* Higher death rate seen in two Benicar studies
* FDA has not concluded Benicar increases death risk
* Agency believes benefits still outweigh risks
(Adds Daiichi comment, study details)
By Bill Berkrot
NEW YORK, June 11 The U.S. Food and Drug
Administration is looking into whether Daiichi Sankyo's
(4568.T) blood pressure medicine Benicar increases the risk of
heart-related death, although the agency said it still believes
the benefits of the drug outweigh its potential risks.
The FDA said it is evaluating data from a pair of clinical
trials in which diabetes patients taking the drug, known
chemically as olmesartan, had a higher rate of death from heart
related causes compared with patients taking a placebo.
In a safety notice posted on Friday, the agency cautioned
that it has not concluded that Benicar increases the risk of
death, and Daiichi has expressed its confidence in the drug.
In addition to reviewing data from the two studies, the FDA
said it is considering additional ways to assess the
cardiovascular effects of Benicar.
In the long-term trials, patients with type 2 diabetes were
given either Benicar or placebo to determine whether Benicar
would slow the progression of kidney disease or progression of
In the larger of the two trials, Benicar did appear to slow
the onset of kidney disease, Daiichi said.
But an unexpected finding in both trials was a greater
number of deaths from heart attack, stroke or sudden death in
the Benicar-treated patients compared with those who took a
placebo, the FDA said.
"Olmesartan has been around for a long time, and the class
of drugs has been around for a very long time. We've been very
confident, as the FDA has been, in both the efficacy and the
safety," Daiichi's chief scientific officer, Dr. Glenn Gormley,
said in a telephone interview.
There are several classes of drugs that work through
different mechanisms to treat high blood pressure. Benicar
belongs to a class known as angiotensin receptor blockers, or
ARBs, that are also used to prevent kidney failure.
Other ARBs include Merck & Co's (MRK.N) Cozaar and
Novartis AG's NOVN.VX Diovan.
"There was a numerical imbalance in some of the
cardiovascular side effects," Gormley said. "We've never seen
that before in other studies and I don't think we've seen that
with other ARBs."
In the larger of the two studies, which included more than
4,400 patients divided about evenly between those taking
Benicar or placebo, there were 15 heart-related deaths in the
drug group versus three on placebo.
In the other 557-patient study, there were 10 heart deaths
in the Benicar group compared with three on placebo.
"It's a very small number and the FDA would just like to
understand it better, as we would," said Gormley, adding that
the company is working with the agency to help with the
The FDA is encouraging healthcare professionals and
patients to report adverse events or side effects related to
the use of Benicar.
(Reporting by Bill Berkrot; Editing by Tim Dobbyn and Gerald