Both Avandia and Actos may raise fracture risk
A new study in the Aug 2010 issue of Diabetes, Obesity & Metabolism suggests that using diabetes drug Avandia or its competitor Actos, both indicated to treat diabetes patients to help control blood sugar, increases fracture risk in both men and women.
Avandia has stirred a debate over its safety. Some studies have found Avandia increases risk of heart attack in diabetes patients. but the FDA advisory committees on Wednesday recommended keeping Avandia on the market.
Dr. David Graham, a drug safety examiner of the FDA and Dr. Steven Nissen, a distinguished cardiologist at Cleveland Clinic said Avandia needs to be pulled off the market not only because it has been found riskier in terms of myocardial infarction risk than its competitor ACTOs, but also because the available Actos is much safer.
But the new study led by Aubert R.E. and colleagues from Medco Health Solutions in Franklin Lakes, New Jersey found both Avandia and Actos increased risk of fracture in diabetics.
The study was meant to determine whether both or either drug in a class called thiazolidinedione or TZD is associated with an increased risk of fracture in men and women with type 2 diabetes mellitus.
What the researchers did is analyse data extracted from a research database of integrated pharmacy and medical claims using Cox models. Factors considered included age, gender, chronic obstructive pulmonary disease, asthma, osteoporosis, stroke, prior fracture and chronic disease score.
The participants were followed for 540 days.
Aubert et al. found diabetes patients, men and women alike, who were exposed to TZD, were 39 percent more likely to suffer fracture, compared to control patients who did not use either Avandia or Actos.
Men treated with Avandia or Actos had a 47 or 43 percent increased likelihood of fracture respectively than control patients. The increases in the fracture risk induced by these two TZDs were identical.
Avandia or Actos increased a higher risk of fracture in women aged above 50 and below 50 and in men, the risk was increased in those aged above 50 years, according to the study. This result suggests that younger women are more susceptible to the influence of these TZds while younger men are less vulnerable.
Avandia is made by GlaxoSmithKline or simply Glaxo and Actos is made by Takeda Pharmaceuticals North America, Inc.
Type 2 diabetes is believed to affect an estimated 20 million Americans. Although risk factors are largely adjustable or controllable, diabetes if acquired can be serious. Cardiovascular disease is one of the major complications of diabetes.
By David Liu



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