Author + information
- Lawrence Leitera,b,
- Francisco J. Tinahonesa,b,
- Dean Karalisa,b,
- Maja Bujas-Bobanovica,b,
- Alexia Letiercea,b,
- Rita Samuela,b and
- Peter Jonesa,b
Background: Individuals with diabetes mellitus (DM) and elevated low density lipoprotein cholesterol (LDL-C) are at increased cardiovascular risk.
Methods: We analyzed alirocumab (ALI) safety in hypercholesterolemic individuals with and without DM (defined by medical history) across 14 double-blind randomized trials (8-104 weeks) that compared ALI 75/150 mg every 2 weeks to control (placebo or ezetimibe).
Results: We analyzed 4834 patients of whom 1554 (32.1%) had DM. Compared with individuals without DM, those with DM had lower baseline LDL-C, fewer had HeFH, fewer were on high-intensity statins, A1C and BMI were higher, and more had CKD (Table). Overall treatment-emergent adverse events (TEAEs) were comparable between ALI and control groups, except for an increased rate of injection site reactions (ISRs) with ALI (Table). Incidence and mean duration of ISRs in ALI-treated individuals with DM was lower vs. non-DM. Overall serious TEAE incidence was higher in those with DM vs. non-DM; however, no pattern was observed and no difference in ALI vs. controls was observed. Major adverse cardiac events (MACE) were reported in 2.7% (ALI) vs 3.3% (control) with DM (HR 0.74 [95% CI: 0.411.35]) and 1.8% (ALI) vs 1.7% (control) without DM (HR 0.95 [95% CI: 0.56-1.62]).
Conclusions: Pooled analysis across 14 trials (8-104 weeks) demonstrated that ALI safety was comparable to control irrespective of DM status, except ISRs were more frequent with ALI. However, DM individuals reported fewer ISRs than those without DM.
Moderated Poster Contributions
Prevention Moderated Poster Theater, Poster Hall, Hall C
Saturday, March 18, 2017, 1:00 p.m.-1:10 p.m.
Session Title: The Intersection of Diabetes and ASCVD
Abstract Category: 32. Prevention: Clinical
Presentation Number: 1222M-07
- 2017 American College of Cardiology Foundation