediction in this population.

Authors of the study published in July in Cardiovascular Diabetology include Ana Palanca, who is affiliated with Autonomous University of Barcelona, Barcelona.

The researchers report that their results demonstrate that multi-territorial ultrasonography is a valid and strong non-invasive tool to help predict CVEs among diabetic individuals with CKD.

They also state that their strategies implemented in routine practice to efficiently quantify sub-clinical arterial lesions in diabetes patients with CKD might be of clinical benefit, and should be considered with a special emphasis on younger women with diabetes.

The authors note that diabetes patients have remarkably high rates of cardiovascular morbidity and mortality, and that incremental cardiovascular risk in diabetes is heterogeneous and has often been related to renal involvement.

They included data from individuals with CKD with-and-without diabetes, free from pre-existing cardiovascular disease, from the NEFRONA cohort. Participants underwent baseline carotid-and-femoral ultrasound, and were followed up for four years. All CVEs during follow-up were registered. Bivariate analysis and Fine–Gray competing-risk models were used to perform the statistical analysis.

During the mean follow-up time of 48 months, 203 CVEs were registered; 107 CVEs occurred among participants without diabetes, and 96 occurred among participants with diabetes.

Following the competing-risk analysis, the variables predicting CVEs in CKD individuals without diabetes were the number of territories with plaque at baseline, age, and serum concentrations of 25-OH vitamin D.

The only variable predicting CVEs among CKD participants with diabetes was the number of territories with plaque at baseline. For both models, concordance (C) index yielded was over 0.7.

CITATION: Ana Palanca, Esmeralda Castelblanco, et. al. Subclinical atherosclerosis burden predicts cardiovascular events in individuals with diabetes and chronic kidney disease. Cardiovascular Diabetology. Received: 30 April 2019. Accepted: 12 July 2019. Published: 19 July 2019.


A thyroid study targets voice outcomes
in weighing surgery risks and benefits

ANN ARBOR, MICH. – A recent study indicates that a high prevalence of abnormal voice per validation with the abnormal voice handicap index (VHI-10) emphasizes the need for heightened awareness of voice abnormalities following surgery---warranting consideration in the pre-operative risk-benefit discussion, planned extent of surgery, and post-operative rehabilitation.

Authors of the study published in July in JAMA Otolaryngology-Head & Neck Surgery include Kevin J. Kovatch and David Reyes-Gastelum, University of Michigan, Ann Arbor, Mich.

The researchers set out to identify the prevalence, severity, and factors associated with poor voice outcomes following surgery for differentiated thyroid cancer (DTC).

They distributed a cross-sectional, population-based survey via a modified Dillman method to 4,185 eligible patients and linked to Surveillance, Epidemiology and End Results (SEER) data from SEER sites in Georgia and Los Angeles, California, from Feb. 1, 2017, to Oct. 31, 2018.

Multi-variable logistic regression and zero-inflated negative binomial analysis were performed to determine factors associated with abnormal voice. Participants included patients undergoing surgery for DTC between Jan. 1, 2014, and Dec. 31, 2015, excluding those with voice abnormalities before surgery.

A total of 2,632 patients responded to the survey; 2,325 met the inclusion criteria. With data reported as unweighted number and weighted percentage, 1,792 were women; weighted mean (SD) age was 49.4 years.

Of these, 599 patients reported voice changes lasting more than three months following surgery, 272 patients were identified as having an abnormal VHI-10 score, and 105 reported vocal-fold motion impairment diagnosed by laryngoscopy.

In multi-variable analysis, factors associated with an abnormal VHI-10 score included:

  • age 45-to-54 years
  • black race
  • Asian race
  • gastrogsophageal-reflux disease
  • lateral-neck dissection

CITATION: Kevin J. Kovatch, MD, David Reyes-Gastelum, MSc, et. al. Assessment of Voice Outcomes Following Surgery for Thyroid Cancer. JAMA Otolaryngology-Head & Neck Surgery. July 18, 2019.


Encouraging results for asthma reveal
leveling-off of increase in adult cases

HELSINKI – Recent research indicates that the previously-observed increase of physician-diagnosed asthma prevalence in adults seems to be leveling off in Helsinki, with patients showing fewer symptoms than 20 years ago.

The study published in August in Respiratory Medicine also indicates that allergic rhino-conjunctivitis is less frequent than 10 years earlier. Its authors---including Hanna Hisinger-Mölkänen, University of Helsinki, Helsinki, and Paula Pallasaho, Espoo City Health Services, Espoo, Finland---evaluated prevalence trends of asthma, asthma symptoms and allergic rhino-conjunctivitis in adults aged 20-to-69 years from 1996-to-2016 in Finland’s capital.

Three cross-sectional postal surveys were conducted in random-population samples 10 years apart. In 1996, 2006 and 2016, a total of 6,062 (response rate 75.9%), 2,449 (61.9%) and 4,026 subjects (50.3%) took part, respectively.
In all responders, the prevalence of physician-diagnosed asthma was 6.6% in 1996, 10% in 2006 and 10.9% in 2016. The prevalence increased from 1996-to-2006, but stabilized from 2006-to-2016, among both men and women, and in smokers and non-smokers.

The prevalence of current asthma (8.5% in 2006 and 8.8% in 2016) and of asthma with rhino-conjunctivitis (7.6% in 2006 and 7.5% in 2016) also remained at the same level.

Allergic rhino-conjunctivitis decreased significantly from 2006-to-2016. Those with physician- diagnosed asthma reported significantly fewer symptoms in 2016 compared to 2006 and 1996, although there was no change in smoking habits or medication use.

Young asthmatics (20-to-29 years) without rhino-conjunctivitis reported the fewest symptoms.

CITATION: Hanna Hisinger-Mölkänen, Paula Pallasaho, et. al. The increase of asthma prevalence has levelled off and symptoms decreased in adults during 20 years from 1996 to 2016 in Helsinki, Finland. Respiratory Medicine. August 2019. Volume 155, Pages 121-126.


Thyroid disorders’ impact on the heart
discussed in Clinician Reviews article

Thyroid disorders can have significant effects on the heart and cardiovascular system, and even sub-clinical hypothyroidism can be very impactful, according to a speaker at the Cardiovascular & Respiratory Summit by the Global Academy for Medical Education in Orlando. A recent article in Clinician Reviews, written by Jeff Craven, quotes Christine Kessler, MN, ANP-C, CNS, BC-ADM, GFAANP, as stating that thyroid function should be evaluated in patients with a fast-resting heart rate, new-onset atrial fibrillation (AFib), idiopathic heart failure, bradycardia, using amiodarone, resistant hypertension, pericardial effusion, and statin-resistant hyperlipidemia. The article can be accessed at



Vol. 3 No. 44

Kidney-disease expert stresses the importance
of quality-of-life discussions with her patients

DALLAS – When it comes to vital discussions with elderly chronic kidney disease (CKD) patients, one CKD expert doesn’t just turn to her medical background---she also relies on her eyes.

