Kelly Elizabeth M, Tungol Alexandra A, Wesolowicz Laurie A
Blue Cross Blue Shield of Michigan/University of Michigan Health Systems, 600 E. Lafayette, Mail Code 512C, Detroit, MI 48226., USA E-mail:
J Manag Care Pharm. 2013 Oct;19(8):642-54. doi: 10.18553/jmcp.2013.19.8.642.
Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities.
To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result.
A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website.
5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate.
Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed.
肥胖可能导致多种慢性疾病状态的发展，包括高血压、血脂异常和2型糖尿病。全球超过5亿成年人受肥胖影响，在美国，超过三分之二的成年人肥胖或超重。饮食和运动一直是该人群的主要治疗方法；然而，一旦失败，缺乏非侵入性、长期有效的治疗方式，药物可能填补这一空白。氯卡色林和苯丁胺/托吡酯分别于2012年6月和7月被美国食品药品监督管理局（FDA）批准，作为饮食和运动的辅助手段，用于对伴有合并症的肥胖（体重指数[BMI]≥30kg/m²）或超重（BMI≥27kg/m²）个体进行慢性体重管理。
回顾氯卡色林和苯丁胺/托吡酯的3期试验，并给出由此可能需要考虑的管理式医疗方面的因素。
利用关键词“氯卡色林”或“苯丁胺/托吡酯”，对截至2012年9月17日发表并可获取的文章进行MEDLINE检索，重点关注3期试验。文献检索限于以英文发表的人体随机对照试验。从FDA网站获取了来自其对氯卡色林审评的更多信息。
确定了5项关键的3期试验：3项针对氯卡色林，2项针对苯丁胺/托吡酯。与安慰剂相比，两种药物在体重减轻≥5%的个体比例上均显示出统计学上的显著更高比例，以及更高的平均体重减轻。氯卡色林的安全问题包括心脏瓣膜病以及精神、认知和血清素能不良反应风险增加。致畸性和心率增加是苯丁胺/托吡酯的主要安全问题。
医疗保健决策者在制定对抗肥胖的策略时需要考虑许多因素。尽管非常需要新的肥胖治疗方法，但用于减肥的药物有显著的副作用和禁忌证，可能会限制治疗。需要一种合适的利用管理策略。
