"The protective effect of pioglitazone was of similar magnitude (with no significant heterogeneity) in subgroups defined by sex, age, weight, race or ethnic group, and fasting glucose level, as well as in patients with both impaired glucose tolerance and impaired fasting glucose and those with isolated impaired glucose tolerance," the authors wrote. Pioglitazone therapy also was associated with a decrease in diastolic blood pressure, a 31 percent reduced rate of CIMT and a greater increase in the level of HDL. Researchers also found that pioglitazone was associated with significantly reduced levels of fasting glucose, two-hour glucose and HbA1c, compared with placebo. Compliance was similar for both groups, around 80 percent.ĭeFronzo and colleagues found an annual incidence rate for type 2 diabetes mellitus at 2.1 percent in the pioglitazone group compared with 7.6 percent in the placebo group, and the hazard ratio for conversion to diabetes in the pioglitazone group was 0.28, a significant difference.Ĭonversion to normal glucose tolerance occurred in 48 percent of the patients in the pioglitazone group and 28 percent of those in the placebo group. Participants were chosen because of their high risk for diabetes, including obesity, family history and impaired glucose tolerance as demonstrated by a glucose test.
The median follow-up period was 2.4 years. Researchers randomly assigned 602 patients to receive pioglitazone or placebo. DeFronzo, MD, from UT, on behalf of the ACT Now investigators, was a randomized, double-blind, placebo-controlled study to examine whether pioglitazone can reduce the risk of type 2 diabetes mellitus in adults with impaired glucose tolerance. We assume that if you reduce the risks for cardiac events, you will reduce the events themselves." Our study did not look at cardiovascular outcomes, but we did show that pioglitazone helped decrease carotid intima-media thickness, which is a surrogate for atherosclerosis. "The advantages of pioglitazone is that it has a marked effect on lowering triglycerides and increases levels of high-density lipoprotein cholesterol, which we have not seen in rosiglitazone. "Although these two drugs belong to the same class, there is a big difference between them," Tripathy said. In fact, the EU has taken the drug off the shelves, while the FDA and the Canadian government have imposed severe restrictions on its use and labeling. However, controversy has surrounded rosiglitazone for its propensity to cause cardiac events. Rosiglitazone (Avandia, GlaxoSmithKline) belongs to the same drug class as pioglitazone, thiazolidinediones. Interventions that may prevent or delay such occurrences are of great clinical importance, the authors noted. Impaired glucose tolerance is associated with increased rates of cardiovascular disease and conversion to type 2 diabetes mellitus. Treatment of 18 participants for one year prevented one case of diabetes, while treatment of eight participants for two years prevented one case of diabetes, Tripathy said. "This is the largest decrease in the conversion rate of pre-diabetes to diabetes ever demonstrated by any intervention including diet, exercise or medication," co-author Devjit Tripathy, MD, PhD, an endocrinologist at the University of Texas (UT) Health Science Center in San Antonio, told Cardiovascular Business News. Compared with placebo, pioglitazone (Actos, Takeda Pharmaceuticals) reduced the risk of conversion of impaired glucose tolerance to type 2 diabetes mellitus by 72 percent, but was associated with significant weight gain and edema, according to a study published March 24 in the New England Journal of Medicine.
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