Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink
Open accessAbstract
OBJECTIVE: To measure the association between orlistat and acute liver injury. DESIGN: Self controlled case series study. SETTING: Population based primary care setting, United Kingdom. PARTICIPANTS: 94,695 patients receiving orlistat and registered in the UK Clinical Practice Research Datalink and linked with Hospital Episode Statistics data between 1999 and 2011. MAIN OUTCOME MEASURE: Relative incidence of acute liver injury comparing periods when patients were receiving orlistat with periods of non-usage. RESULTS: Among 94,695 patients who received orlistat, 988 cases of acute liver injury were identified, with 335 confirmed as definite cases and 653 as probable cases. For all cases an increased incidence of liver injury was detected during the 90 day period before orlistat was first started, with an incidence rate ratio of 1.50 (95% confidence interval 1.10 to 2.06). The incidence remained raised during the first 30 days of treatment (2.21, 1.43 to 3.42), before returning to baseline levels with prolonged treatment. When the risk during the first 90 days of treatment was compared with the 90 days preceding first treatment, the incidence of liver injury was not increased (1.02, 0.67 to 1.56). An analysis restricted to definite cases showed no evidence of an increased risk of liver injury during treatment. CONCLUSION: The incidence of acute liver injury was higher in the periods both immediately before and immediately after the start of orlistat treatment. This suggests that the observed increased risks of liver injury linked to the start of treatment may reflect changes in health status associated with the decision to begin treatment rather than any causal effect of the drug.
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The study used a self-controlled design where each participant acted as her own control to avoid potential confounding caused by differences between patients.
“With this study design, each participant acted as her own control to avoid the potential confounding caused by differences between patients (16).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [16]
The self-controlled design limited the effect of confounding associated with different distribution among patients of relevant characteristics that can influence study outcomes.
“In this setting, participants acted as their own controls, thus limiting the effect of confounding associated with different distribution among patients of relevant characteristics that can influence study outcomes (16).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [16]
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Tutorial in biostatistics: the self‐controlled case series method
Whitaker, H. J., Paddy Farrington, C., Spiessens, B., & Musonda, P. (2006) · Statistics in Medicine · doi:10.1002/sim.2302 · Cited by 719 · see citing works
Use of the UK General Practice Research Database for pharmacoepidemiology
Rodríguez, L. A. G., & Perez‐Gutthann, S. (1998) · British Journal of Clinical Pharmacology · doi:10.1046/j.1365-2125.1998.00701.x · Cited by 560 · see citing works
The General Practice Research Database
Wood, L., & Martínez, C. (2004) · Drug Safety · doi:10.2165/00002018-200427120-00004 · Cited by 330 · see citing works
Guerciolini, R. (1997) · PubMed · Cited by 326 · see citing works
The methodology of self-controlled case series studies
Whitaker, H., Hocine, M. N., & Farrington, P. (2008) · Statistical Methods in Medical Research · doi:10.1177/0962280208092342 · Cited by 225 · see citing works
The General Practice Research Database. Scientific and Ethical Advisory Group
Lawson, D. H. (1998) · QJM · doi:10.1093/qjmed/91.6.445 · Cited by 176 · see citing works
Hepatic Complications of Obesity
Diehl, A. M. (2010) · Gastroenterology Clinics of North America · doi:10.1016/j.gtc.2009.12.001 · Cited by 73 · see citing works
Risk of Hospitalization for Stroke Associated with Antipsychotic Use in the Elderly
Pratt, N. L., Roughead, E. E., Ramsay, E. N., Salter, A. B., & Ryan, P. (2010) · Drugs & Aging · doi:10.2165/11584490-000000000-00000 · Cited by 33 · see citing works
Hepatic Complications of Obesity
Diehl, A. M. (2005) · Gastroenterology Clinics of North America · doi:10.1016/j.gtc.2004.12.012 · Cited by 28 · see citing works
An Integrated Analysis of Liver Safety Data from Orlistat Clinical Trials
Morris, M. W., Lane, P. W., Lee, K. S. S., & Parks, D. C. (2012) · Obesity Facts · doi:10.1159/000341589 · Cited by 24 · see citing works
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- Authors
- Douglas, I. J., Langham, J., Bhaskaran, K., Brauer, R., & Smeeth, L.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Douglas, I. J.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2013-04-12
- Volume
- 346
- Issue
- apr12 1
- Pages
- f1936-f1936
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC3624963
- OpenAlex
- W2135413686
- Cited by
- 73
- References
- 10
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 6 · 2020: 4 · 2019: 4 · 2018: 10 · 2017: 5 · 2016: 12 · 2015: 5 · 2014: 6 · 2013: 6
- FWCI
- 10.44
- 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)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Wellcome Trust (098504)
- National Institute for Health and Care Research (NF-SI-0510-10090, PDF-2011-04-007)
- Medical Research Council (MR/K006584/1)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Keywords
- orlistat, acute liver injury, drug safety, hepatotoxicity, anti-obesity drugs, primary care, drug-induced liver injury
- MeSH terms
- Orlistat, Adult, Female, United Kingdom, Humans, Lactones, Male, Middle Aged, Obesity, Time Factors, Causality, Incidence, Case-Control Studies, Databases, Factual, Anti-Obesity Agents, Chemical and Drug Induced Liver Injury
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