“I look at how these patients enter my office,” says Denise K. Link, MPAS, PA-C, FNKF, who works in nephrology as a physician assistant (PA) at the University of Texas Southwestern Medical Center in Dallas. “I watch them, whether they walk in with canes, walkers, wheelchairs, and I want to know whether they are in nursing homes or living by themselves.”

“I also look at their comorbidities, including diabetes and coronary artery disease. We need to have hard, necessary conversations about what they want, and whether conservative, palliative care is a better option than dialysis. We don’t push them to dialysis. It may not match their desired quality of life (QoL).”

Link is a faculty member of Cardiovascular & Respiratory Summit (CARPS) who cares for CKD, dialysis, and post-transplant patients, and trains physician assistant (PA), nurse practitioner (NP), and MD students. She commented on a study published in the March-April issue of Peritoneal Dialysis International.

That research concludes that QoL outcomes in frail older assisted peritoneal dialysis (aPD) patients were equivalent to those receiving in-center hemodialysis (HD).

The research concludes that aPD is a valid alternative to HD for older patients with end-stage kidney disease (ESKD) who want to dialyze at home.

Link---while noting that the UK study included assessments of aPD, which isn’t used much in this country--seized on its application to U.S. health-care professionals’ conversations with CKD patients.

Link says that health-care providers, notably PAs and NPs, should have dialysis-and-QoL-patient discussions in separate office visits.

“It is vitally important that these conversations take place prior to our patients reaching kidney failure,” she says. “We can incorporate these QoL discussions into our CKD visits. However, I prefer to have a separate visit to discuss QoL and various treatment options. I want to know what all advanced CKD patients’ desired QoLs would look like.”

These conversations are purposeful.

“I have this discussion with all patients in stage four and five of CKD,” says Link. “At times when I bring up dialysis, they immediately freeze; there is shock and denial. All of these patients know someone who has had dialysis. They know that they will be spending one day at the hemodialysis center, and the next day recovering. I make sure to ask, ‘What do you want your life to look like, what is important to you, your family, your friends?”

Link underscores the importance of specific, targeted, consultations.
She emphasizes, “In the U.S., the assumption is that everyone wants to prolong their life, independent of what ‘life’ will look like. This is not always the case. We want patients to know that we are interested in what they want their lives to look like.”

“Sometimes,” she says “elderly patients are happier with conservative options which may provide a much-different QoL compared to thrice-weekly hemodialysis sessions. In this scenario, I will continue to take care of their CKD while at the same time referring them to palliative care. We aren’t pushing anyone to dialysis. If they want to prolong their lives, there is the dialysis option. We let them know that dialysis is not going to change the disease process. It prolongs life with potential significant changes to QoL.”

CITATION: Osasuyi Iyasere, Edwina Brown, et. al. Longitudinal Trends in Quality of Life and Physical Function in Frail Older Dialysis Patients: A Comparison of Assisted Peritoneal Dialysis and In-Center Hemodialysis. Peritoneal Dialysis International. March-April, 2019. 


Research into diabetes incidence indicates
longest period ever of decline in diagnoses

ATLANTA – Research published in BMJ Open Diabetes Research & Care indicates that after an almost 20-year increase in the national prevalence and incidence of diagnosed diabetes, an eight-year period of stable prevalence and a decrease in incidence has occurred.

Authors of the study published in May include Stephen R. Benoit and Israel Hora, who are affiliated with the Centers for Disease Control and Prevention, Atlanta.
The researchers report the longest period of a sustained plateau in prevalence since the 1980s and longest period of declining incidence ever.

Although an encouraging sign of success, due to the persistence of major risk factors such as obesity and pre-diabetes, the authors caution that trends are likely affected by changing awareness, detection, and diagnostic practices.

The researchers also note that even in the event of true reductions in incidence, the high prevalence and declining mortality signifies a continued high overall burden of diabetes. For these reasons, they urge a continued emphasis on multi-level, multi-disciplinary prevention to reduce both type 2 diabetes and diabetes complications, along with improved surveillance of trends in screening and detection.

They calculated annual prevalence and incidence of diagnosed diabetes (type 1 and type 2 combined) for civilian, non-institutionalized adults aged 18-to-79 years using annual, nationally-representative cross-sectional survey data from the National Health Interview Survey from 1980-to-2017.

Overall, the prevalence of age-adjusted, diagnosed diabetes did not change significantly from 1980-to-1990, but increased significantly from 1990-to-2009 to a peak of 8.2 per 100 adults, and then plateaued through 2017.

The incidence of age-adjusted, diagnosed diabetes did not change significantly from 1980-to-1990, but increased significantly from 1990-to-2007 to 7.8 per 1,000 adults, and then decreased significantly to 6.0 in 2017. The decrease in incidence appears to be driven by non-Hispanic whites with an annual percentage change (APC) of −5.1% after 2008.

CITATION: Stephen R. Benoit, Israel Hora, et. al.  New directions in incidence and prevalence of diagnosed diabetes in the USA. BMJ Open Diabetes Research & Care. Received January 22, 2019. Revised March 20, 2019. Accepted April 20, 2019. First published May 28, 2019.


Study: For obese adults, weight cycling
is associated with lower muscle mass

VERONA, ITALY – Recent research indicates that, for obese adults, weight cycling is associated with lower muscle mass and strength and a greater likelihood of developing sarcopenic obesity.

The study published in June in Obesity was designed to determine whether multiple weight cycles in adulthood are an independent predictor of lower muscle mass and reduced strength, with potential implications for sarcopenia in adults with obesity.

Its authors---including Andrea P. Rossi and Sofia Rubele, University of Verona, Verona, Italy---urge additional research to identify which type of weight cycling has the most unfavorable consequences for those with obesity undergoing weight‐loss programs.

They also stress the importance of understanding which patients are at greater risk of weight cycling.

Their study assessed 60 males and 147 females with obesity; muscle strength was evaluated with handgrip, and appendicular skeletal-muscle mass was measured with dual‐energy X‐ray absorptiometry.

Participants were categorized into the following groups:
•    non‐weight cyclers
•    mild-weight cyclers
•    severe-weight cyclers

From a binary-logistic regression that considered muscle-mass categories as a dependent variable and weight-cycling categories, age, and sex as independent variables, severe weight cyclers showed a 3.8‐times increased risk of low muscle mass.

Considering handgrip-strength categories as a dependent variable and weigh-cycling categories, age, sex, and body mass index (BMI) as independent variables, severe weight cycling was associated with an increased risk of low muscle mass.

Severe weight cyclers showed a 5.2‐times greater risk of developing sarcopenia.
Participants were recruited from consecutive referrals by family doctors to the rehabilitative-treatment programs for obesity at the Villa Garda Hospital Department of Eating and Weight Disorders Inpatient Unit and the University of Verona Department of Medicine Outpatient Clinic during the years 2015-to-2016.

