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.
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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DOI：
10.3945/ajcn.111.024927
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发表时间：
2012-02
期刊：
影响因子：
--
通讯作者：
Bowden CH
中科院分区：
文献类型：
--
作者：
Garvey WT;Ryan DH;Look M;Gadde KM;Allison DB;Peterson CA;Schwiers M;Day WW;Bowden CH
背景：肥胖是一种严重的慢性疾病。控释芬特明/托吡酯（PHEN/TPM CR），作为生活方式改变的辅助治疗，在一项56周的研究中，与安慰剂相比，在超重和肥胖受试者中有≥2种体重相关的合并症，显示出显著的体重减轻。目的：本研究评价PHEN/TPM CR治疗超重和肥胖心脏代谢疾病患者的长期疗效和安全性。设计图：这是一项安慰剂对照、双盲、52周的扩展研究;选定研究中心的志愿者继续接受最初随机分配的治疗[安慰剂、7.5 mg芬特明/46 mg托吡酯控释片（7.5/46）或15 mg芬特明/92 mg托吡酯控释片（15/92）]，共完成108周。所有受试者都参加了生活方式改变计划。结果：在866例合格受试者中，676例（78%）选择继续参加扩展期。总体而言，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，PHEN/TPM CR与显著、持续的体重减轻相关（意向治疗与末次观察值结转;与安慰剂相比P < 0.0001）;安慰剂组、7.5/46组和15/92组体重较基线的最小二乘平均百分比变化分别为-1.8%、-9.3%和-10.5%。与安慰剂相比，每种剂量下接受PHEN/TPM CR治疗的受试者中体重减轻≥ 5%、≥ 10%、≥ 15%和≥20%的受试者明显更多（P < 0.001）。与安慰剂相比，PHEN/TPM CR改善了心血管和代谢变量，降低了糖尿病发病率。PHEN/TPM CR在108周内耐受良好，与0周和56周之间的发生率相比，56周和108周之间的不良事件发生率降低。结论：PHEN/TPM CR联合生活方式改变可能为肥胖合并心脏代谢疾病的持续治疗提供耐受性良好且有效的选择。本试验在clinicaltrials.gov上注册为NCT 00796367。
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 clinicaltrials.gov as NCT00796367.
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影响因子：
120.7
作者：
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