Efficacy and safety of atorvastatin in major cardiovascular events: Meta-analysis

Authors

  • Víctor Eder Villegas-Quintero <p>Instituto Mexicano del Seguro Social, Coordinaci&oacute;n de Investigaci&oacute;n en Salud, Centro de Adiestramiento en investigaci&oacute;n Cl&iacute;nica. Ciudad de M&eacute;xico, M&eacute;xico.</p> http://orcid.org/0000-0002-9282-9531
  • Rodolfo Rivas-Ruíz <p>Instituto Mexicano del Seguro Social, Coordinaci&oacute;n de Investigaci&oacute;n en Salud, Centro de Adiestramiento en investigaci&oacute;n Cl&iacute;nica. Ciudad de M&eacute;xico, M&eacute;xico.</p> http://orcid.org/0000-0002-5967-7222
  • Alexis Alejandro García-Rivero <p>Instituto Mexicano del Seguro Social, Coordinaci&oacute;n de Investigaci&oacute;n en Salud, Centro de Adiestramiento en investigaci&oacute;n Cl&iacute;nica. Ciudad de M&eacute;xico, M&eacute;xico.</p> http://orcid.org/0000-0002-6678-8115
  • Pedro Rivera-Lara <p>Instituto Mexicano del Seguro Social, Centro M&eacute;dico Nacional Siglo XXI, Hospital de Cardiolog&iacute;a, Servicio de Urgencias. Ciudad de M&eacute;xico, M&eacute;xico.</p> http://orcid.org/0000-0002-4877-1678
  • Nelly Berenice González-Tovar <p>Instituto Mexicano del Seguro Social, Centro M&eacute;dico la Raza, Hospital de Especialidades, Servicio de Urgencias. Ciudad de M&eacute;xico, M&eacute;xico.</p> http://orcid.org/0000-0002-2959-7643
  • Gloria Angélica Ortiz-Pérez <p>Secretar&iacute;a de Salud Federal, CENETEC, Departamento de Evaluaci&oacute;n Cl&iacute;nica de Insumos para la Salud. Ciudad de M&eacute;xico, M&eacute;xico.</p> http://orcid.org/0009-0001-3649-6795

DOI:

https://doi.org/10.5281/zenodo.8319748

Keywords:

Meta-Analysis, Heart Disease Risk Factor, Safety, Efficacy, Atorvastatin

Abstract

Introduction: Atorvastatin has been used in the management of dyslipidemia and little is known about the efficacy and safety of high-dose atorvastatin administration for secondary prevention of Major Cardiovascular Events (MACE).

Objective: To evaluate the impact of high-dose atorvastatin on secondary prevention of MACE and adverse events. Material and methods: A systematic review and meta-analysis of Pubmed, Embase, Bireme and Cochrane Library Plus databases was performed, with a time scope from 1990 to July 2022. Six randomized clinical trials were included with a total of 29,333 patients who were treated with 80 mg, 10 mg or placebo doses of Atorvastatin where the main outcomes evaluated were Major Cardiovascular Events (MACE), mortality and treatment safety.

Results: In the comparative study between the use of Atorvastatin 80 mg and other therapies, a relative risk (RR) of 0.8 (95%CI 0.69-0.92) was found, representing a 20% reduction in risk (RRR) and a number needed to treat (NNT) of 30-55. In the analysis of adverse effects, an RR of 2.37 (95% CI 0.86-6.53) and a number needed to harm (NNH) of 14-19 were observed. The use of 80 mg atorvastatin is associated with similar adverse events at lower doses.

Conclusions: The use of atorvastatin 80 mg is effective in the secondary prevention of Major Cardiovascular Event (MACE). The drug has adverse events that should be taken into account in secondary prevention.

Downloads

Download data is not yet available.

