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"The effect of spironolactone on
morbidity and mortality in patients with severe heart failure,"
by Bertam Pitt and 7 others, for the Randomized Aldactone Evaluation Study
investigators, New England Journal of Medicine, 341(10):709-17, 2
September 1999.
[Authors' affiliations: University of
Michigan, Ann Arbor; Clinique de Nancy, France; Cardiovascular Research
Foundation, Rotterdam, Netherlands; Hopital Henri Mondor, Creteil, France;
Searle, Global Medical Operations, Skokie, IL; Statistics Collaborative,
Washington, DC]
Abstract: "Background and
Methods. Aldosterone is important in the pathophysiology of heart failure.
In a double-blind study, we enrolled 1663 patients who had severe heart
failure and a left ventricular ejection fraction of no more than 35 percent
and who were being treated with an angiotensin-converting-enzyme inhibitor, a
loop diuretic, and in most cases digoxin. A total of 882 patients were
randomly assigned to receive 25 mg of spironolactone daily, and 841 to receive
placebo. The primary end point 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 percent) and 284 in the
spironolactone group (35 percent; relative risk of death, 0.70; 95 percent
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 percent lower in the spironolactone group than in the placebo
group (relative risk of hospitalization, 0.65; 95 percent 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 or breast pain was reported in 10 percent of men who were treated
with spironolactone, as compared with 1 percent of men in the placebo group
(P<0.001). The incidence of serious hyperkalemia was minimal in both groups
of patients. Conclusions. Blockade of aldosterone receptors by
spironolactone, in addition to standard therapy, substantially reduces the
risk of both morbidity and death among patients with severe heart
failure."
This 1999 report from the New England
Journal of Medicine was cited 25 times in current journal
articles indexed by ISI during September-October 2001. With its latest
two-month citation total, the report currently ranks as the second-most-cited
paper in medicine published in the last two years, aside from reviews. Prior
to the most recent bimonthly count, citations to the paper have accrued as
follows:
July-August 2001: 23 citations
May-June 2001: 30
March-April 2001: 27
January-February 2001: 25
November-December 2000: 28
September-October 2000: 29
July-August 2000: 18
May-June 2000: 25
March-April 2000: 21
January-February 2000: 11
September-October 1999: 2
Total citations to date: 264
SOURCE: Hot
Papers Database (Available from the ISI
Research Services Group in a CD-ROM version containing data on
hundreds of highly cited papers published during the last two years.
User interface permits searching by author, organization, journal,
field, and more. Total citations, as well as citations accrued during
successive bimonthly periods, can be assessed and graphed. Database is
combined with subscription to the ISI newsletter Science
Watch®; updated discs containing the
most recent bimonthly data are mailed with each new issue, six times a
year.)
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