GlaxoSmithKline (GSK) confirms that a letter to the editor summarising additional Avandia cardiovascular safety data from several large-scale clinical trials was published online today in The Lancet.
This letter, written by Ronald L. Krall, MD, Chief Medical Officer of GlaxoSmithKline, provides the necessary context and clarifies the safety record of Avandia, which is based on sound science and backed by one of the largest research programs ever in diabetes.
Key data points include:
The recent meta-analysis published in New England Journal of Medicine, which has been widely cited in media reports, omitted the total percentage number of events. The actual number of heart attacks represents a very low frequency of events ? 0.6% for both Avandia and the control group (Avandia 86/14,371; control 72/11,634).
Further analyses from ADOPT and DREAM ? two long-term prospective clinical trials ? show that the incidence of ischemic cardiovascular events with Avandia is comparable to the two gold standard medicines used to treat type 2 diabetes (metformin or a sulfonylurea) in the ADOPT study, and to placebo in the DREAM study.
Findings from a soon-to-be-published study, using a managed care database of more than 30,000 diabetes patients in a real-world setting, show the incidence of hospitalisations for heart attack, and/or for a surgery known as revascularisation for patients on Avandia is the same as for other diabetes treatments.
The independent safety monitoring board for the RECORD trial ? a large, long-term clinical trial, which has been designed to look at cardiovascular outcomes in people with diabetes? reviewed an interim analysis of cardiovascular endpoints in all study participants, and determined that the study should be allowed to continue.
To summarise, data from long-term, large-scale, prospective clinical trials show that the overall ischemic cardiovascular safety profile, including cardiovascular death, among diabetes patients treated with Avandia is comparable to patients treated with two other widely used diabetes medicines.
Avandia is an effective medicine that is an important treatment for millions of patients who are using it to manage their diabetes, a disease with potentially devastating consequences if left unmanaged.
Diabetes is at epidemic proportions, and GlaxoSmithKline believes that a balanced and responsible approach to assessing the risks and benefits of all available treatments is in the best interests of patients and everyone with a stake in treating this disease successfully.