Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial
Primary resultResult — go to the resultHodges-Lehmann median estimate of treatment difference 0.75 95% CI 0.67–0.83Authors' conclusion
Lipoprotein apheresis was discontinued in 63.4% of patients on alirocumab who were previously undergoing regular apheresis, and the rate was at least halved in 92.7% of patients. Alirocumab was generally safe and well tolerated.
Study context
- Population
- Heterozygous familial hypercholesterolaemia (HeFH) patients undergoing regular weekly or Q2W lipoprotein apheresis
- Participants
- 62 patients
- Comparison
- Alirocumab vs placebo
- Alirocumabn = 41
- Placebon = 21reference
- Primary endpoint
- Rate of apheresis treatments, standardised to number of planned treatments
- Follow-up
- Over 12 weeks (weeks 7-18)
Methodological detailsdouble-blind, placebo-controlled, 2:1 randomisation, Weeks 1-6 apheresis at fixed established schedule; weeks 7-18 adjusted by blinded low-density lipoprotein cholesterol (LDL-C) response; apheresis not performed when LDL-C ≥30% below baseline
- Double-blind
- Placebo-controlled
- 2:1 randomisation
- Weeks 1-6 apheresis at fixed established schedule; weeks 7-18 adjusted by blinded LDL-C response; apheresis not performed when LDL-C ≥30% below baseline
Primary result
As reported in the abstract
Hodges-Lehmann median estimate of treatment difference
0.75
95% CI 0.67–0.83
P < 0.0001
Alirocumab vs Placebo
Hodges-Lehmann median estimate of treatment difference 0.75 (95% CI 0.67–0.83); P < 0.0001
Further findings
| Outcome | Alirocumab | Placebo |
|---|---|---|
| % change in pre-apheresis LDL-C from baseline · week 6 | LS mean −53.7 (SE 2.3) % | LS mean 1.6 (SE 3.1) % |
| 95% CI | −58.2 to - 49.2 | −4.7 to 7.9 |
- Apheresis avoided (alirocumab) · weeks 7-18
- 63.4% · Avoided all apheresis · Avoided at least half of apheresis 92.7%
Safety
Adverse events
Adverse events
- Adverse event rates were similar
Original publication
Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. Eur Heart J. Published 29 August 2016. doi:10.
Summarised from the published abstract; every number is checked against it