Study finds diabetes drug increases risk of heart attacks
- From: Roman Bystrianyk <rbystrianyk@xxxxxxxxx>
- Date: 22 May 2007 05:03:49 -0700
JAMIE TALAN, "Study finds diabetes drug increases risk of heart
attacks", Newsday, May 22, 2007,
Link: http://www.newsday.com/news/health/ny-hsdrug225224516may22,0,5386526.story?coll=ny-health-print
It's taken eight years and 60 million prescriptions to identify what
researchers now say is a very worrisome side effect of the diabetes
drug Avandia. A new study suggests it may increase a person's risk for
heart attack and cardiovascular death.
Avandia, sold by the London-based GlaxoSmithKline, controls blood
glucose levels as a means of reducing cardiovascular disease
associated with diabetes. Dr. Steven Nissen and his colleagues at the
Cleveland Clinic in Ohio analyzed 15,560 diabetes patients and found
that those on medicine had a 43 percent increased risk for heart
attack and a 64 percent increased risk for cardiovascular-related
death.
"The results of this analysis raise serious concerns about the
cardiovascular safety of rosiglitazone," said Nissen, referring to the
drug's generic name. Patients with diabetes are at high risk for heart
disease, with 65 to 80 percent of deaths due to cardiovascular
problems. "When a drug increases this risk even further, it is a major
public health concern."
The study was published yesterday in an online version of the New
England Journal of Medicine.
"We remain very confident in the safety and, of course, in the
efficacy of Avandia as an important diabetic medicine," Glaxo's head
of diabetes drug development, Dr. Lawson McCartney, said in a news
conference.
The FDA held its own briefing yesterday and said it would conduct an
investigation of the drug.
Nissen and his colleague Kathy Wolski analyzed information from dozens
of studies in which patients were either on Avandia, another diabetes
drug or a placebo pill. The increase in heart attacks and death was
identified only in those taking Avandia, which was approved in 1999.
Based on Nissen's study, "the rationale for prescribing rosiglitazone
is not clear," said Dr. Bruce Psaty, a professor of medicine and
epidemiology at the University of Washington in Seattle. He co-wrote
an accompanying editorial in the journal.
There are 18 million people in the United States with Type 2 diabetes.
Avandia helps insulin work better in regulating blood glucose. Nissen
warned that patients should not stop taking the medication before
talking to their doctors. He suggested doctors read the study to make
an informed decision for patients.
.
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