title: Risk of colorectal cancer after initiation of orlistat: matched cohort study.
abstract: OBJECTIVE
  To examine the risk of colorectal cancer after orlistat initiation in the UK population.
  
  
  METHODS
  Retrospective matched cohort study.
  
  
  METHODS
  Data from the UK Clinical Practice Research Datalink from September 1998 to December 2008.
  
  
  METHODS
  33,625 adults aged 18 years or over who started treatment with orlistat; each orlistat initiator was matched to up to five non-initiators (n=160,347) on age, sex, body mass index, and calendar time.
  
  
  METHODS
  Associations between orlistat initiation and the risk of colorectal cancer, assessed by calculating hazard ratios with propensity score adjusted Cox proportional hazard models.
  
  
  RESULTS
  Of 193,972 patients with a median age of 47 (interquartile range 37-57) years, 77% were women and approximately 90% were obese (body mass index ≥ 30). Orlistat initiators were more likely to have a previous history of diabetes or hypertension and to receive prescriptions for anti-diabetes drugs, statins, and aspirin compared with non-initiators. In the intention to treat analysis, 57 colorectal cancer events were identified among orlistat initiators and 246 among non-initiators, with median follow-up times of 2.96 and 2.86 years, respectively. The calculated incidence rate of colorectal cancer per 100,000 person years was 53 (95% confidence interval 41 to 69) for orlistat initiators and 50 (44 to 57) for non-initiators. Orlistat initiation was not associated with a higher risk of colorectal cancer (adjusted hazard ratio 1.11, 95% confidence interval 0.84 to 1.47). Findings were robust in the as treated analyses and in patients who were aged 50 years or over, were morbidly obese, or had a history of diabetes.
  
  
  CONCLUSIONS
  This study found no evidence of an increased risk of colorectal cancer after the initiation of orlistat. It is limited by the relatively short follow-up time, and the possibility of adverse effects of long term orlistat use on risk of colorectal cancer cannot be excluded.
authors: Department of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, McGavran-Greenberg, CB # 7435, Chapel Hill, NC 27599-7435, USA. email.unc.edu
authors: Jin-Liern
authors: JL
authors: Hong
authors: Christoph R
authors: CR
authors: Meier
authors: Robert S
authors: RS
authors: Sandler
authors: Susan S
authors: SS
authors: Jick
authors: Til
authors: T
authors: Stürmer
mesh_terms: D000328:Adult; D019440:Anti-Obesity Agents / Q000009:adverse effects*; D015179:Colorectal Neoplasms / Q000139:chemically induced*; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007783:Lactones / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy; D000077403:Orlistat
chemical_list: D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat
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