GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)

Issued: London UK

GlaxoSmithKline (GSK) continues to work in the best interest of diabetes patients who face this chronic and serious disease. Patients taking Avandia should speak with their doctor about their treatment and any questions they may have regarding their medicine.

Contrary to suggestions within the article produced by BMJ journalists, GSK has carried out an extensive research programme involving more than 50,000 patients to analyse the safety and benefits of rosiglitazone. No other diabetes medicine introduced in the last 10 years has such an extensive safety database.

We reject any suggestion that there is a lack of publicly available trial results related to rosiglitazone for independent scientific scrutiny. We have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.

The company is fully committed to maintaining best practice disclosure of clinical data for all its medicines to serve the interests of patients, physicians and regulators.

The European and US medicines regulatory authorities are currently reviewing the benefit risk profile of Avandia based on the totality of the data. GSK acknowledges the efforts of these independent bodies to apply scientific rigour to enhance understanding of the benefit-risk profile of our medicine and we will continue to work with regulatory authorities worldwide in the best interest of patients.

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Notes to Editors:

Results from six long-term randomised cardiovascular safety trials, which included rosiglitazone, have been publicly reported since the medicine was previously reviewed in 2007. These randomised studies are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines. Together, these data have shown that rosiglitazone does not increase the overall risk of heart attack, stroke or death compared to other diabetes treatments.

The results from the RECORD study, announced in 2009, showed there was no statistical difference in cardiovascular hospitalisation or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) between the two study groups after an average of 5.5 years of therapy. RECORD is the largest and longest prospective clinical trial specifically examining cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea. It was conducted according to Good Clinical Practice and the FDA recently stated that there is no evidence “of systemic or pervasive findings that would undermine the reliability of the RECORD data”.

This study also showed that patients receiving Avandia achieved sustained blood sugar control, as measured by mean hemoglobin A1c. Although RECORD was not designed to study microvascular endpoints, previous studies such as the United Kingdom Prospective Diabetes Study, which studied other medicines, have found that improved blood sugar control may reduce complications of diabetes that can lead to amputations, kidney failure and eye damage.

GSK has consistently indicated that the studies used within the GSK meta-analysis published in 2006 and other subsequent meta analysis were not designed to assess CV safety. This type of analysis can be useful for raising scientific questions, but it cannot definitively determine risk. We continue to believe that from the totality of the data – particularly randomised controlled studies – Avandia is a safe and effective diabetes medicine when used appropriately according to its labelling.

At GSK we are committed to running our business in a responsible and open way. Within our 2009 Corporate Responsibility report, GSK provided comprehensive details on a wide variety of its activities including raising ethical standards, increasing transparency in clinical research, improving access to medicines and enhancing research into neglected tropical diseases.

GSK remains at the forefront of industry efforts to publish clinical trial findings. We disclose all trial information, irrespective of outcome, on our Clinical Trial Register. At the end of 2009, there were 3,687 clinical trial results summaries on GSK’s Clinical Study Register.

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 further information please visit www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.