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

Claudio Bilotta, Carlotta Franchi, Alessandro Nobili, Paola Nicolini, Codjo Djignefa Djade, Mauro Tettamanti, Ida Fortino, Angela Bortolotti, Luca Merlino, Carlo Vergani
European Journal of Clinical Pharmacology 2013, 69 (4): 909-17

PURPOSE: To analyse, in older community-dwelling people living in Italy's Lombardy region, 8-year trends in new users of spironolactone co-prescribed with angiotensin-converting-enzyme inhibitors (ACE-Is) and/or angiotensin receptor blockers (ARBs); blood test monitoring; and independent predictors of appropriate blood test monitoring.

METHODS: The region's administrative health database from 2001 to 2008 was used to retrieve yearly frequencies of subjects aged 65+ who started this co-prescription. Multivariate analyses were adjusted for age, sex, local health unit, treatment with beta-blockers, drugs for diabetes, and polypharmacy (i.e., exposure to five or more different drugs).

RESULTS: Only new users of spironolactone co-prescribed with ARBs increased from 2001 to 2008 (P < 0.001). In the 6 months before starting the co-prescriptions 96 to 100% of patients measured serum creatinine (mean 99.3%), sodium (97.3%) and potassium (98.6%). Within 3 months of starting the co-prescriptions 96 to 99% of patients measured serum sodium (mean 97.3%) and potassium (98.6%), but on average only 48% of them (range 43 to 53%) measured serum creatinine, with an increase over time (odds ratio [change in regression per year] = 1.03, 95% CI 1.02-1.05, P < 0.001). At multivariate analysis polypharmacy was found to be the only independent predictor of such creatinine monitoring (P < 0.001).

CONCLUSIONS: Our results support the need for greater awareness within the medical community of the potential renal toxicity of the association of spironolactone with ACE-Is and/or ARBs. Adequate short-term monitoring of serum creatinine in all older community-dwelling people who receive such co-prescription is necessary in order to ensure safe usage of these medications.

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