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# Mixed Vote on Cardio Risk Trials for Diabetes Drugs
- URL: https://www.fdaweb.com/mixed-vote-on-cardio-risk-trials-for-diabetes-drugs/
- Published: 2018-10-26T12:00:00.000Z
- Updated: 2026-09-15T00:40:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142681

An FDA Advisory Committee has delivered a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all new diabetes drugs. In delivering the mixed vote, the majority of panel members recommended that modifications are necessary to the requirements for conducting such trials, for example allowing more flexible and efficient trial designs. Some members also suggested studying cardiovascular and other risks premarket in Phase 2 and Phase 3 trials by broadening patient populations, instead of costly post-approval studies that are currently conducted.

The cardiovascular outcomes studies are detailed in a 2008 [guidance](https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf?ref=fdaweb.com) “Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” An agency [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM623913.pdf?ref=fdaweb.com) distributed in advance of the meeting said that concerns were raised in the past that treatment of patients with diabetes was too “glucocentric” and that there may be therapies that lower blood glucose but also increase the risk for adverse cardiovascular events. Over the past decade, cardiovascular risk assessments for new antidiabetic drugs have been conducted in accordance with the guidance recommendations, the committee was told.

  
The briefing document said that eight trials had been conducted under the guidance and all eight have demonstrated no excess cardiovascular risk, with some showing a reduced risk for adverse cardiovascular events. “Now that we have results of several trials and 10 years of experience with drug development under the guidance,” the document said, “it seems apropos to review what we have learned and consider what changes to the approach, if any, are necessary.”