Author + information
- Dirk Müller-Wielanda,b,
- Daniel Radera,b,
- Patrick Moriartya,b,
- Jean Bergerona,b,
- Gisle Langsleta,b,
- Kausik Raya,b,
- Garen Manveliana,b,
- Desmond Thompsona,b,
- Maja Bujas-Bobanovica,b and
- Eli Rotha,b
Background: Individuals with diabetes and elevated LDL-C are at particularly high risk for atherosclerotic cardiovascular disease. ODYSSEY CHOICE I (NCT01926782) assessed alirocumab (ALI) at a dose of 300 mg every 4 weeks (Q4W) in patients with hypercholesterolemia. We evaluated efficacy and safety of ALI in a patient subgroup with type 2 diabetes (T2DM) on maximally tolerated statins from CHOICE I.
Methods: Individuals received either ALI 300 mg Q4W (n=458) or placebo (PBO; n=230) for 48 weeks, with dose adjustment for the ALI group to 150 mg Q2W at Week (W)12 if W8 LDL-C levels were >70/100 mg/dL, depending on cardiovascular risk, or if LDL-C reduction was <30% from baseline. Efficacy endpoints included % change from baseline to W24 for LDL-C and other lipids, and in time-averaged LDL-C over W21-24.
Results: For individuals identified as having T2DM, baseline characteristics were similar in the ALI and PBO groups (n=146; Table). For LDL-C, reductions from baseline to W24 and average reductions from baseline to W21-24 were significantly greater with ALI (-61.6% and −68.8% vs PBO, respectively; Table). At W24, ALI also significantly reduced levels of non-HDL-C, Apo B, TG and Lp(a). In total, 84.4% (ALI) and 74.0% (PBO) of individuals with T2DM experienced TEAEs, with upper respiratory tract infection and injection-site reaction among the most common (Table).
Conclusions: In individuals with T2DM who required additional LDL-C lowering, ALI 300 mg Q4W significantly improved their lipid profiles.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Advances in Cholesterol Measurement and Management
Abstract Category: 32. Prevention: Clinical
Presentation Number: 1106-055
- 2017 American College of Cardiology Foundation