Open
Do PCSK9 inhibitors cause more adverse events & safety versus placebo?
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
Unlikely. So far, the results disagree.
NoUnsureYes
- Belief
- 0.00 (range 0.00–0.55)
- Trials for
- 0
- Trials against
- 4
- Inconclusive
- 1
Already under way
No registered trial that could settle this is recruiting or active.
The evidence so far
- Registered trials
- 75
- With posted results
- 16
- Published papers
- 16
Of 7 decided analyses: 3 favor pcsk9 inhibitors, 4 find no difference, 0 favor the comparator.
Papers
- Efficacy and safety of evolocumab in statin-treated patients with cardiovascular risk factors: a systematic review and meta-analysis.Meta-analysis / systematic review · 2025
- Increased Risk of Adverse Neurocognitive Outcomes With Proprotein Convertase Subtilisin-Kexin Type 9 Inhibitors.Meta-analysis / systematic review · 2017
- A Meta-analysis of the Regulation of Low-Density Lipoprotein Cholesterol and Proprotein Convertase Subtilisin-Kexin Type 9 with Inclisiran.Meta-analysis / systematic review · 2025
- 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
- Benefits and Risks of Antihyperlipidemic Medication in Adults with Different Low-Density Lipoprotein Cholesterol Based on the Number Needed to Treat.Meta-analysis / systematic review · 2024
Trials
- 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
- Impact of the PCSK9 Inhibitor Evolocumab on the Pharmacodynamic Effects of Clopidogrel in Patients With Atherosclerotic Cardiovascular Disease and High On-Treatment Platelet ReactivityNCT03096288 · 2 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
- A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)NCT04929249 · 1 posted result
- A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome (VICTORION-INCEPTION)NCT04873934 · 1 posted result
- 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
- Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot TrialNCT03542110