Settled
Do PCSK9 inhibitors improve all-cause mortality versus placebo?
Mostly studied in coronary & atherosclerotic disease.
Not modeled yetTrial evidence exists, but no mechanistic model yetWithout a model there is no decisive experiment to propose. Help build it. →
Where the evidence stands
Very likely. So far, repeated by independent trials.
NoUnsureYes
- Belief
- 1.00 (range 0.85–1.00)
- Trials for
- 2
- Trials against
- 0
- Inconclusive
- 1
Already under way
- Impact of PCSK9 Monoclonal Antibody Very Early Administered in Hospital to Reduce Cardiovascular Events in Acute Myocardial Infarction (IMMEDIATE -MI)NCT07208006 · recruiting · started 2026
- Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in RussiaNCT06858332 · recruiting · started 2025
- Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT AngiographyNCT06863545 · recruiting · started 2025
- Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary…NCT06909565 · recruiting · started 2025
- Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or StrokeNCT07734753 · active not recruiting · started 2025
The evidence so far
- Registered trials
- 33
- With posted results
- 3
- Published papers
- 10
Of 14 decided analyses: 9 favor pcsk9 inhibitors, 5 find no difference, 0 favor the comparator.
Papers
- PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.Meta-analysis / systematic review · 2020
- PCSK9 inhibitors for secondary prevention in patients with cardiovascular diseases: a bayesian network meta-analysis.Meta-analysis / systematic review · 2022
- Efficacy and Safety of PCSK9 Monoclonal Antibodies in Patients at High Cardiovascular Risk: An Updated Systematic Review and Meta-Analysis of 32 Randomized Controlled Trials.Meta-analysis / systematic review · 2020
- Association of baseline LDL-C with total and cardiovascular mortality in patients using proprotein convertase subtilisin-kexin type 9 inhibitors: A systematic review and meta-analysis.Meta-analysis / systematic review
- Beyond maximally tolerated statins: PCSK9 inhibitors as a critical adjunct for cardiovascular risk reduction in peripheral artery disease-a systematic review and meta-analysis.Meta-analysis / systematic review · 2026
- PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.Meta-analysis / systematic review · 2017
Trials
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or StrokeNCT03872401 · 8 posted results
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular DiseaseNCT01764633 · 5 posted results
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary SyndromeNCT01663402 · 4 posted results
- Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients: a Randomized Crossover TrialNCT06381947
- Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and CancerNCT05976893
- Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis - a Prospective, Randomized, Open-label, Blinded End-point Study with High-resolution MR Vessel Wall ImagingNCT05001984
- A Single-center, Randomized, Parallel-group, Open-label Pilot Study to Evaluate the Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary SyndromeNCT04719221
- Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT AngiographyNCT06863545