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 The data presented on Monday had some potentially troubling side
effects that researchers said need further analysis, but they felt
the benefits outweighed the risk.
"I think this is a big deal," said Dr. Marc Pfeffer of Brigham and
Women's Hospital in Boston, who critiqued the study at an American
Heart Association scientific meeting in Orlando, Florida.
Treatment guidelines should be changed accordingly, he said. "If
there is a problem with an individual patient, you can always back
off."
The scheduled five-year study of more than 9,300 patients with
hypertension was stopped almost two years early after independent
monitors saw a clear benefit on mortality and other risk factors.
Preliminary results comparing patients whose blood pressure was
lowered to below 120 versus those with a target of under 140 were
announced in September, a month after the study was halted. More
detailed data unveiled at the AHA meeting showed additional benefits
of more intensive lowering of systolic pressure, the top number in a
blood pressure reading.
Blood pressure of 140 over 90 has been a commonly used target, but a
lack of consensus was a prime reason for conducting the trial.
Heart failure, a leading cause of hospitalizations, was reduced by
38 percent, and death from heart-related causes was 43 percent lower
in the more aggressively treated patients, researchers found.
Previously reported findings showed reducing blood pressure to below
120 cut the combined rate of heart attacks, strokes and heart
failure by almost a third, and the risk of death from any cause by
nearly a quarter.
But the more intensive treatment group had 1-2 percent higher rates
of adverse side effects, including hypotension, or unusually low
blood pressure, fainting, electrolyte abnormalities and, perhaps
most troubling, kidney damage or failure.
The rate of kidney problems was 4.1 percent in the lower blood
pressure group versus 2.5 percent for the under 140 group.
Patients over age 75 appeared to have no additional problems
tolerating more intensive treatment, which researchers found
comforting.
People who had a prior stroke or diabetes were excluded from the
study, but 30 percent had chronic kidney disease. High blood
pressure is considered a leading risk factor for heart disease,
kidney failure and other health problems.
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DEBATE ON GUIDELINES LIKELY
The results are sure to set off a lively debate over whether
guidelines for treating hypertension should be changed to the lower
target.
"The magnitude of benefit has been so clearly demonstrated that we
do believe the evidence from the Sprint trial should be considered
when providers and the guidelines committees decide what should be
the optimal blood pressure target," said Dr. Jackson Wright, lead
author of a New England Journal of Medicine article, on the study.
Researchers are still analyzing the data to see if more intensive
blood pressure lowering affects cognitive decline one way or the
other, or has an impact on long-term kidney disease.
The lower blood pressure was achieved by adding one additional
medicine, for an average of three medications, from a variety of
classes available as inexpensive generic drugs.
The classes include angiotensin receptor blockers, or ARBs, such as
Novartis' Diovan, calcium channel blockers, like Pfizer's Norvasc,
ACE inhibitors, including Pfizer's Altace, and diuretics, such as
Merck's Hyzaar.
(Reporting by Bill Berkrot; Editing by Richard Chang)
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