title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Geriatric Medicine Outpatient Service, Department of Urban Outpatient Services, Istituti Clinici di Perfezionamento Hospital, viale Doria 52, 20124 Milan, Italy. claudio.bilotta@gmail.com
authors.forename: Claudio
authors.initials: C
authors.lastname: Bilotta
authors.forename: Carlotta
authors.initials: C
authors.lastname: Franchi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Nobili
authors.forename: Paola
authors.initials: P
authors.lastname: Nicolini
authors.forename: Codjo Djignefa
authors.initials: CD
authors.lastname: Djade
authors.forename: Mauro
authors.initials: M
authors.lastname: Tettamanti
authors.forename: Ida
authors.initials: I
authors.lastname: Fortino
authors.forename: Angela
authors.initials: A
authors.lastname: Bortolotti
authors.forename: Luca
authors.initials: L
authors.lastname: Merlino
authors.forename: Carlo
authors.initials: C
authors.lastname: Vergani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D016208:Databases, Factual; D016903:Drug Monitoring / Q000379:methods*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D017723:Drug Utilization Review; D005260:Female; D006801:Humans; D007558:Italy; D016015:Logistic Models; D008297:Male; D012189:Retrospective Studies; D013148:Spironolactone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D013148:Spironolactone