CITATION: Andrea P. Rossi, Sofia Rubele, et. al. Weight Cycling as a Risk Factor for Low Muscle Mass and Strength in a Population of Males and Females with Obesity. Obesity. First published: 23 June 2019.


Evidence is seen for the future development
of interventions for Asthma-COPD Overlap

ST. JOHN’S, NEWFOUNDLAND – A recent study offers evidence for future development of female-specific prevention-and-public-health intervention programs in aboriginal communities to reduce the burden of Asthma-COPD Overlap (ACO).

Authors of the study published in June in the Journal of Asthma include Adetola Koleade and Jamie Farrell, who are affiliated with Memorial University of Newfoundland,  Memorial University, St. John’s, Newfoundland.

They noted that sex differences in incidence, susceptibility and severity of many chronic-respiratory diseases have been long recognized, and that ACO is a newly-recognized disease, with its management guidelines reported in 2015.

They point out that the Aboriginal Peoples Survey (APS) 2012 (28,410 subjects) is the fourth cycle of a national cross-sectional survey representative of the First Nations living off-reserve, Metis and Inuit.

The 2012 APS collected information on employment, education, health status, housing, family background and income. Survey-logistic regression was used to identify the significant risk factors for ACO in the multi-variate analysis.

The prevalence of ACO was 1.65% and 3.53% in males and females, respectively. The following factors were significantly associated with increased risk of ACO in both males and females:
•    increased age
•    living in Quebec
•    living in a rented dwelling
•    living in a dwelling in need of major repairs

However, factors including marital status (widowed, separated, or divorced), smoking status (current daily smoker), having a diagnosis of diabetes, and working 40 hours-and-over a week, were significantly associated with increased risk of ACO in females, though not in males.

CITATION: Adetola Koleade, Jamie Farrell, et. al. Female-specific risk factors associated with risk of ACO (asthma COPD overlap) in aboriginal people. Journal of Asthma. Received 18 Feb 2019. Accepted 16 May 2019. Accepted author version posted online: 20 May 2019. Published online: 05 Jun 2019.


A substantial difference is reported in rate
of revision surgery after ARCR procedure

CHICAGO – A substantial difference in the revision-surgery rate after arthroscopic rotator-cuff repair (ARCR) in patients with osteoporosis compared with matched controls was shown in a study published in June in Arthroscopy.

Authors of the level III, retrospective-cohort study include Jourdan M. Cancienne, who is affiliated with Midwest Orthopaedics at Rush, Chicago, and Stephen F. Brockmeier, University of Virginia Health System, Charlottesville, Va.

They set out to examine any association between osteoporosis and the failure of ARCR leading to revision surgery and to investigate whether the use of bisphosphonates had any influence on the observed associations.

Patients who underwent ARCR with a diagnosis of osteoporosis were identified from the PearlDiver data-base and stratified according to whether there was a filled prescription for a bisphosphonate in the perioperative period.

Osteoporosis patients who underwent ARCR with bisphosphonate use were compared with age- and sex-matched patients who underwent ARCR with osteoporosis without a prescription for a bisphosphonate within one year of surgery, and patients who underwent ARCR without a diagnosis of osteoporosis and no bisphosphonate use.

The primary-outcome measure was ipsilateral-revision rotator-cuff surgery, including revision repair, debridement for a diagnosis of a rotator-cuff tear, or reverse-shoulder arthroplasty. A multi-variable logistic-regression analysis was used to control for patient demographic characteristics and comorbidities during comparisons.

The authors identified 2,706 patients, including:
•    451 in the bisphosphonate-study group
•    902 in the osteoporosis, no-bisphosphonate control group
•    1,353 in the non-osteoporosis control group

Patients with osteoporosis, including those to whom bisphosphonates were prescribed, had a significantly-higher rate of revision rotator-cuff surgery than patients without osteoporosis.
No significant difference in the rate of revision surgery was found between patients with osteoporosis using bisphosphonates and age- and sex-matched patients with osteoporosis not using bisphosphonates.

CITATION: Jourdan M. Cancienne, Stephen F. Brockmeier, et. al. The Association of Osteoporosis and Bisphosphonate Use With Revision Shoulder Surgery After Rotator Cuff Repair. Arthroscopy. Published online: June 20, 2019. Accepted: March 16, 2019. Received: November 14, 2018.


Clinician Reviews article details need
for endocrine-hypertension screening

Endocrine-hypertension screening is addressed in a June posting in Clinician Reviews. The article by Aimee Pragle, MMSc, MSPH, PA-C, Florida State University, Tallahassee, Fla., notes the importance of identifying cases of secondary hypertension, which can lead to cardiovascular and renal disease if left undiagnosed and untreated. Pragle summarizes screening-and-diagnosis guidelines for possible causes of endocrine hypertension: primary aldosteronism, Cushing syndrome, and pheochromocytoma. The article can be accessed at



Vol. 3 No. 43

‘Stark’ maternal-adiposity results highlight
importance of pre-conception weight loss

KING GEORGE, VA. – Research indicating that adult children of mothers with pre-pregnancy overweight or obesity have higher body mass index (BMI) and greater odds of adult obesity than adult children of normal-weight mothers is another wake-up call on the importance of weight loss.

It also provides a strong motivation for overweight mothers-to-be, says one obesity management expert, to act on behalf of their unborn children even when they are less inclined to help themselves.

The study published in November in Obesity examined the relationship between pre-natal, maternal weight and the progressive BMI of offspring throughout adulthood during a 40-year follow-up. Children of mothers with pre-natal overweight or obesity demonstrated greater BMI throughout adulthood with a more rapid consistent weight acceleration in early and mid-adulthood---something that was not seen in children of mothers with normal pre-conception weight.  This held true even in women with obesity who lost weight prior to conception.

The findings from this study associating pre-natal overweight and obesity to offspring adiposity doesn’t surprise nurse practitioner (NP) Christine Kessler, founder of Metabolic Medicine Associates in King George, Va., Kessler, faculty co-chair of the Metabolic & Endocrine Disease Summit (MEDS), notes that “for many years there has been accumulating evidence that suggest increased obesity risk may begin in utero due to fetal exposure to maternal adiposity, although the biological mechanism for this is not clearly understood.  This large longitudinal study, adjusted for inherited, genetic pre-disposition and lifestyle factors, offers greater support for the causal relationship of maternal weight and offspring obesity.”

Based on Framingham Heart Study data and funded by the National Institutes of Health, the study urges lifestyle interventions, which Kessler fully supports.

“This study,” says Kessler, “provides us with the stark results of excess maternal adiposity on a child’s obesity risk and long-term weight trajectory, compared to normal weight mothers.  It also highlights the importance of weight reduction prior to conception focusing on life-long, evidenced-based lifestyle interventions that promote healthy weight loss and maintenance, which includes individualized plans for nutrition, sleep, and physical-activity levels.  Bariatric surgery may also be an option for those contemplating pregnancy. Although prescription weight-loss medications are useful, none are currently approved for use in pregnancy.”

