The adverse effects associated with tirzepatide use in patients at increased risk of cardiovascular events: a systematic review with meta-analysis and Trial Sequential Analysis.

Sillassen CDB, Faltermeier P, Bjerg JL, Andersen RK, Petersen JJ, Andersen PB, Kamp CB, Karlsson F, Grand J, Dominguez H, Frølich A, Gæde P, Gluud C, Mathiesen O, Jakobsen JC

BMC medicine27 Mar 2026

PMID41896878PMCIDPMC13147618DOI10.1186/s12916-026-04824-wPepBankPUB-41896878

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

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

01HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, a meta-analysis found no difference in all-cause mortality between tirzepatide and placebo (OR 1.02).
In plain wordsIn people at higher heart risk, tirzepatide and placebo showed no difference in deaths from any cause, but the evidence was weak.
Peptide
Tirzepatide
Outcome
No significant changeAll-cause mortality
Study
n = 8,043
Comparator
Placebo
Analysis
Primary
Outcome group
Mortality · Cardiovascular
Studied dose
Dose not stated
Measurements
OR
1.02 ratio
all-cause mortality
Source sentences
Summary
all-cause mortality (odds ratio 1.02, 95% CI 0.57 to 1.81; p = 0.95; 21 trials; TSA: underpowered meta-analysis; very low certainty of evidence)
2 context sentences(design, population, supporting numbers)
Summary · context
A meta-analysis of all-cause mortality showed no evidence of a difference
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687801
02HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, a meta-analysis found no difference in serious adverse events between tirzepatide and placebo (OR 0.98).
In plain wordsIn people at higher heart risk, tirzepatide and placebo showed no difference in serious side effects.
Peptide
Tirzepatide
Outcome
No significant changeSerious adverse events
Study
n = 8,043
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
OR
0.98 ratio
serious adverse events
Source sentences
Summary
SAEs (odds ratio 0.98, 95% CI 0.82 to 1.17; p = 0.80; 21 trials; TSA: sufficiently powered meta-analysis; moderate certainty of evidence)
2 context sentences(design, population, supporting numbers)
Summary · context
Current evidence indicates that tirzepatide does not appear to influence the risk of serious adverse events.
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687802
03HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, tirzepatide increased the risk of several non-serious adverse events versus placebo.
In plain wordsIn people at higher heart risk, tirzepatide caused more minor side effects than placebo, mostly in the digestive system.
Peptide
Tirzepatide
Outcome
IncreaseNon-serious adverse events overall
Study
n = 8,043
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Meta-analysis showed that tirzepatide increased the risk of several nsAEs, primarily gastrointestinal nsAEs such as nausea, diarrhea, decreased appetite, and vomiting.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687803
04HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, tirzepatide increased the risk of nausea versus placebo.
In plain wordsIn people at higher heart risk, tirzepatide caused more nausea than placebo.
Peptide
Tirzepatide
Outcome
IncreaseNausea
Study
n = 8,043
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Meta-analysis showed that tirzepatide increased the risk of several nsAEs, primarily gastrointestinal nsAEs such as nausea, diarrhea, decreased appetite, and vomiting.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687804
05HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, tirzepatide increased the risk of diarrhea versus placebo.
In plain wordsIn people at higher heart risk, tirzepatide caused more diarrhea than placebo.
Peptide
Tirzepatide
Outcome
IncreaseDiarrhea
Study
n = 8,043
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Meta-analysis showed that tirzepatide increased the risk of several nsAEs, primarily gastrointestinal nsAEs such as nausea, diarrhea, decreased appetite, and vomiting.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687805
06HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, tirzepatide increased the risk of decreased appetite versus placebo.
In plain wordsIn people at higher heart risk, tirzepatide caused more loss of appetite than placebo.
Peptide
Tirzepatide
Outcome
IncreaseDecreased appetite
Study
n = 8,043
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Meta-analysis showed that tirzepatide increased the risk of several nsAEs, primarily gastrointestinal nsAEs such as nausea, diarrhea, decreased appetite, and vomiting.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687806
07HumanSystematic reviewSafety outcome
In patients at increased cardiovascular risk, tirzepatide increased the risk of vomiting versus placebo.
In plain wordsIn people at higher heart risk, tirzepatide caused more vomiting than placebo.
Peptide
Tirzepatide
Outcome
IncreaseVomiting
Study
n = 8,043
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Meta-analysis showed that tirzepatide increased the risk of several nsAEs, primarily gastrointestinal nsAEs such as nausea, diarrhea, decreased appetite, and vomiting.
1 context sentence(design, population, supporting numbers)
Summary · context
Randomized clinical trials comparing tirzepatide with placebo in patients at increased risk of cardiovascular events were eligible for inclusion.
Report a problemFND-4189687807

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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.

Version 2Current
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:07 UTC
First added · source update from Europe PMC

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