Cutting down deaths in heartfailure
The RALES study was designed at a time when the aldosterone blocking, potassium sparing diuretic spironolactone (brandname Aldactone) was seriously out of fashion, due to problems with sideeffects at larger doses. This trial changed all that. This multicentre (15 countries), randomized, double blind, placebo controlled trial enrolled enrolled 1663 patients with severe (type III-IV) heartfailure and gave half of these 25 mg spironolactone in addition to their already preexisting medication. Follow up was ca 3 years.
The results were so impressive that the study had to be stopped 18 months earlier, as it would have been ethically unsound to ignore the interim results and not have the placebo using patients deny the benefit of the drug.
The numbers speak for themselves: there were 386 deaths (46 percent, n=841) in the placebo group and 284 deaths (35 percent, n=822) in the spironolactone group, improving mortality quite significantly. Non-fatal hospital admissions were also reduced by 30%.
As heartfailure is a disease with a pretty bad prognosis (50-60% of patients with this diagnosis die in 5-6 years: that's a worse mortality than cancer), this was really good news for the medical community, and makes this study one of the most important in cardiology over the last 10 years.
Am J Cardiol, Oct 1996; 78: 902-7