Residual inflammatory risk on treatment with PCSK9 inhibition and statin therapy

Circulation

Volumn 138, Issue 2, 2018, Pages 141-149

  Pradhan, Aruna D ^a,b   Aday, Aaron W ^b   Rose, Lynda M ^b   Ridker, Paul M ^b  

^a VA BOSTON HEALTHCARE SYSTEM   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

hsCRP; Inflammation; LDL C; PCSK9; PCSK9 inhibitor; Residual risk

Indexed keywords

ATORVASTATIN; BOCOCIZUMAB; C REACTIVE PROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PROPROTEIN CONVERTASE 9; ROSUVASTATIN; SIMVASTATIN; ANTIINFLAMMATORY AGENT; BIOLOGICAL MARKER; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT; MONOCLONAL ANTIBODY; PCSK9 PROTEIN, HUMAN; SERINE PROTEINASE INHIBITOR;

ADULT; AGED; ARTICLE; CARDIOVASCULAR INFLAMMATION; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; CONTROLLED STUDY; ENZYME INHIBITION; FEMALE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HOSPITALIZATION; HUMAN; INCIDENCE; LOW DENSITY LIPOPROTEIN CHOLESTEROL LEVEL; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; OUTPATIENT; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RISK ASSESSMENT; RISK FACTOR; THERAPY EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; BLOOD; CARDIOVASCULAR DISEASE; COMBINATION DRUG THERAPY; COMPLICATION; DOUBLE BLIND PROCEDURE; DYSLIPIDEMIA; ENZYMOLOGY; INFLAMMATION; METABOLISM; RANDOMIZED CONTROLLED TRIAL; TIME FACTOR;

AGED; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTICHOLESTEREMIC AGENTS; BIOMARKERS; C-REACTIVE PROTEIN; CARDIOVASCULAR DISEASES; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; INFLAMMATION; MALE; MIDDLE AGED; PROPROTEIN CONVERTASE 9; RISK ASSESSMENT; RISK FACTORS; SERINE PROTEINASE INHIBITORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 85053595552     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.118.034645     Document Type: Article

References (22)

