Lipids & metabolic liver disease
Inclisiran in individuals with diabetes or obesity: Post hoc pooled analyses of the ORION ‐9, ORION ‐10 and ORION ‐11 Phase 3 randomized trials
Authors' conclusion
Inclisiran provided substantial and sustained LDL cholesterol lowering across glycaemic/BMI strata, with a modest excess of transient mild-to-moderate TEAEs at the injection site.
Study context
- Population
- Individuals with normoglycaemia, prediabetes or diabetes, across body mass index (BMI) strata (<25, ≥25 to <30, ≥30 to <35, ≥35 kg/m²), on background oral lipid-lowering therapyrandomized 1:1
- Comparison
- Inclisiran 300 mg vs placebo
- Outcome
- Co-primary: percentage and time-adjusted percentage change in LDL-C from baseline
- Follow-up
- Day 510; after Day 90 and up to Day 540
Methodological detailsrandomized 1:1, placebo-controlled, stratified by glycaemic status and BMI
- Randomized 1:1
- Placebo-controlled
- Stratified by glycaemic status and BMI
Pooled result
As reported in the abstract
% LDL-C change, baseline to Day 510, across glycaemic strata
−47.6% to −51.9%
% LDL-C change, baseline to Day 510, across BMI strata
−48.8% to −54.4%
Time-adjusted % LDL-C change, after Day 90 up to Day 540, across glycaemic strata
−46.8% to −52.0%
Time-adjusted % LDL-C change, after Day 90 up to Day 540, across BMI strata
−48.6% to −53.3%
Further pooled results
PCSK9 and other atherogenic lipids and lipoproteins
- Significant reductions with inclisiran vs placebo across glycaemic/BMI strata
Achievement of LDL-C <1.8 mmol/L and <1.4 mmol/L
- Proportions achieving thresholds with inclisiran increased with increasing glycaemic and BMI strata
Safety
| Outcome | Inclisiran | Placebo |
|---|---|---|
| Mild/moderate injection-site TEAEs across glycaemic/BMI strataRange across strata | 2.8%-7.7% | 0.2%-2.1% |
Original publication
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