Rates of Hyperkalemia After Publication of the Randomized Aldactone Evaluation Study

摘要

Background The Randomized Aldactone Evaluation Study (RALES) demonstrated that spironolactone significantly improves outcomes in patients with severe heart failure (HF). Use of angiotensin-converting enzyme inhibitors (ACEIs) is also indicated in these patients; however, life-threatening hyperkalemia can occur when these drugs ate used together;Methods We conducted a population-based, time-series analysis to examine trends in the rate of spi-tonolactone prescriptions and the rate of hospitalization for hyperkalemia in ambulatory patients before and after the publication of RALES. We linked prescription claims data and hospital admission records for > 1.3 million adults >66 years in Ontario, Canada, for the period from 1994 through 2001.Results Among patients treated with ACEIs who had recently been hospitalized for HF, the spironolactone prescription rate was 34 per 1000 patients in 1994; it increased immediately after the publication of RALES to 149 per 1000 patients by late 2001 (fxO.001). The rate of hospitalization for hyperkalemia rose from 2.4 per 1000 patients in 1994 to 11.0 per 1000 patients in 2001 (f>< 0.001); the associated mortality rose from 0.3 per 1000 to 2.0 per 1000 patients (f><0.001). As compared with the expected numbers of events, there were 560 (95% confidence interval [CI], 285-754) additional hyperkalemia-related hospitalizations and 73 (95% CI, 27-120) additional hospital deaths during 2001 among older patients with HF who were treated with ACEIs in Ontario. The publication of RALES was not associated with significant decreases in the rates of readmission for HF or death from all causes. Conclusions The publication of RALES was associated with abrupt increases in the rate of prescriptions for spironolactone and in hyper kale -mia-associated morbidity and mortality Closer laboratory monitoring and more judicious use of spironolactone may reduce the occurrence of this complication