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Risk of colorectal cancer after initiation of orlistat: matched cohort study
Open accessAbstract
OBJECTIVE: To examine the risk of colorectal cancer after orlistat initiation in the UK population. DESIGN: Retrospective matched cohort study. SETTING: Data from the UK Clinical Practice Research Datalink from September 1998 to December 2008. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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.
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Orlistat has occasionally been associated with case reports of colon and breast cancer.
“Orlistat, a gastrointestinal lipase inhibitor, has occasionally been associated with case reports of colon and breast cancer.”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [148]
The Discussion (page not provided) mentions a small number of colon-cancer cases in the spontaneous adverse-event reporting system, which supports the colon-cancer portion as a report of cases, not a causal association. Neither the Introduction nor the Discussion mentions breast-cancer case reports. (LLM, conf=0.84)
Experimental — accuracy not yet measuredA large population-based analysis using UK registry data over 10 years found no increase in colorectal cancer risk with orlistat.
“However, a large population-based analysis using UK registry data over 10 years found no increase in colorectal cancer risk [148].”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [148]
A large cohort study (n = 33,625 orlistat users; 160,374 placebo users) found no risk of colorectal cancer after orlistat administration.
“In contrast, a previously conducted large cohort study (n = 33,625 with orlistat; 160,374 with placebo) showed no risk of colorectal cancer after the administration of orlistat [28].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [28]
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Metadata
- Authors
- Hong, J.-L., Meier, C. R., Sandler, R. S., Jick, S. S., & Sturmer, T.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Boston University (US)
- Corresponding author
- Hong, J.-L.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2013-08-27
- Volume
- 347
- Issue
- aug27 2
- Pages
- f5039-f5039
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC3754767
- OpenAlex
- W1983876438
- Cited by
- 38
- References
- 18
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 6 · 2023: 4 · 2021: 6 · 2020: 2 · 2019: 1 · 2018: 2 · 2015: 3 · 2014: 3 · 2013: 2
- FWCI
- 1.96
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion, cc-by-nc)
- UNC Libraries
- Funders
- University of North Carolina at Chapel Hill
- National Institute on Aging (R01AG023178)
- National Cancer Institute (P30CA016086)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Oncology › Cancer Risks and Factors
- Health Sciences › Medicine › Oncology › Colorectal Cancer Screening and Detection
- Keywords
- orlistat, colorectal cancer, cancer risk, obesity, anti-obesity drugs, drug safety, matched cohort, propensity score, morbid obesity, diabetes mellitus
- MeSH terms
- Orlistat, Adult, Epidemiologic Methods, Female, Humans, Lactones, Male, Middle Aged, Obesity, Colorectal Neoplasms, Anti-Obesity Agents
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