Nuffer Wesley, Trujillo Jennifer M, Megyeri Jade
University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA
University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
Ann Pharmacother. 2016 May;50(5):376-88. doi: 10.1177/1060028016634351. Epub 2016 Feb 17.
To review and compare the phase 3 clinical trial evidence on the 4 new pharmacological agents approved for the management of overweight and obesity.
Searches were performed (from 1966 through January 2016) in PubMed/MEDLINE, Scientific Citation Index, and product package inserts to identify key phase 3 clinical trials that were used in the approval of each agent.
Phase 3 clinical trials that listed end points of ≥5% and ≥10% weight loss benchmarks from baseline as well as total percentage of weight loss by participants were selected for the review.
No head-to-head trials have been identified between these agents at this point, which limits comparisons across agents. Phentermine/topiramate ER appeared to have the best overall average weight loss from baseline as well as highest percentages of patients achieving both ≥5% and ≥10% weight loss benchmarks, followed second by naltrexone/bupropion, and then liraglutide, with lorcaserin showing the lowest rates. Phentermine/topiramate ER completion rates were highest for both treatment and placebo groups, followed by liraglutide, with lorcaserin and naltrexone/bupropion showing similar completion rates, below that of the other 2 agents. Common side effects reported differed between agents, although the most common adverse events reported were gastrointestinal in nature, with liraglutide demonstrating the highest reported rates and lorcaserin demonstrating the lowest.
These 4 new pharmacological agents represent new options for the clinician to utilize when trying to manage the problem of obesity. No clear first-line agent has emerged, so treatment decisions should be based on patient-specific factors.
回顾并比较4种获批用于治疗超重和肥胖的新型药物的3期临床试验证据。
检索(1966年至2016年1月)PubMed/MEDLINE、科学引文索引和产品包装说明书,以确定每种药物获批所依据的关键3期临床试验。
选择列出从基线起体重减轻≥5%和≥10%基准点以及参与者体重减轻总百分比作为终点的3期临床试验进行综述。
目前尚未发现这些药物之间的直接对比试验,这限制了不同药物之间的比较。复方盐酸苯丁胺/托吡酯缓释剂从基线起的总体平均体重减轻效果似乎最佳,达到≥5%和≥10%体重减轻基准点的患者百分比也最高,其次是纳曲酮/安非他酮,然后是利拉鲁肽,氯卡色林的比例最低。复方盐酸苯丁胺/托吡酯缓释剂治疗组和安慰剂组的完成率最高,其次是利拉鲁肽,氯卡色林和纳曲酮/安非他酮的完成率相似,低于其他两种药物。不同药物报告的常见副作用有所不同,尽管报告的最常见不良事件本质上是胃肠道问题,利拉鲁肽报告的发生率最高,氯卡色林报告的发生率最低。
这4种新型药物为临床医生在治疗肥胖问题时提供了新的选择。目前尚未出现明确的一线药物,因此治疗决策应基于患者的具体情况。