GlaxoSmithKline has received a major boost after data from a major study suggested that Avandia showed no increased cardiovascular risk compared with other type 2 diabetes treatments.

Data was presented at the American Diabetes Association meeting in New Orleans, and published in The Lancet, from the RECORD trial. In the study, 2,220 patients were treated with Avandia (rosiglitazone) as an add-on to metformin or sulphonylurea, and 2,227 patients were given a combination of metformin and sulphonylurea. GSK said the findings demonstrateded that "cardiovascular hospitalisation and cardiovascular death was not statistically different between the two groups after an average of 5.5 years of therapy."

GSK also noted that glycaemic control was significantly better in the Avandia group. Philip Home, chairman of the RECORD steering committee and a professor at Newcastle University, said the data “provides a robust assessment” of Avandia’s cardiovascular safety and “leads us to conclude that rosiglitazone carries no increased risk of overall cardiovascular death or hospitalisation compared to the most commonly used diabetes medicines…which have been used for decades,”

This represents good news for Avandia which has been plagued with safety concerns about a notorious meta-analysis in 2007 authored by Steven Nissen of the Cleveland Clinic which linked the drug to a 43% increased risk in heart attacks and strokes. However the findings of RECORD are being questioned.

In a editorial, Ravi Retnakaran and Bernard Zinman of Mount Sinai Hospital in Toronto wrote that “definitive conclusions about the relation between rosiglitazone and cardiovascular disease remain elusive, owing to study limitations”. Two of the problems in analysing the data included a significant number of people in the Avandia group taking statins and 45% of participants dropped out of the trial at some point.

Dr Nissen said that "it is impossible to assess the safety of a drug when patients are not actually taking it," but GSK responded by noting that patients dropped out near the end of the study and did not affect its primary aim.

Syncria shows promise
Staying with the ADA meeting and GSK presented Phase II data which showed that Syncria (albiglutide) reduced blood glucose levels and provided weight loss in various dosing options, compared with placebo or Eli Lilly's and Amylin's blockbuster Byetta (exenatide).

Syncria, like Byetta, is a glucagon-like peptide-1 (GLP-1) analogue, and the data from the 356-patient study showed that the GSK drug, administered once-weekly, reduced HbA1C by 0.9% compared to 0.5% for Byetta, which is injected twice-daily. A Phase III trial was initiated earlier this year.