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Cardiovascular disease and type 2 diabetes mellitus: regulating glucose and regulating drugs
M Odette Gore1, Darren K McGuire
1Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX 75235-9047, USA.
Abstract:
Type 2 diabetes mellitus is a major and increasingly prevalent independent risk factor for cardiovascular morbidity and mortality worldwide. Glycemic control is a target of therapy and a principal marker of therapeutic success in diabetes, but whether lowering glucose is accompanied by a commensurate reduction in cardiovascular risk is a matter of ongoing controversy. It has become increasingly apparent from recent large-scale clinical outcome trials that glucose lowering is a poor predictor of cardiovascular outcome, and several instances of unexpectedly increased cardiovascular risk with antihyperglycemic drugs have sounded the alarm with regulatory agencies. This article reviews the critical facts that have led to a recent shift in the regulation of glucose-lowering drugs and makes the case for why new and existing antidiabetic medications should be assessed in clinical trials of cardiovascular outcome.
Insights
Type 2 diabetes increases cardiovascular risks. While glycemic control is key, lowering glucose doesn't always reduce cardiovascular events, prompting a re-evaluation of antidiabetic drug safety and efficacy.
Area of Science:
- Endocrinology
- Cardiology
- Pharmacology
Background:
- Type 2 diabetes mellitus is a significant global risk factor for cardiovascular disease (CVD) morbidity and mortality.
- Glycemic control is a primary therapeutic goal in diabetes management, but its direct impact on cardiovascular risk reduction remains controversial.
- Recent clinical trials indicate that glucose-lowering is an unreliable predictor of cardiovascular outcomes, with some drugs showing increased cardiovascular risk.
Purpose of the Study:
- To review the evidence prompting regulatory shifts in glucose-lowering drug assessment.
- To advocate for the mandatory evaluation of cardiovascular outcomes in clinical trials for all antidiabetic medications.
Main Methods:
- Review of large-scale clinical outcome trials.
- Analysis of regulatory agency alerts regarding antihyperglycemic drugs.
- Synthesis of evidence on the relationship between glycemic control and cardiovascular risk.
Main Results:
- Glucose-lowering efficacy does not consistently correlate with reduced cardiovascular risk.
- Certain antihyperglycemic agents have demonstrated unexpected increases in cardiovascular risk.
- Regulatory agencies have initiated changes in drug evaluation protocols.
Conclusions:
- The link between glycemic control and cardiovascular risk reduction in Type 2 diabetes is complex and not fully understood.
- New and existing antidiabetic drugs require rigorous assessment for cardiovascular safety and efficacy through dedicated outcome trials.
- A paradigm shift in antidiabetic drug development and regulation is necessary to prioritize patient cardiovascular health.
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