Recent Updates on the Use of PCSK9 Inhibitors in Patients with Atherosclerotic Cardiovascular Disease.
Level 5 - mechanism / opinion, no new human data
Narrative review synthesizing published trials without systematic review or meta-analytic methodology
PubMed 30877491 · doi:10.1007/s11883-019-0778-6
What was done
This narrative review summarizes clinical trial evidence from phase II, phase III, and cardiovascular outcome trials evaluating the efficacy, safety, guideline updates, and cost-effectiveness of the PCSK9 inhibitors alirocumab and evolocumab in patients with atherosclerotic cardiovascular disease (ASCVD).
What was found
Alirocumab and evolocumab reduce LDL-C levels by up to 60% and are relatively safe, with injection site reactions being the primary reported adverse effect. Two randomized controlled clinical trials established that both agents reduce ASCVD events when added to statin therapy compared with statin alone. Based on these trials, the 2018 Cholesterol Guideline recommended PCSK9 inhibitors for select secondary prevention patients with LDL-C ≥ 70 mg/dL on maximally tolerated statin plus ezetimibe. Specific numerical event reductions, hazard ratios, and study sizes were not reported in the abstract.
Why it matters
PCSK9 inhibitors provide substantial additional LDL-C lowering and clinical event reduction in high-risk ASCVD patients with residual risk, although cost-effectiveness remains a major barrier to wider implementation.
Limits
As a narrative review, it lacks a systematic search protocol and quantitative pooled analysis. The abstract does not report precise numerical outcome effect sizes, and evidence remains insufficient for primary prevention, statin-intolerant patients, and acute myocardial infarction settings.
Cited by
- supports PCSK9 inhibitors were first approved in 2015.