June 28, 2005Circulation
Adoption of Spironolactone Therapy for Older Patients With Heart Failure and Left Ventricular Systolic Dysfunction in the United States, 1998–2001
Key result
Spironolactone use in older heart failure patients increased from 3.0% to 21.3% (P<0.0001) after RALES, with 30.9% of post-RALES prescriptions given to patients not meeting trial enrollment criteria.
Population
19,226 Medicare beneficiaries ≥65 years old discharged after hospitalization for the primary diagnosis of…
Design
Cross-sectional
Authors
Discussion
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Implication
May warrant stricter adherence to RALES criteria in older HF patients; leaves open optimal implementation strategies for trial results.
Key Points
- To assess national adoption trends and clinical appropriateness of spironolactone therapy among older patients hospitalized with heart failure and left ventricular systolic dysfunction following publication of the RALES trial.
- Evaluated serial cross-sectional samples of Medicare beneficiaries aged ≥65 years hospitalized with heart failure and left ventricular systolic dysfunction before (April 1998–March 1999, n=9,758) and after (July 2000–June 2001, n=9,468) publication of the RALES trial.
- Identified discharge prescription rates for spironolactone stratified by RALES enrollment criteria, and used multivariable logistic regression to analyze factors associated with off-criteria prescribing.
- Spironolactone prescriptions at hospital discharge increased more than sevenfold after RALES publication, rising from 3.0% to 21.3% (P < 0.0001).
- Of all post-RALES spironolactone prescriptions, 30.9% were given to patients not meeting trial criteria, including 22.8% with serum potassium ≥5.0 mmol/L, 14.1% with serum creatinine ≥2.5 mg/dL, and 17.3% with estimated glomerular filtration rate <30 mL/min/1.73 m².
- Non-criteria prescriptions were independently associated with advanced age, noncardiovascular comorbidities, discharge to skilled nursing facilities, and treatment by physicians without board certification.
Study Design
Type
Cross-Sectional (n=19,226)
Multicenter
Yes
Structured PICO
P
Population
19,226 Medicare beneficiaries ≥65 years old discharged after hospitalization for the primary diagnosis of heart failure and with left ventricular systolic dysfunction (n=9,758 before RALES publication, n=9,468 after RALES publication)
I
Intervention
Spironolactone prescription at hospital discharge
O
Outcome
Spironolactone prescription rates at hospital discharge and appropriateness based on RALES enrollment criteria
Main Result
Absolute Event Rate: 21.3% vs 3%
p-value: p=<0.0001
Following the RALES trial, spironolactone use in older heart failure patients increased significantly, but nearly a third of prescriptions were potentially inappropriate, highlighting the need for better translation of trial safety criteria into clinical practice.
Cite This Study
Masoudi et al. (2005) conducted a cross-sectional in Heart failure and left ventricular systolic dysfunction (n=19,226). Spironolactone vs. Before publication of RALES was evaluated on Spironolactone prescriptions at hospital discharge (p=<0.0001). Spironolactone use in older heart failure patients increased from 3.0% to 21.3% (P<0.0001) after RALES, with 30.9% of post-RALES prescriptions given to patients not meeting trial enrollment criteria.