Actos may reduce heart attacks, strokes

WASHINGTON, Oct 6, 2005 (UPI via COMTEX) -- British scientists said Thursday a new study funded by the manufacturers of the diabetes drug Actos indicates the medication reduces the risk of death, heart attack and stroke in patients with type 2 diabetes.

A researcher not involved with the study, however, said the conclusions may be murky at best.

The results of the study, which was funded by Takeda Pharmaceutical Company and Eli Lilly, "indicate that giving 1,000 patients pioglitazone (Actos) would avoid 21 first heart attacks, strokes or deaths over 3 years," John Dormandy of St. George's Hospital in London and colleagues wrote in the Oct. 8 issue of The Lancet.

Takeda and Lilly each had one member on the study's steering committee and the executive committee. The research team stated in the journal the data analysis and writing of the article were conducted by the executive committee.

"All the authors had full access to all the data in the study and had final responsibility for the decision to submit for publication," they added.

Many of the 30 authors listed on the paper have financial ties to the companies, served as consultants or received travel expenses or payment for speaking at meetings. One author had been an employee of Takeda, another currently is employed by the company and yet another is employed by Lilly.

Actos was approved by the Food and Drug Administration for the treatment of type 2 diabetes in 1999. The drug belongs to a class known as thiazolidinediones, which help keep diabetes in check by increasing the body's sensitivity to insulin, which regulates blood-sugar levels.

The study, known as PROactive -- for PROspective pioglitAzone Clinical Trial In macroVascular Events -- involved 5,238 patients with type 2 diabetes with macrovascular disease in 19 European countries. Patients were assigned randomly to receive either pioglitazone or placebo along with any medications they already were taking for diabetes or heart disease.

At an average follow-up time of about 34 months, there were 803 deaths, heart attacks, strokes, acute coronary syndrome and cardiac or leg interventions in the pioglitazone group, compared to 900 in those receiving the placebo.

The patients receiving pioglitazone also were able to delay taking insulin.

"We believe our results are generalizable to all patients with type 2 diabetes," Dormandy's team wrote.

In an accompanying commentary, Hannele Yki-Jarvinen of the University of Helsinki in Finland called the findings "important" but said they may leave some key questions unanswered.

"The clinician, of course wants to know who should be treated with pioglitazone," Yki-Jarvinen wrote. "Unfortunately, the study does not provide such answers. It showed that pioglitazone is beneficial in patients with type 2 diabetes and pre-existing macrovascular disease who do not develop heart failure."

Yki-Jarvinen also noted the patients taking pioglitazone had higher rates of heart failure and edema not due to heart failure than the placebo group, and added that the medication appeared to increase body weight, which could increase the risk of heart failure.

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