July 5, 2010 – Should the anti-diabetic drug Avandia, which, according to two important studies, increase the risk of myocardial infarction, stroke, heart failure and death, be taken off the market?
This is the question the Food and Drug Administration (FDA) is looking into in the United States, and the conclusion of which could influence Health Canada.
Last week, two studies concluded that taking Avandia (rosiglitazone), prescribed to treat high blood sugar in people with type 2 diabetes, increased from 25% to 28% (1.25 to 1.28 times) the overall risk of having a heart attack, stroke, heart failure or death, compared to diabetics who take Actos (pioglitazone).
It has been known since 2007 that Avandia poses an increased risk of heart problems. In the United States, the FDA has created a committee to assess the appropriateness of maintaining rosiglitazone on the market, based on studies conducted on the subject.
Both studies were first published on the Internet when this committee was due to meet.
Published in the JAMA, the first study1 has followed more than 227,000 diabetics aged 65 and over since 2006. It concludes that Avandia causes additional heart disorder for every 60 patients treated with this drug for 1 year.
The second study2, which evaluated 56 clinical trials including more than 35,000 patients, comes to a similar conclusion: treating 58 patients with Avandia for 1 year results in an additional case of heart problem.
Towards a withdrawal from Avandia?
The authors of these two studies believe that the risks associated with the use of Avandia outweigh the benefits that the drug can provide. They also question the relevance of continuing to prescribe it.
This is also the opinion of a Canadian diabetes specialist, Dr.r David Juurlink. In an editorial accompanying the study published in the JAMA, this indicates that it is “difficult to justify why a patient would want to receive [l’Avandia] or why a doctor would prescribe it, while there are other safer drugs ”.
Last May, the Dr Juurlink even argued that this drug should be withdrawn from the US and Canadian markets because of the risk it poses to the health of patients.
In this regard, he also called on the FDA to stop a cohort study, called TIDE, which aims to recruit 16,000 patients to compare the effect of Avandia, with that of Actos – another hypoglycemic drug – and to that of vitamin D, on diabetics4.
Martin LaSalle – PasseportSanté.net
1. Graham DJ, et al, Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone, Journal of the American Medical Association (JAMA) 2010 Jun 28; 304 (4) 🙁 doi: 10.1001 / jama.2010.920).
2. Nissen SE, et al, Rosiglitazone Revisited – An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality, Archives of Internal Medicine2010 Jun; 170 (14). (doi: 10.1001 / archinternmed.2010.207).
3. Juurlink DN, Rosiglitazone and the Case for Safety Over Certainty, JAMA, published online June 28, 2010 (doi: 10.1001 / jama.2010.954).
4. McAllister J, La rosiglitazone sur la hotette, Profession Santé, June 14, 2010. To access this article, you must register on the site www.professionsante.ca.
