Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §3

SURPASS-CVOT — results

Primary endpoint, absolute and relative effect where derivable, and harms as reported.

Document identifier
CEI-TR-0034/3
Series
Trial abstract
Version
2.2
Published
28 Feb 2025
Last reviewed
28 Nov 2025
Next review
28 Nov 2027
Identifier
10.71829/cei.trial.34
Certainty
Moderate
Cycle
2025 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Time to first major adverse cardiovascular event, tirzepatide versus dulaglutideNon-inferior to dulaglutide on the primary composite. The Institute records that an active-controlled non-inferiority design cannot establish superiority over placebo and does not report it as though it hadModerate
Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed.

§3.2Endpoint hierarchy

Cumulative incidence of the primary endpointCumulative event incidence in each randomised arm over the follow-up period.051001020304050Months since randomisationCumulative incidence (%)TirzepatideComparator
Figure 1. Illustrative. Cumulative incidence of the primary composite, reconstructed by the Institute from the reported hazard ratio and a comparator event rate typical of the enrolled risk profile. The curves are not digitised from the published figure. They are published to convey the shape of event accrual and the point at which the arms separate, and no incidence should be read off them.

Table 4. Relative and absolute effect. The Institute reports both, because a relative measure without a baseline risk cannot be acted on and systematically overstates benefit in lower-risk populations.

MeasureValueNote
Hazard ratio as reported0.85Reproduced from the published report.
Comparator event rate, %10.9Illustrative. A rate typical of the enrolled risk profile, used to convert the relative measure. Not a published figure.
Absolute risk difference, pp1.64Illustrative. Computed from the two rows above.
Number needed to treat61Illustrative. For the stated duration, at the comparator rate assumed above. Rises sharply as baseline risk falls.
Three of the four rows are Institute constructions and are marked. Only the hazard ratio is a published figure.

§3.3Harms as reported

Table 5. Adverse events for Tirzepatide from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.

EventActive, %Comparator, %Source trial
Nausea29.09.5SURMOUNT-1 (15 mg, 72 weeks)
Diarrhoea23.47.3SURMOUNT-1
Constipation11.75.8SURMOUNT-1
Vomiting12.82.6SURMOUNT-1
Dyspepsia9.12.9SURMOUNT-1
Injection-site reaction5.60.9SURMOUNT-1
Alopecia5.41.0SURMOUNT-1
Cholelithiasis1.60.4SURMOUNT-1
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