Author + information
- Jennifer Robinsona,b,
- Michel Farniera,b,
- William J. Sasielaa,b,
- Tu Nguyena,b,
- Jonas Mandela,b and
- John Kasteleina,b
Background: Individuals with elevated low density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD) are at increased risk for recurrent events. We present a post-hoc analysis of the efficacy and safety of alirocumab (ALI) vs. placebo (PL) among individuals with ASCVD from the ODYSSEY LONG TERM trial.
Methods: The 78-week LONG TERM trial examined the LDL-C lowering effect of ALI 150 mg every 2 weeks as add-on to maximally tolerated statin +/- other lipid lowering therapy in high risk individuals with and without ASCVD. Changes in LDL-C, occurrence of major adverse cardiovascular events (MACE) and overall safety were assessed in a subset of individuals from LONG TERM with ASCVD (n=1075).
Results: For individuals with ASCVD in LONG TERM, percent LDL-C change from baseline to Week 24 was −62.7% vs. 0.1% for ALI vs. PL (P<0.0001), and was sustained for up to 78 weeks. Treatment emergent MACE were seen in 2.3% vs. 5.1% of individuals with ASCVD in LONG TERM for ALI vs. PL. Kaplan-Meier estimates for the time to first event were significantly lower for ALI vs. PL (HR 0.438, 95% CI 0.225-0.852, P=0.0149; Figure). An overall risk reduction of 26.5% (95% CI 6.8-42.0%, P=0.0109) was observed for each 38.6 mg/dL decrease in LDL-C level during the treatment period (Cox model analysis). Overall safety was similar with ALI and PL.
Conclusions: In a subset of individuals with ASCVD from the ODYSSEY LONG TERM trial, ALI significantly reduced LDL-C and the risk of MACE vs. PL.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Advances in Lipid Management
Abstract Category: 3. Acute and Stable Ischemic Heart Disease: Therapy
Presentation Number: 1203-305
- 2017 American College of Cardiology Foundation