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 drug’s 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.
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 ACTOS. ACTOS can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath.
Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, and anemia. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking ACTOS.
Please visit the ACTOS Web site at www.actos.com for Complete Prescribing Information.
Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc., is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, and gastroenterology treatments, and through Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease, and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com .
ACTOS® (pioglitazone HCl) is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc.
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