242
Views
1
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Economic Burden Associated with the Treatment with a Cardiovascular Polypill in Secondary Prevention in Spain: Cost-Effectiveness Results of the NEPTUNO Study

ORCID Icon, ORCID Icon, , , , , ORCID Icon, ORCID Icon & show all
Pages 559-571 | Received 28 Nov 2022, Accepted 23 May 2023, Published online: 19 Jul 2023

References

  • Ference BA, Ginsberg HN, Graham I, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European atherosclerosis society consensus panel. Eur Heart J. 2017;38(32):2459–2472. doi:10.1093/eurheartj/ehx144
  • Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease. Circulation. 2019;140(11):e596–e646. doi:10.1161/CIR.0000000000000678
  • Turk-Adawi K, Sarrafzadegan N, Fadhil I, et al. Cardiovascular disease in the eastern Mediterranean region: epidemiology and risk factor burden. Nat Rev Cardiol. 2018;15(2):106–119. doi:10.1038/nrcardio.2017.138
  • Wilkins E, Wickramasinghe K, Leal J, et al. European Cardiovascular Disease Statistics 2017. European Heart Network; 2017.
  • Bernick A, Davis C. Coste económico de las enfermedades cardiovasculares desde 2014 a 2020 en seis países europeos [Economic cost of cardiovascular diseases from 2014 to 2020 in six European countries]. Acta Sanitaria. 2014;2014:1.
  • Soriano JB, Rojas-Rueda D, Alonso J, et al. La carga de enfermedad en España: resultados del Estudio de la Carga Global de las Enfermedades 2016 [The burden of disease in Spain: results from the Global Burden of Disease Study 2016]. Med Clín. 2018;151(5):171–190. doi:10.1016/j.medcli.2018.05.011
  • Ministerio de Sanidad, Consumo y Bienestar Social. Informe anual del Sistema Nacional de Salud 2019. Aspectos destacados [The burden of disease in Spain: results from the Global Burden of Disease Study 2016; 2021]; 2021. Available from: https://www.mscbs.gob.es/estadEstudios/estadisticas/sisInfSanSNS/tablasEstadisticas/InfAnualSNS2019/Informe_SNS_2019.pdf. Accessed May 24, 2023.
  • Piepoli MF, Hoes AW, Agewall S, et al. 2016 European guidelines on cardiovascular disease prevention in clinical practice: the sixth joint task force of the European society of cardiology and other societies on cardiovascular disease prevention in clinical practice. Eur Heart J. 2016;37(29):2315–2381. doi:10.1093/eurheartj/ehw106
  • World Health Organization. Prevention of cardiovascular disease. Guidelines for assessment and management of cardiovascular risk; 2007. Available from: https://www.who.int/cardiovascular_diseases/guidelines/Full%20text.pdf. Accessed June 21, 2021.
  • Fitzsimons D, Stępińska J, Kerins M, et al. Secondary prevention and cardiovascular care across Europe: a survey of European society of cardiology members’ views. Eur J Cardiovasc Nurs. 2020;19(3):201–211. doi:10.1177/1474515119877999
  • Coca A, Agabiti-Rosei E, Cifkova R, Manolis AJ, Redón J, Mancia G. The polypill in cardiovascular prevention: evidence, limitations and perspective – position paper of the European society of hypertension. J Hypertens. 2017;35(8):1546–1553. doi:10.1097/HJH.0000000000001390
  • Visseren FLJ, Mach F, Smulders YM, et al. 2021 ESC guidelines on cardiovascular disease prevention in clinical practice: developed by the task force for cardiovascular disease prevention in clinical practice with representatives of the European society of cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Eur Heart J. 2021:ehab484. doi:10.1093/eurheartj/ehab484
  • Coll PP, Roche V, Olsen JS, Voit JH, Bowen E, Kumar M. The prevention of cardiovascular disease in older adults. J Am Geriatr Soc. 2020;68(5):1098–1106. doi:10.1111/jgs.16353
  • Solomon MD, Leong TK, Levin E, et al. Cumulative adherence to secondary prevention guidelines and mortality after acute myocardial infarction. J Am Heart Assoc. 2020;9(6):e014415. doi:10.1161/JAHA.119.014415
  • Redón J, Usó R, Trillo JL, et al. Number of drugs used in secondary cardiovascular prevention and late survival in the population of Valencia Community, Spain. Int J Cardiol. 2019;293:260–265. doi:10.1016/j.ijcard.2019.05.071