“Fertility,” she adds “also improves with weight loss, which can be another motivator. We need to inform our child-bearing women about the perils of overweight and obesity with regard to the ability to conceive, and the increased life-long risk of un-healthy adiposity in their children. Women aren’t always aware that their own weight can contribute to a two-and-a-half to five-fold risk of increased obesity for their offspring. This is huge.”

Kessler also stresses that NPs and physician assistants (PAs) “have a great opportunity to positively affect a mother’s health and that of her offspring with regard to the life-long trajectory of weight issues and associated complications. We can’t change genetics,” she admits, “but we can help educate and motivate women to adapt pre-conception, weight-loss lifestyle changes, armed with information about the disease of obesity and its impact on their children. Doing so will reap great rewards for both mother and child with a positive heath impact that will last long into the future.”

“To effectively provide weight loss interventions,” she concludes, “providers should be knowledgeable about the chronic disease of obesity and its treatment options. Both the American Association of Nurse Practitioners (AANP) and the American Association of Physician Assistants (AAPA) offer online obesity-education programs. Obesity-medicine guidelines can also be found online, including a thorough one offered by the American Association of Clinical Endocrinologists (AACE). It’s past time to help these mother and babies at risk.”

CITATION: Isabelle Schoppa, Asya Lyass, et. al. Association of Maternal Prepregnancy with Offspring Adiposity Throughout Adulthood Over 37 Years of Follow-up. Obesity (Silver Spring). First published: 25 November 2018.


Research on the risk of adult-onset asthma
suggests a greater non-genetic factor role

CHICAGO – Genetic risk factors for adult-onset asthma are largely a subset of the genetic risk for childhood-onset asthma but with overall smaller effects, according to a recent study suggesting a greater role for non-genetic risk factors in adult-onset asthma.

The study published in April in The Lancet  indicates that, combined with gene-expression and tissue-enrichment patterns, the establishment of disease in children is driven more by dysregulated allergy and epithelial-barrier function genes, while the cause of adult-onset asthma is more lung-centered and environmentally-determined---but with immune-mediated mechanisms driving disease progression in both children and adults.

Authors of the research include Milton Pividori and Nathan Schoettler, The University of Chicago.

The study, funded by the National Institutes of Health, involved genome-wide and transcriptome-wide studies, using data from the UK Biobank, in individuals with asthma, including adults with childhood-onset asthma (onset before 12-years-of-age), adults with adult-onset asthma (onset between 26-and-65 years of age), and adults without asthma (controls; aged older than 38 years).

The authors conducted genome-wide association studies (GWAS) for childhood-onset asthma and adult-onset asthma, each compared with shared controls, and for age of asthma onset in all asthma cases.

Enrichment studies determined the tissues in which genes at GWAS loci were most highly expressed; PrediXcan, a transcriptome-wide gene-based test, was used to identify candidate-risk genes.

Of 376,358 British white individuals from the UK Biobank, the researchers included 37,846 with self-reports of doctor-diagnosed asthma: 9,433 adults with childhood-onset asthma; 21,564 adults with adult-onset asthma; and an additional 6,849 young adults with asthma with onset between 12-and-25 years of age.

For the first and second GWAS analyses, 318,237 individuals older than 38 without asthma were used as controls. The authors detected 61 independent asthma loci: 23 were childhood-onset specific, one was adult-onset specific, and 37 were shared; 19 loci were associated with age of asthma onset.

CITATION: Milton Pividori, Ph.D., Nathan Schoettler, MD, et. al. Shared and distinct genetic risk factors for childhood-onset and adult-onset asthma: genome-wide and transcriptome-wide studies. The Lancet. Volume 7, Issue 6, P509-522, June 1, 2019. Published: April 26, 2019.


Investigation into HRQOL suggested prior
to fracture in assessment of osteoporosis

KINGSTON, ONTARIO – A study involving data from more than 7,000 subjects provides evidence of substantially-reduced health-related quality of life (HRQOL) in women and men with self-reported and/or bone-mineral density (BMD)-confirmed osteoporosis, even in the absence of fragility fracture.

The study published in May in Osteoporosis International indicates that HRQOL should be thoroughly investigated even prior to fracture in order to develop appropriate interventions for all stages of the disease.

Its authors---including Wilma M. Hopman, Kingston Health Sciences Centre, Kingston, Ontario---noted that fragility fractures have a detrimental effect on HRQOL of osteoporosis patients, and that less is known about the association between HRQOL and osteoporosis in the absence of fracture.

The study included responses to the Canadian Multicentre Osteoporosis Study by participants who completed the SF-36, a detailed health questionnaire. The researchers reported on the results of participants aged 50-and-older, with 10-year follow-up.

Self-reported osteoporosis at baseline and BMD-based osteoporosis at follow-up were ascertained. Multi-variable linear-regression models were developed for baseline SF-36 domains, component summaries, and change over time, adjusting for relevant baseline information.

Baseline data were available for 5,266 women and 2,112 men. Women in the osteoporosis group had substantially lower SF-36 baseline scores, especially in the physically-oriented domains, than those without osteoporosis.

A similar-but-attenuated pattern was evident for men. After 10-year follow-up (2,797 women and 1,023 men), most domain scores dropped for women and men regardless of osteoporosis status, with the exception of mentally-oriented ones. In general, a fragility fracture was associated with lower SF-36 scores and larger declines over time.

CITATION: W.M. Hopman, C. Berger, et. al. Longitudinal assessment of health-related quality of life in osteoporosis: data from the population-based Canadian Multicentre Osteoporosis Study. Osteoporosis International. Pages 1-10. First Online: 08 May 2019.


Joint model for prediction of CKD progression
to ESKD said no better than traditional approach

NIJMEGEN, NETHERLANDS – Recent research indicates that in studies in which outcome is rare and follow-up data highly complete, the joint model for early prediction of chronic kidney disease (CKD) progression to end-stage kidney disease (ESKD) doesn’t offer improvement in predictive performance over more traditional approaches such as a survival model with time-varying estimated glomerular filtration rate (eGFR), or a model with eGFR slope.

Authors of the study published in May in PLOS ONE include Jan A. J. G. van den Brand, Radboud University Medical Center, Nijmegen, Netherlands, and Tjeerd M.H. Dijkstra, University Tubingen, Tubingen, Germany.

Early predictions of CKD progression to ESKD use Cox models including baseline eGFR only. Alternative approaches include a Cox model that includes eGFR slope determined over a baseline period of time, a Cox model with time-varying GFR, or a joint-modeling approach.

All models in the prospective-cohort study included age, sex, eGFR, and albuminuria, known prognostic markers for ESKD.

