Spironolactone Use and the Risk of Upper Gastrointestinal Bleeding: a Population-based Case-control Study

Overview

Journal Br J Clin Pharmacol

Specialty Pharmacology

Date 2008 May 30

PMID 18507655

Citations 3

Authors

Sinem E Gulmez

Annmarie T Lassen

Claus Aalykke

Michael Dall

Alin Andries

Birthe S Andersen

Jane M Hansen

Morten Andersen

Jesper Hallas

Affiliations

Soon will be listed here.

Abstract

Aims: Recent studies have suggested an increased risk of upper gastrointestinal bleeding (UGB) in spironolactone users. The aim was to confirm the association, identify the risk factors and quantify the absolute risk.

Methods: A population based case-control study was conducted in the County of Funen, Denmark. Cases (n = 3652) were all subjects with a first discharge diagnosis of serious UGB during the period 1995 to 2006. Age- and gender-matched controls (10 for each case) (n = 36 502) were selected by risk set sampling. Data on all subjects' drug exposure and past medical history were retrieved from a prescription database and from the County's patient register. Confounders were controlled by conditional logistic regression.

Results: The adjusted odds ratio (OR) associating current use of spironolactone with UGB was 2.7 [95% confidence interval (CI) 2.2, 3.2]. The risk increased with higher doses of spironolactone (5.4; 3.4, 8.6) for 100-mg tablets. No trend was found with increasing cumulative dose. The strongest association was found among users aged 55-74 years (OR 13.1; 6.5, 26.3). Current use of loop diuretics was also associated with an increased risk of UGB (1.9; 1.7, 2.1).

Conclusion: The use of spironolactone is associated with increased risk of UGB. The risk increases with higher doses.

Citing Articles

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New prescriptions of spironolactone associated with angiotensin-converting-enzyme inhibitors and/or angiotensin receptor blockers and their laboratory monitoring from 2001 to 2008: a population study on older people living in the community in Italy.

Bilotta C, Franchi C, Nobili A, Nicolini P, Djade C, Tettamanti M Eur J Clin Pharmacol. 2012; 69(4):909-17.

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Ex-drinking may be a surrogate for unmeasured risk factors for upper gastrointestinal bleeding: reappraisal and an additional survey of subjects from a case-control study in Japan.

Watanabe H, Kamijima Y, Sato T, Kaufman D, Kubota K Eur J Epidemiol. 2009; 24(3):143-7.

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