When workplace wellness plans integrate access to antiobesity medications (AOMs) along with a weight management program (WMP), individuals with obesity had better and sustained weight loss compared with those undertaking a WMP alone, according to a study from the Cleveland Clinic and published in JAMA Network Open.
In fact, by adhering to the WMP plus AOM (WMP+Rx), more than half of the individuals in the study were able to achieve at least 5% weight loss, which Kevin M. Pantalone, DO, from the Cleveland Clinic’s Endocrinology and Metabolism Institute in Cleveland, Ohio, and colleagues, noted is “a benchmark associated with clinically meaningful improvement in certain obesity-related comorbid conditions. These clinical benefits were observed without unexpected safety concerns.”
Overall, those in the WMP+Rx group had nearly double the weight loss at 12 months compared with those in the WMP only group, −7.7% versus −4.2% respectively.
“The results of this pragmatic [randomized controlled trial] (RCT), which reflected real-world medical practice in the workforce, indicate that the use of AOMs in conjunction with an interdisciplinary wellness program for obesity management yields clinical benefits similar to those seen in RCTs,” Pantalone and colleagues wrote. “Such results should inform employer decisions regarding employee access to these medications and guide the development of best practices for comprehensive employer-based interdisciplinary weight management programs.”
In their open-label, parallel-group, real world RCT, conducted at the Cleveland Clinic’s Endocrinology and Metabolism Institute in Ohio, 200 participants with a mean weight of 105 kg (just over 231 lbs), and a mean BMI of 38.9 were randomized to either the WMP+RX group or to WMP alone.
For those who received AOMs, the medications were one of the following—orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, or liraglutide, 3.0 mg—all of which are FDA approved for weight management.
Most of the participants in the study were women, and nearly 90% had three or more comorbid conditions, including dyslipidemia, hypertension, depression, anxiety, osteoarthritis, and prediabetes. In the WMP+Rx group, most participants were White; in the WMP group, 66% were White and 33% were Black. All were enrolled in the Cleveland Clinic Employee Health plan.
“Although data showing the clinical efficacy of AOMs are robust, data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by U.S. private employers is limited,” Pantalone and colleagues wrote. “Unlike other chronic diseases, employers must opt in to include AOMs in employee health care, even when AOMs are on formulary.”
Thus, the intent of their study was to see the effect that access to AOMs had on weight loss, with a primary endpoint of percentage change from baseline to 12 months. Secondary endpoints included the percentage of participants achieving at least a 5% and 10% weight loss from baseline at 12 months, the number of shared medical appointments attended during the study, the proportion of days covered (PDC) by AOM for those in the WMP+RX group only, plus the change from baseline to 12 months in the following: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem v2.0 (WPAI:SHP v 2.0) 4 domain scores (absenteeism, presenteeism, work productivity loss, and activity impairment), the Work Limitations Questionnaire 8-item (WLQ-8) 4 domain scales, and the overall WLQ-8 index. The WLQ-8 looked at the amount of time having excess weight made tasks such as time management, physical tasks, mental or interpersonal tasks, or output tasks difficult.
Overall, looking that the primary endpoint, “the estimated mean (SE) weight loss was −7.7% (0.7%) for the WMP+Rx group versus −4.2% (0.7%) for the WMP group, with an estimated treatment difference of −3.5% (95% CI, −5.5%to −1.5%; P<0.001),” Pantalone and colleagues reported.
“The mean (SE) weight loss per the secondary (efficacy) estimand was −9.2% (0.6%) for WMP+Rx versus −4.1% (0.6%) for WMP, for an [estimated treatment difference] ETD of −5.0% (95% CI, −6.7% to −3.4%) (P<0.001). For the analysis of data from completers, the mean (SE) weight loss was −10.6% (1.0%) for WMP+Rx versus −5.4% (0.9%) for WMP, for an ETD of −5.2% (95% CI, −8.0% to −2.4%) (P<0.001).”
For the secondary endpoints, the study authors noted that 62.5% of those in the WMP+Rx group achieved at least a 5% weight loss, compared with 44.8% of those in the WMP (P=0.02), and 34.3% in the WMP+Rx group achieved at least a 10% weight loss, compared with 16.7% in the WMP group.
More participants in the WMP+Rx arm attended the 12 SMPs — 9.7 visits compared with 7.4 in the WMP arm.
“Potential hypotheses for [the difference in attendance to the SMPs] include the positive motivation participants had with increased weight loss and the continued monthly prescribing of AOMs associated with SMA attendance, “Pantalone and colleagues reported. “This observation has clinical implications because SMA adherence is associated with greater weight loss, and a correlation has been observed between the number of SMAs attended and the magnitude of weight lost. Access to AOMs may increase the potential benefits of other interventions, long-term lifestyle changes, and maintenance of weight loss. However, maintenance of weight loss may diminish without long-term AOM use.”
Notably, Pantalone and colleagues reported that less than half (43%) of the participants in the WMP+Rx were adherent to taking the AOMs. “However, adherence was based on pharmacy fills rather than on actual use, and this approach may underestimate adherence to AOMs, especially for medications requiring titration, with participants potentially taking lower doses than prescribed,” Pantalone and colleagues noted. “Although there is not a measure consistently used in RCTs that is comparable to standard real-world measures of adherence, completion rates in most weight loss RCTs range from 50% to 70%.”
The study authors noted that their study was not powered to assess changes in workplace productivity, but noted it was minimal and the difference between the two arms was not meaningful.
Limitations of the study included its size, which was not conducive to subgroup assessment, response to individual medications, or heterogeneity of effect. They also noted that when the SMAs shifted to virtual meetings because of Covid-19, some data were missing, and weight was self-reported. Also, being a single-center study is among the limitations, especially given that the study population was mostly women.
-
When workplace wellness plans integrate access to antiobesity medications (AOMs) along with a weight management program (WMP) individuals with obesity had better and sustained weight loss compared with those undertaking a WMP alone.
-
With a weight management program plus AOM (WMP+Rx), more than half of the participants in the study were able to achieve at least a 5% weight loss.
Candace Hoffmann, Managing Editor, BreakingMED™
Pantalone reported receiving personal fees from AstraZeneca, Bayer, Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co, Novo Nordisk, and Sanofi; and research support from Bayer, Merck & Co, and Novo Nordisk.
Cat ID: 795
Topic ID: 76,795,730,795,518,917
