Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, Ohio.
Novo Nordisk Inc, Plainsboro, New Jersey.
JAMA Netw Open. 2021 Jul 1;4(7):e2116595. doi: 10.1001/jamanetworkopen.2021.16595.
The clinical efficacy of antiobesity medications (AOMs) as adjuncts to lifestyle intervention is well characterized, but data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by US private employers is limited.
To determine the effect of combining AOMs with a comprehensive, interdisciplinary, employer-based weight management program (WMP) compared with the WMP alone on weight loss, treatment adherence, and work productivity and limitations.
DESIGN, SETTING, AND PARTICIPANTS: This 1-year, single-center, open-label, parallel-group, real-world, randomized clinical trial was conducted at the Cleveland Clinic's Endocrinology and Metabolism Institute in Cleveland, Ohio, from January 7, 2019, to May 22, 2020. Participants were adults with obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥30) enrolled in the Cleveland Clinic Employee Health Plan.
In total, 200 participants were randomized 1:1, 100 participants to WMP combined with an AOM (WMP+Rx), and 100 participants to WMP alone. The WMP was the Cleveland Clinic Endocrinology and Metabolism Institute's employer-based integrated medical WMP implemented through monthly multidisciplinary shared medical appointments. Participants in the WMP+Rx group initiated treatment with 1 of 5 US Food and Drug Administration-approved medications for chronic weight management (orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide, 3.0 mg) according to standard clinical practice.
The primary end point was the percentage change in body weight from baseline to month 12.
The 200 participants were predominately (177 of 200 [88.5%]) women, had a mean (SD) age of 50.0 (10.3) years, and a mean (SD) baseline weight of 105.0 (19.0) kg. For the primary intention-to-treat estimand, the estimated mean (SE) weight loss was -7.7% (0.7%) for the WMP+Rx group vs -4.2% (0.7%) for the WMP group, with an estimated treatment difference of -3.5% (95% CI, -5.5% to -1.5%) (P < .001). The estimated percentage of participants achieving at least 5% weight loss was 62.5% for WMP+Rx vs 44.8% for WMP (P = .02). The rate of attendance at shared medical appointments was higher for the WMP+Rx group than for the WMP group. No meaningful differences in patient-reported work productivity or limitation measures were observed.
Clinically meaningful superior mean weight loss was achieved when access to AOMs was provided in the real-world setting of an employer-based WMP, compared with the WMP alone. Such results may inform employer decisions regarding AOM coverage and guide best practices for comprehensive, interdisciplinary employer-based WMPs.
ClinicalTrials.gov Identifier: NCT03799198.
抗肥胖药物（AOM）作为生活方式干预的辅助手段的临床疗效已得到充分证实，但关于它们与工作场所健康计划一起使用的数据却很少，而且美国私人雇主对 AOM 的覆盖范围有限。
确定将 AOM 与全面的、跨学科的、基于雇主的体重管理计划（WMP）联合使用与单独使用 WMP 相比，在体重减轻、治疗依从性以及工作生产力和限制方面的效果。
设计、设置和参与者：这是一项为期 1 年、单中心、开放性、平行组、真实世界、随机临床试验，在俄亥俄州克利夫兰的克利夫兰诊所内分泌和代谢研究所进行，时间为 2019 年 1 月 7 日至 2020 年 5 月 22 日。参与者为参加克利夫兰诊所员工健康计划的肥胖成年人（体重指数[BMI；计算为体重以千克为单位除以身高以米为单位的平方]≥30）。
共有 200 名参与者被随机分为 1:1 组，100 名参与者被分配到 WMP 联合 AOM（WMP+Rx）组，100 名参与者被分配到 WMP 组。WMP 是克利夫兰诊所内分泌和代谢研究所的基于雇主的综合医疗 WMP，通过每月的多学科共享医疗预约实施。WMP+Rx 组的参与者根据标准临床实践开始使用 5 种美国食品和药物管理局批准的用于慢性体重管理的药物之一（奥利司他、lorcaserin、苯丁胺/托吡酯、纳曲酮/安非他酮和利拉鲁肽，3.0 毫克）进行治疗。
主要终点是从基线到第 12 个月时体重的百分比变化。
200 名参与者主要为（200 名中的 177 名[88.5%]）女性，平均（SD）年龄为 50.0（10.3）岁，平均（SD）基线体重为 105.0（19.0）kg。对于主要的意向治疗估计值，WMP+Rx 组的估计平均（SE）体重减轻为-7.7%（0.7%），WMP 组为-4.2%（0.7%），治疗差异估计为-3.5%（95%CI，-5.5%至-1.5%）（P < .001）。WMP+Rx 组至少减轻 5%体重的参与者比例估计为 62.5%，而 WMP 组为 44.8%（P = .02）。参加共享医疗预约的比例 WMP+Rx 组高于 WMP 组。在患者报告的工作生产力或限制方面没有观察到有意义的差异。
与单独使用 WMP 相比，在基于雇主的 WMP 的真实环境中提供 AOM 时，可实现更有临床意义的平均体重减轻。这些结果可能为雇主关于 AOM 覆盖范围的决策提供信息，并指导全面的、跨学科的基于雇主的 WMP 的最佳实践。
ClinicalTrials.gov 标识符：NCT03799198。
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