Author + information
- Aris Karatasakisa,b,
- Barbara Daneka,b,
- Judit Karacsonyia,b,
- Bavana Rangana,b,
- Michele Roeslea,b,
- Amy Atwella,b,
- Erica Resendesa,b,
- Thomas Knickelbinea,b,
- Michael Miedemaa,b,
- Shuaib Abdullaha,b,
- Houman Khalilia,b,
- Subhash Banerjeea,b and
- Emmanouil Brilakisa,b
Background: Monoclonal antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) greatly improved lipid profiles in phase 3 trials. Results from large cardiovascular outcomes trials (CVOTs) are expected in late 2016.
Methods: We performed a systematic review and meta-analysis of randomized controlled phase 2 and 3 clinical trials examining the effect of evolocumab, alirocumab and bococizumab on lipid levels and clinical outcomes of adults with hypercholesterolemia.
Results: Thirty-three trials comprising 16,721 patients were included; 10,532 that received PCSK9 inhibitors, and 6,189 controls. Compared with no antibody treatment, PCSK9 inhibitors significantly reduced low-density lipoprotein cholesterol levels from baseline (weighted mean difference: −49.4% [95% CI: −53.6%, −45.2%]; p<0.001; heterogeneity p<0.001, I2= 94.0%). All-cause mortality was lower in the PCSK9 inhibitor group (odds ratio [OR]: 0.54 [95% CI: 0.33, 0.90]; p=0.023; heterogeneity p=0.645; I2= 0%, Figure). The rates of serious adverse events (OR: 0.97 [95% CI: 0.86, 1.09]; p=0.636; heterogeneity p=0.989; I2= 0%) and adjudicated cardiovascular events (OR: 0.93 [95% CI: 0.73, 1.18]; p=0.585; heterogeneity p=0.563; I2= 0%) were similar between the two groups.
Conclusions: PCSK9 inhibitors improve lipid profiles and lower all-cause mortality in patients with hypercholesterolemia. Results from large CVOTs will provide further insights on the clinical benefits of this drug category.
Room 147 A
Sunday, March 19, 2017, 8:38 a.m.-8:48 a.m.
Session Title: Highlighted Original Research: Prevention and the Year in Review
Abstract Category: 32. Prevention: Clinical
Presentation Number: 911-08
- 2017 American College of Cardiology Foundation