The Fuster-CNIC-Ferrer Cardiovascular Polypill: a polypill for secondary cardiovascular prevention

International Journal of Cardiology

Volumn 201, Issue , 2015, Pages S15-S23

  Tamargo, Juan ^a   Castellano, José M ^b,c,d   Fuster, Valentín ^b,d  

^a SCHOOL OF MEDICINE   (Spain)

^b CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CNIC   (Spain)

^c Grupo HM Hospitales   (Spain)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Aspirin; Atorvastatin; Iltria cardiovascular polypill; Ramipril; Secondary prevention; Simvastatin; Sincronium ; Trinomia

Indexed keywords

ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID PLUS ATORVASTATIN PLUS RAMIPRIL; ANTITHROMBOCYTIC AGENT; ATORVASTATIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HEMOGLOBIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; RAMIPRIL; UNCLASSIFIED DRUG; CARDIOVASCULAR AGENT; DRUG COMBINATION;

ALLERGIC REACTION; AMNESIA; ANAPHYLAXIS; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; ASTHMA; BIOEQUIVALENCE; BLURRED VISION; BRAIN HEMORRHAGE; CARDIOVASCULAR DISEASE; CONCEPTUAL FRAMEWORK; CONSTIPATION; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG ANTAGONISM; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG CONTRAINDICATION; DRUG EXCRETION; DRUG FORMULATION; DRUG HALF LIFE; DRUG MARKETING; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG SOLUBILITY; DRUG STABILITY; DYSGEUSIA; DYSPEPSIA; EDEMA; EPISTAXIS; FLATULENCE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HEMATOCRIT; HEMATURIA; HEPATITIS; HUMAN; HYPERKALEMIA; HYPERTRANSAMINASEMIA; HYPOTENSION; IMPOTENCE; INSOMNIA; LIVER INJURY; MAXIMUM PLASMA CONCENTRATION; MELENA; MYOPATHY; NAUSEA; NIGHTMARE; PANCREATITIS; PARESTHESIA; PERIPHERAL EDEMA; PHARMACODYNAMICS; PHOTOSENSITIVITY; PILL; POLYPILL; PREVENTIVE MEDICINE; PRIORITY JOURNAL; PRURITUS; RASH; SECONDARY PREVENTION; SIDE EFFECT; SKIN BRUISING; THROMBOCYTOPENIA; TINNITUS; URTICARIA; VESICULAR RASH; WEAKNESS; WEIGHT GAIN; CARDIOVASCULAR DISEASES; DRUG COMBINATION; ECONOMICS; PROCEDURES;

ASPIRIN; ATORVASTATIN CALCIUM; CARDIOVASCULAR AGENTS; CARDIOVASCULAR DISEASES; DRUG COMBINATIONS; HUMANS; RAMIPRIL; SECONDARY PREVENTION;

EID: 84964914194     PISSN: 01675273     EISSN: 18741754     Source Type: Journal    
DOI: 10.1016/S0167-5273(15)31028-7     Document Type: Article

References (60)

