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首页> 美国卫生研究院文献>The American Journal of Clinical Nutrition >Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized placebo-controlled phase 3 extension study
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Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized placebo-controlled phase 3 extension study

机译：肥胖和超重成年人（SEQUEL）中的芬特明/托吡酯控释可维持两年的持续减肥和代谢益处（一项随机安慰剂对照3期扩展研究）

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>Background: Obesity is a serious chronic disease. Controlled-release phentermine/topiramate (PHEN/TPM CR), as an adjunct to lifestyle modification, has previously shown significant weight loss compared with placebo in a 56-wk study in overweight and obese subjects with ≥2 weight-related comorbidities.>Objective: This study evaluated the long-term efficacy and safety of PHEN/TPM CR in overweight and obese subjects with cardiometabolic disease.>Design: This was a placebo-controlled, double-blind, 52-wk extension study; volunteers at selected sites continued with original randomly assigned treatment [placebo, 7.5 mg phentermine/46 mg controlled-release topiramate (7.5/46), or 15 mg phentermine/92 mg controlled-release topiramate (15/92)] to complete a total of 108 wk. All subjects participated in a lifestyle-modification program.>Results: Of 866 eligible subjects, 676 (78%) elected to continue in the extension. Overall, 84.0% of subjects completed the study, with similar completion rates between treatment groups. At week 108, PHEN/TPM CR was associated with significant, sustained weight loss (intent-to-treat with last observation carried forward; P < 0.0001 compared with placebo); least-squares mean percentage changes from baseline in body weight were –1.8%, –9.3%, and –10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more PHEN/TPM CR–treated subjects at each dose achieved ≥5%, ≥10%, ≥15%, and ≥20% weight loss compared with placebo (P < 0.001). PHEN/TPM CR improved cardiovascular and metabolic variables and decreased rates of incident diabetes in comparison with placebo. PHEN/TPM CR was well tolerated over 108 wk, with reduced rates of adverse events occurring between weeks 56 and 108 compared with rates between weeks 0 and 56.>Conclusion: PHEN/TPM CR in conjunction with lifestyle modification may provide a well-tolerated and effective option for the sustained treatment of obesity complicated by cardiometabolic disease. This trial was registered at as .
机译：>背景：肥胖是一种严重的慢性疾病。在56周的超重和肥胖受试者中，体重≥2的合并症患者中，控释芬特明/托吡酯（PHEN / TPM CR）作为改善生活方式的辅助手段，与安慰剂相比，先前显示出明显的体重减轻。 >目的：本研究评估了PHEN / TPM CR在超重和肥胖的心脏代谢疾病中的长期疗效和安全性。>设计：这是安慰剂对照的双盲疗法，52周扩展研究；选定地点的志愿者继续接受最初随机分配的治疗[安慰剂，7.5 mg苯丁胺/ 46 mg控释托吡酯（7.5 / 46）或15 mg苯丁胺/ 92 mg控释托吡酯（15/92）]，以完成总的108周。所有受试者都参加了改变生活方式的项目。>结果：在866名合格受试者中，有676名（78％）选择继续进行这项扩展。总体而言，有84.0％的受试者完成了研究，治疗组之间的完成率相似。在第108周时，PHEN / TPM CR与持续的显着体重减轻有关（打算进行治疗，最后观察到的结果；与安慰剂相比P <0.0001）；安慰剂，7.5 / 46和15/92的相对于基线的最小二乘平均体重百分比变化分别为–1.8％，– 9.3％和–10.5％。与安慰剂相比，每种剂量的PHEN / TPM CR治疗的受试者体重减轻≥5％，≥10％，≥15％和≥20％（P <0.001）。与安慰剂相比，PHEN / TPM CR改善了心血管和代谢变量，并降低了糖尿病的发病率。 PHEN / TPM CR在108周内具有良好的耐受性，与第0周至第56周相比，在第56周至第108周发生不良事件的比率有所降低。>结论： PHEN / TPM CR与生活方式的改变相结合可以为持续性肥胖并发心脏代谢疾病的持续治疗提供良好耐受的有效选择。该审判的注册地址为。

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