PHILADELPHIA, Dec. 11 /PRNewswire-FirstCall/ -- The following is GlaxoSmithKline's (NYSE: GSK) response to the retrospective analysis by the Institute for Clinical Evaluative Sciences (ICES) titled "Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes".
GSK believes that the ICES retrospective analysis of the Ontario Drug Benefit (ODB) database has significant limitations and generates misleading conclusions regarding acute myocardial infarction and death. These conclusions are inconsistent with a more robust body of evidence from large, long-term, prospective, well-designed clinical studies, including ADOPT and RECORD.
In addition, the RESULT clinical study specifically examined an elderly diabetic population, ages 59 to 89, in which 43 percent of the patients were greater than 70 years of age, and demonstrated the safety profile of rosiglitazone to be consistent with the control medicine (sulfonylurea).
Importantly, the results of this study do not reproduce what is already known about the risk of CHF in TZD users. TZDs can cause fluid retention which can lead to or exacerbate heart failure. TZDs also have a similar increased risk of CHF. Yet, in this analysis, pioglitazone is not associated with an increased risk of CHF (Adjusted RR of 0.91 (95% CI = 0.52-1.59) whereas rosiglitazone is associated with 2 fold-increased risk of CHF (Adjusted RR = 1.98 and 95% CI=1.44-2.72) compared to oral anti-diabetic combination therapy. This is inconsistent with the product labeling.
Moreover, the authors of this retrospective analysis fail to acknowledge the findings of large epidemiological studies, encompassing over 1.3 million patients with type 2 diabetes, as well as other similar studies presented during the recent FDA Advisory Committee meeting. These studies have investigated whether use of rosiglitazone in the real world setting is associated with an increase in myocardial infarction or coronary revascularization. The majority of these studies show that rosiglitazone is not associated with an increased risk of myocardial infarction compared to other anti-diabetic agents.
GSK cites the following as examples of the limitations of this retrospective analysis:
Avandia(R) (rosiglitazone maleate) is a widely studied oral anti-diabetic medicine for the treatment of type 2 diabetes, and importantly, Avandia has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines - up to five years. When used in the appropriate patient, it is an important treatment option for health-care professionals managing the chronic and life threatening disease of diabetes. Across multiple sources of data, there is no consistent or systematic evidence that rosiglitazone increases the risk of myocardial ischemic events or death in comparison to other anti-diabetic agents.
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.
Important Safety Information for Avandia(R) (rosiglitazone maleate)
Avandia, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes.
Avandia can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on Avandia. Avandia is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.
Avandia may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin. Taking Avandia with insulin or with nitrates is not recommended.
If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking.
Women taking Avandia should know that Avandia may increase the risk of pregnancy.
More fractures have been observed in women taking Avandia.
For more information about Avandia, please see Patient Information. For further information on Avandia, please see full Prescribing Information.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the company's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report 2006.