PMID- 25683504
OWN - NLM
STAT- MEDLINE
DCOM- 20160204
LR  - 20150330
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 24
IP  - 4
DP  - 2015 Apr
TI  - Risk of hyperkalemia and combined use of spironolactone and long-term ACE 
      inhibitor/angiotensin receptor blocker therapy in heart failure using real-life 
      data: a population- and insurance-based cohort.
PG  - 406-13
LID - 10.1002/pds.3748 [doi]
AB  - PURPOSE: Clinical trials and few observational studies report increased 
      hyperkalemia risks in heart failure patients receiving aldosterone blockers in 
      addition to standard therapy. The aim of this study is to assess the hyperkalemia 
      risk and combined use of spironolactone and long-term ACE (angiotensin-converting 
      enzyme) inhibitor/angiotensin receptor blocker (ARB) therapy for heart failure in 
      a real-life setting of a heterogeneous population. 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.
CI  - Copyright (c) 2015 John Wiley & Sons, Ltd.
FAU - Abbas, Sascha
AU  - Abbas S
AD  - PMV Research Group at the Department of Child and Adolescent Psychiatry and 
      Psychotherapy, University of Cologne, Cologne, Germany.
FAU - Ihle, Peter
AU  - Ihle P
FAU - Harder, Sebastian
AU  - Harder S
FAU - Schubert, Ingrid
AU  - Schubert I
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150212
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 27O7W4T232 (Spironolactone)
SB  - IM
MH  - Aged
MH  - Angiotensin-Converting Enzyme Inhibitors/*adverse effects/therapeutic use
MH  - Cohort Studies
MH  - Databases, Factual
MH  - Female
MH  - Heart Failure/*drug therapy
MH  - Humans
MH  - Hyperkalemia/*chemically induced
MH  - Insurance/*statistics & numerical data
MH  - Male
MH  - Risk Factors
MH  - Spironolactone/*adverse effects/therapeutic use
MH  - Time Factors
OTO - NOTNLM
OT  - ACE inhibitors
OT  - case-control study
OT  - drug safety
OT  - heart failure
OT  - hyperkalemia
OT  - pharmacoepidemiology
OT  - spironolactone
EDAT- 2015/02/17 06:00
MHDA- 2016/02/05 06:00
CRDT- 2015/02/17 06:00
PHST- 2014/06/06 00:00 [received]
PHST- 2014/11/24 00:00 [revised]
PHST- 2014/12/08 00:00 [accepted]
PHST- 2015/02/17 06:00 [entrez]
PHST- 2015/02/17 06:00 [pubmed]
PHST- 2016/02/05 06:00 [medline]
AID - 10.1002/pds.3748 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2015 Apr;24(4):406-13. doi: 10.1002/pds.3748. Epub 
      2015 Feb 12.