In 2005, Takeda was the first company to complete a rigorous, randomized, placebo-controlled study, the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, assessing significant CV outcomes in people living with type 2 diabetes. The PROactive trial demonstrated that although there was no statistically significant difference between ACTOS and standard-of-care alone for the primary endpoint, there was no increase in mortality or total macrovascular events with ACTOS. This safety information has been included in both the FDA-approved product label and EMA-approved Summary of Product Characteristics (SPC) since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of ACTOS.

Takeda is the inventor and developer of ACTOS, which was launched commercially in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new or worsen heart failure. In clinical trials using ACTOS in monotherapy, the most common adverse events (greater than or equal to 5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus and pharyngitis.

SOURCE Takeda Pharmaceutical North America, Inc.