Issued: 17 July 2007, Philadelphia, PA

The following is GlaxoSmithKline’s [NYSE: GSK] response to an online review published by The Cochrane Collaboration titled “Rosiglitazone for type 2 diabetes mellitus.”

This review is another analysis of existing data that have previously been reported. GSK believes that the limited number of studies evaluated generate misleading conclusions and provide no new evidence about the use of rosiglitazone in clinical practice and research.

The review includes 18 already existing studies and does not include all data available on GSK’s Clinical Trial Register. Rosiglitazone has been studied in one of the largest programs ever undertaken to evaluate the safety and effectiveness of a medicine (52,000 patients) and the largest for any oral anti-diabetic medicine to date.

Furthermore, the studies included in the review primarily measured differences in blood glucose control over the short term, not mortality or morbidity outcomes. It is therefore not surprising that positive conclusions were not drawn on this outcome.

The conclusions regarding increased cardiovascular risk are not substantiated by the totality of the existing data on rosiglitazone. The authors performed their own meta-analysis on myocardial infarction rates and could not confirm any significant difference in risk between rosiglitazone and control groups.

Questions about the safety of rosiglitazone should be answered by reviewing the totality of the evidence, in particular long-term prospective studies. In ADOPT, all major adverse cardiovascular events (MACE) were analysed and such events were rare in this population and comparable for all treatments - rosiglitazone, metformin and glibenclamide. Furthermore, RECORD, the only study specifically designed to look at cardiovascular outcomes, was not included in the review. Though RECORD is ongoing, the interim findings do not show evidence of a difference in cardiovascular death between rosiglitazone and control groups and showed no significant difference for heart attack.

The review concludes that no clinically relevant differences regarding metabolic control were noted between rosiglitazone and other anti-diabetic therapies. The conclusion is drawn primarily from a limited number of short-term studies, when clinical guidelines have highlighted the importance of maintaining long-term glycaemic control. ADOPT, the only long term study (4-6 years) that compares rosiglitazone with metformin and glibenclamide found that rosiglitazone maintained glycaemic control for longer than these commonly used agents (a 32 and 63 percent risk reduction of monotherapy failure compared to metformin and glibenclamide respectively).

GSK strongly disagrees with the authors’ conclusion which questions the ethics of starting new studies with rosiglitazone. We are committed to patient safety and carry out our clinical trials with the highest level of ethical conduct. The totality of the data - including long-term studies such as ADOPT and RECORD and an epidemiological analysis of more than 33,000 patients in a US managed care database - show that rosiglitazone has a comparable ischaemic cardiovascular profile to other oral anti-diabetic medicines. GSK stands firmly behind the safety profile of rosiglitazone when used appropriately.

GSK is strongly committed to full transparency of our scientific information. We have actively shared our data on rosiglitazone with regulatory agencies worldwide as quickly as scientifically possible. We have updated the rosiglitazone label over time in order to help physicians appropriately care for their patients. Data is made available to scientists in the public domain in a variety of ways, including postings on our Clinical Trial Register, which GSK was one of the first to develop and contains results from 114 clinical trials on rosiglitazone.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

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