GSK confirms Avandia cardiovascular safety profile

GlaxoSmithKline (GSK) has announced the presentation of data regarding the cardiovascular safety of Avandia (rosiglitazone maleate) in a letter published this week in the Lancet medical journal online.

This letter includes a number of data points to provide context and clarify the past safety record of the compound, which the firm reports is based on firm scientific evidence and a large research programme.

In the letter, GSK notes the low frequency of adverse events in trials of the compound – at 0.6 per cent for both control and Avandia group patients, while also reporting that the incidence of ischemic cardiovascular events in patients administered with the compound is comparable to other top treatments for type two diabetes.

Furthermore, the company reports that its managed care database of 30,000 diabetes patients shows comparable hospitalisation rates for Avandia compared to other treatments, while an independent board has decided to continue the ongoing Record trial of the drug.

The company summarised: “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.”

Last week, GSK responded to an article regarding the cardiovascular safety profile of Avandia, claiming that the meta-analysis of data upon which the article was based lacked precision and was not adequately equipped to provide any definite conclusions regarding the incidence of adverse events in patients.