Author + information
- Peter H. Jonesa,b,
- Seth Martina,b,
- Harold Baysa,b,
- G.B. John Mancinia,b,
- Maurizio Avernaa,b,
- Andrei C. Spositoa,b,
- Michael Korena,b,
- Rita Samuela,b,
- Alexia Letiercea,b,
- Marie Baccara-Dineta,b and
- R. Scott Wrighta,b
Background: The alirocumab (ALI) ODYSSEY clinical trial program recruited patients with hypercholesterolemia, ∼70% of whom had atherosclerotic cardiovascular disease (ASCVD) and were at very high ASCVD risk. This analysis evaluated the lipid-lowering efficacy and safety of ALI among patients with or without clinical ASCVD.
Methods: The dataset originated from 4,983 patients with hypercholesterolemia randomized in 10 Phase 3 trials. Data were grouped into 4 pools based on ALI dose and control (placebo, Pools 1+2; ezetimibe, Pools 3+4) (Table). Patients in Pools 1–3 received background statins, which were at maximally tolerated dose in most patients (85%); patients in Pool 4 did not receive statins.
Results: LDL-C % reductions from baseline and goal achievement at Week 24 were comparable in patients with or without clinical ASCVD in placebo-controlled trials (Table). LDL-C goal achievement was consistent in ALI-treated patients in ezetimibe-controlled trials. Treatment emergent adverse event (TEAE) rates and discontinuations due to TEAEs with ALI were similar to controls regardless of clinical ASCVD status (Table).
Conclusions: Compared with controls, ALI administration substantially reduced LDL-C levels, allowed greater LDL-C goal achievement, and was generally well tolerated in both patients with and without clinical ASCVD.
Moderated Poster Contributions
Prevention Moderated Poster Theater, Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:10 a.m.
Session Title: The PCSK9 Revolution: New Insights Into Evaluation and Treatment
Abstract Category: 32. Prevention: Clinical
Presentation Number: 1133M-03
- 2017 American College of Cardiology Foundation