Settled
Do PCSK9 inhibitors improve lipids more than other treatments?
Mostly studied in coronary & atherosclerotic disease. Also asked 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
Very likely. So far, established.
NoUnsureYes
- Belief
- 0.88 (range 0.65–0.97)
- Trials for
- 7
- Trials against
- 1
- Inconclusive
- 0
Already under way
- PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS): Study Protocol for a Multicenter Randomized…NCT06791031 · not yet recruiting · started 2026
- PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary PreventionNCT07581808 · recruiting · started 2026
- Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early…NCT07684469 · not yet recruiting · started 2026
- Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)NCT06770543 · recruiting · started 2025
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background…NCT06813911 · recruiting · started 2025
The evidence so far
- Registered trials
- 112
- With posted results
- 44
- Published papers
- 38
Of 880 decided analyses: 663 favor pcsk9 inhibitors, 50 find no difference, 167 favor the comparator.
Papers
- Effect of inclisiran on lipids in primary prevention: the ORION-11 trial.Trial report · 2022
- Clinical Efficacy and Safety of Evolocumab in High-Risk Patients Receiving a Statin: Secondary Analysis of Patients With Low LDL Cholesterol Levels and in Those Already Receiving a Maximal-Potency Statin in a Randomized Clinical Trial.Trial report · 2017
- Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients.Trial report · 2017
- A placebo-controlled proof-of-concept study of alirocumab on postprandial lipids and vascular elasticity in insulin-treated patients with type 2 diabetes mellitus.Trial report · 2020
- A 52-week placebo-controlled trial of evolocumab in hyperlipidemia.Trial report · 2014
- Estimating potential cardiovascular health benefits of improved population level control of LDL cholesterol through a twice-yearly siRNA-based approach: A simulation study of a health-system level intervention.Trial report · 2024
Trials
- Double-blind, Randomized, Placebo-controlled, Single Site Study to Evaluate the Effects of Evolocumab (AMG 145) Treatment, Alone and in Combination With Atorvastatin, on Lipoprotein KineticsNCT02189837 · 15 posted results
- A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin TherapyNCT02642159 · 20 posted results
- A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed DyslipidemiaNCT01763866 · 309 posted results
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed DyslipidemiaNCT01953328 · 96 posted results
- A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or LessNCT01763827 · 88 posted results
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)NCT02662569 · 46 posted results
- A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase InhibitorNCT01763905 · 44 posted results
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial HypercholesterolemiaNCT01763918 · 44 posted results