  • Kotseva K, De Backer G, De Bacquer D, et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: results from the European society of cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardiol. 2019;26(8):824–835. doi:10.1177/2047487318825350
  • Fuster V. An alarming threat to secondary prevention: low compliance (lifestyle) and poor adherence (drugs). Rev Esp Cardiol. 2012;65(Suppl 2):10–16. doi:10.1016/j.recesp.2012.07.005
  • Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009;119(23):3028–3035. doi:10.1161/CIRCULATIONAHA.108.768986
  • Mahtta D, Rodriguez F, Jneid H, Levine GN, Virani SS. Improving adherence to cardiovascular guidelines: realistic transition from paper to patient. Expert Rev Cardiovasc Ther. 2020;18(1):41–51. doi:10.1080/14779072.2020.1717335
  • Bansilal S, Castellano JM, Fuster V. Global burden of CVD: focus on secondary prevention of cardiovascular disease. Int J Cardiol. 2015;201:S1–S7. doi:10.1016/S0167-5273(15)31026-3
  • Webster R, Patel A, Selak V, et al. Effectiveness of fixed dose combination medication (‘polypills’) compared with usual care in patients with cardiovascular disease or at high risk: a prospective, individual patient data meta-analysis of 3140 patients in six countries. Int J Cardiol. 2016;205:147–156. doi:10.1016/j.ijcard.2015.12.015
  • Roshandel G, Khoshnia M, Poustchi H, et al. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (POLYIRAN): a pragmatic, cluster-randomised trial. Lancet. 2019;394(10199):672–683. doi:10.1016/S0140-6736(19)31791-X
  • Castellano JM, Verdejo J, Ocampo S, et al. Clinical effectiveness of the cardiovascular polypill in a real-life setting in patients with cardiovascular risk: the SORS study. Arch Med Res. 2019;50(1):31–40. doi:10.1016/j.arcmed.2019.04.001
  • Wilke T, Weisser B, Predel HG, et al. Effects of single pill combinations compared to identical multi pill therapy on outcomes in hypertension, dyslipidemia and secondary cardiovascular prevention: the START-study. IBPC. 2022;15:11–21. doi:10.2147/IBPC.S336324
  • Fuster V, Gambús F, Patriciello A, Hamrin M, Grobbee DE. The polypill approach - an innovative strategy to improve cardiovascular health in Europe. BMC Pharmacol Toxicol. 2017;18(1):10. doi:10.1186/s40360-016-0102-9
  • Ibañez B, Castellano JM, Fuster V. Polypill strategy at the heart of cardiovascular secondary prevention. Heart. 2019;105(1):9–10. doi:10.1136/heartjnl-2018-313464
  • Gómez-álvarez E, Verdejo J, Ocampo S, Ruiz E, Martinez-Rios MA. Reaching blood pressure guideline targets with the CNIC polypill in patients with a previous cardiovascular event in Mexico: a post hoc analysis of the SORS study. Future Cardiol. 2020;16(1):53–60. doi:10.2217/fca-2019-0075
  • Tamargo J, Castellano JM, Fuster V. The Fuster-CNIC-Ferrer Cardiovascular Polypill: a polypill for secondary cardiovascular prevention. Int J Cardiol. 2015;201(Suppl 1):S15–S22. doi:10.1016/S0167-5273(15)31028-7
  • González-Juanatey JR, Tamargo J, Torres F, Weisser B, Oudovenko N. Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents? Rev Esp Cardiol. 2021;74(1):51–58. doi:10.1016/j.rec.2019.11.008
  • Castellano JM, Sanz G, Peñalvo JL, et al. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014;64(20):2071–2082. doi:10.1016/j.jacc.2014.08.021
  • González-Juanatey JR, Mostaza JM, Lobos JM, et al. Consensus document for the use of the polypill in the secondary prevention of cardiovascular disease. Med Clín. 2017;148(3):139.e1–139.e15. doi:10.1016/j.medcle.2016.10.047
  • Agencia Española de Medicamentos y Productos Sanitarios. Ficha técnica. Trinomia 100 mg/40 mg/10 mg cápsulas duras [Spanish Agency of Medicines and Health Products. Technical Data Sheet. Trinomia 100 mg/40 mg/10 mg cápsulas duras]; 2021. Available from: https://cima.aemps.es/cima/dochtml/ft/81774/FT_81774.html. Accessed February 28, 2022.
  • Agencia Española de Medicamentos y Productos Sanitarios. Ficha técnica. Trinomia 100 mg/20 mg/5 mg cápsulas duras [Spanish Agency of Medicines and Health Products. Technical Data Sheet. Trinomia 100 mg/20 mg/5 mg cápsulas duras]; 2021. Available from: https://cima.aemps.es/cima/pdfs/es/ft/78575/78575_ft.pdf. Accessed February 28, 2022.
