Pioglitazone is a glucose-reducing drug in the class “thiazolidinediones” used in the treatment of type 2 diabetes. Manufactured by the Japanese company Takeda Pharmaceutical Co. for treatment of diabetes, pioglitazone has shown both promise and increased risks in the treatment of diabetes. Often called an insulin sensitizer, because it attaches itself to insulin receptors in the body, making cells more responsive to insulin. It also reduces insulin by reducing production and secretion of glucose into the body by the liver.
Pre Diabetes – Pioglitazone as Prevention
A study conducted by the Texas Diabetes Institute and University of Texas Health Science Center looked into the possibility of using pioglitazone as a preventative measure against type 2 diabetes in individuals with impaired glucose tolerance. Using a test group of 602 people over two and a half years, individuals were given pioglitazone or a placebo to control blood glucose with quarterly fasting glucose tests and yearly glucose tolerance tests. The result of the study found that the individuals on pioglitazone had an annual incidence rate of diabetes of 2.1% while the placebo group had a rate of 7.6%. Further, 48% of the patients on pioglitazone had normalized glucose tolerance versus 28% in the placebo group. Yielding a significant difference in the prevention of diabetes, pioglitazone reduced the incidence rate of the disease by 72% though with the side effects of weight gain and edema.
Treatment of Diabetes – Pioglitazone Risk Factors
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) conducted a review of the increased risk of bladder cancer in diabetics using pioglitazone. Investigating evidence of increased risk of bladder cancer, particularly in patients in the U.S.A. and E.U., the CHMP reviewed preclinical studies by the drug manufacturer as well as other population-based studies concluding that there is indeed increased risk. Their analysis of several separate trials found that the statistical occurrence of bladder cancer in patients on pioglitazone was 19 of 12,506 (0.15%). While France temporarily suspended use of the drug, the CHMP decided that due to the benefits to diabetes treatment, pioglitazone should still be used. In a report released in January 2012, the European Commission adopted the EMA’s position that Actos remains suitable for type 2 diabetes treatments though a more careful selection of patients is advised due to side effects and increased risk factors associated with the drug. The U.S. Food and Drug Administration (FDA) acknowledged the increased risk of bladder cancer, ultimately approving the drug in August of 2011 with new labeling highlighting the increased risk of cancer in patients who take pioglitazone for more than one year.
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