1. NJ Wald, MR Law A strategy to reduce cardiovascular disease by more than 80% BMJ 326 7404 2003 1419
2. G Sanz, V Fuster Fixed-dose combination therapy and secondary cardiovascular prevention: rationale, selection of drugs and target population Nature Clin Prac Cardiovasc Med 6 2 2009 101 110
3. JM Castellano, G Sanz, V Fuster Evolution of the polypill concept and ongoing clinical trials Can J Cardiol 30 5 2014 520 526
4. JM Castellano, G Sanz, JL Penalvo, S Bansilal, A Fernandez-Ortiz, L Alvarez et al. A polypill strategy to improve adherence: results from the FOCUS project J Am Coll Cardiol 64 20 2014 2071 2082
5. SC Smith, EJ Benjamin, RO Bonow, LT Braun, MA Creager, BA Franklin et al. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association J Am Coll Cardiol 58 23 2011 2432 2446
6. J Perk, G De Backer, H Gohlke, I Graham, Ž Reiner, M Verschuren et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR) Eur Heart J 2012 ehs092
7. PG Steg, SK James, D Atar, LP Badano, CB Lundqvist, MA Borger et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation Eur Heart J 2012 ehs215
8. CW Hamm, J-P Bassand, S Agewall, J Bax, E Boersma, H Bueno et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Eur Heart J 32 23 2011 2999 3054
9. SD Fihn, JM Gardin, J Abrams, K Berra, JC Blankenship, PS Douglas et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons J Am Coll Cardiol 60 24 2012 e44 e164
10. G Montalescot, U Sechtem, S Achenbach, F Andreotti, C Arden, A Budaj et al. 2013 ESC guidelines on the management of stable coronary artery disease Eur Heart J 34 38 2013 2949 3003
11. AK Gehi, S Ali, B Na, NB Schiller, MA Whooley Inducible ischemia and the risk of recurrent cardiovascular events in outpatients with stable coronary heart disease: the heart and soul study Arch Intern Med 168 13 2008 1423 1428
12. M Calhoun, LB Cross, RM Cooper-DeHoff Clinical utility of β -blockers for primary and secondary prevention of coronary artery disease Expert Rev Cardiovasc Ther 11 3 2013 289 291
13. S Bangalore, G Steg, P Deedwania, K Crowley, KA Eagle, S Goto et al. β-Blocker use and clinical outcomes in stable outpatients with and without coronary artery disease JAMA 308 13 2012 1340 1349
14. VG Athyros, AA Papageorgiou, BR Mercouris, VV Athyrou, AN Symeonidis, EO Basayannis et al. Treatment with atorvastatin to the National Cholesterol Educational Program goal versus' usual' care in secondary coronary heart disease prevention Curr Med Res Opin 18 4 2002 220 228
15. J Cleland, L Erhardt, A Hall, C Winter, S Ball, AS Investigators Validation of primary and secondary outcomes and classification of mode of death among patients with clinical evidence of heart failure after a myocardial infarction: a report from the Acute Infarction Ramipril Efficacy (AIRE) Study Investigators J Cardiovasc Pharmacol 22 1993 S22 S27
16. TAIREA Study Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure Lancet 342 8875 1993 821 828
17. Trinomia®. Summary of Product Characteristics. http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC-PA1744-002-001-09022015101132.pdf
18. Tamboli A, Todkar P, Zope P, Sayyad F. An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. J Bioequiv Availab 2: 086-092. doi:10.4172/jbb.1000037. OMICS Publishing Group J Bioequiv Availab ISSN; 2010.
19. GT Warner, CM Perry Ramipril Drugs 62 9 2002 1381 1405
20. B Neal, S MacMahon, N Chapman Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials Blood pressure lowering treatment trialists' collaboration Lancet 356 9246 2000 1955 1964
21. G Mancia, R Fagard, K Narkiewicz, J Redon, A Zanchetti, M Böhm et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) Blood Pres 22 4 2013 193 278
22. S Yusuf, P Sleight, J Pogue, J Bosch, R Davies, G Dagenais Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators N Engl J Med 342 3 2000 145 153
23. GR Dagenais, J Pogue, K Fox, ML Simoons, S Yusuf Angiotensin-convertingenzyme inhibitors in stable vascular disease without left ventricular systolic dysfunction or heart failure: a combined analysis of three trials Lancet 368 9535 2006 581 588
24. N Danchin, M Cucherat, C Thuillez, E Durand, Z Kadri, PG Steg Angiotensin-converting enzyme inhibitors in patients with coronary artery disease and absence of heart failure or left ventricular systolic dysfunction: an overview of long-term randomized controlled trials Arch Intern Med 166 7 2006 787 796
25. P Ruggenenti, A Perna, G Gherardi, F Gaspari, R Benini, G Remuzzi et al. Renal function and requirement for dialysis in chronic nephropathy patients on long-term ramipril: REIN follow-up trial Lancet 352 9136 1998 1252 1256
26. JW Nawrocki, SR Weiss, MH Davidson, DL Sprecher, SL Schwartz, P-J Lupien et al. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor Arterioscler Thromb Vasc Biol 15 5 1995 678 682
27. NJ Stone, CNB Merz, F ScM, FCB Blum, FP McBride, FRH Eckel et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults J Am Coll Cardiol 63 25 2014 2889 2934
28. CT Trialists Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins Lancet 366 9493 2005 1267 1278
29. FJ Penning-van Beest, F Termorshuizen, WG Goettsch, OH Klungel, JJ Kastelein, RM Herings Adherence to evidence-based statin guidelines reduces the risk of hospitalizations for acute myocardial infarction by 40%: a cohort study Eur Heart J 28 2 2007 154 159
30. T Dohi, K Miyauchi, S Okazaki, T Yokoyama, N Yanagisawa, H Tamura et al. Early intensive statin treatment for six months improves long-term clinical outcomes in patients with acute coronary syndrome (Extended-ESTABLISH trial): a follow-up study Atherosclerosis 210 2 2010 497 502
