Diabetes Drugs and Heart Risk
New Studies Link Avandia, but Not Actos, to Heart Attacks
Study: Actos Has Heart Attack-Stroke Benefit, Not Risk
The second JAMA study analyzes clinical trial data on Actos. It comes from
Cleveland Clinic researchers A. Michael Lincoff, MD, and colleagues --
The study shows that Actos does not increase risk of heart attack but
instead reduces diabetes patients' risk of heart attack, stroke, and death by
"We can say with confidence that Actos not only does not have the risk
seen with Avandia, but has a benefit beyond that," Lincoff tells WebMD.
"I am a cardiologist, not a diabetologist. But if a drug of this class is
thought to be a good drug for a diabetic patient, Actos has benefit beyond its
blood sugar and insulin-resistance indications for reducing death and heart
attack and stroke; all reduced about 20%."
An editorial accompanying the studies notes that the two drugs have
"strikingly different" effects on heart attack risk. Editorialist
Daniel H. Solomon, MD, PhD, is associate professor of medicine at Harvard
Medical School and a rheumatologist in the division of pharmacoepidemiology at
Brigham and Women's Hospital, Boston.
"While this is by no means definitive -- we don't absolutely know the
two drugs are different -- there is increasing evidence the two agents produce
different effects regarding [heart attack and stroke] complications. If one is
thinking about taking one of these drugs, one should take this into
account," Solomon tells WebMD.
GSK takes issue with the Lincoff study. The company notes that much of the
data comes from a study funded by Actos maker Takeda Pharmaceuticals.
"No clinical head-to-head trial data specifically evaluates
cardiovascular risk between Avandia and Actos; however, the head-to-head data
that does exist, and the overwhelming majority of comparative observational
data, show no significant differences in cardiovascular events," the GSK
statement says. "Analyzed studies show no difference in the [heart attack
and stroke] effects of Avandia versus other oral antidiabetic medicines,
Lincoff says the new analysis offers new information on Actos.
"The previous study showed the reduction in heart attacks in a high-risk
group of patients," he says. "This now includes patients at lower risk,
without established risk of heart disease, and we saw the same results. There
is the same benefit in all subgroups. All of the data points in the same
direction. It is much more reassuring that these results are indicative of the
real outcomes in patients."
Robert Spanheimer, MD, Takeda's senior medical director for diabetes, agrees
that the Lincoff study strengthens the conclusions of the Takeda-funded study
of Actos's heart-related effects.
"This information, combined with the [earlier] study, should give
patients the confidence that Actos does not increase heart attack-related
events or mortality," Spanheimer tells WebMD.
Actos, Avandia: New Drug Class, New Side Effects
Actos and Avandia are the two available members of a class of drugs called
thiazolidinediones, TZDs, or PPAR agonists. They're also called glitazones,
after the suffix used in the drugs' generic names.