Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).
Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).
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DOI：
10.1038/oby.2011.330
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发表时间：
2012-02
期刊：
影响因子：
6.9
通讯作者：
Day, Wesley W.
中科院分区：
文献类型：
--
作者：
Allison, David B.;Gadde, Kishore M.;Garvey, William Timothy;Peterson, Craig A.;Schwiers, Michael L.;Najarian, Thomas;Tam, Peter Y.;Troupin, Barbara;Day, Wesley W.
进行了一项为期56周的随机对照试验，以评估芬特明和托吡酯控释组合（PHEN/TPM CR）用于减肥（WL）和代谢改善的安全性和有效性。II级和III级肥胖（BMI ≥ 35 kg/m2）的男性和女性被随机分配到安慰剂组、PHEN/TPM CR 3.75/23 mg组或PHEN/TPM CR 15/92 mg组，并添加到低能量饮食中。主要终点是WL百分比和达到5% WL的患者比例。次要终点包括腰围（WC）、收缩压和舒张压（BP）、空腹血糖和血脂指标。在主要分析中（至少有一次基线后体重测量的随机化患者，至少服用一剂分配的药物或安慰剂），安慰剂组、3.75/23和15/92组的患者在第56周分别减轻了基线体重（BW）的1.6%、5.1%和10.9%（P < 0.0001）。在分类分析中，17.3%的安慰剂组患者、44.9%的3.75/23例患者和66.7%的15/92例患者在第56周时体重至少下降5%（P < 0.0001）。与安慰剂组相比，15/92组的WC、收缩压和舒张压、空腹血糖、甘油三酯、总胆固醇、低密度脂蛋白（LDL）和高密度脂蛋白（HDL）的变化显著更大。最常见的不良事件是感觉异常、口干、便秘、味觉障碍和失眠。安慰剂组患者的研究脱落率为47.1%，23例患者中的3.75例为39.0%，92例患者中的15例为33.6%。PHEN/TPM CR对体重和代谢变量表现出剂量依赖性作用，预期有益，没有证据表明治疗诱导了严重不良事件。
A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m2) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks (P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.
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影响因子：
120.7
作者：
Flegal, Katherine M.;Carroll, Margaret D.;Curtin, Lester R.
通讯作者：
Curtin, Lester R.
DOI：
10.1038/oby.2003.78
发表时间：
2003-04-01
期刊：
OBESITY RESEARCH
影响因子：
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作者：
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通讯作者：
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影响因子：
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作者：
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通讯作者：
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影响因子：
120.7
作者：
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通讯作者：
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DOI：
10.1046/j.1467-789x.2000.00004.x
发表时间：
2000-05-01
期刊：
Obesity reviews : an official journal of the International Association for the Study of Obesity
影响因子：
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作者：
Astrup, A;Rossner, S
通讯作者：
Rossner, S