The researchers trained the models on data on 505 subjects and 55 ESKD events, and determined discrimination and calibration for each model at two years follow-up for a prediction horizon of two years in a test of 1,385 subjects and 72 events.

They benchmarked the predictive performance against the Kidney Failure Risk Equation (KFRE).

The C-statistic for the KFRE was 0.94. Performance was similar for the Cox model with time-varying eGFR, eGFR, and the joint model. The Cox model with eGFR slope showed the best calibration.

The authors recommend a straightforward survival model with GFR slope, estimated from an ordinary least squares (OLS) regression model, when the outcome of interest is rare and follow-up is highly complete.

In these cases, bias due to informative drop-out is unlikely to have a substantial impact on predictive performance. In practice, this means that a physician can use the most recent GFR value (or series of values when calculating a slope eGFR) to fill out a risk calculator.

CITATION: Jan A. J. G. van den Brand, Tjeerd M. H. Dijkstra, et. al. Predicting kidney failure from longitudinal kidney function trajectory: A comparison of models. PLOS ONE. May 9, 2019.


Self-discipline, self-control, management
touted as tools against depression, diabetes

KUWAIT CITY, KUWAIT – Recent research indicates that battling depression in diabetes patients is crucial to control of blood-glucose and metabolic-disorder complications, and that patients can benefit from increased self-discipline, self-control, and disease management.

The study published in May in Diabetes Research and Clinical Practice focuses on the association between fasting during the month of Ramadan---a period of self-discipline, self-control, and spirituality---and depression.

Its authors---including Ebaa Al-Ozairi and Manar M. AlAwadhi, Kuwait University, Safat, Kuwait City, Kuwait---utilized data from 463 participants, which was collected at three time points. A paired t-test was used to examine the difference between PHQ-9 scores and Psychometric Properties of the Problem Areas in Diabetes (PAID) scores before- and-after Ramadan to measure depression.

A multi-variable regression adjusted for potential confounders was used to study the association between fasting and depression.

The difference in PHQ-9 scores before and after Ramadan was -3.5 points, and the difference in PAID scores before-and-after Ramadan was -5.02 points.

For every one-year increase in diabetes diagnosis, PHQ-9 scores decreased by 0.09 after Ramadan. Female participants had decreases of 1.17 more points in PHQ-9 scores than male participants.

CITATION: Ebaa Al-Ozairi, Manar M. AlAwadhi, et. al. A prospective study of the effect of fasting during the month of Ramadan on depression and diabetes distress in people with type 2 diabetes. Diabetes Research and Clinical Practice. Published online: May 17, 2019. Accepted: May 9, 2019. Received: February 14, 2019.


Bone health for kidney-disease patients
is addressed in Clinician Reviews article

An article posted in June in Clinician Reviews takes on the topic of using dual-energy X-ray absorptiometry (DXA) and bisphosphonates in patients with chronic kidney disease (CKD) and end-stage renal disease. Written by Rebecca Grillo, PA-C, RD, LD/N, the piece points out that mineral-and-bone disorder (MBD) is a common complication for kidney-disease patients, and that CKD-MBD is a systemic disorder that encompasses abnormalities in mineral metabolism, skeletal health, and soft-tissue calcifications. The article also reports that, before starting treatment for CKD-associated osteoporosis, regardless of stage, it is important to manage vitamin D deficiency, hyperphosphatemia, and hyperparathyroidism. The story can be accessed at



Vol. 3 No. 42

Role of health-care providers called key
to improving lives of asthmatic children

NAMPA, IDAHO – Research indicating that home-based environmental-control interventions don’t reduce asthma emergency department (ED) re-visits for children with poorly-controlled asthma and second-hand smoke (SHS) exposure doesn’t surprise one asthma expert, who points to special challenges faced by asthmatic children.

Brian K. Bizik, MS, PA-C, physician assistant, Terry Reilly Health Center, Nampa, Idaho, says the study published in January in Pediatric Pulmonology underscores the fact that “asthma is different for children.”

Bizik, past president, Association of PAs in Allergy, Asthma and Immunology, and a faculty member of Cardiovascular, Allergy, & Respiratory Summit (CARPS), says asthma among children “can be severe, and make for bigger challenges.”

He explains that, “for one thing, there are infections: The number-one cause of asthma flare-ups are infections. Children are exposed to these more, at school, and playing with their friends. There is a spike in asthma-related incidents caused by infections early in the school year, in the first two weeks.”

“Children are germ factories,” he continues. “They share toys, and they also have an inability to communicate and describe what they are feeling, that, for instance, they have been wheezing. And inhalers are hard for them to use; there is a learning curve. There are factors that are hard for them to control, like whether their parents smoke.”

And while the study points to the dangers of SHS exposure for asthmatic children, which Bizik says parents are well-aware of, behavior often lags far behind good intentions.

“All the patients I see who smoke say they are quitting,” says Bizik, “and when I see them a year later, they are quitting again. They know, and understand, that SHS isn’t good for their children. While there is awareness, and understanding, it is still very hard for them to quit.”

He adds that health-care practitioners, including physician assistants (PAs) and nurse practitioners (NPs), can play key roles in turning this around.

“The most effective smoking-cessation tool we have,” he says, “is clear communication about what smoking does to patients, and to those around them. If someone comes in for a sprained ankle, we ask about smoking. NPs and PAs are on the front line of urgent care: We have opportunities to tell people they need to stop smoking.”

Bizik praised the study, but cautions that unless health-care professionals are pro-active, its lessons will remain unlearned, let alone acted upon.

The researchers, he notes, “used a very-well thought out plan that included allergy blood tests and treatment, traps for cockroaches and mice as well, as intensive parental education.  Despite this, however, most parents did not stop smoking during the three-year study. The study also showed that when patients over-used their rescue inhalers, the risk of an ED visit increased greatly.  Even with all these well thought-out interventions, this study showed just how difficult it is to change home environments.”,

Bizik stresses that, “in terms of turning this around, we can suggest well-studied interventions like the use of air purifiers and SHS avoidance, but in the end, the best tracking tool we have is the use, and over-use, of rescue inhalers”

He points to the “rule of twos that we try to encourage for our patients. This rule encourages using less than two rescue inhalers in a year, and using a rescue inhaler less than two times per week when not sick. When patients stick to this rule of twos, we know the risk for a visit to the ED is reduced. In the past few years, we have greatly increased our ability to track prescriptions like opiates; we need to move that tracking to asthma rescue inhalers to really make a dent in the ED visits for asthma.”  

Again, education is essential.

“We need to make sure,” he concludes, “that parents realize that asthma is different for children than for adults. Children still die of asthma, even mild asthma. This is a serious, life-threatening disease, nothing to be toyed with. We can make a dent through education and through tracking inhaler use: If an inhaler is used more than twice a week, come in and see me. Maybe there is an infection.”

