(Circulation. 1999;99:2486-2491.)
© 1999 American Heart Association, Inc.
Cardiovascular News |
Meeting Highlights
Highlights of the 71st Scientific Sessions of the American Heart Association
From St Luke's Episcopal Hospital, Texas Heart Institute, and the University of Texas Medical School at Houston, Houston, Tex.
The following studies were presented at the 71st Scientific Sessions of the American Heart Association, November 8–11, 1998, in Dallas, Tex.
Heart Failure
The Trial: RALES
Presenter: Bertram Pitt, The University of
Michigan, Ann Arbor, Mich.
The study: A randomized, placebo-controlled trial of
spironolactone (an aldosterone antagonist) in
patients with severe congestive heart failure (CHF). A total of 1663
patients with a left ventricular ejection fraction
35% and NYHA class III or IV CHF who were taking ACE
inhibitors were randomized to spironolactone (25 mg/d) or
placebo. The dose of spironolactone could be increased to 50 mg/d or
decreased to 25 mg QOD at the 8-week follow-up point at the
investigator's discretion. All patients were taking ACE
inhibitors (if tolerated) and a loop diuretic, with
or without digoxin. Sixty percent of patients had an ischemic
origin of their CHF; 89% were taking ACE inhibitors at
baseline. The primary end point was the composite of total mortality
and rehospitalization. The study was originally designed to continue
for 3 years but was terminated early (after 2 years) on the
recommendation of the data safety monitoring board because of
excess benefit in the spironolactone group.
The results: There were a total of 372 deaths in the placebo
group (44%) and 283 deaths in the spironolactone group (34%).
Rehospitalization was also significantly reduced in the spironolactone
group, most prominently in rehospitalizations for exacerbation of CHF,
which were reduced 36% in the spironolactone group. The advantages of
spironolactone were evident at 3 months of follow-up and persisted
through the 2-year
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