Deerfield, IL, September 11, 2007 Takeda Pharmaceuticals North America, Inc. is aware of the review of ACTOS (pioglitazone HCl) data conducted by A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, published in the Journal of the American Medical Association which concluded that ACTOS is associated with a significantly lower risk of heart attack, stroke, or death among a diverse population of 16,390 patients with diabetes versus control therapy.
This new meta-analysis is consistent with the depth and breadth of ACTOS cardiovascular data: ACTOS studies, conducted over the past 10 years, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death.
Meta-analyses are pooled data across a number of studies. Although not definitive, they can offer insight into aspects of a compound or product that may not be readily available from individual studies. The overall effect calculated from a group of like or similar randomized trials can provide an estimate of the drugs overall effects in an expanded population.
This meta-analysis adds important information to the body of evidence regarding ACTOS and macrovascular ischemic events, and further documents the consistency of data from prospective studies, to meta-analysis, to observational studies.
Critical in this body of data is PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events), a trial of patients with type 2 diabetes who are at high risk for cardiovascular events. Results from this prospective, randomized, placebo-controlled outcomes trial - considered by scientists to be the most scientifically rigorous type of study - were reviewed by the FDA and added to the ACTOS label. These data show no increase in mortality or total macrovascular events with ACTOS. ACTOS is the only thiazolidinedione (TZD) with safety data from a cardiovascular outcomes trial in its label.
Given the strength and consistency of the ACTOS data as demonstrated by the prospective studies, meta-analysis, and observational studies, Takeda remains confident in the ACTOS safety profile regarding the risk of macrovascular ischemic events.
|Contact: Amy Losak|