PMID- 12535810
OWN - NLM
STAT- MEDLINE
DCOM- 20030304
LR  - 20190708
IS  - 0735-1097 (Print)
IS  - 0735-1097 (Linking)
VI  - 41
IP  - 2
DP  - 2003 Jan 15
TI  - Complications of inappropriate use of spironolactone in heart failure: when an 
      old medicine spirals out of new guidelines.
PG  - 211-4
AB  - OBJECTIVES: This study was designed to investigate the appropriateness and 
      complications of the use of spironolactone for heart failure (HF) in clinical 
      practice. BACKGROUND: Spironolactone was reported by one prospective randomized 
      trial to decrease morbidity and mortality in patients with New York Heart 
      Association (NYHA) class III and IV HF. With this report (Randomized 
      Spironolactone Evaluation Study [RALES] trial), we noted a marked increase in 
      widespread use of spironolactone in patients with HF. Long-term outcome data with 
      respect to safety and utilization of this medication in HF are not available. 
      METHODS: To investigate the use of spironolactone for HF in a clinical setting, 
      we analyzed the application of the RALES trial protocol to the care of 104 
      patients, whom we identified as being started on spironolactone for HF after 
      prerelease of the RALES trial. RESULTS: We found broader use, less intensive 
      follow-up, and increased complications with spironolactone treatment compared 
      with the RALES trial. Cardiologists provided more appropriate care than did 
      primary care providers. CONCLUSIONS: These data suggest that spironolactone is 
      being used widely in HF without consideration of the NYHA class and ejection 
      fraction, and without optimization of background treatment with 
      angiotensin-converting enzyme inhibitors and beta-blockers. Clinical follow-up 
      does not adhere to the RALES trial guidelines, resulting in higher complications. 
      We conclude that long-term studies with further safety and efficacy data are 
      needed.
FAU - Bozkurt, Biykem
AU  - Bozkurt B
AD  - Winters Center For Heart Failure Research, VA Medical Center, Baylor College of 
      Medicine, Houston, Texas, USA.
FAU - Agoston, Ildiko
AU  - Agoston I
FAU - Knowlton, A A
AU  - Knowlton AA
LA  - eng
PT  - Clinical Trial
PT  - Comment
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Mineralocorticoid Receptor Antagonists)
RN  - 27O7W4T232 (Spironolactone)
SB  - IM
CON - J Am Coll Cardiol. 2003 Jan 15;41(2):215-6. PMID: 12535811
CIN - J Am Coll Cardiol. 2003 May 21;41(10):1851-2. PMID: 12767683
MH  - Aged
MH  - Guideline Adherence
MH  - Heart Failure/*drug therapy
MH  - Humans
MH  - Hyperkalemia/etiology
MH  - Hyponatremia/etiology
MH  - Hypotension/etiology
MH  - Male
MH  - Middle Aged
MH  - Mineralocorticoid Receptor Antagonists/*adverse effects/therapeutic use
MH  - Patient Selection
MH  - Practice Guidelines as Topic
MH  - Randomized Controlled Trials as Topic
MH  - Severity of Illness Index
MH  - Spironolactone/*adverse effects/therapeutic use
EDAT- 2003/01/22 04:00
MHDA- 2003/03/05 04:00
CRDT- 2003/01/22 04:00
PHST- 2003/01/22 04:00 [pubmed]
PHST- 2003/03/05 04:00 [medline]
PHST- 2003/01/22 04:00 [entrez]
AID - S0735109702026943 [pii]
AID - 10.1016/s0735-1097(02)02694-3 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2003 Jan 15;41(2):211-4. doi: 10.1016/s0735-1097(02)02694-3.