31. Smith MB, Lee NJ, Haney E, Carson S. Drug class review: Hmg-coa reductase inhibitors (statins) and fixed-dose combination products containing a statin: Final report update 5. Drug Class Reviews. 2009.
32. S Rabar, M Harker, N O'Flynn, AS Wierzbicki Lipid modification and cardiovascular risk assessment for the primary and secondary prevention of cardiovascular disease: summary of updated NICE guidance BMJ 349 2014 g4356
33. ML Capone, S Tacconelli, MG Sciulli, M Grana, E Ricciotti, P Minuz et al. Clinical pharmacology of platelet, monocyte, and vascular cyclooxygenase inhibition by naproxen and low-dose aspirin in healthy subjects Circulation 109 12 2004 1468 1471
34. DW Taylor, HJ Barnett, RB Haynes, GG Ferguson, DL Sackett, KE Thorpe et al. Low-dose and high-dose acetylsalicylic acid for patients undergoing carotid endarterectomy: a randomised controlled trial Lancet 353 9171 1999 2179 2184
35. A Trialists' Collaboration Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients BMJ 324 7329 2002 71 86
36. D Mozaffarian, EJ Benjamin, AS Go, DK Arnett, MJ Blaha, M Cushman et al. Executive Summary: Heart Disease and Stroke Statistics - 2015 Update A Report From the American Heart Association Circulation 131 4 2015 434 441
37. J Van Griensven, R Schoemaker, A Cohen, H Luus, M Seibert-Grafe, H-J Röthig Pharmacokinetics, pharmacodynamics and bioavailability of the ACE inhibitor ramipril Eur J Clin Pharmacol 47 6 1995 513 518
38. MH Davidson, JG Robinson Lipid-lowering effects of statins: a comparative review Expert Opin Pharmacother 7 13 2006 1701 1714
39. H Lennernäs Clinical pharmacokinetics of atorvastatin Clin Pharmacokinet 42 13 2003 1141 1160
40. LH Amir, MV Pirotta, M Raval Breastfeeding: Evidence Based Guidelines for the Use of Medicines Austr Family Physician 40 9 2011 684
41. EM Antman, JS Bennett, A Daugherty, C Furberg, H Roberts, KA Taubert Use of nonsteroidal antiinflammatory drugs an update for clinicians: a scientific statement from the American Heart Association Circulation 115 12 2007 1634 1642
42. P Dargan, C Wallace, A Jones An evidence based flowchart to guide the management of acute salicylate (aspirin) overdose Emerg Med J 19 3 2002 206 209
43. A Carré, D Vasmant, J Elmalem, P Thiéry Tolerability of ramipril in a multicenter study of mild-to-moderate hypertension in general practice J Cardiovasc Pharmacol 18 1991 S141 S1S3
44. JB Kostis, M Packer, HR Black, R Schmieder, D Henry, E Levy Omapatrilat and enalapril in patients with hypertension: the Omapatrilat Cardiovascular Treatment vs. Enalapril (OCTAVE) trial Am J Hypertens 17 2 2004 103 111
45. CB Newman, G Palmer, H Silbershatz, M Szarek Safety of atorvastatin derived from analysis of 44 completed trials in 9,416 patients Am J Cardiol 92 6 2003 670 676
46. MR Law, NJ Wald, A Rudnicka Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis BMJ 326 7404 2003 1423
47. RC Pasternak, SC Smith, CN Bairey-Merz, SM Grundy, JI Cleeman, C Lenfant ACC/AHA/NHLBI clinical advisory on the use and safety of statins12 J Am Coll Cardiol 40 3 2002 567 572
48. T Ma, L Tien, C-L Fang, Y-S Liou, G-P Jong Statins and new-onset diabetes: a retrospective longitudinal cohort study Clin Therapeut 34 9 2012 1977 1983
49. N Sattar, D Preiss, HM Murray, P Welsh, BM Buckley, AJ de Craen et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials Lancet 375 9716 2010 735 742
50. M Hayden, M Pignone, C Phillips, C Mulrow Aspirin for the primary prevention of cardiovascular events: a summary of the evidence for the US Preventive Services Task Force Ann Intern Med 136 2 2002 161 172
51. KR McQuaid, L Laine Systematic review and meta-analysis of adverse events of low-dose aspirin and clopidogrel in randomized controlled trials Am J Med 119 8 2006 624 638
52. JA Delaney, L Opatrny, JM Brophy, S Suissa Drug-drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding Can Med Assoc J 177 4 2007 347 351
53. TIP Study Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial The Lancet 373 9672 2009 1341 1351
54. JG Peterson, MS Lauer Using aspirin and ACE inhibitors in combination: why the hullabaloo? Cleveland Clin J Med 68 6 2001 569 573
55. KJ Harjai, S Solis, A Prasad, J Loupe Use of aspirin in conjunction with angiotensin-converting enzyme inhibitors does not worsen long-term survival in heart failure Int J Cardiol 88 2 2003 207 214
56. FA McAlister, WA Ghali, Y Gong, J Fang, PW Armstrong, JV Tu Aspirin use and outcomes in a community-based cohort of 7352 patients discharged after first hospitalization for heart failure Circulation 113 22 2006 2572 2578
57. KK Tea, S Yusuf, M Pfeffer, L Kober, A Hall, J Pogue et al. Effects of long-term treatment with angiotensin-converting-enzyme inhibitors in the presence or absence of aspirin: a systematic review Lancet 360 9339 2002 1037 1043
58. R Latini, G Tognoni, AP Maggioni, C Baigent, E Braunwald, Z-M Chen et al. Clinical effects of early angiotensin-converting enzyme inhibitor treatment for acute myocardial infarction are similar in the presence and absence of aspirin: systematic overview of individual data from 96,712 randomized patients J Am Coll Cardiol 35 7 2000 1801 1807
59. HM Krumholz, Y-T Chen, Y Wang, MJ Radford Aspirin and angiotensin-converting enzyme inhibitors among elderly survivors of hospitalization for an acute myocardial infarction Arch Intern Med 161 4 2001 538 544
60. V Athyros, D Mikhailidis, A Papageorgiou, V Bouloukos, A Pehlivanidis, A Symeonidis et al. Effect of statins and ACE inhibitors alone and in combination on clinical outcome in patients with coronary heart disease J Hum Hypertens 18 11 2004 781 788