Pioglitazone Prevents Conversion to Diabetes Among Insulin-Resistant Patients: Presented at ADA

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Title: Pioglitazone Prevents Conversion to Diabetes Among Insulin-Resistant Patients: Presented at ADA
URL: http://www.pslgroup.com/dg/2235DA.htm
Doctor's Guide
June 11, 2008

By Ed Susman

SAN FRANCISCO -- June 11, 2008 -- Patients with impaired glucose tolerance treated with pioglitazone were able to stave off conversion to type 2 diabetes by 81% when compared with individuals who received placebo, according to long-term results of a phase 3 trial presented here at the American Diabetes Association (ADA) 68th Scientific Sessions.

In a late-breaking oral presentation here on June 9, Ralph A. DeFronzo, MD, Diabetes Division, University of Texas Health Science Center, San Antonio, San Antonio, Texas, presented data from the Actos Now Study for the Prevention of Diabetes (ACT NOW). The prospective, double-blind, placebo-controlled study examined whether pioglitazone can reduce the incidence of type 2 diabetes in patients with impaired glucose tolerance at high risk of diabetes.

To be included in this study, subjects needed to have had a 2-hour plasma glucose between 140 and 199 mg/dL during a single oral glucose tolerance test. The researchers screened 1,850 subjects and identified 602 individuals with impaired glucose tolerance -- 407 had impaired fasting glucose as well as impaired glucose tolerance, and 195 subjects had isolated impaired glucose tolerance.

ACT NOW subjects were recruited over a 2-year period, and then followed for 2 years after the last patient was recruited, meaning that some patients were followed for up to 4 years, Dr. DeFronzo noted.

The definition of conversion to type 2 diabetes was based on a fasting glucose measurement of 126 mg/dL or higher on follow-up for a 2-hour oral glucose tolerance test measurement of 200 mg/dL or higher, plus confirmation with a second oral glucose tolerance test.

The researchers assigned 299 patients to placebo and 303 subjects to pioglitazone. About 60% of the subjects were women, and nearly 75% were white. The mean age was 52 years; subjects had a mean body mass index of 34.

The conversion to type 2 diabetes in placebo subjects occurred at a rate of 6.8% per year, while the rate for subjects on pioglitazone was 1.5% per year, translating to a highly significant relative risk reduction of 81% (P < .00001). Overall, 45 of the placebo patients converted to type 2 diabetes, compared with 10 in the pioglitazone group.

Dr. DeFronzo reported that only 84 of the placebo patients normalised their glucose tolerance (28% of the group) compared with 127 individuals on pioglitazone (42%), which also was statistically significant (P < .001).

In terms of adverse events, pioglitazone subjects experienced more oedema (22%) than did placebo subjects (15%). Also, 15 patients in the placebo group experienced cardiac events compared with 12 among the pioglitazone subjects. One sudden death occurred in each group.

"Pioglitazone treatment of subjects with impaired glucose tolerance was both safe and efficacious during the 4-year study," Dr. DeFronzo said.

Funding for this study was provided by Takeda Pharmaceuticals North America, Inc.

[Presentation title: ACTos NOW for the Prevention of Diabetes (ACT NOW) Study.]

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