Clinical trial was conducted in the real-world setting of a workplace health plan
Tuesday, July 20, 2021, CLEVELAND: A Cleveland Clinic study demonstrates that adults with obesity lost significantly more weight when they had access to medications for chronic weight management in conjunction with their employer-based weight management program, compared to adults who did not have access to the medications. The study was published in JAMA Network Open.
Obesity is a complex disease that is caused by multiple factors, including genetic, environmental, and biological. A lifestyle intervention with a focus on nutrition and exercise is often not enough to treat obesity, which is a chronic disease that requires long-term therapy. The U.S. Food and Drug Administration (FDA) has approved several prescription medications for weight loss and chronic weight management, also called anti-obesity medications. However, they have limited health insurance coverage.
“The research results support the need to treat patients with a multidisciplinary weight management program that incorporates safe and effective medications to lose weight and maintain weight loss,” said Bartolome Burguera, M.D., Ph.D., chair of Cleveland Clinic’s Endocrinology & Metabolism Institute and primary investigator of the study. “Doctors prescribe medications to treat some of the health consequences associated with obesity, such as hypertension and type 2 diabetes. However, medications for weight loss and chronic weight management are underutilized.”
The Centers for Disease Control and Prevention (CDC) reported that more than 42% of U.S. adults have obesity. In addition to the serious health conditions associated with obesity – such as type 2 diabetes, obstructive sleep apnea, high-blood pressure, heart disease and stroke – the CDC also reported the economic impact of obesity on the U.S. healthcare system. The estimated medical care costs of the disease in the United States represented $147 billion (in 2008 dollars).
The objective of this study was to determine the effect of combining anti-obesity medications with a multidisciplinary employer-based weight management program.
The one-year, single-center, pragmatic clinical trial was conducted in the real-world setting of a workplace health plan. The study included 200 adults with obesity (body mass index of 30 or greater) who were enrolled in the Cleveland Clinic Employee Health Plan between January 2019 and May 2020. As part of the health plan, participants had access to a comprehensive weight management program.
In this real-world setting, eligible participants were randomized 1:1 to either a weight management program with FDA-approved anti-obesity medications or a weight management program alone. The weight management program was administered through monthly shared medical appointments (SMAs) that offered a multidisciplinary approach, including nutrition education. The monthly SMA visits focused on adopting a healthier lifestyle and addressed the five components of the weight management program: nutrition, physical activity, appetite control, sleep, and mental health. Due to the COVID-19 pandemic, some of the SMAs were conducted virtually.
The 100 study participants, randomized to the weight management program combined with access to the medications, received their prescriptions at the time of their monthly SMAs, based on recommended clinical practice.
Patients were prescribed one of five FDA-approved medications for chronic weight management – orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, liraglutide 3.0 mg. The medication selected for each patient was at the discretion of the treating provider, and was determined after a thorough assessment and discussion with the participants. (Lorcaserin was withdrawn from the market in February 2020. The eight patients taking lorcaserin at the time were notified immediately and either switched medications or discontinued medication due to proximity to the end of the study.)
Research results showed that the participants who had access to the anti-obesity medications averaged significantly greater weight loss at 12 months (-7.7%), compared to the participants who were in the weight management program alone (-4.2%). In the group who had access to the medications, 62.5% of the participants lost at least 5% of their weight, compared to 44.8% of the participants in the group with the weight management program alone. SMA attendance was higher among the participants who had access to the weight loss medications.
“Many patients see improvement in their health when they lose 5% of their weight,” said Kevin M. Pantalone, D.O., first author of the study and an endocrinologist at Cleveland Clinic. “Based on our study results, access to anti-obesity medications combined with a multidisciplinary weight management program provides a more effective treatment compared to a weight management program without access to these medications.”
More long-term research is needed in real-world, employer-based settings to evaluate the costs and benefits of anti-obesity medications and their use in conjunction with workplace wellness plans.
This study was funded by Novo Nordisk. Representatives of Novo Nordisk (the sponsor) were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript. Dr. Burguera reported receiving consulting honorarium as a member of the U.S. National Expert Panel for the SELECT trial, a steering committee member for the study being reported, and research support from Novo Nordisk. Dr. Pantalone reported receiving consulting and speaking honorarium, as well as research support from Novo Nordisk, and currently serves as the principal investigator at Cleveland Clinic for the Novo Nordisk sponsored SOUL trial.
About Cleveland Clinic
Cleveland Clinic – now in its centennial year – is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 70,800 employees worldwide are more than 4,660 salaried physicians and researchers, and 18,500 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 19 hospitals, more than 220 outpatient facilities, and locations in southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2020, there were 8.7 million total outpatient visits, 273,000 hospital admissions and observations, and 217,000 surgical cases throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.
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