Abstract | PURPOSE: METHODS: Using claims data of the statutory health insurance fund AOK, covering 30% of the German population, we performed a nested case-control study in a cohort of heart failure patients receiving continuous ACE/ARB therapy (n = 1,491,894). Hyperkalemia risk associated with concurrent use of spironolactone and ACE/ARB was calculated by conditional logistic regression in 1062 cases and 10,620 risk-set-sampling-matched controls. RESULTS: Risk of hyperkalemia in heart failure patients was significantly associated with spironolactone use (odds ratio (OR) (95% confidence interval (CI)) = 13.59 (11.63-15.88) in all and 11.05 (8.67-14.08) in those with information on New York Heart Association (NYHA) stage of disease). In the NYHA subpopulation, higher risk estimates were observed in short-term as compared with long-term users (OR (95%CI) = 13.00 (9.82-17.21) and 9.12 (6.78-12.26), respectively). Moreover, the association was stronger in older (≥70 years of age) as compared with younger patients (<70 years of age) (OR (95%CI) = 12.32 (9.35-16.23) and 8.73 (5.05-15.08), respectively), although interaction was not significant (pinteraction = 0.07). CONCLUSIONS:
Hyperkalemia risk associated with combined use of spironolactone and ACE/ARB is much stronger in real-life practice than observed in clinical trials. Careful potassium level monitoring in concomitant users of spironolactone and ACE/ARB is necessary.
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Authors | Sascha Abbas, Peter Ihle, Sebastian Harder, Ingrid Schubert |
Journal | Pharmacoepidemiology and drug safety
(Pharmacoepidemiol Drug Saf)
Vol. 24
Issue 4
Pg. 406-13
(Apr 2015)
ISSN: 1099-1557 [Electronic] England |
PMID | 25683504
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 John Wiley & Sons, Ltd. |
Chemical References |
- Angiotensin-Converting Enzyme Inhibitors
- Spironolactone
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Topics |
- Aged
- Angiotensin-Converting Enzyme Inhibitors
(adverse effects, therapeutic use)
- Cohort Studies
- Databases, Factual
- Female
- Heart Failure
(drug therapy)
- Humans
- Hyperkalemia
(chemically induced)
- Insurance
(statistics & numerical data)
- Male
- Risk Factors
- Spironolactone
(adverse effects, therapeutic use)
- Time Factors
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