CITATIONS: Butz AM, Bollinger ME, et. al. Children with poorly controlled asthma: Randomized controlled trial of a home-based environmental control intervention. Pediatric Pulmonology. 2019 Jan. 6.


Assessment of hypertensive population
targets risks of T2D, low blood pressure

PISA, ITALY – Research utilizing a Renal Insufficiency and Cardiovascular Events (RIACE) Italian multi-center study cohort, at variance with the general hypertensive population, indicates that resistant hypertension does not predict death beyond target- organ damage.

Findings in the study published in April in BMC Medicine may be explained by the high mortality risk conferred by type 2 diabetes (T2D) and the low blood-pressure (BP) values observed in controlled-hypertensive patients.

The researchers---including Anna Solini and Giuseppe Penno, University of Pisa, Pisa, Italy---indicate that this may mask risk associated with resistant hypertension, and that less-stringent BP goals may be preferable in high-risk patients with T2D.

The researchers retrieved vital-status information in 2015 for 15,656 of the 15,773 participants enrolled in 2006-to-2008. Based on baseline BP values and treatment, participants were categorized as:
•    normotensive
•    untreated hypertensive
•    controlled hypertensive
•    uncontrolled hypertensive
•    resistant hypertensive

Using the 130/80 mmHg targets for categorization, crude mortality rates and Kaplan–Meier estimates were highest among resistant hypertension participants, especially those with controlled-resistant hypertension.

As compared with resistant hypertension, risk for all-cause mortality was significantly lower for all the other groups, but became progressively similar between resistant-and-controlled hypertension after adjustment for cardiovascular risk factors and complications/comorbidities.

When compared with controlled-resistant hypertension, mortality risk was significantly lower for all the other groups, including controlled hypertension, even after adjusting for cardiovascular risk factors, but not for complications/comorbidities.

In individuals with T2D from the RIACE cohort, resistant hypertension did not predict death beyond the increased burden of target-organ damage characterizing this condition.

In addition, risk of death was higher in individuals with controlled-resistant hypertension than in those with uncontrolled resistant hypertension.

CITATION: Anna Solini, Giuseppe Penno, et. al. Is resistant hypertension an independent predictor of all-cause mortality in individuals with type 2 diabetes? A prospective cohort study. BMC Medicine. Received: 3 November 2018. Accepted: 25 March 2019. Published: 25 April 2019.


Research: Baseline-hypertension status
linked to faster kidney-function decline

BALTIMORE – A study assessing nearly 15,000 subjects indicates that, compared to normotension, baseline-hypertension status is associated with faster kidney-function decline over 30-year follow-up in a general-population cohort.

The study, published in April in the American Journal of Kidney Diseases, also indicates that this difference is attenuated among people using anti-hypertensive medications.
Its authors---including Zhi Yu and Casey M. Rebholz, Johns Hopkins Bloomberg School of Public Health, Baltimore---set out to gauge the relationship between hypertension, anti-hypertension medication use, and change in glomerular filtration rate (GFR) over time among patients with preserved GFR.

Their observational study involved 14,854 participants from the Atherosclerosis Risk in Communities (ARIC) Study.

They noted that baseline-hypertension status (1987-to-1989) was categorized according to the 2017 American College of Cardiology/American Heart Association Clinical Practice Guideline as:
•    normal blood pressure
•    elevated blood pressure
•    stage 1 hypertension
•    stage 2 hypertension without medication
•    stage 2 hypertension with medication

Mixed models with random intercepts and random slopes were fit to evaluate the association between baseline-hypertension status and slope of estimated GFR (eGFR).

At baseline, 13.2%, 7.3%, and 19.4% of whites and 15.8%, 14.9%, and 39.9% of African-Americans had stage 1 hypertension, stage 2 hypertension without medication, and stage 2 hypertension with medication.

Compared with those with normal blood pressure, the annual eGFR decline was greater in people with higher blood pressure.

The 30-year predicted probabilities of developing chronic kidney disease CKD) stage G3a+ with normal blood pressure, elevated blood pressure, stage 1 hypertension, stage 2 hypertension without medication, or stage 2 hypertension with medication among whites were 54.4%, 61.6%, 64.7%, 78.1%, and 70.9%, respectively, and 55.4%, 62.8%, 60.9%, 76.1%, and 66.6% among African Americans.

CITATION: Zhi Yu, Casey M. Rebholz, et. al. Association Between Hypertension and Kidney Function Decline: The Atherosclerosis Risk in Communities (ARIC) Study. American Journal of Kidney Diseases. Published online: April 25, 2019.


An inherited obesity-susceptibility approach
said to offer clinical-prevention opportunities

CAMBRIDGE, MASS. – Recent research indicates that a new approach to quantify inherited susceptibility to obesity offers new opportunities for clinical prevention and mechanistic assessment.

The study published in April in Cell, whose authors include Amit V. Khera and Mark Chaffin, Broad Institute, Cambridge, Mass., indicates that:
•    a genome-wide polygenic score (GPS) can quantify inherited susceptibility to obesity
•    polygenic-score effect on weight emerges early in life and increases into adulthood
•    effect of polygenic score can be similar to a rare, monogenic-obesity mutation
•    high polygenic score is a strong risk factor for severe obesity and associated diseases

The researchers noted that severe obesity is a rapidly-growing global-health threat, and that, while often attributed to unhealthy lifestyle choices or environmental factors, it is known to be heritable and highly polygenic.

Pointing out that most inherited susceptibility is related to the cumulative effect of many common DNA variants, the authors derived and validated a new polygenic predictor comprised of 2.1 million common variants to quantify this susceptibility and tested this predictor in more than 300,000 subjects, ranging from middle age to birth.

Among middle-aged adults, the researchers observed a 13-kg gradient in weight and a 25-fold gradient in risk of severe obesity across polygenic-score deciles.
In a longitudinal-birth cohort, they note minimal differences in birthweight across score deciles; a significant gradient emerged in early childhood and reached 12 kg by 18 years of age.

They also report that a high GPS for weight and obesity can indicate increased risk of:
•    extreme obesity
•    bariatric surgery
•    coronary disease
•    heart failure
•    mortality

The researchers also conclude that a clear understanding of genetic pre-disposition to obesity may help destigmatize obesity among patients, their health-care providers, and the general public.

CITATION: Khera AV, Chaffin M, et. al. Polygenic Prediction of Weight and Obesity Trajectories from Birth to Adulthood. Cell. 2019 Apr 18;177(3):587-596.e9.


Study ties socio-economic, marital status
to likelihood of seeking osteoporosis help

SEOUL, SOUTH KOREA – A recent study involving more than 900 female subjects indicates that people with poor knowledge of osteoporosis and those of lower socio-economic status, including the unmarried with low income levels, are less likely to be assessed and treated for the disease.

The study published in April in Osteoporosis International also indicates that individuals with particular osteoporosis risk factors, including smokers and heavy drinkers, are overlooked for diagnosis.

