Purpose: Real-life experience with anti-obesity drugs has shown that psychiatric and cardiovascular diseases may be reported as adverse drug reactions. For adequate risk assessment of these drugs knowledge on baseline risks of patients starting anti-obesity drugs and insight in patterns of use is needed. The aim was to assess whether baseline characteristics of patients starting anti-obesity drugs differ from those not being prescribed these drugs, and to study patterns of anti-obesity drug use. Methods: A population-based cohort study was conducted in the IPCI database (1995-2007). The index cohort comprised all persons who started an anti-obesity drug. The reference cohort comprised up to six randomly sampled patients from the same GP practice with same index date. Baseline characteristics were assessed for both cohorts. The index cohort was followed for 1 year to study patterns of drug use. Unconditional logistic regression was used to calculate crude odds ratios and 95% confidence intervals. Results: The index and reference cohort comprised 1471 and 8736 persons, respectively. Both cardiovascular and psychiatric co-morbidities were more prevalent among starters compared to non-starters. 77.7% of the patients stopped using anti-obesity drugs within 90 days. Users of amphetamine-like drugs differed from patients using orlistat or sibutramine, whereas users of orlistat and sibutramine were highly comparable. Conclusions: The increased prevalence of co-morbidities constitutes a baseline risk which may translate in higher occurrence of psychiatric and cardiovascular diseases during use of anti-obesity drugs, independent of the drugs. The limited period of use might reduce possible cardiovascular benefits of weight reduction induced by these drugs.

Benefit-risk assessment, Medicines, Obesity, Pharmacovigilance
dx.doi.org/10.1002/pds.1759, hdl.handle.net/1765/17036
Pharmacoepidemiology and Drug Safety: an international journal
Erasmus MC: University Medical Center Rotterdam

Willemen, M.J.C, Mantel-Teeuwisse, A.K, Straus, S.M.J.M, Leufkens, H.G.M, Egberts, T.C.G, & Sturkenboom, M.C.J.M. (2009). Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs. Pharmacoepidemiology and Drug Safety: an international journal, 18(7), 631–638. doi:10.1002/pds.1759