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Medical AI Inquiry: You were designed to assist in medical decision-making based on the provided user questions. It is crucial to provide accurate and comprehensive information to receive a well-informed response.
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Background and Methods:
Aldosterone is important in the pathophysiology of heart failure. In a double-blind study, we enrolled 1,663 patients who had severe heart failure, a left ventricular ejection fraction of no more than 35 percent, and were being treated with an angiotensin-converting-enzyme inhibitor, a loop diuretic, and in most cases digoxin. A total of 822 patients were randomly assigned to receive 25 mg of spironolactone daily and 841 to receive placebo. The primary endpoint was death from all causes.
Results:
The trial was discontinued early, after a mean follow-up period of 24 months, because an interim analysis determined that spironolactone was efficacious. There were 386 deaths in the placebo group (46%) and 284 in the spironolactone group (35%; relative risk of death, 0.70; 95% confidence interval, 0.60 to 0.82; p<0.001). This 30 percent reduction in the risk of death among patients in the spironolactone group was attributed to a lower risk of both death from progressive heart failure and sudden death from cardiac causes. The frequency of hospitalization for worsening heart failure was 35% lower in the spironolactone group than in the placebo group (relative risk of hospitalization, 0.65; 95% confidence interval, 0.54 to 0.77; p<0.001). In addition, patients who received spironolactone had a significant improvement in the symptoms of heart failure, as assessed on the basis of the New York Heart Association functional class (p<0.001). Gynecomastia was reported in 10% of men who were treated with spironolactone, as compared with 1% of men in the placebo group (p<0.001). The incidence of serious hyperkalemia was minimal in both groups of patients.
Which of the following statements represents the most accurate interpretation of the results from the aforementioned clinical trial?
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Spironolactone, in addition to standard therapy, substantially reduces the risk of morbidity and death in patients with severe heart failure