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Research

Spironolactone and risk of upper gastrointestinal events: population based case-control study

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38883.479549.2F (Published 10 August 2006) Cite this as: BMJ 2006;333:330
  1. Katia Verhamme, senior researcher (k.verhamme{at}erasmusmc.nl)1,
  2. Georgio Mosis, research fellow1,
  3. Jeanne Dieleman, senior researcher1,
  4. Bruno Stricker, professor of pharmacoepidemiology2,
  5. Miriam Sturkenboom, associate professor of pharmacoepidemiology1
  1. 1 Department of Medical Informatics, Erasmus MC, PO Box 1738, 3000 Rotterdam, Netherlands
  2. 2 Department of Epidemiology and Biostatistics, Erasmus MC
  1. Correspondence to: K Verhamme
  • Accepted 26 May 2006

Abstract

Objective To confirm and quantify any association between spironolactone and upper gastrointestinal bleeding and ulcers.

Design Population based case-control study.

Setting A primary care information database in the Netherlands.

Participants All people on the database who were aged 18 or more between 1 January 1996 and 30 September 2003. Patients with a history of alcoholism or gastrointestinal cancer were excluded. Ten controls were matched to each case of gastroduodenal ulcer or upper gastrointestinal bleeding by age (year of birth), sex, and index date.

Main outcome measures The occurrence of an upper gastrointestinal event (bleeding or ulcers), adjusted for potential confounders with conditional logistic regression analysis.

Results Within the source population of 306 645 patients, 523 cases of gastric or duodenal ulcer or upper gastrointestinal bleeding were identified and matched to 5230 controls. Current use of spironolactone was associated with a 2.7-fold (95% confidence interval 1.2 to 6.0) increased risk of a gastrointestinal event.

Conclusion The risk of gastroduodenal ulcers or upper gastrointestinal bleeding is significantly increased in patients using spironolactone.

Footnotes

  • Contributors All authors helped conceive the idea for the study, design the study, and analyse and interpret the data. KMCV and MCJMS drafted the manuscript. JPD, BHChS, and MCJMS revised the manuscript and provided statistical expertise. MCJMS supervised the study. MCJMS is guarantor.

  • Funding None.

  • Competing interests None declared by KMCV, GM, JPD, and BHChS. MCJMS is leader of the IPCI database, a general practice database used for research by pharmaceutical companies. She has received several research grants in cardiovascular disease from Pfizer (license holder of Aldactone), but none was related to the topic of this paper. She has also received travel reimbursement from Pfizer for participation in conferences.

  • Ethical approval internal review board of the integrated primary care information project database.

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