Abhinav Sharma, MD, PhD
Assistant Professor of Medicine
Christopher B. Granger, MD, FAHA, FACC
Professor of Medicine
Director, Cardiac Intensive Care Unit
Duke University Medical Center
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future Directions
Type 2 diabetes; Regulatory; Cardiovascular risk; Food and Drug Administration; FDA; Patient outcomes; Anti-hyperglycemic medications
- The hallmark of type 2 diabetes mellitus is insulin resistance and relative insulin deficiency. Ninety percent of all cases of diabetes are type 2 diabetes, and the diagnosis can occur at any age.
- While people with type 2 diabetes can often initially manage their condition through exercise and diet, over time most people will require oral drugs or insulin.
- Strategies are needed reduce the burden of cardiovascular outcomes in patients with diabetes.
- In 2008, the U.S. Food and Drug Administration (FDA) issued guidelines for sponsors to demonstrate that their anti-hyperglycemic medications do not increase the risk of cardiovascular disease. In March 2020, the FDA updated the guidance in a draft for comment: Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry.
Is the cardiovascular protection of some anti-hyperglycemic drugs independent of the effect on blood glucose?
How can regulators, industry, academia, payers, and patient advocacy groups assure that evidence generation to improve care is incentivized without undue regulatory burdens?
Should post-marketing studies include comparative effectiveness pragmatic trials in order to improve translation into clinical practice?
Read more on this topic from Sharma and colleagues in a recent publication in Circulation.