Dec. 4, 2009 -- Concerns that the diabetes drugs Avandia and Actos raise
the risk for
heart failure led the FDA to require label changes warning of the potential
risk two years ago.
Now a new study suggests this concern might be unfounded, but it also raises
questions about a different class of oral diabetes drugs that have been used
since the 1950s: sulfonylureas.
Researchers reported that diabetes patients who used sulfonylureas had a
higher risk of death from all causes and a higher risk of heart failure than
diabetes patients who used the most widely prescribed diabetes drug,
Compared with metformin, also known as
Glucophage, single-drug treatment with first- and second-generation
sulfonylureas was associated with up to a 61% increased risk for death. Users
of second-generation sulfonylureas had up to a 30% higher risk for congestive
Patients treated with Actos or Avandia did not appear to have a greater risk
heart attacks than those treated with metformin.
As many as 180 million people worldwide have
type 2 diabetes, and heart attacks and heart failure are among the major
killers associated with the disease.
Over the past two decades, a host of drugs have been approved to treat
diabetes. The drugs improve blood sugar control, but there have also been
concerns that some may raise the risk of cardiovascular events in people who
are already at high risk.
In an effort to explore the issue, researchers in the U.K. examined the
treatment records of more than 91,000 diabetes patients enrolled in a national
database between 1990 and 2005.
During the follow-up, almost 36,000 patients had heart attacks, 6,900
developed congestive heart failure, and just over 18,500 died.
Metformin was the most widely prescribed drug, followed by second-generation
sulfonylureas. Many patients took more than one diabetes drug.
Among the major findings:
Compared with metformin, single-drug treatments with first- or
second-generation sulfonylureas was associated with a 24% to 61% increased risk
for death from all causes.
Compared to metformin, second-generation sulfonylurea use was associated
with an 18% to 30% increased risk for heart failure.
Compared to metformin, treatment with Actos was associated with a 31% to
39% decreased risk for death.
Metformin as a First-Line Treatment
First-generation sulfonylureas in this study include the drugs acetohexamide
and tolazamide (Tolinase).
Second-generation versions from the study include glipizide (Glucotrol),
(Amaryl), and glyburide (Diabeta, Micronase, Glycron, Glynase).
Study researcher Ionna Tzoulaki, PhD, of the Imperial College London, tells
WebMD the findings are consistent with current recommendations by the American
Diabetes Association (ADA) and other diabetes groups designating metformin as
the first-line oral treatment for type 2 diabetes.
ADA president-elect for medicine and science Richard M. Bergenstal, MD,
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