The researchers---including E. S. Lee, who is affiliated with Ewha Womans University, Seoul, South Korea---recommend further study to identify and address the existing barriers and to promote osteoporosis management for women with these risk factors.

They utilized a nationwide online survey involving 926 Korean women over age 50. Their survey included questions addressing three domains:
•    clinical and socio-demographic characteristics
•    reasons for undergoing or avoiding osteoporosis assessment or treatment
•    knowledge of osteoporosis as measured using the modified Korean version of Facts on Osteoporosis Quiz

The highest-ranked reason for undergoing osteoporosis assessment was fear of osteoporotic fracture, while the highest-ranked reason for avoiding osteoporosis assessment was not feeling a need to get tested.

Participants who sought assessment for osteoporosis were older and more likely to be married, and had greater knowledge of osteoporosis than those who did not seek assessment; the two groups were found to be similar in terms of tobacco use and daily alcohol use.

Patients who had been diagnosed with osteoporosis but either did not initiate or discontinued osteoporosis treatment within one year were younger and had lower levels of annual income than those who began and continued treatment.

CITATION: Y.H. Roh, E.S. Lee, et. al. Factors affecting willingness to get assessed and treated for osteoporosis. Osteoporosis International. First online: 03 April 2019.


Clinician Reviews article details the path
to CMV certification for diabetes patients

An article posted in Clinician Reviews addresses the issue of commercial motor vehicle (CMV) drivers with diabetes. Noting that about one-third of CMV drivers have been diagnosed with the disease, the story, written by Shaun Lynch, MS, MMSc, PA-C, Elon University, N.C., reports that U.S. Department of Transportation (DOT) physical exams are mandated for CMV drivers. Federal regulations permit those with stable insulin regimens and properly-controlled diabetes to qualify to operate CMVs. The article can be accessed at



Vol. 3 No. 41

Nitrogen-bisphosphonate research called
‘great avenue’ for osteoporosis progress

SOUTHBURY, CONN. – Research suggesting that nitrogen bisphosphonate (BP) treatment for osteoporosis improves survival irrespective of fracture-risk prevention has been touted by one osteoporosis expert as “a great avenue for progress.”

The study published in January in Osteoporosis International indicates that nitrogen BPs (alendronate, risedronate) but not non-nitrogen BPs (etidronate) are associated with a significant 34% mortality-risk reduction compared to non-treated propensity-score matched controls.

The assessment---a prospective-cohort study of 6,120 participants, male and female, aged 50-and-older---aimed to determine the association between BPs and mortality-risk in participants with or without fractures.

One notable finding is the fact that, despite the availability of effective medications, osteoporosis-treatment rates continue to be low: Fewer-than-30% of women and less-than-20% of men with fragility fractures use validated pharmaceutical treatments.

Southbury, Conn., resident Rick Pope, (PA-C), Department of Rheumatology, Western Connecticut Medical Group, Danbury, Conn.---founder and past president of the Society of Physician Assistants in Rheumatology (SPAR), and faculty member of the Metabolic & Endocrine Disease Summit (MEDS)---attributes this to patients’ attitudes, misunderstandings of side effects, what they have heard from family and friends, and poor interpretations of available information.

“Many older people who experience fractures think it’s bad luck,” notes Pope, “and that they aren’t going to fracture again, and think “I will be very careful.” Also, they don’t want to take another medication, when they already are taking multiple medications.”

Pope adds that publicity in the early 2000’s tying osteonecrosis of the jaw to BPs “caused a falloff in patients taking these medications,” and that, in 2007 and 2008, patients were reading Internet articles indicating that BPs cause fractures, referred to as atypical femoral fractures.

“You have people reading headlines, but not the actual stories---which may be inaccurate---making it hard to institute therapy and adherence. It’s like what we have now, with the misinformation about vaccinations.”

The question, then is how to turn this around.

The answers, says Pope, lie in studies such as the one in Osteoporosis International, as well as the benefits of Fracture Liaison Services, which aims to reduce fracture risk among fragility-fracture risk patients through identification at point-of-fracture treatments.

“It would be an asset to get the message out,” Pope says. “This study is a good first step. There is a desperate need to see an increase in the use of these BPs, for osteoporosis, as well as to promote their potential beneficial effects on the immune system, anti-tumor effect, and endothelial function, which was referenced in the article.

And as the study indicates that, compared to no treatment, nitrogen but not non-nitrogen BPs appear to be associated with better survival, especially among women, Pope stresses the importance of reaching providers, including physician assistants (PAs) and nurse practitioners (NPs), as well as patients, with this information.

He expects the study to be discussed this year by the National Osteoporosis Foundation (NOF), noting that such research “should promote a decrease in mortality. Prevention is important, and when you can reduce death by 34%, and these are statements we need to be making to our patients, which may move the dial in the right direction and be important motivators for our patients.”

“This study,” Pope says, “combines a number of randomized-control trials to suggest that the use of nitrogen-BPs decrease mortality risk and overall mortality. And I would like to see more research.”

This, he says, would include studies focusing on Forteo (teriparatide, targeting men and post-menopausal women with very low-bone density with fractures caused by steroid medication) and Tymlos (abaloparatide, a daily injectable treatment for severe osteoporosis).

“This kind of information,” he concludes, “is a great avenue for progress.”

CITATION: D. Bliuc, T. Tran, et. al. Mortality risk reduction differs according to bisphosphonate class: a 15-year observational study. Osteoporosis International. First online: 03 January 2019. Received: 19 June 2018. Accepted: 11 December 2018.


Moderate muscle strength is associated
with reduced risk of T2D development

AMES, IOWA – Moderate muscular strength, but not upper muscular strength, is associated with reduced risk of type 2 diabetes (T2D) development, independent of estimated cardio-respiratory fitness (CRF), according to research involving more than 4,600 subjects.

Results of a study published in March in Mayo Clinic Proceedings indicate that very high levels of resistance-exercise (RE) training may not be necessary to obtain the considerable health benefits of T2D prevention.

Its authors---including Yuehan Wang and Duck-chul Lee, Iowa State University, Ames, Iowa---recommend additional observational studies with larger sample size and randomized-controlled trials on dose-response relationship of RE and muscular strength with T2D and related chronic diseases.

A total of 4,681 adults aged 20-to-100 without T2D at baseline were included in the current prospective-cohort study. The participants underwent muscular-strength tests and maximal-treadmill exercise tests between Jan. 1, 1981, and Dec. 31, 2006.

Muscular strength was measured by leg-and-bench press and categorized as age group- and sex-specific thirds (lower, middle, and upper) of the combined-strength score.
T2D was defined on the basis of fasting plasma-glucose levels, insulin therapy, or physician diagnoses.

During a mean follow-up of 8.3 years, 229 of the 4,681 patients developed T2D.
Participants with the middle level of muscular strength had a 32% lower risk of T2D development compared with those with the lower level of muscular strength, after adjusting for potential confounders, including estimated CRF.

