Atherosclerosis stabilization with PCSK-9 inhibition: An evolving concept for cardiovascular prevention

Atherosclerosis

Volumn 243, Issue 2, 2015, Pages 593-597

  Robinson, Jennifer G ^a   Heistad, Donald D ^a   Fox, Keith A A ^b  

^a UNIVERSITY OF IOWA   (United States)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

Cardiovascular prevention; PCSK 9 inhibitor; Plaque stabilization; Regression; Statin

Indexed keywords

AGENTS AFFECTING LIPID METABOLISM; CHOLESTEROL ESTER TRANSFER PROTEIN INHIBITOR; EZETIMIBE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MONOCLONAL ANTIBODY; PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9; SERINE PROTEINASE; SERINE PROTEINASE INHIBITOR; UNCLASSIFIED DRUG; ANTILIPEMIC AGENT; BIOLOGICAL MARKER; PCSK9 PROTEIN, HUMAN;

ARTICLE; ATHEROSCLEROSIS; CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; DRUG INHIBITION; ENZYME INHIBITION; FOLLOW UP; HUMAN; META ANALYSIS (TOPIC); NONHUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); ANIMAL; ANTAGONISTS AND INHIBITORS; ATHEROSCLEROTIC PLAQUE; BLOOD; COMBINATION DRUG THERAPY; COMPLICATION; DYSLIPIDEMIAS; ENZYMOLOGY; IMMUNOLOGY; METABOLISM; MOLECULARLY TARGETED THERAPY; PROCEDURES; SECONDARY PREVENTION; TREATMENT OUTCOME;

ANIMALS; ANTIBODIES, MONOCLONAL; ATHEROSCLEROSIS; BIOMARKERS; CHOLESTEROL, LDL; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPOLIPIDEMIC AGENTS; MOLECULAR TARGETED THERAPY; PLAQUE, ATHEROSCLEROTIC; PROPROTEIN CONVERTASES; SECONDARY PREVENTION; SERINE ENDOPEPTIDASES; SERINE PROTEINASE INHIBITORS; TREATMENT OUTCOME;

EID: 84946077162     PISSN: 00219150     EISSN: 18791484     Source Type: Journal    
DOI: 10.1016/j.atherosclerosis.2015.10.023     Document Type: Article

References (34)

1. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010, 376:1670-1681. Cholesterol Treatment Trialists Collaboration.
2. Robinson J.G., Farnier M., Krempf M., Bergeron J., Luc G., Averna M., Stroes E.S., Langslet G., Raal F.J., El Shahawy M., Koren M.J., Lepor N.E., Lorenzato C., Pordy R., Chaudhari U., Kastelein J.J.P. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N. Engl. J. Med. 2015, 372(16):1489-1499. PubMed PMID: 25773378. 10.1056/NEJMoa1501031.
3. Sabatine M.S., Giugliano R.P., Wiviott S.D., Raal F.J., Blom D.J., Robinson J., Ballantyne C.M., Somaratne R., Legg J., Wasserman S.M., Scott R., Koren M.J., Stein E.A. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N. Engl. J. Med. 2015, 372(16):1500-1509. PubMed PMID: 25773607. 10.1056/NEJMoa1500858.
4. Regeneron Pharmaceuticals Inc, Sanofi Aventis, Regeneron and Sanofi Announce FDA Approval of Praluent® (alirocumab) Injection, the First PCSK9 Inhibitor in the U.S., for the Treatment of High LDL Cholesterol in Adult Patients, 2015 [updated July 24, 2015; cited July 24, 2015], Available from: . http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announcefda-approval-of-praluent-alirocumab-injection-the-first-pcsk9-inhibitor-in-the-us-for-the-treatment-of-high-ldl-cholesterol-inadult-patients-300118572.html.
5. Amgen, Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER). Identifier: NCT01764633, 2014 [updated December 12, 2014; cited April 3, 2015], Available from: . https://clinicaltrials.gov/ct2/show/NCT01764633?term=fourier+amgen&rank=1.
6. Sanofi/Regeneron, ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes after an Acute Coronary Syndrome during Treatment with Alirocumab SAR236553 (REGN727). Identifier: NCT01663402, 2015 [updated March 26, 2015; cited April 3, 2015], Available from: . https://clinicaltrials.gov/ct2/show/NCT01663402?term=odyssey+outcomes&rank=1.
7. Pfizer, The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-2), Identifier: NCT01975389, 2015 [updated March 13, 2015; cited April 3, 2015], Available from: . https://clinicaltrials.gov/ct2/show/NCT01975389?term=pfizer+SPIRE&rank=3.
8. Pfizer, The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-1), Identifier: NCT01975376, 2015 [updated March 18, 2015; cited April 3, 2015], Available from: . https://clinicaltrials.gov/ct2/show/NCT01975376?term=pfizer+SPIRE&rank=4.
9. Lv H-l, Jin D-m, Liu M., Liu Y-m, Wang J-f, Geng D-f Long-term efficacy and safety of statin treatment beyond six years: a meta-analysis of randomized controlled trials with extended follow-up. Pharmacol. Res. 2014, 81(0):64-73. 10.1016/j.phrs.2014.02.006.
10. Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20 536 high-risk individuals: a randomised controlled trial. Lancet 2011, 378:2013-2020. Heart Protection Study Collaborative G. 10.1016/s0140-6736(11)61125-2.
11. Noyes A.M., Thompson P.D. A systematic review of the time course of atherosclerotic plaque regression. Atherosclerosis 2014, 234:75-84. 10.1016/j.atherosclerosis.2014.02.007.
12. Banach M., Serban C., Sahebkar A., Mikhailidis D., Ursoniu S., Ray K., Rysz J., Toth P., Muntner P., Mosteoru S., Garcia-Garcia H., Hovingh G., Kastelein J., Serruys P. Lipid, Group BPM-aC. Impact of statin therapy on coronary plaque composition: a systematic review and meta-analysis of virtual histology intravascular ultrasound studies. BMC Med. 2015, 13(1):229. 10.1186/s12916-015-0459-4.
13. Puri R., Nissen S.E., Shao M., Uno K., Kataoka Y., Kapadia S.R., Tuzcu E.M., Nicholls S.J. Impact of Baseline lipoprotein and C-Reactive protein levels on coronary atheroma regression following high-intensity statin therapy. Am. J. Cardiol. 2014, 114:1465-1472. 10.1016/j.amjcard.2014.08.009.
14. Kataoka Y., Hammadah M., Puri R., Duggal B., Uno K., Kapadia S.R., Murat Tuzcu E., Nissen S.E., Nicholls S.J. Plaque microstructures in patients with coronary artery disease who achieved very low low-density lipoprotein cholesterol levels. Atherosclerosis 2015, 242(2):490-495. 10.1016/j.atherosclerosis.2015.08.005.
15. Boekholdt S.M., Hovingh G.K., Mora S., Arsenault B.J., Amarenco P., Pedersen T.R., LaRosa J.C., Waters D.D., DeMicco D.A., Simes R.J., Keech A.C., Colquhoun D., Hitman G.A., Betteridge D.J., Clearfield M.B., Downs J.R., Colhoun H.M., Gotto A.M., Ridker P.M., Grundy S.M., Kastelein J.J.P. Very low levels of Atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials. J. Am. Coll. Cardiol. 2014, 64:485-494. 10.1016/j.jacc.2014.02.615.
16. Robinson J.G., Nedergaard B.S., Rogers W.J., et al. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on ldl-c lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA 2014, 311:1870-1882. 10.1001/jama.2014.4030.
17. Navarese E.P., Kołodziejczak M., Schulze V., Gurbel P.A., Tantry U., Lin Y., Brockmeyer M., Kandzari D.E., Kubica J.M., D'Agostino Sr R.B., Kubica J., Volpe M., Agewall S., Kereiakes D.J., Kelm M. Effects of proprotein convertase Subtilisin/Kexin type 9 antibodies in adults with Hypercholesterolemia a systematic review and meta-analysis effects of PCSK9 antibodies in adults with hypercholesterolemia. Ann. Intern. Med. 2015, N/A (N/A):N/A-N/A. 10.7326/M14-2957.
18. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005, 366:1267-1278. Cholesterol Treatment Trialists' (CTT) Collaborators.
19. Cannon C. Improve-it trial: a comparison of Ezetimibe/Simvastatin versus simvastatin monotherapy on cardiovascular outcomes after acute coronary syndrome; presented at the American Heart Association Scientific Sessions, November 17, 2014. Circulation 2014, 130:2105-2126. On behalf of the IMPROVE-IT study group. 10.1161/01.cir.0000457464.79076.2c.
20. Robinson J.G., Smith B., Maheshwari N., Schrott H. Pleiotropic effects of statins: benefit beyond cholesterol reduction? A meta-regression analysis. J. Am. Coll. Cardiol. 2005, 46:1855-1862.
21. Robinson J.G. Models for describing relations among the various statin drugs, low-density lipoprotein cholesterol lowering, pleiotropic effects, and cardiovascular risk. Am. J. Cardiol. 2008, 101:1009-1015.
22. Amgen, GLobal Assessment of Plaque reGression with a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV) NCT01813422, 2015 [updated March 17, 2015; cited April 1, 2015], Available from: . https://clinicaltrials.gov/ct2/show/NCT01813422.
23. Williams K.J., Feig J.E., Fisher E.A. Rapid regression of atherosclerosis: Insights from the clinical and experiemental literature. Nat. Clin. Pract. Cardiovasc Med. 2008, 5:91-102.
24. Kühnast S., van der Hoorn J.W.A., Pieterman E.J., van den Hoek A.M., Sasiela W.J., Gusarova V., Peyman A., Schäfer H.-L., Schwahn U., Jukema J.W., Princen H.M.G. Alirocumab inhibits atherosclerosis, improves the plaque morphology, and enhances the effects of a statin. J. Lipid Res. 2014, 55(10):2103-2112. 10.1194/jlr.M051326.
25. Packard C., Ford I., Murray H.M., McCowan C. Lifetime clinical and economic benefits of statin-based LDL lowering in the 20-year followup of the West of Scotland coronary prevention study. Circulation 2014, 130:2105-2126. 10.1161/01.cir.0000457464.79076.2c.
26. Hlatky M.A., Douglas P.S., Cook N.L., Wells B., Benjamin E.J., Dickersin K., Goff D.C., Hirsch A.T., Hylek E.M., Peterson E.D., Roger V.L., Selby J.V., Udelson J.E., Lauer M.S. Future directions for cardiovascular disease comparative effectiveness research: report of a workshop sponsored by the National Heart, Lung, and Blood Institute. J. Am. Coll. Cardiol. 2012, 60(7):569-580. 10.1016/j.jacc.2011.12.057.
27. Hlatky M.A., Ray R.M., Burwen D.R., Margolis K.L., Johnson K.C., Kucharska-Newton A., Manson J.E., Robinson J.G., Safford M.M., Allison M., Assimes T.L., Bavry A.A., Berger J., Cooper-DeHoff R.M., Heckbert S.R., Li W., Liu S., Martin L.W., Perez M.V., Tindle H.A., Winkelmayer W.C., Stefanick M.L. Use of medicare data to identify coronary heart disease outcomes in the Women's Health Initiative. Circ. Cardiovasc. Qual. Outcomes 2014, 7(1):157-162. 10.1161/circoutcomes.113.000373.
28. Joshi N.V., Vesey A.T., Williams M.C., Shah A.S.V., Calvert P.A., Craighead F.H.M., Yeoh S.E., Wallace W., Salter D., Fletcher A.M., van Beek E.J.R., Flapan A.D., Uren N.G., Behan M.W.H., Cruden N.L.M., Mills N.L., Fox K.A.A., Rudd J.H.F., Dweck M.R., Newby D.E. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet 2014, 383(9918):705-713. 10.1016/S0140-6736(13)61754-7.
29. Navar-Boggan A.M., Peterson E.D., D'Agostino R.B., Neely B., Sniderman A.D., Pencina M.J. Hyperlipidemia in early adulthood increases long-term risk of coronary heart disease. Circulation 2015, 10.1161/circulationaha.114.012477.
30. Kühnast S., van der Tuin S.J.L., van der Hoorn J.W.A., van Klinken J.B., Simic B., Pieterman E., Havekes L.M., Landmesser U., Lüscher T.F., Willems van Dijk K., Rensen P.C.N., Jukema J.W., Princen H.M.G. Anacetrapib reduces progression of atherosclerosis, mainly by reducing non-HDL-cholesterol, improves lesion stability and adds to the beneficial effects of atorvastatin. Eur. Heart J. 2015, 36(1):39-50. 10.1093/eurheartj/ehu319.
31. University of Oxford, Merck. REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-Modification, Identifier: NCT01252953, 2014 [updated April 16, 2014; cited April 3, 2015], Available from . https://clinicaltrials.gov/ct2/show/NCT01252953?term=reveal+merck&rank=1.
32. Eli Lilly and Company, A Study of Evacetrapib in High-Risk Vascular Disease (ACCELERATE), Identifier: NCT01687998, 2015 [updated February 23, 2015; cited April 3, 2015], Available from: . https://clinicaltrials.gov/ct2/show/NCT01687998?term=evacetrapib+lilly&rank=19.
33. LaRosa J.C., Grundy S.M., Waters D.D., Shear C., Barter P., Fruchart J.-C., Gotto A.M., Greten H., Kastelein J.J.P., Shepherd J., Wenger N.K. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N. Engl. J. Med. 2005, 352:1425-1435. the Treating to New Targets (TNT) Investigators.
34. Robinson J., Stone N. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardivoascular disease risk: a new paradigm supported by more evidence. Eur. Heart J. 2015, 36:2110-2118. 10.1093/eurheartj/ehv182.