Safety and Tolerability of Inclisiran for Treatment of Hypercholesterolemia in 7 Clinical Trials
Authors' conclusion
Long-term treatment with inclisiran was well tolerated in a diverse population, without new safety signals, supporting the safety of inclisiran in patients with dyslipidemia.
Study context
- Population
- Patients with hypercholesterolemia in the ORION-1, −3, −5, −8, −9, −10 and −11 trialspooled ORION trials
- Participants
- 3,576 vs 1,968
- Comparison
- Inclisiran vs placebo
- Inclisirann = 3,576
- Placebon = 1,968reference
- Outcome
- Long-term safety: exposure-adjusted incidence rates and Kaplan-Meier cumulative incidence of TEAEs, abnormal laboratory measurements and antidrug antibodies
Methodological detailscompleted (ORION-1, −3, −5, −9, −10, and −11) and ongoing (ORION-8) trials
- Completed (ORION-1, −3, −5, −9, −10, and −11) and ongoing (ORION-8) trials
Pooled result
As reported in the abstract
TEAEs (serious or leading to discontinuation; hepatic, muscle, kidney events; incident DM; creatine kinase or creatinine elevations) · up to 1.5 years
- Accrued at a comparable rate between groups for up to 1.5 years, with similar trends continuing for inclisiran beyond
- Numerically fewer major CV events reported as treatment-emergent adverse events (TEAEs) with inclisiran
- Post hoc analysis
- Exposure 9,982.1 (inclisiran) and 2,647.7 (placebo) patient-years
Safety
| Outcome | Inclisiran |
|---|---|
| Treatment-induced antidrug antibodies | 4.6% |
| Persistent | 1.4% |
Treatment-induced antidrug antibodies
- Not associated with greater incidence of TEAEs leading to discontinuation or serious TEAEs
Original publication
Safety and Tolerability of Inclisiran for Treatment of Hypercholesterolemia in 7 Clinical Trials. J Am Coll Cardiol. Published 12 December 2023. doi:10.
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