Cleveland Clinic Study Shows Commonly Used Diabetes Drug Increases Risk Of Heart Attack And Cardiovascular Death
05/23/07
A drug commonly used to treat
patients with type 2 diabetes mellitus, raises patients' risk of heart
attack and cardiovascular death, according to an analysis completed by the
Chairman of Cardiovascular Medicine at Cleveland Clinic.
In an analysis of 42 trials, Steven Nissen, M.D., found that use of the
drug rosiglitazone (Avandia(TM)) raises patients' risk of heart attack and
cardiovascular death by 43% and 64%, respectively, in comparison to the use
of a placebo or other anti-diabetic therapies. The findings represent a
particular public health concern because more than 65% of the deaths
amongst diabetic patients are attributed to heart disease.
Dr. Nissen's manuscript was posted on-line by the New England Journal
of Medicine at 5 pm today and will subsequently appear in the print version
of the journal. His co-author is Cleveland Clinic statistician Kathy
Wolski.
"The results of this analysis raise serious concerns about the
cardiovascular safety of rosiglitazone," Dr. Nissen said. "While our study
was limited by lack of access to original source data, which would have
enabled time-to-event analysis, patients and providers should consider the
potential for serious adverse cardiovascular effects of treatment with
rosiglitazone for type 2 diabetes."
Rosiglitazone was approved for use by the Food and Drug Administration
in 1999, based on the drug's ability to lower blood glucose and reduce
glycohemoglobin levels. Since then, approximately 60 million prescriptions
have been issued and several million patients currently take the drug.
Rosiglitazone is one of the primary therapies used to lower blood sugar
in patients with type 2 diabetes. "However, the objective of lowering blood
sugar is the reduction of the complications of diabetes," Dr. Nissen
explains. "The effect of anti-diabetic therapy on cardiovascular outcomes
is of critical importance because cardiovascular disease represents the
overwhelming source of diabetic mortality. Unfortunately, rosiglitazone
appears to increase, rather than decrease, the most serious complication of
diabetes, heart disease."
In the 42 studies comprising the analysis, 15,560 patients were
randomized to regimens including rosiglitazone and 12,283 were assigned to
comparator groups that did not. Patients were relatively young, averaging
less than 57 years of age for both treatment groups and there was a
moderate male predominance (53-61%).
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit
multispecialty academic medical center that integrates clinical and
hospital care with research and education. Cleveland Clinic was founded in
1921 by four renowned physicians with a vision of providing outstanding
patient care based upon the principles of cooperation, compassion and
innovation. U.S. News & World Report consistently names Cleveland Clinic as
one of the nation's best hospitals in its annual "America's Best Hospitals"
survey. Approximately 1,800 full-time salaried physicians and researchers
at Cleveland Clinic and Cleveland Clinic Florida represent more than 100
medical specialties and subspecialties. In 2005, there were 2.9 million
outpatient visits to Cleveland Clinic. Patients came for treatment from
every state and from more than 80 countries. There were nearly 54,000
hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web
site address is
(Author: http://www.clevelandclinic.org)
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