Takeda Statement on ACTOS(R) (Pioglitazone HCl) Meta-Analysis Published in the Journal of the American Medical Association

Wednesday, September 12, 2007 General News
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DEERFIELD, Ill., Sept. 11 Takeda Pharmaceuticals NorthAmerica, Inc. is aware of the review of ACTOS(R) (pioglitazone HCl) dataconducted by A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic,published in the Journal of the American Medical Association which concludedthat ACTOS is associated with a significantly lower risk of heart attack,stroke, or death among a diverse population of 16,390 patients with diabetesversus control therapy.

This new meta-analysis is consistent with the depth and breadth of ACTOScardiovascular data: ACTOS studies, conducted over the past 10 years,including short- and long-term trials, as well as prospective andobservational studies, have shown no evidence that ACTOS is associated with anincreased risk of heart attack, stroke, or death.

Meta-analyses are pooled data across a number of studies. Although notdefinitive, they can offer insight into aspects of a compound or product thatmay not be readily available from individual studies. The overall effectcalculated from a group of like or similar randomized trials can provide anestimate of the drug's overall effects in an expanded population.

This meta-analysis adds important information to the body of evidenceregarding ACTOS and macrovascular ischemic events, and further documents theconsistency of data from prospective studies, to meta-analysis, toobservational studies.

Critical in this body of data is PROactive (PROspective PioglitAzoneClinical Trial In MacroVascular Events), a trial of patients with type 2diabetes who are at high risk for cardiovascular events. Results from thisprospective, randomized, placebo-controlled outcomes trial -- considered byscientists to be the most scientifically rigorous type of study -- werereviewed by the FDA and added to the ACTOS label. These data show no increasein mortality or total macrovascular events with ACTOS. ACTOS is the onlythiazolidinedione (TZD) with safety data from a cardiovascular outcomes trialin its label.

Given the strength and consistency of the ACTOS data as demonstrated bythe prospective studies, meta-analysis, and observational studies, Takedaremains confident in the ACTOS safety profile regarding the risk ofmacrovascular ischemic events.

About the PROactive Study

The PROactive (PROspective PioglitAzone Clinical Trial In MacroVascularEvents) study was a prospective, randomized, placebo-controlled outcomestrial. The study included 5,238 patients with type 2 diabetes and a history ofmacrovascular disease, who were force titrated up to 45 mg daily of eitherACTOS or placebo. In this study, there was no difference in the number ofmacrovascular events between standard of care and ACTOS, and standard of carealone. Although there was no statistically significant difference betweenACTOS and standard of care for the primary endpoint, there was no increase inmortality or total macrovascular events with ACTOS.

The ACTOS Prescribing Information was recently revised by the FDA toinclude this reassuring cardiovascular safety data making ACTOS the only TZDwith safety data from a cardiovascular outcomes trial in its label.


ACTOS works by directly targeting insulin resistance, a condition in whichthe body does not efficiently use the insulin it produces to control bloodglucose 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 bloodglucose 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 tolower blood sugar (glucose) in adults with type 2 diabetes. ACTOS is takenonce daily either alone or in combination with insulin, sulfonylureas, ormetformin.

ACTOS is not for everyone. Certain patients with

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