GlaxoSmithKline Responds to JAMA Articles

GlaxoSmithKline (GSK) has issued a response to the recent meta-analyses published by Drs. Nissen et. al. and Furberg et. al. in the Journal of the American Medical Association (JAMA), saying the conclusions do not confirm a difference in the safety profile of Avandia and Actos.

According to GSK, the analyses did not yield data robust enough to guide doctors in selecting appropriate diabetes treatments for their patients, and comparisons between different meta-analyses with different endpoints and patient populations were even more unreliable.

The company said the Actos (pioglitazone) meta-analysis is based 19 studies provided directly by Takeda, and is heavily biased by data from the 5,238-patient PROactive study, which contributed 80 percent of the endpoint data. The patient population in the PROactive study was at high risk of cardiovascular disease, the company added.

The JAMA article on Avandia (rosiglitazone) is an iteration of previously analyzed data, and offers no new information on the safety of the drug, the company said.

According to GSK, the conclusions of the meta-analyses conflict with accumulated data on Avandia — including 116 clinical trials in more than 52,000 patients and epidemiological studies of databases in over 1 million patients. Analyzed studies show no difference in the ischemic cardiovascular effects of Avanida versus other oral antidiabetic medicines, including Actos, the company added.