SynthesisBritish journal of clinical pharmacology2016
Systematic review of published Phase 3 data on anti-PCSK9 monoclonal antibodies in patients with hypercholesterolaemia.
Synthesis in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03634293 (PCSK9 Inhibitor), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PCSK9 Inhibitor: a New Tool to Fight Septic Shock
Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy.International journal of environmental research and public health · 2022Pooled it
- Anti-PCSK9 antibodies for hypercholesterolaemia: Overview of clinical data and implications for primary care.International journal of clinical practice · 2017Pooled it
- Systematic review of published Phase 3 data on anti-PCSK9 monoclonal antibodies in patients with hypercholesterolaemia.British journal of clinical pharmacology · 2016Pooled it
- A Systematic Review of Clinical Features and Treatment Outcomes of Xanthoma Disseminatum.Journal of cutaneous medicine and surgeryPooled it
- Timing of Evolocumab Initiation After Acute Coronary Syndrome and Long-Term Lipid and Cardiovascular Outcomes: A Multicenter Real-World Cohort Study.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Proprotein Convertase Subtilisin Kexin 9 Inhibitor in Severe Sepsis and Septic Shock Patients in a Phase II Prospective Cohort Study-Preliminary Results.Infectious disease reports · 2024Article
- Classical and Novel Lipid-Lowering Therapies for Diabetic Patients with Established Coronary Artery Disease or High Risk of Coronary Artery Disease-A Narrative Clinical Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- The German CaRe high registry for familial hypercholesterolemia - Sex differences, treatment strategies, and target value attainment.Atherosclerosis plus · 2023Review
- The Multifaceted Biology of PCSK9.Endocrine reviews · 2022Review
- Rethinking the ethical principles of genomic medicine services.European journal of human genetics : EJHG · 2020Article
- Gender Disparities in Health Resource Utilization in Patients with Atherosclerotic Cardiovascular Disease: A Retrospective Cross-Sectional Study.Advances in therapy · 2019Article
- Alirocumab as add-on therapy to statins: current evidence and clinical potential.Therapeutic advances in cardiovascular disease · 2018Review
- Familial Hypercholesterolemia: New Horizons for Diagnosis and Effective Management.Frontiers in pharmacology · 2018Review
- Diversity and inclusion in genomic research: why the uneven progress?Journal of community genetics · 2017Article
- Pharmacoeconomics of PCSK9 inhibitors in 103 hypercholesterolemic patients referred for diagnosis and treatment to a cholesterol treatment center.Lipids in health and disease · 2016Article
- Article
- PCSK9 Antibody-based Treatment Strategies for Patients With Statin Intolerance.In vivo (Athens, Greece)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTwo anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies, alirocumab and evolocumab, have been approved for the treatment of hypercholesterolaemia in certain patients. We reviewed data from Phase 3 studies to evaluate the efficacy and safety of these antibodies.
methodsWe systematically reviewed Phase 3 English-language studies in patients with hypercholesterolaemia, published between 1 January 2005 and 20 October 2015. Congress proceedings from 16 November 2012 to 16 November 2015 were also reviewed.
resultsWe identified 12 studies of alirocumab and nine of evolocumab, including over 10 000 patients overall. Most studies enrolled patients with hypercholesterolaemia and used anti-PCSK9 antibodies with statins. The ODYSSEY FH I, FH II and HIGH FH alirocumab studies and the RUTHERFORD-2 evolocumab study exclusively recruited patients with heterozygous familial hypercholesterolaemia. Two evolocumab studies focused mainly on homozygous familial hypercholesterolaemia (HoFH): TESLA Part B and TAUSSIG (a TESLA sub-study); only those data for HoFH are reported here. All comparator studies demonstrated a reduction in LDL cholesterol (LDL-C) with the anti-PCSK9 antibodies. No head-to-head studies were conducted between alirocumab and evolocumab. Up to 87% of patients receiving alirocumab and up to 98% receiving evolocumab reached LDL-C goals. Both antibodies were effective and well tolerated across a broad population of patients and in specific subgroups, such as those with type 2 diabetes.
conclusionsUsing anti-PCSK9 antibodies as add-on therapy to other lipid-lowering treatments or as monotherapy for patients unable to tolerate statins may help patients with high cardiovascular risk to achieve their LDL-C goals.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.