FDA expands tirzepatide indication to cardiovascular risk reduction - Takeaways - MDSpire
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FDA expands tirzepatide indication to cardiovascular risk reduction

SURPASS-CVOT compared tirzepatide head-to-head with dulaglutide in 13,299 participants.

  • By

  • Kathryn Wighton

  • August 28, 2026

  • 3 min

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  • 1

    The FDA approved tirzepatide to reduce major cardiovascular event risk in adults with type 2 diabetes at high risk.

  • 2

    The approval includes reducing the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

  • 3

    The indication was based on the SURPASS-CVOT trial, which involved 13,299 participants with type 2 diabetes.

  • 4

    Tirzepatide was found noninferior to dulaglutide for major adverse cardiovascular events over a median follow-up of 4 years.

  • 5

    Common adverse events with tirzepatide included gastrointestinal issues, generally mild to moderate in severity.

Original Source(s)

FDA expands tirzepatide indication to cardiovascular risk reduction

  • by Kathryn Wighton

  • August 28, 2026

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