Douglas Ian J, Bhaskaran Krishnan, Batterham Rachel L, Smeeth Liam
Epidemiology Population Health, London School of Hygiene Tropical Medicine, London, United Kingdom.
Centre for Obesity Research, Rayne Institute, Department of Medicine, University College London, London, United Kingdom.
Br J Clin Pharmacol. 2015 Jun;79(6):1020-7. doi: 10.1111/bcp.12578.
Drug treatments for obesity have proven efficacy from randomized trials, but their effectiveness in routine clinical practice is unknown. We assessed the effects on weight and body mass index (BMI) of orlistat and sibutramine when delivered in routine primary care.
We used United Kingdom data from the Clinical Practice Research Datalink to estimate the effects of orlistat or sibutramine on weight and BMI over 3 years following treatment initiation. For comparison, we matched each patient with up to five obese patients receiving neither drug. Mixed effects linear regression with splines was used to model change in weight and BMI. Mean change with 95% confidence intervals (CI) was estimated.
We identified 100 701 patients receiving orlistat, 15 355 receiving sibutramine and 508 140 non-intervention patients, with body mass index of 37.2, 36.6 and 33.2 kg m(-2) , respectively. Patients receiving orlistat lost, on average, 0.94 kg month(-1) (0.93 to 0.95) over the first 4 months. Weight gain then occurred, although weight remained slightly below baseline at 3 years. Patients receiving sibutramine lost, 1.28 kg month(-1) (1.26 to 1.30) over the first 4 months, but by 3 years had exceeded baseline weight. Non-intervention patients had slight increases in weight throughout the 3 year period, with gains ranging between 0.01 and 0.06 kg month(-1) .
Orlistat and sibutramine had early effects on weight loss, not sustained over 3 years. As new treatments for obesity are approved, their effectiveness should be measured in routine clinical practice, as effectiveness may be considerably less than seen in randomized trials.
肥胖症的药物治疗在随机试验中已证实具有疗效,但在常规临床实践中的效果尚不清楚。我们评估了在常规初级保健中使用奥利司他和西布曲明对体重和体重指数(BMI)的影响。
我们使用来自英国临床实践研究数据链的数据,以估计奥利司他或西布曲明在开始治疗后3年内对体重和BMI的影响。为作比较,我们为每位患者匹配了多达五名未接受任何药物治疗的肥胖患者。使用带样条的混合效应线性回归对体重和BMI的变化进行建模。估计了平均变化及95%置信区间(CI)。
我们识别出接受奥利司他治疗的患者100701例、接受西布曲明治疗的患者15355例以及未接受干预的患者508140例,其体重指数分别为37.2、36.6和33.2kg/m²。接受奥利司他治疗的患者在最初4个月平均每月减重0.94kg(0.93至0.95)。随后体重开始增加,尽管在3年时体重仍略低于基线水平。接受西布曲明治疗的患者在最初4个月平均每月减重1.28kg(1.26至1.30),但到3年时体重已超过基线水平。未接受干预的患者在整个3年期间体重略有增加,每月增加0.01至0.06kg。
奥利司他和西布曲明对体重减轻有早期影响,但在3年内未持续。随着肥胖症新治疗方法的获批,应在常规临床实践中衡量其有效性,因为其有效性可能远低于随机试验中的效果。