Trial abstract · §3
HARMONY-OUTCOMES — results
Primary endpoint, absolute and relative effect where derivable, and harms as reported.
§3Results
§3.1Primary endpoint
Table 3. Primary endpoint as reported.
| Endpoint | Result as reported | Certainty |
|---|---|---|
| Time to first occurrence of cardiovascular death, myocardial infarction or stroke | Hazard ratio 0.78 (95 % CI 0.68 to 0.90) | Moderate |
| 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
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.
| Measure | Value | Note |
|---|---|---|
| Hazard ratio as reported | 0.78 | Reproduced from the published report. |
| Comparator event rate, % | 5.0 | Illustrative. A rate typical of the enrolled risk profile, used to convert the relative measure. Not a published figure. |
| Absolute risk difference, pp | 1.10 | Illustrative. Computed from the two rows above. |
| Number needed to treat | 91 | Illustrative. 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 Dulaglutide 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.
| Event | Active, % | Comparator, % | Source trial |
|---|---|---|---|
| Nausea | 12.4 | 5.3 | AWARD programme pooled (1.5 mg) |
| Diarrhoea | 8.9 | 5.0 | AWARD pooled |
| Vomiting | 6.0 | 2.3 | AWARD pooled |
| Abdominal pain | 6.5 | 4.7 | AWARD pooled |
| Decreased appetite | 4.9 | 1.6 | AWARD pooled |
| Acute pancreatitis | 0.1 | 0.1 | REWIND |
| Discontinuation for adverse events | 5.1 | 2.9 | AWARD pooled |
| Antibody formation | 1.6 | — | AWARD pooled; neutralising antibodies rare |
Compound Evidence Institute · CEI-TR-0095/3 · https://compoundevidence.com/trials/harmony-outcomes/results/ · retrieved 30 July 2026