Critics Split on New Avandia Study

CanadaA Canadian study suggests new benefits to taking Avandia, but critics disagree on exactly what the results mean. The study was published at the same time settlements were announced in lawsuits concerning Avandia risks, which reportedly include an increased risk of heart attack and stroke.

The Canadian study, published in the British journal The Lancet on 6/03/10, found that a low-dose combination of Avandia and metformin could reduce the progression of type 2 diabetes in people who are at risk of developing the condition. The study, called CANOE (Canadian Normoglycemia Outcomes Evaluation), suggested that the risk of developing Type 2 diabetes was lowered by 26 percent when patients were given half doses of both Avandia and metformin.

The study, however, was funded by GlaxoSmithKline, maker of Avandia. The intent was to show that lower doses of the two drugs would provide the benefits of both drugs without the side effects.

A study comparing the safety of Avandia with that of another drug in its class, Actos, is currently underway, although critics have called to end it on the grounds that the study is unethical. They cite the risks associated with Avandia and argue that patients in the trial are put at unnecessary risk of serious health problems.

Researchers involved in the CANOE trial said they saw no sign of serious side effects in the people in their trial, but noted that the study was very small and consisted of approximately 200 subjects. The study was also not designed to consider cardiovascular issues.

One critic of the study, Dr. Victor Montori, said that putting patients on low-dose Avandia early does not delay the onset of diabetes, but rather speeds up the process of treating at-risk people as though they have diabetes. The treatment does not avert the development of diabetes; it simply masks the condition.

Dr. Baiju Shah at Sunnybrook Health Sciences Centre said the study does not show that use of a low-dose Avandia-metformin combination is any more effective than high-dose metformin on its own. Shah also does not agree with treating patients for a condition they do not yet have.

Many doctors agree that lifestyle changes, including exercise and losing weight, are the best way to prevent glucose intolerance from turning into type 2 diabetes.

GlaxoSmithKline faces thousands of lawsuits concerning Avandia side effects, approximately half of which are said to have been settled. The next Avandia lawsuits are scheduled for court in October 2010.