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

Sillassen CDB, Petersen JJ, Faltermeier P, Yucel D, Siddiqui F, Andersen RK, Graever L, Bjerg JL, Kamp CB, Grand J, Dominguez H, Frølich A and 4 more

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Gæde P, Gluud C, Mathiesen O, Jakobsen JC

BMC medicine24 Nov 2025Cited by 3 (Europe PMC)

PMID41286875PMCIDPMC12642075DOI10.1186/s12916-025-04486-0PepBankPUB-41286875

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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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanSystematic reviewEfficacy outcome
In patients at increased risk of cardiovascular events, semaglutide reduced all-cause mortality compared with placebo.
In plain wordsIn people at higher risk of cardiovascular events, semaglutide lowered the risk of death from any cause compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseAll-cause mortality
Study
n = 54,972
Comparator
Placebo
Analysis
Primary
Outcome group
Mortality · Whole body
Studied dose
Dose not stated
Measurements
RR
0.85 NA
all-cause mortality
Source sentences
Summary
beneficial effects of semaglutide on all-cause mortality (relative risk (RR) 0.85; 95% CI 0.79 to 0.91; I² = 0.0%; p < 0.01)
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized trials comparing semaglutide (oral or subcutaneous) with placebo in patients at increased risk of cardiovascular events were eligible.
Summary · context
The analysis included 50 trials, with a total of 54,972 participants randomized.
Report a problemFND-4128687501
02HumanSystematic reviewSafety outcome
In patients at increased risk of cardiovascular events, semaglutide reduced the risk of serious adverse events compared with placebo.
In plain wordsIn people at higher risk of cardiovascular events, semaglutide caused fewer serious adverse events than placebo.
Peptide
Semaglutide
Outcome
DecreaseSerious adverse events
Study
n = 54,972
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
RR
0.93 NA
serious adverse events
Source sentences
Summary
semaglutide decreased the risk of SAEs (RR 0.93, 95% CI 0.88 to 0.98; I² = 24.1%; p < 0.01)
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized trials comparing semaglutide (oral or subcutaneous) with placebo in patients at increased risk of cardiovascular events were eligible.
Summary · context
The analysis included 50 trials, with a total of 54,972 participants randomized.
Report a problemFND-4128687503
03HumanSystematic reviewEfficacy outcome
In patients at increased risk of cardiovascular events, semaglutide reduced myocardial infarction compared with placebo.
In plain wordsIn people at higher risk of cardiovascular events, semaglutide lowered the risk of heart attack compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseMyocardial infarction
Study
n = 54,972
Comparator
Placebo
Analysis
Secondary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
Dose not stated
Measurements
RR
0.77 NA
myocardial infarction
Source sentences
Summary
myocardial infarction (RR 0.77, 95% CI 0.69 to 0.85; I² = 0.0%; p < 0.01).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized trials comparing semaglutide (oral or subcutaneous) with placebo in patients at increased risk of cardiovascular events were eligible.
Summary · context
The analysis included 50 trials, with a total of 54,972 participants randomized.
Report a problemFND-4128687502
04HumanSystematic reviewSafety outcome
In patients at increased risk of cardiovascular events, semaglutide increased the risk of non-serious nausea compared with placebo.
In plain wordsIn people at higher risk of cardiovascular events, semaglutide caused more nausea than placebo.
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
RR
3 NA
nausea
Source sentences
Summary
but increased the risk of several non-serious gastrointestinal AEs including nausea (RR 3.00, 95% CI 2.63 to 3.42), vomiting (RR 4.12, 95% CI 3.47 to 4.90), and diarrhea (RR 1.88, 95% CI 1.68 to 2.11).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized trials comparing semaglutide (oral or subcutaneous) with placebo in patients at increased risk of cardiovascular events were eligible.
Summary · context
The analysis included 50 trials, with a total of 54,972 participants randomized.
Report a problemFND-4128687504
05HumanSystematic reviewSafety outcome
In patients at increased risk of cardiovascular events, semaglutide increased the risk of non-serious vomiting compared with placebo.
In plain wordsIn people at higher risk of cardiovascular events, semaglutide caused more vomiting than placebo.
Peptide
Semaglutide
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
RR
4.12 NA
vomiting
Source sentences
Summary
but increased the risk of several non-serious gastrointestinal AEs including nausea (RR 3.00, 95% CI 2.63 to 3.42), vomiting (RR 4.12, 95% CI 3.47 to 4.90), and diarrhea (RR 1.88, 95% CI 1.68 to 2.11).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized trials comparing semaglutide (oral or subcutaneous) with placebo in patients at increased risk of cardiovascular events were eligible.
Summary · context
The analysis included 50 trials, with a total of 54,972 participants randomized.
Report a problemFND-4128687505
06HumanSystematic reviewSafety outcome
In patients at increased risk of cardiovascular events, semaglutide increased the risk of non-serious diarrhea compared with placebo.
In plain wordsIn people at higher risk of cardiovascular events, semaglutide caused more diarrhea than placebo.
Peptide
Semaglutide
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Measurements
RR
1.88 NA
diarrhea
Source sentences
Summary
but increased the risk of several non-serious gastrointestinal AEs including nausea (RR 3.00, 95% CI 2.63 to 3.42), vomiting (RR 4.12, 95% CI 3.47 to 4.90), and diarrhea (RR 1.88, 95% CI 1.68 to 2.11).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized trials comparing semaglutide (oral or subcutaneous) with placebo in patients at increased risk of cardiovascular events were eligible.
Summary · context
The analysis included 50 trials, with a total of 54,972 participants randomized.
Report a problemFND-4128687506

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.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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