Abstract
AimsDrug 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.MethodsWe 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.ResultsWe 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.ConclusionsOrlistat 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.
Highlights
The prevalence of obesity and related health problems is increasing [1]
Follow-up post-baseline varied, with orlistat recipients followed on average for 4.9 years compared with 5.7 years for patients prescribed sibutramine and 4.5 years amongst no-intervention patients
We assessed the effects on weight and body mass index (BMI) of drug interventions for obesity delivered in routine clinical practice among the general population
Summary
The prevalence of obesity and related health problems is increasing [1]. Worldwide, over 500 million adults are obese with a body mass index (BMI) of 30 kg mÀ2 or more [2]. Strategies to reduce weight range from transport policy and food labelling standards to lifestyle changes and targeted clinical interventions such as drug treatment and bariatric surgery. The only drug treatment with a license for use in obesity in Europe is orlistat. The license for sibutramine was suspended in 2010 for safety reasons. Three new treatments (lorcaserin, phentermine/topiramate and bupropion/ naltrexone) have been approved for use in the US, licenses were not obtained in Europe for lorcaserin and phentermine/topiramate with safety concerns highlighted [3, 4] whilst European approval for bupropion/naltrexone is awaited. 01 May 2009 when orlistat became available without prescription, and excluding patients receiving a single orlistat or sibutramine prescription, anticipating this group included patients who never took either drug. Approval was obtained from the Medicines and Healthcare products Regulatory Agency’s Independent Scientific Advisory Committee and ethical approval granted by the London School of Hygiene and Tropical Medicine ethics committee
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