1. Ridker PM, Rifai N, Pfeffer MA, Sacks FM, Moye LA, Goldman S, Flaker GC, Braunwald E. Inflammation, pravastatin, and the risk of coronary events after myocardial infarction in patients with average cholesterol levels: Cholesterol and Recurrent Events (CARE) Investigators. Circulation. 1998;98:839-844.
2. Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, Gotto AM Jr; Air Force/Texas Coronary Atherosclerosis Prevention Study Investigators. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med. 2001;344:1959-1965. doi: 10.1056/NEJM200106283442601.
3. Nissen SE, Tuzcu EM, Schoenhagen P, Crowe T, Sasiela WJ, Tsai J, Orazem J, Magorien RD, O'Shaughnessy C, Ganz P; Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) Investigators. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med. 2005;352:29-38. doi: 10.1056/NEJMoa042000.
4. Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005;352:20-28. doi: 10.1056/NEJMoa042378.
5. Morrow DA, de Lemos JA, Sabatine MS, Wiviott SD, Blazing MA, Shui A, Rifai N, Califf RM, Braunwald E. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor Trial. Circulation. 2006;114:281-288. doi: 10.1161/CIRCULATIONAHA.106.628909.
6. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Macfadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Trial Study Group. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009;373:1175-1182. doi: 10.1016/S0140-6736(09)60447-5.
7. OT trials. Eur Heart J. 2012;33:430-432. doi: 10.1093/eurheartj/ehr310.
8. Ridker PM. Residual inflammatory risk: addressing the obverse side of the atherosclerosis prevention coin. Eur Heart J. 2016;37:1720-1722. doi: 10.1093/eurheartj/ehw024.
9. Ridker PM. How common is residual inflammatory risk? Circ Res. 2017;120:617-619. doi: 10.1161/CIRCRESAHA.116.310527.
10. Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med. 2017;377:1119-1131. doi: 10.1056/NEJMoa1707914.
11. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. doi: 10.1056/NEJMoa1615664.
12. Ridker PM, Revkin J, Amarenco P, Brunell R, Curto M, Civeira F, Flather M, Glynn RJ, Gregoire J, Jukema JW, Karpov Y, Kastelein JJP, Koenig W, Lorenzatti A, Manga P, Masiukiewicz U, Miller M, Mosterd A, Murin J, Nicolau JC, Nissen S, Ponikowski P, Santos RD, Schwartz PF, Soran H, White H, Wright RS, Vrablik M, Yunis C, Shear CL, Tardif JC; SPIRE Cardiovascular Outcome Investigators. Cardiovascular efficacy and safety of bococizumab in high-risk patients. N Engl J Med. 2017;376:1527-1539. doi: 10.1056/NEJMoa1701488.
13. Schwartz GG, Bessac L, Berdan LG, Bhatt DL, Bittner V, Diaz R, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Mahaffey KW, Moryusef A, Pordy R, Roe MT, Rorick T, Sasiela WJ, Shirodaria C, Szarek M, Tamby JF, Tricoci P, White H, Zeiher A, Steg PG. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: rationale and design of the ODYSSEY outcomes trial. Am Heart J. 2014;168:682-689. doi: 10.1016/j.ahj.2014.07.028.
14. Ridker PM, Amarenco P, Brunell R, Glynn RJ, Jukema JW, Kastelein JJ, Koenig W, Nissen S, Revkin J, Santos RD, Schwartz PF, Yunis C, Tardif JC; Studies of PCSK9 Inhibition and the Reduction of Vascular Events (SPIRE) Investigators. Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) lipid lowering and SPIRE cardiovascular outcomes trials. Am Heart J. 2016;178:135-144. doi: 10.1016/j.ahj.2016.05.010.
15. Myers GL, Rifai N, Tracy RP, Roberts WL, Alexander RW, Biasucci LM, Catravas JD, Cole TG, Cooper GR, Khan BV, Kimberly MM, Stein EA, Taubert KA, Warnick GR, Waymack PP; CDC; AHA. CDC/AHA workshop on markers of inflammation and cardiovascular disease: application to clinical and public health practice: report from the laboratory science discussion group. Circulation. 2004;110:e545-e549. doi: 10.1161/01.CIR.0000148980.87579.5E.
16. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195-2207. doi: 10.1056/NEJMoa0807646.
17. Ridker PM. Mortality differences associated with treatment responses in CANTOS and FOURIER: insights and implications. Circulation. 2018;137:1763-1766. doi: 10.1161/CIRCULATIONAHA.117.033254.
18. OT). https://clinicaltrials.gov/ct2/show/NCT02551094. Accessed March 8, 2017.
19. Everett BM, Pradhan AD, Solomon DH, Paynter N, Macfadyen J, Zaharris E, Gupta M, Clearfield M, Libby P, Hasan AA, Glynn RJ, Ridker PM. Rationale and design of the Cardiovascular Inflammation Reduction Trial: a test of the inflammatory hypothesis of atherothrombosis. Am Heart J. 2013;166:199.e15-207.e15. doi: 10.1016/j.ahj.2013.03.018.
20. Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-reduction variability and antidrug-antibody formation with bococizumab. N Engl J Med. 2017;376:1517-1526. doi: 10.1056/NEJMoa1614062.
21. Ference BA, Cannon CP, Landmesser U, Luscher TF, Catapano AL, Ray KK. Reduction of low density lipoprotein-cholesterol and cardiovascular events with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors and statins: an analysis of FOURIER, SPIRE, and the Cholesterol Treatment Trialists Collaboration [published online ahead of print August 14, 2017]. Eur Heart J. doi: 10.1093/eurheartj/ehx450. https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehx450/4082634.
22. Steg P. The ODYSSEY outcomes trial: topline results. American College of Cardiology Annual Scientific Session, May 10, 2018, Orlando, FL.