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Insulin sensitizers in 2023: lessons learned and new avenues for investigation.
Expert Opin Investig Drugs
October 2023
Department of Medicine, Center for Human Nutrition, Washington University in St Louis, Euclid Ave, MO, USA.
Introduction: 'Insulin sensitizers' derived discoveries of the Takeda Company in 1970s. Pioglitazone remains the best in class with beneficial pleiotropic pharmacology, although use is limited by tolerability issues. Various attempts to expand out of this class assumed the primary molecular target was the transcription factor, PPARγ.
View Article and Find Full Text PDFImpact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions.
Circulation
March 2020
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (N.J.P., J.B.G., M.T.R., C.G.).
Responding to concerns about the potential for increased risk of adverse cardiovascular outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were granted regulatory approval primarily from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on cardiovascular outcomes.
View Article and Find Full Text PDFUpdate on Youth-Onset Type 2 Diabetes: Lessons Learned from the Treatment Options for Type 2 Diabetes in Adolescents and Youth Clinical Trial.
Adv Pediatr
August 2016
Section of Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 265, Aurora, CO, USA. Electronic address:
Geographic Variation in Rosiglitazone Use Surrounding FDA Warnings in the Department of Veterans Affairs.
J Manag Care Spec Pharm
December 2015
Southern Methodist University, P.O. Box 750333, Dallas, TX 75275-0333.
Background: Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later.
View Article and Find Full Text PDFLessons learned from cardiovascular outcome clinical trials with dipeptidyl peptidase 4 (DPP-4) inhibitors.
Endocrine
August 2016
Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Viale Europa, 88100, Catanzaro, Italy.
Previous trials of glucose-lowering strategies in subjects with type 2 diabetes have demonstrated a beneficial effect of intensive glycemic control on microvascular complications but failed to show a clear benefit on cardiovascular complications. The findings of meta-analyses of rosiglitazone trials suggesting that rosiglitazone might increase the risk of myocardial infarction have cast doubt on the cardiovascular safety of glucose-lowering drugs. In 2008, the US Food and Drug Administration has implemented rigorous criteria to approve new glucose-lowering drugs, requiring proof of cardiovascular safety.
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