HOUSTON, TEXAS. Researchers at the Veterans Affairs Medical Center at Baylor College of Medicine have just completed a study aimed at determining the extent of complications resulting from the use of the potassium-sparing diuretic, spironolactone, in the treatment of heart failure patients. The use of spironolactone took a big jump after the release of the results of the RALES trial in July 1999. The RALES trial involved heart failure patients with class III or class IV disease and a left ventricular ejection fraction (LVEF) of less than 0.35 – in other words, pretty sick people. The trial found that the addition of 12.5 to 25 mg/day of spironolactone to the conventional treatment with beta-blockers and ACE inhibitors decreased mortality by about 30%.
The authors of the RALES study set out quite specific guidelines for the use of spironolactone and the Baylor College researchers wanted to see how well these guidelines were being followed in actual practice. Their study involved 104 patients who had been put on spironolactone following the publication of the RALES trial. Their findings revealed a serious mismatch between the RALES guidelines and their application in actual practice.
Thus, even though the 104 patients had less advanced disease than the RALES patients they were far heavier medicated. This, combined with poor follow-up by attending physicians, led to the following complications among the 104 patients:
The researchers conclude that the rate of complications arising from the use of spironolactone in heart
failure patients is significantly higher in actual practice than in a rigidly controlled clinical trial.