PCSK9 inhibitor (ALN-PCS)

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Indications

Benefit/risk

Dosage

* MK-0616 is an investigational oral PCSK9 inhibitor[14]

Adverse effects

Mechanism of action

Notes

More general terms

More specific terms

Additional terms

References

  1. Roth EM et al Atorvastatin with or without an Antibody to PCSK9 in Primary Hypercholesterolemia. N Engl J Med. Oct 31, 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23113833 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1201832
  2. Giugliano RP et al Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study The Lancet, Early Online Publication, 6 November 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23141813 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61770-X/abstract
    Koren MJ et al Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study The Lancet, Early Online Publication, 6 November 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23141812 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61771-1/abstract
    Tonkin AM and Watts GF Into the future: diversifying lipid management The Lancet, Early Online Publication, 6 November 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23141810 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61888-1/fulltext
  3. 3.0 3.1 3.2 Fitzgerald K et al Effect of an RNA interference drug on the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) and the concentration of serum LDL cholesterol in healthy volunteers: a randomised, single-blind, placebo-controlled, phase 1 trial. The Lancet, Early Online Publication, 3 October 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24094767 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61914-5/abstract
    Fitzgerald K, White S, Borodovsky A et al. A highly durable RNAi therapeutic inhibitor of PCSK9. N Engl J Med 2016 Nov 13 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27959715 <Internet> http://www.nejm.org/doi/10.1056/NEJMoa1609243
  4. 4.0 4.1 Krumholz HM More Promising Results for PCSK9 Inhibitors. NEJM Journal Watch. March 15 2015 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
    Robinson JG et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015 Mar 15; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25773378 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1501031
    Sabatine MS et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 2015 Mar 15 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25773607 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1500858
    Stone NJ and Lloyd-Jones DM. Lower LDL cholesterol is better, but it matters how you get there, and in whom. N Engl J Med 2015 Mar 15 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25773740 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1502192
  5. 5.0 5.1 Navarese EP et al Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis. Ann Intern Med. Published online 28 April 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25915661 <Internet> http://annals.org/article.aspx?articleid=2279798
    Cainzos-Achirica M PCSK9 Inhibitors: A New Era in Lipid-Lowering Treatment? Ann Intern Med. Published online 28 April 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25915768 <Internet> http://annals.org/article.aspx?articleid=2279799
  6. Prescriber's Letter 22(8): 2015 PCSK9 Inhibitors for High Cholesterol Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=310813&pb=PRL http://www.prescribersletter.com (subscription needed)
  7. 7.0 7.1 7.2 New England Comparative Effectiveness Public Advisory Council (CEPAC) PCSK9 Inhibitors for Treatment of High Cholesterol. http://cepac.icer-review.org/adaptations/cholesterol/
    Kazi DS, Moran AE, Coxson PG. Cost-effectiveness of PCSK9 Inhibitor Therapy in Patients With Heterozygous Familial Hypercholesterolemia or Atherosclerotic Cardiovascular Disease. JAMA. 2016;316(7):743-753 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27533159 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2544639
  8. 8.0 8.1 8.2 Khan AR, Bavishi C, Riaz H et al. Increased risk of adverse neurocognitive outcomes with proprotein convertase subtilisin-kexin type 9 inhibitors. Circ Cardiovasc Qual Outcomes 2017 Jan; 10:e003153 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28073851 <Internet> http://circoutcomes.ahajournals.org/content/10/1/e003153
    Everett BM Low-Density Lipoprotein Cholesterol and the On-Target Effects of Therapy. How Low Is Too Low? J Am Coll Cardiol 69(5) Feb 2017 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28153103
  9. 9.0 9.1 Arrieta A, Hong JC, Khera R et al Updated Cost-effectiveness Assessments of PCSK9 Inhibitors From the Perspectives of the Health System and Private Payers. Insights Derived From the FOURIER Trial. JAMA Cardiol. Published online October 18, 2017. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29049467 https://jamanetwork.com/journals/jamacardiology/article-abstract/2657541
    Kazi DS, Lu CY, Lin GA et al Nationwide Coverage and Cost-Sharing for PCSK9 Inhibitors Among Medicare Part D Plans. JAMA Cardiol. 2017;2(10):1164-1166 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28903137 https://jamanetwork.com/journals/jamacardiology/article-abstract/2653354
    Mark DB, Richman I, Hlatky MA. Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Therapy
    Breakthrough in Low-Density Lipoprotein Cholesterol Lowering, Breakdown in Value. JAMA Cardiol. 2017;2(10):1066-1068 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28832860 https://jamanetwork.com/journals/jamacardiology/article-abstract/2649270
    Bonow RO, Harrington RA, Yancy CW Cost-effectiveness of PCSK9 Inhibitors. Proof in the Modeling. JAMA Cardiol. Published online October 18, 2017. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29049827 https://jamanetwork.com/journals/jamacardiology/article-abstract/2657544
  10. 10.0 10.1 10.2 Phend C. AHA: Revised Lipid Guide Boosts PCSK9s, Coronary Calcium Scans. New recommendations aim to cut statins in low-risk primary prevention. Med Page Today. Nov 10, 2018 https://www.medpagetoday.com/meetingcoverage/aha/76250
    Grundy SM, Stone NJ, Bailey AL et al 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 Nov 8. pii: S0735-1097(18)39034-X. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30423393
    Lloyd-Jones DM, Braun LT, Ndumele CE et al Use of risk assessment tools to guide decision-making in the primary prevention of atherosclerotic cardiovascular disease: A special report from the American Heart Association and American College of Cardiology. J Am Coll Cardiol. 2018 Nov 3. pii: S0735-1097(18)39036-3. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30423392
    Grundy SM, Stone NJ, Bailey AL et al 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30586774
    Grundy SM, Stone NJ, Bailey AL et al 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1046-e1081. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30565953
    Forman DE, Stone NJ, Grundy SM. Treating Hypercholesterolemia in Older Adults. JAMA. 2019 Aug 20;322(7):695. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/31429891-
  11. Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
  12. 12.0 12.1 Kazi DS, Penko J, Coxson PG, et al. Cost-effectiveness of alirocumab: A just-in-time analysis based on the ODYSSEY outcomes trial. Ann Intern Med 2019 Jan 1; PMID: https://www.ncbi.nlm.nih.gov/pubmed/30597485
    Hlatky MA. A pound of prevention? Assessing the value of new cholesterol- lowering drugs. Ann Intern Med 2019 Jan 1; PMID: https://www.ncbi.nlm.nih.gov/pubmed/30597487
  13. 13.0 13.1 13.2 Carter JP et al. Cochrane corner: PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Heart 2022 Jan; 108:14. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34815331 https://heart.bmj.com/content/108/1/14
  14. 14.0 14.1 Ballantyne et al Efficacy and safety of the oral PCSK9 inhibitor MK-0616: a phase 2b randomized controlled trial J Am Coll Cardiol. Mar 06, 2023. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36889610 https://www.jacc.org/doi/10.1016/j.jacc.2023.02.018