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.
About the PROactive Study
The PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study was a prospective, randomized, placebo-controlled outcomes trial. The study included 5,238 patients with type 2 diabetes and a history of macrovascular disease, who were force titrated up to 45 mg daily of either ACTOS or placebo. In this study, there was no difference in the number of macrovascular events between standard of care and ACTOS, and standard of care alone. Although there was no statistically significant difference between ACTOS and standard of care for the primary endpoint, there was no increase in mortality or total macrovascular events with ACTOS.
The ACTOS Prescribing Information was recently revised by the FDA to include this reassuring cardiovascular safety data making ACTOS the only TZD with safety data from a cardiovascular outcomes trial in its label.
ACTOS works by directly targeting insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS is taken once daily as an adjunct to diet and exercise, and is approved for use for type 2 diabetes as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.
Important Safety Information About ACTOS
The prescription medication ACTOS is used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes. ACTOS is taken once daily either alone or in combination with insulin, sulfonylureas, or metformin.
ACTOS is not for everyone. Certain patients with heart failure should
not start taking
|SOURCE Takeda Pharmaceuticals North America, Inc.|
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