April 28, 2008 -- The "glitazone" diabetes drugs Actos and Avandia may double or triple the risk of broken bones
after a year or two of use.
The finding comes from Swiss researchers who analyzed 12 years of data on
U.K. diabetes patients. They compared the 1,020 patients who suffered some kind
of fracture to 3,728 matched patients who did not break any bones.
Over the course of the study, most of the patients took several diabetes
drugs. But those who refilled their Actos or Avandia prescriptions eight times or
more -- about 12 to 18 months of use -- had nearly twice the fracture risk of
And those who refilled their Actos or Avandia prescriptions 15 times or more
-- two or more years of treatment -- nearly tripled their risk of fracture,
found Christophe R. Meier, PhD, head of pharmacoepidemiology research at
University Hospital Basel, Switzerland, and colleagues.
"We found a very strong signal here for higher risk of fractures in people taking glitazones," Meier tells
WebMD. "Our evidence fits together nicely with animal models and clinical
reports suggesting that these drugs have a detrimental effect on bone. And we
did not find any increased risk for other diabetes drugs, so all together, it
looks like something really is going on here."
The Meier study, all by itself, looked at too few patients to prove
anything. But University of Pittsburgh researcher Jane A. Cauley, DrPH, who has
studied bone loss in people with diabetes, agrees with Meier that it adds to a
growing body of evidence.
"These animal and laboratory studies show these drugs interfere with the
cells that grow new bone," Cauley tells WebMD. "That there is basic
research supporting this study is important."
Nancy Pekarek, vice president of corporate media relations for
GlaxoSmithKline, notes that Avandia already has language on its label warning
users of possible fracture risk. She notes that the ADOPT clinical trial of
Avandia did not detect increased hip or spine fractures, although it did find
increased upper arm, hand, and foot fractures in women but not in men.
Meier, whose study showed increased fractures in both women and men, says
the difference might be that patients in his study had an average age over 60,
while the average age of ADOPT patients was in the mid-50s.
"Previous findings in younger individuals with fractures at the lower
and upper distal limbs might reflect the kinds of fractures that younger women
would tend to experience," Meier and colleagues suggest in their
Meier does not think either Avandia or Actos should be taken off the market.
He strongly agrees with Pekarek that all drugs carry risks, including other
types of diabetes drugs.
Given that Avandia has also been linked to heart risks, Cauley suggests that
patients should try older diabetes drugs before trying either Avandia or
Takeda Pharmaceuticals, which makes Actos, was unable to respond to WebMD's
request for comment in time for deadline.
Meier and colleagues' report, and an accompanying editorial by Cauley,
appear in the April 28 issue of Archives of Internal Medicine.
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