Trial abstract · §3
PIONEER-6 — 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 major adverse cardiovascular event | Hazard ratio 0.79 (95 % CI 0.57 to 1.11); the trial was designed and powered to exclude harm, not to establish benefit, and the Institute reports it as such | High |
| 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 | 0.79 | Reproduced from the published report. |
| Comparator event rate, % | 6.4 | Illustrative. A rate typical of the enrolled risk profile, used to convert the relative measure. Not a published figure. |
| Absolute risk difference, pp | 1.34 | Illustrative. Computed from the two rows above. |
| Number needed to treat | 75 | 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 Semaglutide, oral 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 | 20.0 | 2.4 | PIONEER 1 (14 mg, 26 weeks) |
| Diarrhoea | 9.0 | 2.4 | PIONEER 1 |
| Vomiting | 7.0 | 1.2 | PIONEER 1 |
| Decreased appetite | 7.0 | 1.6 | PIONEER 1 |
| Discontinuation for adverse events | 7.3 | 2.4 | PIONEER 1 |
| Nausea | 36.5 | 12.2 | OASIS 1 (50 mg) |
| Vomiting | 24.6 | 4.2 | OASIS 1 |
Compound Evidence Institute · CEI-TR-0018/3 · https://compoundevidence.com/trials/pioneer-6/results/ · retrieved 30 July 2026