BACKGROUND: The Randomized Aldactone Evaluation Study (RALES) demonstra ted tha t spironolactone significantly improves outcomes in patients with severe heart f ailure. Use of angiotensin-converting-enzyme(ACE)-inhibi...BACKGROUND: The Randomized Aldactone Evaluation Study (RALES) demonstra ted tha t spironolactone significantly improves outcomes in patients with severe heart f ailure. Use of angiotensin-converting-enzyme(ACE)-inhibitors is also indicate d in these patients. However, life-threatening hyperkalemia can occur when thes e drugs are used together. METHODS: We conducted a population-based time-serie s analysis to examine trends in the rate of spironolactone prescriptions and the rate of hospitalization for hyperkalemia in ambulatory patients before and afte r the publication of RALES. We linked prescription-claims data and hospital-ad mission records for more than 1.3 million adults 66 years of age or older in Ont ario, Canada, for the period from 1994 through 2001. RESULTS: Among patients tre ated with ACE inhibitors who had recently been hospitalized for heart failure, t he spironolactone-prescription rate was 34 per 1000 patients in 1994, and it in creased immediately after the publication of RALES, to 149 per 1000 patients by late 2001 (P< 0.001). The rate of hospitalization for hyperkalemia rose from 2.4 per 1000 patients in 1994 to 11.0 per 1000 patients in 2001 (P< 0.001), and the associated mortality rose from 0.3 per 1000 to 2.0 per 1000 patients (P< 0.001) . As compared with expected numbers of events, there were 560(95 percent confide nce interval, 285 to 754) additional hyperkalemia-related hospitalizations and 73 (95 percent conf idence interval, 27 to 120) additional hospital deaths during 2001 among older p atients with heart failure who were treated with ACE inhibitors in Ontario. Publ ication of RALES was not associated with significant decreases in the rates of r eadmission for heart failure or death from all causes. CONCLUSIONS: The publicat ion of RALES was associated with abrupt increases in the rate of prescriptions f or spironolactone and in hyperkalemia- associated morbidity and mortality. Closer laboratory monitoring and more judi cious use of spironolactone may reduce the occurrence of this complication.展开更多
文摘BACKGROUND: The Randomized Aldactone Evaluation Study (RALES) demonstra ted tha t spironolactone significantly improves outcomes in patients with severe heart f ailure. Use of angiotensin-converting-enzyme(ACE)-inhibitors is also indicate d in these patients. However, life-threatening hyperkalemia can occur when thes e drugs are used together. METHODS: We conducted a population-based time-serie s analysis to examine trends in the rate of spironolactone prescriptions and the rate of hospitalization for hyperkalemia in ambulatory patients before and afte r the publication of RALES. We linked prescription-claims data and hospital-ad mission records for more than 1.3 million adults 66 years of age or older in Ont ario, Canada, for the period from 1994 through 2001. RESULTS: Among patients tre ated with ACE inhibitors who had recently been hospitalized for heart failure, t he spironolactone-prescription rate was 34 per 1000 patients in 1994, and it in creased immediately after the publication of RALES, to 149 per 1000 patients by late 2001 (P< 0.001). The rate of hospitalization for hyperkalemia rose from 2.4 per 1000 patients in 1994 to 11.0 per 1000 patients in 2001 (P< 0.001), and the associated mortality rose from 0.3 per 1000 to 2.0 per 1000 patients (P< 0.001) . As compared with expected numbers of events, there were 560(95 percent confide nce interval, 285 to 754) additional hyperkalemia-related hospitalizations and 73 (95 percent conf idence interval, 27 to 120) additional hospital deaths during 2001 among older p atients with heart failure who were treated with ACE inhibitors in Ontario. Publ ication of RALES was not associated with significant decreases in the rates of r eadmission for heart failure or death from all causes. CONCLUSIONS: The publicat ion of RALES was associated with abrupt increases in the rate of prescriptions f or spironolactone and in hyperkalemia- associated morbidity and mortality. Closer laboratory monitoring and more judi cious use of spironolactone may reduce the occurrence of this complication.