No significant association between the upper level of muscular strength and incident T2D was observed.

CITATION: Yuehan Wang, BM, Duck-chul Lee, Ph.D., et. al. Association of Muscular Strength and Incidence of Type 2 Diabetes. Mayo Clinic Proceedings. Published online: March 11, 2019.


Study indicates that CKD patients experience
higher rates of pre-operative cardiac disease

SUZHOU, CHINA – A recent study indicates that chronic kidney disease (CKD) patients show higher occurrences of pre-operative cardiac disease than non-CKD patients.

The study published in March in the Journal of Orthopaedic Surgery and Research also indicates that CKD patients have a higher risk of receiving a blood transfusion and being transferred to intensive care units (ICUs) after hip surgery.

Its authors---including Yongqing You, Nanjing Medical University, Suzhou, China, and Yijian Zhang, The First Affiliated Hospital of Soochow University, Suzhou, China---indicate that pre-operative anemia is an independent-risk factor for obtaining a blood transfusion and, therefore, should be focused on during the perioperative period.

Their study enrolled 230 patients (30 with CKD) who underwent hip surgery between 2013-and-2016. Pre-operative, intra-operative, and post-operative data was collected and analyzed between CKD and non-CKD patients.

Logistic regression was used to evaluate the independent-risk factor for post-operative complications.

There were significant differences in the number of people with hypertension, diabetes, coronary-heart disease, smoking habits, anemia, and low hemoglobin levels between CKD and non-CKD patients before surgery.

Receiving a blood transfusion was significantly more common in CKD patients; post-operatively, significant differences were detected in the average number of patients who transferred to the ICU.

Also, differences were found in the quantity of hemoglobin and albumin measured between CKD and non-CKD patients.

Logistic-regression analysis indicated that diabetes, alcohol, and anemia were independent-risk factors for obtaining a blood transfusion, while age, CKD, and osteoporosis were independent-risk factors for ICU transfers.

CITATION: Yongqing You, Yijian Zhang, et. al. Prevalence and risk factors for perioperative complications of CKD patients undergoing elective hip surgery. Journal of Orthopaedic Surgery and Research. Received: 22 August 2018. Accepted: 6 March 2019. Published: 20 March 2019.


Obesity assessment shows connections
between metabolic issues, CVD chances

BOSTON – A study published in March in the Journal of the American Heart Association showed no evidence that metabolically-unhealthy individuals with obesity are at higher risk of cardio-metabolic disease or cardiovascular disease (CVD) than would be expected given the individual associations of those two risk factors with disease states.

Its authors---including Todd R. Sponholtz, Boston University School of Medicine, Boston, and Edwin R. van den Heuvel, Eindhoven University of Technology Eindhoven, The Netherlands---also found that, compared with obesity, being metabolically-unhealthy appeared to be more strongly associated with CVD risk, with the strength of chronic kidney disease (CKD) associations reported as similar.

Obesity was associated with an increased risk of becoming metabolically-unhealthy.

The researchers also observed evidence that body mass index (BMI) variability is associated with higher risk of cardio-metabolic conditions only among individuals without obesity.

While being metabolically-unhealthy increases the risk of obesity, the authors found little evidence that metabolic-health variability was associated with cardio-metabolic risk.

Metabolic-health variability further increased the risk of CVD among metabolically- unhealthy individuals, while BMI variability did not appear to be associated with CVD or CKD.

BMI variability is detrimental to the metabolic health of community‐dwelling adults without obesity. Metabolic-health variability appears primarily to be associated with CVD risk among metabolically-unhealthy individuals.

The authors assessed data involving 3,632 Framingham Heart Study offspring-cohort participants (mean age, 50.8 years; 53.8% women) who were followed-up from 1987-to- 2014.

They defined participants whose variance independent of the mean for a metabolic syndrome-associated measure was in the top quintile as being “variable” for that measure, and investigated the interaction between obesity and metabolic health in their associations with cardio-metabolic disease and CVD.

The researchers also estimated the associations of BMI variability and variable metabolic health with study outcomes within categories of obesity- and metabolic-health status, respectively.

CITATION: Todd R. Sponholtz, Edwin R. van den Heuvel, et. al. Association of Variability in Body Mass Index and Metabolic Health With Cardiometabolic Disease Risk. Journal of the American Heart Association. Originally published 22 March 2019.


Significant positive association reported
between dietary-acid load, hypertension

TEHRAN, IRAN – Recent research indicates a significant positive association between dietary-acid load and hypertension.

The study published in March in Nutrition, Metabolism, & Cardiovascular Diseases also indicates that further studies, especially those with a prospective nature, are needed to confirm these findings.

Its authors---including Mohammad Parohan and Alireza Sadeghi, Tehran University of Medical Sciences, Tehran, Iran---searched online data-bases for relevant publications up to February, 2019, using relevant keywords.

Overall, 14 studies including 306,183 individuals and 62,264 cases of hypertension were included in the meta-analysis.

Combining effect sizes from both prospective- and cross-sectional studies revealed no significant non-linear association between dietary-acid load (based on net-endogenous acid production [NEAP] method) and hypertension.

However, stratified analysis based on study design showed a significant non-linear association between dietary-acid load and hypertension in prospective studies, but not cross-sectional ones.

According to linear dose-response analysis, no significant association was found between dietary-acid load (based on NEAP) and hypertension. In terms of dietary-acid load based on potential renal-acid load (PRAL) method, no significant non-linear association was seen with hypertension.

However, in linear dose-response analysis, a 20-unit increase in PRAL values was associated with 3% increased risk of hypertension.

CITATION: Mohammad Parohan, Alireza Sadeghi, et. al. Dietary acid load and risk of hypertension: a systematic review and dose-response meta-analysis of observational studies. Nutrition, Metabolism, & Cardiovascular Diseases. Published online: March 23, 2019. Accepted: March 15, 2019. Received in revised form: February 12, 2019. Received: August 5, 2018.


Starting, stopping dialysis addressed
in pair of Clinician Reviews postings

Two recent Clinician Reviews postings address dialysis---both when to start, and when to stop. Tricia Howard, MHS, PA-C, DFAAPA, Georgia Regional Medical Team, Savannah, Ga., replying to a question about beginning dialysis, notes there is no compelling evidence that dialysis initiation based solely on kidney-function measurement improves outcomes, and adds that age and fragility must be considered. Marlene Shaw-Gallagher, PA-C, Michigan Medicine, Ann Arbor, Mich., answering a query about ending dialysis, explains that the prospect of discontinuing dialysis with a diagnosis of end-stage renal disease (ESRD) is very low. She adds that a patient’s underlying etiology influences the chances of recovery, and that those with acute kidney injuries (AKIs) tend to have the best chance. The postings can be accessed at: ;



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