The Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.
JAMA Intern Med. 2014 Apr;174(4):615-9. doi: 10.1001/jamainternmed.2013.14629.
In 2012, the US Food and Drug Administration approved 2 drugs for long-term weight loss: lorcaserin hydrochloride (Belviq; Eisai Inc) and phentermine-topiramate (Qysmia; Vivus Inc). The approvals were based on 1-year trials showing that on top of recommendations to follow a calorie-restricted diet and to increase exercise, patients randomized to either drug lost more weight than patients randomized to placebo (3% [95% CI, 3%-4%] more weight lost with lorcaserin; 7% [95% CI, 3%-4%] more with phentermine /topiramate). The drugs have been associated with serious harms: Both drugs' labels include warnings about memory, attention, or language problems and depression; for lorcaserin, the label also warns of valvular heart disease and euphoria; and for phentermine-topiramate, the label warns of metabolic acidosis, increased heart rate, anxiety, insomnia, and elevated creatinine levels. Neither medication is marketed in Europe because of safety concerns. The manufacturer withdrew its application for lorcaserin in Europe after the European Medicines Agency (EMA) said approval was unlikely, and the EMA rejected phentermine-topiramate. In the United States, the required postmarketing safety trials are behind schedule. Until there is more convincing evidence about the cardiovascular safety of these drugs, physicians and patients should approach them cautiously. Patients who do not lose at least 5% of their body weight within 12 weeks of starting to take either drug should stop taking it, as stated in the prescribing information.
2012 年，美国食品和药物管理局批准了两种用于长期减肥的药物：盐酸氯卡色林（Belviq；卫材公司）和 phentermine-topiramate（Qysmia；Vivus 公司）。这些批准是基于为期 1 年的试验结果，表明在遵循低热量饮食和增加运动的建议的基础上，随机接受任何一种药物治疗的患者比随机接受安慰剂的患者体重减轻更多（lorcaserin 组患者体重减轻 3%[95%CI，3%-4%]；phentermine-topiramate 组患者体重减轻 7%[95%CI，3%-4%]）。这些药物与严重危害有关：这两种药物的标签都包含有关记忆、注意力或语言问题和抑郁的警告；对于 lorcaserin，标签还警告可能出现心脏瓣膜疾病和欣快感；对于 phentermine-topiramate，标签警告可能出现代谢性酸中毒、心率增加、焦虑、失眠和肌酐水平升高。由于安全性问题，这两种药物均未在欧洲上市。由于安全性问题，在欧洲药品管理局（EMA）表示不太可能批准后，制造商撤回了 lorcaserin 在欧洲的申请，EMA 也拒绝了 phentermine-topiramate。在美国，上市后安全性试验的进度落后。在有更令人信服的证据表明这些药物的心血管安全性之前，医生和患者都应谨慎使用这些药物。根据说明书，开始服用这两种药物后 12 周内体重没有至少减轻 5%的患者应停止服用。
