Inexpensive Medication Cuts Heart Failure Hospitalizations in New Study
Watertown, MA, November 18, 2013 – Important new clinical trial results show that a
medication, available for decades, may significantly reduce the risk of hospitalization in people
with less severe heart failure (clinically recognized heart failure, but with the heart pumping
normally – an ejection fraction ≥ 45%). This study investigated the effect of the inexpensive
medication spironolactone on cardiovascular death, cardiac arrest, or hospitalization specifically
for heart failure. While spironolactone did not reduce the risk of having at least one of these
three outcomes, it did significantly reduce the risk of one component – hospitalization
specifically for heart failure, when compared to a placebo.
“It is exciting to show that heart failure hospitalizations can be reduced by using a long-
established, low-risk, and inexpensive drug,” said Sonja McKinlay PhD, Principal Investigator on
TOPCAT and President of New England Research Institutes, which served as the study’s
Clinical Trial Coordinating Center, collaborating with clinicians at Brigham and Women’s
Hospital, under the leadership of Marc Pfeffer MD, and with the study Chair, Bertram Pitt, MD.
Spironolactone has been used for decades to lower blood pressure and for other medical
conditions. Previous studies showed that it reduced the risks of heart-related death and
hospitalizations in people with heart failure and a dilated heart (not pumping efficiently).
TOPCAT is the first large-scale study to look at whether the medication also works in people
with heart failure, but with a heart able to pump reasonably efficiently.
3445 participants with this kind of heart failure from 270 medical centers around the world took
part in the study. Roughly a third of participants came from centers in the United States.
Participants were randomly assigned to get either spironolactone or placebo (average dose of
30 mg. daily). They were then monitored for an average of nearly 3.5 years. At the end of the
study, 206 out of 1722 patients on spironolactone (12%) had been hospitalized for heart failure,
compared to 245 of 1723 patients (14%) given the placebo. Considering all heart failure
hospitalizations over the entire study period, the average number of heart failure hospitalizations
per person was also lower in the spironolactone group than the placebo group. There were no
statistically significant differences between the groups in deaths or hospitalizations from any
cause, incidence of serious low blood pressure, or of other serious adverse events.
Investigators note that patients taking spironolactone must have their potassium and creatinine
levels checked regularly in order to use the drug safely and achieve its benefits.
“Heart failure with preserved ejection fraction is a serious and increasingly prevalent disease,
and despite progress, there are no evidence-based options for treatment,” said Marc A. Pfeffer,
TOPCAT Clinical Principal Investigator and Dzau Professor of Medicine at Harvard Medical
School and Brigham and Women’s Hospital. “The reduction in heart failure hospitalizations
observed in TOPCAT represents a real step forward in the treatment of heart failure patients
The size and international nature of the TOPCAT study was a challenge for the researchers at
NERI who coordinated all aspects of the study. Two key indicators of how successfully NERI
addressed these challenges are the speed with which the final, massive, database was finalized
(only 3 months after the last study participant finished the trial) and the incredibly short time
between the database “lock” and submission of the results for publication (only 1 month).
NERI is a global, privately held specialty Contract Research Organization providing customized
clinical trial solutions and patient registry services to pharmaceutical, biotechnology, biomaterial
and medical device companies. NERI also has extensive experience collaborating on federally-
funded research with organizations like the National Institutes of Health. Since its founding in
1986, NERI has earned widespread recognition for its scientific credibility, efficiency, and
expertise in conducting clinical trials in a variety of medical specialties. For more information,
TOPCAT was funded by National Heart, Lung, and Blood Institute, Contract Number
HHSN268200425207C. Registration: ClinTrials.gov NCT00094302
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