  • Barrios V, Kaskens L, Castellano JM, et al. Usefulness of a cardiovascular polypill in the treatment of secondary prevention patients in Spain: a cost-effectiveness study. Rev Esp Cardiol. 2017;70(1):42–49. doi:10.1016/j.rec.2016.05.009
  • Marquina C, Zomer E, Vargas-Torres S, et al. Novel treatment strategies for secondary prevention of cardiovascular disease: a systematic review of cost-effectiveness. Pharmacoeconomics. 2020;38(10):1095–1113. doi:10.1007/s40273-020-00936-0
  • Ntaios G, Vemmos K, Papapetrou P, Zafeiri S, Rubio G. PCV53 cost-effectiveness of the CNIC polypill - fixed dose combination of acetylsalicylic acid, ramipril and atorvastatin - for the secondary prevention of cardiovascular disease in Greece. Value Health. 2019;22:S550. doi:10.1016/j.jval.2019.09.778
  • Aguiar C, Araujo F, Rubio-Mercade G, et al. Cost-effectiveness of the CNIC-polypill strategy compared with separate monocomponents in secondary prevention of cardiovascular and cerebrovascular disease in Portugal: the MERCURY study. J Health Econ Outcomes Res. 2022;9(2):134–146. doi:10.36469/001c.39768
  • Becerra V, Gracia A, Desai K, et al. Cost-effectiveness and public health benefit of secondary cardiovascular disease prevention from improved adherence using a polypill in the UK. BMJ Open. 2015;5(5):e007111. doi:10.1136/bmjopen-2014-007111
  • González-Juanatey JR, Cordero A, Castellano JM, et al. The CNIC-polypill reduces recurrent major cardiovascular events in real-life secondary prevention patients in Spain: the NEPTUNO study. Int J Cardiol. 2022;361:116–123. doi:10.1016/j.ijcard.2022.05.015
  • European network of centres for pharmacoepidemiology and pharmacovigilance. BIG-PAC; 2021. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=29236. Accessed April 13, 2021.
  • Sicras-Mainar A, Enriquez JL, Hernández I, Sicras-Navarro A, Aymerich T, Leon M. PMU146 validation and representativeness of the Spanish BIG-PAC database: integrated computerized medical records for research into epidemiology, medicines and health resource use (real world evidence). Value Health. 2019;22:S734. doi:10.1016/j.jval.2019.09.1764
  • Ministerio de Sanidad, Consumo y Bienestar Social. International classification of diseases (9th edition) clinical modification (ICD-09-CM) [Ministry of Health, Consumption and Social Welfare. International classification of diseases (9th edition) clinical modification (ICD-09-CM)]; 2021. Available from: https://eciemaps.mscbs.gob.es/ecieMaps/browser/index_9_mc.html. Accessed June 11, 2021.
  • Matchar DB, McCrory DC, Orlando LA, et al. Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treating essential hypertension. Ann Intern Med. 2008;148(1):16–29. doi:10.7326/0003-4819-148-1-200801010-00189
  • Riella LV, Gabardi S, Chandraker A. Dyslipidemia and its therapeutic challenges in renal transplantation. Am J Transplant. 2012;12(8):1975–1982. doi:10.1111/j.1600-6143.2012.04084.x
  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383. doi:10.1016/0021-9681(87)90171-8
  • World Health Organization. The Anatomical Therapeutic Chemical Classification System with Defined Daily Doses (ATC/DDD). Available from: https://www.who.int/standards/classifications/other-classifications/the-anatomical-therapeutic-chemical-classification-system-with-defined-daily-doses. Accessed April 8, 2021.
  • Consejo General de Colegios Oficiales de Farmacéuticos. BOT plus 2. Base de Datos de Medicamentos [General Council of Official Associations of Pharmacists. BOT plus 2. Medicines Database]. Available from: https://botplusweb.portalfarma.com/. Accessed April 13, 2021.
  • Instituto Nacional de Estadística. Ganancia media laboral por edad y sexo [National Institute of Statistics. Average labor earnings by age and sex]. Available from: https://www.ine.es/dynt3/inebase/index.htm?padre=4563&capsel=4563. Accessed April 8, 2021.
  • Official Journal of the European Union. Regulation (EU) 2016/679 of the European parliament and of the council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing directive 95/46/EC (general data protection regulation). Vol L119/1; 2016. Available from: https://eur-lex.europa.eu/eli/reg/2016/679/oj. Accessed April 13, 2021.
  • Boletín Oficial del Estado. Ley Orgánica 3/2018, de 5 de Diciembre, de Protección de Datos Personales y Garantía de Los Derechos Digitales. Vol 294 [Official State Gazette. Organic Law 3/2018, of December 5, 2018, on the Protection of Personal Data and Guarantee of Digital Rights]; 2018:119788–119857. Available from: https://www.boe.es/buscar/doc.php?id=BOE-A-2018-16673. Accessed April 13, 2021.
  • Castellano JM, Pocock SJ, Bhatt DL, et al. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022;387(11):967–977. doi:10.1056/NEJMoa2208275