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Study · Observational study · n = 3,308 · 2026

7 results

Sex-based differences in clinical outcomes among patients with obesity and heart failure with preserved ejection fraction treated with tirzepatide.

Mortada I, Lee AW, Buckingham D, Quach V, Rice J, Mansour S, Chatila K, Shalaby M, Jehle D, Boyars MC, Blackwell TA, Jneid H

Therapeutic advances in cardiovascular disease1 Jan 2026

PMID42605954 (opens in a new tab)PMCIDPMC13482057 (opens in a new tab)DOI10.1177/17539447261478928 (opens in a new tab)PepBankPUB-42605954
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Summary

BackgroundSex-related differences are well recognized in heart failure with preserved ejection fraction (HFpEF), but real-world data describing clinical outcomes by sex among patients with obesity and HFpEF treated with tirzepatide remain limited.ObjectivesTo compare observed hospitalization, cardiovascular, and gastrointestinal outcomes between male and female patients with obesity and HFpEF treated with tirzepatide.DesignRetrospective, propensity score-matched, within-treatment cohort study.MethodsA retrospective study was conducted using TriNetX database which included 110 healthcare organizations. Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified. Males and females were balanced using 1:1 propensity score matching (n=1,654 per group). Primary outcome assessed included all-cause hospitalization. Secondary outcomes were all-cause mortality, HF exacerbation, major adverse cardiovascular events (MACE), incident atrial fibrillation, nausea/vomiting and diarrhea. Two prespecified falsification endpoints were used.ResultsDuring 1-year follow-up, males had a lower hazard of all-cause hospitalization compared with females (HR 0.87, 95% CI 0.77-0.98). No significant differences were observed for all-cause mortality (HR 1.73, 95% CI 0.95-3.18), HF exacerbation (HR 1.14, 95% CI 0.90-1.44), MACE (HR 1.28, 95% CI 0.99-1.65), or incident atrial fibrillation (HR 1.21, 95% CI 0.61-2.43). Males experienced lower rates of nausea and vomiting (HR 0.50, 95% CI 0.37-0.67), while diarrhea was similar (HR 0.84, 95% CI 0.59-1.19). Falsification endpoints showed no significant associations.ConclusionAmong tirzepatide-treated patients with obesity and HFpEF, no statistically significant sex-associated differences were detected in major cardiovascular outcomes. Males had a modestly lower observed hazard of hospitalization and fewer coded nausea and vomiting events. Because this was a within-treatment observational comparison without an external comparator, these findings should not be interpreted as evidence of differential tirzepatide effectiveness by sex.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanObservational studyEfficacy outcome

    In tirzepatide-treated adults with obesity and HFpEF, males had a lower 1-year hazard of all-cause hospitalization than females (HR 0.87).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, men had somewhat fewer hospital stays than women over one year.

    Peptide
    Tirzepatide
    Outcome
    DecreaseAll-cause hospitalization at 1 year
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    Dose not stated

    Measurements

    HR
    0.87 ratio
    males vs females, all-cause hospitalization

    Source sentences

    Summary
    During 1-year follow-up, males had a lower hazard of all-cause hospitalization compared with females (HR 0.87, 95% CI 0.77-0.98).
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).
  2. 02HumanObservational studyEfficacy outcome

    In tirzepatide-treated adults with obesity and HFpEF, all-cause mortality did not differ significantly between males and females (HR 1.73).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, death rates were not clearly different between men and women.

    Peptide
    Tirzepatide
    Outcome
    No significant changeAll-cause mortality
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Secondary
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    Dose not stated

    Measurements

    HR
    1.73 ratio
    males vs females, all-cause mortality

    Source sentences

    Summary
    all-cause mortality (HR 1.73, 95% CI 0.95-3.18)
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).
  3. 03HumanObservational studyEfficacy outcome

    In tirzepatide-treated adults with obesity and HFpEF, heart failure exacerbation did not differ significantly between males and females (HR 1.14).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, worsening of heart failure was not clearly different between men and women.

    Peptide
    Tirzepatide
    Outcome
    No significant changeHeart failure exacerbation
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Secondary
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    Dose not stated

    Measurements

    HR
    1.14 ratio
    males vs females, HF exacerbation

    Source sentences

    Summary
    HF exacerbation (HR 1.14, 95% CI 0.90-1.44)
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).
  4. 04HumanObservational studyEfficacy outcome

    In tirzepatide-treated adults with obesity and HFpEF, MACE did not differ significantly between males and females (HR 1.28).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, major heart and blood vessel events were not clearly different between men and women.

    Peptide
    Tirzepatide
    Outcome
    No significant changeMajor adverse cardiovascular events (MACE)
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    Dose not stated

    Measurements

    HR
    1.28 ratio
    males vs females, MACE

    Source sentences

    Summary
    MACE (HR 1.28, 95% CI 0.99-1.65)
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).
  5. 05HumanObservational studyEfficacy outcome

    In tirzepatide-treated adults with obesity and HFpEF, incident atrial fibrillation did not differ significantly between males and females (HR 1.21).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, new atrial fibrillation was not clearly different between men and women.

    Peptide
    Tirzepatide
    Outcome
    No significant changeIncident atrial fibrillation
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    Dose not stated

    Measurements

    HR
    1.21 ratio
    males vs females, incident atrial fibrillation

    Source sentences

    Summary
    incident atrial fibrillation (HR 1.21, 95% CI 0.61-2.43)
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).
  6. 06HumanObservational studySafety outcome

    In tirzepatide-treated adults with obesity and HFpEF, males had lower rates of nausea and vomiting than females (HR 0.50).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, men had less nausea and vomiting than women.

    Peptide
    Tirzepatide
    Outcome
    DecreaseNausea and vomiting
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Secondary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    HR
    0.5 ratio
    males vs females, nausea and vomiting

    Source sentences

    Summary
    Males experienced lower rates of nausea and vomiting (HR 0.50, 95% CI 0.37-0.67)
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).
  7. 07HumanObservational studySafety outcome

    In tirzepatide-treated adults with obesity and HFpEF, diarrhea rates were similar in males and females (HR 0.84).

    In plain wordsAmong people with obesity and heart failure taking tirzepatide, diarrhea was about equally common in men and women.

    Peptide
    Tirzepatide
    Outcome
    No significant changeDiarrhea
    Study

    n = 3,308

    Comparator
    Female patients on tirzepatide
    Analysis
    Secondary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    HR
    0.84 ratio
    males vs females, diarrhea

    Source sentences

    Summary
    while diarrhea was similar (HR 0.84, 95% CI 0.59-1.19).
    2 context sentences
    Summary · context
    Adults with obesity, HFpEF, and taking tirzepatide between June 1, 2022 and January 1, 2025 were identified.
    Summary · context
    Males and females were balanced using 1:1 propensity score matching (n=1,654 per group).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:58 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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