The following is GlaxoSmithKline?s [NYSE:GSK] response to editorials written in the New England Journal of Medicine (NEJM) regarding Avandia? for the treatment of type 2 diabetes.
We believe the NEJM editorials are selective in their use of data to support a biased view, and therefore do a disservice to patients, physicians, science and public health.
Dr. Home?s paper as published in the NEJM, clearly shows that the hypotheses in Dr Nissen?s paper have not been validated. The paper says the data do not allow a conclusion regarding myocardial infarction; yet the editorials largely ignore this point, and seem to assume this risk is self-evident. None of the editorials mention the fact that RECORD refutes the second element of Dr. Nissen?s hypothesis, a suggested 64% increase in cardiovascular deaths. RECORD shows a 17% decrease in risk of cardiovascular death.
Editorial comments on ADOPT also selectively ignore the fact that cardiovascular events with metformin – the gold standard therapy ? were comparable to those on Avandia. This ignores the experience of one-third of the patients in this trial.
Dr. Home?s peer reviewed paper also concludes: ?There is no evidence of any increase in death from either cardiovascular causes or all causes.? In addition to not referencing that patients on Avandia had 17% fewer deaths from cardiovascular events, the editorials also ignore the fact that there was no increase in all-cause mortality, and no increase in the MACE endpoint, comprised of CV mortality, myocardial infarction and stroke. These endpoints are very relevant for patients and their physicians.
The editorials continue to place equal emphasis on a meta-analysis compared with a much more rigorous, prospectively designed trial to look at cardiovascular safety, such as RECORD.
Though criticized by the editorials, cardiovascular event rates in the RECORD study are low because of the appropriate and intensive management of patients? type 2 diabetes, including glucose, blood pressure and lipids. This is a good thing for diabetes patients. The impact of the improved medical care for type 2 diabetic patients should be applauded and supported, because it represents a very important advance in the treatment of diabetic patients and public health.
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