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  1. Medical Information Right
  2. Diabetes Right
  3. Mounjaro (tirzepatide) injection Right
  4. Is Mounjaro® (tirzepatide) approved to reduce the risk of major adverse cardiovascular events (MACE)?
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Mounjaro ® (tirzepatide) injection

2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

Is Mounjaro® (tirzepatide) approved to reduce the risk of major adverse cardiovascular events (MACE)?

Tirzepatide is not approved to reduce the risk of major adverse cardiovascular events. An ongoing study (SURPASS-CVOT) will evaluate the cardiovascular outcomes of tirzepatide in patients with T2D.

US_cFAQ_TZP146_CARDIOVASCULAR_INDICATION_ONLABEL
US_cFAQ_TZP146_CARDIOVASCULAR_INDICATION_ONLABEL
en-US

See important safety information, including boxed warning, in the attached prescribing information.

Cardiovascular Outcomes

Tirzepatide is not indicated to reduce the risk of major adverse cardiovascular events (MACEs) in adults with type 2 diabetes (T2D).1

The ongoing study, SURPASS-CVOT (cardiovascular outcome trial) is currently evaluating the effect of tirzepatide versus dulaglutide on MACEs in people with T2D.2

Enclosed Prescribing Information

MOUNJARO® (tirzepatide) injection, for subcutaneous use, Lilly

References

1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.

2A study of tirzepatide (LY3298176) compared with dulaglutide on major cardiovascular events in participants with type 2 diabetes (SURPASS-CVOT). ClinicalTrials.gov identifier: NCT04255433. Updated February 21, 2022. Accessed March 8, 2022. https://clinicaltrials.gov/ct2/show/NCT04255433

Date of Last Review: August 11, 2023

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