Weight-Loss Therapy in Type 2 Diabetes: Effects of Phentermine and Topiramate Extended Release
Weight-Loss Therapy in Type 2 Diabetes: Effects of Phentermine and Topiramate Extended Release
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DOI：
10.2337/dc14-0930
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发表时间：
2014-12-01
期刊：
影响因子：
16.2
通讯作者：
Troupin, Barbara
中科院分区：
文献类型：
--
作者：
Garvey, W. Timothy;Ryan, Donna H.;Troupin, Barbara
2型糖尿病的治疗算法建议减肥用于疾病管理。在两个随机、双盲、研究设计和方法OB-202/DM-230研究是一项56周的肥胖/超重成人2型糖尿病安慰剂对照研究。2周2期试验，随机受试者接受每日一次安慰剂或PHEN/TPMER 15 mg/92 mg（15/92）。主要终点是HbA（1c）水平的变化。还介绍了第二项研究CONQUER中2型糖尿病亚群的事后分析。所有受试者进行生活方式的改变，合并症的管理标准的care.Results的研究组包括130名受试者与2型糖尿病入组的OB-202/DM-230研究（平均基线HbA（1c）8.7%[72 mmol/mol]）和388名受试者与2型糖尿病在CONQUER研究（平均基线HbA1c 6.8%[51 mmol/mol]）。在OB-202/DM-230研究中，第56周时，安慰剂组体重变化（相对于末次观察值结转的意向治疗样本[ITT-LOCF]）为-22.7%，PHEN/TPM ER 15/92组为-9.4%（与安慰剂相比，P <0.0001）。安慰剂组和PHEN/TPM ER 15/92组的HbA（1c）水平变化（ITT-LOCF）分别为21.2%（-13.1 mmol/mol）和-1.6%（-17.5 mmol/mol）（P = 0.0381）。在OB-202/DM-230和CONQUER中，与安慰剂组相比，更多随机接受PHEN/TPM ER治疗的患者达到了HbA（1c）目标，同时减少了对糖尿病药物的需求。常见的不良事件包括感觉异常、便秘和失眠。结论PHEN/TPM ER加生活方式改变可以有效促进体重减轻并改善血糖控制，作为肥胖/超重2型糖尿病患者的治疗方法。
Treatment algorithms for type 2 diabetes recommend weight loss for disease management. The safety and efficacy of treatment with phentermine (PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized, double-blind, placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes.RESEARCH DESIGN AND METHODS The OB-202/DM-230 Study was a 56-week phase 2 trial that randomized subjects to receive once-daily placebo or PHEN/TPMER 15 mg/92 mg (15/92). The primary end point was change in HbA(1c) level. A post hoc analysis of a subpopulation with type 2 diabetes from a second study, CONQUER, is also presented. All subjects made lifestyle modifications, and comorbidities were managed to the standard of care.RESULTS The study groups comprised 130 subjects with type 2 diabetes enrolled in the OB-202/DM-230 Study (mean baseline HbA(1c) 8.7% [72 mmol/mol]) and 388 subjects with type 2 diabetes in the CONQUER Study (mean baseline HbA1c 6.8% [51 mmol/mol]). At week 56 in the OB-202/DM-230, change in weight (from intent-to-treat sample with last observation carried forward [ITT-LOCF]) was - 22.7% for placebo and -9.4% for PHEN/TPM ER 15/92 (P < 0.0001 vs. placebo). Change in HbA(1c) level (from ITT-LOCF) was 21.2% (-13.1 mmol/mol) for placebo and -1.6% (-17.5 mmol/mol) for PHEN/TPM ER 15/92 (P = 0.0381). In both the OB-202/DM-230 and CONQUER, greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved HbA(1c) targets with reduced need for diabetic medications when compared with the placebo group. Common adverse events included paraesthesia, constipation, and insomnia.CONCLUSIONS PHEN/TPM ER plus lifestyle modification can effectively promote weight loss and improve glycemic control as a treatment approach in obese/overweight patients with type 2 diabetes.