Author + information
- John R. Guytona,b,
- G. Kees Hovingha,b,
- Gisle Langsleta,b,
- Robert Dufoura,b,
- Marie Baccara-Dineta,b,
- Chantal Din-Bella,b,
- Garen Manveliana,b and
- Michel Farniera,b
Background: The ODYSSEY open-label extension (OLE) study (NCT01954394) of 4 Phase 3 trials (FH I; FH II; LONG TERM; HIGH FH) is assessing the long-term efficacy and safety of alirocumab (ALI) in patients with heterozygous familial hypercholesterolemia (HeFH) for up to 3.5yrs. We assessed the safety of ALI in patients on maximally tolerated statin ± other lipid-lowering therapies using data from OLE.
Methods: HeFH patients entering OLE from FH I, FH II and LONG TERM started on ALI 75 mg every 2 weeks (Q2W) and patients from HIGH FH started on 150 mg Q2W. This analysis compares patients who received ALI vs placebo (PBO) in the parent trials (18 months) during at least 12 months of ALI treatment in OLE.
Results: Baseline LDL-C values (Table) reflect the 8-week wash-out in LONG TERM and PBO allocation in the other parent trials (no wash-out). Over 73.4 weeks of mean exposure to ALI in OLE, 77.4% of patients reported treatment-emergent adverse events (TEAE) and 2.2% discontinued due to a TEAE. Safety profiles were similar between patients who received ALI vs PBO in the parent trials, except for injection-site reactions of which a lower rate was observed in patients who received ALI vs PBO during the parent studies (Table).
Conclusions: In OLE, the safety profile was similar regardless of treatment during the parent trials, and was consistent with data from the 18-month double-blind parent studies. Fewer patients who received ALI in the parent studies had injection site reactions in OLE compared with patients who received PBO.
Moderated Poster Contributions
Prevention Moderated Poster Theater, Poster Hall, Hall C
Friday, March 17, 2017, 10:30 a.m.-10:40 a.m.
Session Title: The PCSK9 Revolution: New Insights Into Evaluation and Treatment
Abstract Category: 32. Prevention: Clinical
Presentation Number: 1133M-07
- 2017 American College of Cardiology Foundation