Intensive Glucose Lowering and Cardiovascular Outcomes N Engl J Med 2011; 364:2263-2264 June 9, 2011
If you can't get the full letter to display here are the salient statements it contains. The quote refers to the ACCORD study where the intensive-therapy group was the group of people with Type 2 Diabetes who were urged to get their A1c down below 6.5%:
44.7% of subjects in the intensive-therapy group, as compared with 25.2% of patients in the standard-therapy group, received rosiglitazone [Avandia] just before the study transition date. According to the 2008 article summarizing the results of the ACCORD trial up to the point of protocol transition, 91.2% of subjects in the intensive-therapy group, as compared with 57.5% of patients in the standard-therapy group, had received rosiglitazone.The signers of this letter are Almut G. Winterstein, Ph.D., University of Florida, Gainesville, FL, Susan R. Heckbert, M.D., Ph.D., University of Washington, Seattle, WA, and Morris Schambelan, M.D. University of California, San Francisco, CA.
Although other differences in drug exposure warrant further analysis, we think that the authors[of the ACCORD publications] should consider (and address in a secondary analysis) the role of rosiglitazone in the excess deaths from cardiovascular causes, especially in the absence of biologic plausibility of a glucose-mediated effect. Given unbalanced exposure, we think that the ACCORD trial is inconclusive and that the recommendation to abandon lower glucose targets is not supported and has unknown consequences for the long-term management of diabetes. [Emphasis mine]
This is a VERY important point. The ACCORD results have been used to justify doctors' and insurers' refusal to give people with Type 2 the medications and blood sugar meters they need to achieve normal blood sugars. Since it was published and interpreted as meaning that intensive efforts to your lower blood sugar will result in your having a higher risk of experiencing a heart attack I have heard from dozens of people whose doctors cautioned them to keep their A1c at 7.0% or higher and based their conclusions on this study.
This kind of toxic advice has been given to many thousands of people with Type 2 diabetes who will go on to suffer unnecessary diabetic complications that become inevitable at A1cs over 6.0% .
My guess is that the makers of Avandia had something to do with the fact that the health media blamed the excess heart attacks that occurred in the lower A1c group on their lower blood sugar rather than on these subjects' taking a drug that raises the risk of heart attacks.
It is odd, isn't it, that these journals did not make public in accessible form the numbers linking this exposure to Avandia with the excess deaths in ACCORD until now, after Avandia has been, for all practical purposes, taken off the market.
Coinicidental? I think not. Not with the power GlaxoSmithKline wields with its huge advertising budget and its research grants. No media outlet is going to risk losing those full two- and three- page drug company spreads just to save the limbs, vision and kidneys of a bunch of fat old people with diabetes.
Shame on the mainstream medical journals for not making this information public when they first knew of it.