Author Biographies

  • Víctor Eder Villegas-Quintero, <p>Instituto Mexicano del Seguro Social, Coordinaci&oacute;n de Investigaci&oacute;n en Salud, Centro de Adiestramiento en investigaci&oacute;n Cl&iacute;nica. Ciudad de M&eacute;xico, M&eacute;xico.</p>

    Actualmente soy residente de 3er año de la especialidad de Medicina del Trabajo y Ambiental de la Sede de la UMAE Hospital de Oncología. Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Centro de Adiestramiento en investigación Clínica. Ciudad de México, México

  • Rodolfo Rivas-Ruíz, <p>Instituto Mexicano del Seguro Social, Coordinaci&oacute;n de Investigaci&oacute;n en Salud, Centro de Adiestramiento en investigaci&oacute;n Cl&iacute;nica. Ciudad de M&eacute;xico, M&eacute;xico.</p>

    Encargado CAIC, Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Centro de Adiestramiento en investigación Clínica. Ciudad de México, México

  • Alexis Alejandro García-Rivero, <p>Instituto Mexicano del Seguro Social, Coordinaci&oacute;n de Investigaci&oacute;n en Salud, Centro de Adiestramiento en investigaci&oacute;n Cl&iacute;nica. Ciudad de M&eacute;xico, M&eacute;xico.</p>

    Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Centro de Adiestramiento en investigación Clínica. Ciudad de México, México

  • Pedro Rivera-Lara, <p>Instituto Mexicano del Seguro Social, Centro M&eacute;dico Nacional Siglo XXI, Hospital de Cardiolog&iacute;a, Servicio de Urgencias. Ciudad de M&eacute;xico, M&eacute;xico.</p>

    Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Hospital de Cardiología, Servicio de Urgencias. Ciudad de México, México.

  • Nelly Berenice González-Tovar, <p>Instituto Mexicano del Seguro Social, Centro M&eacute;dico la Raza, Hospital de Especialidades, Servicio de Urgencias. Ciudad de M&eacute;xico, M&eacute;xico.</p>

    Instituto Mexicano del Seguro Social, Centro Médico la Raza, Hospital de Especialidades, Servicio de Urgencias. Ciudad de México, México.

References

Crea F. How epidemiology can improve the understanding of cardiovascular disease: from mechanisms to treatment. Eur Heart J. 2021;42(44):4503-7. doi: 10.1093/eurheartj/ehab797.

Vasan RS, Benjamin EJ. The Future of Cardiovascular Epidemiology. Circulation. 2016;133(25):2626-33. doi: 10.1161/ CIRCULATIONAHA.116.023528.

Pownall HJ, Gotto AM. Lipids and Cardiovascular Disease: Putting It All Together. Methodist DeBakey Cardiovasc J. 2019; 15(1):5-8. doi: 10.14797/mdcj-15-1-5.

Chou R, Cantor A, Dana T, Wagner J, Ahmed AY, Fu R, et al. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022; 328(8):754-71. doi: 10.1001/jama.2022.12138.

Taylor F, Huffman MD, Macedo AF, Moore THM, Burke M, Davey Smith G, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013;2013 (1):CD004816. doi: 10.1002/14651858.CD004816.pub5.

Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11): e563-95. doi: 10.1161/ CIR.0000000000000678.

Jayawardana KS, Mundra PA, Giles C, Barlow CK, Nestel PJ, Barnes EH, et al. Changes in plasma lipids predict pravastatin efficacy in secondary prevention. JCI Insight. 2019;4(13): e128438-128438. doi: 10.1172/jci.insight.128438.

Rhee MY, Ahn T, Chang K, Chae SC, Yang TH, Shim WJ, et al. The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia. BMC Pharmacol Toxicol. 2017;18(1):2. doi: 10.1186/ s40360-016-0112-7.

Hwang SD, Kim K, Kim YJ, Lee SW, Lee JH, Song JH. Effect of statins on cardiovascular complications in chronic kidney disease patients: A network meta-analysis. Medicine. 2020; 99(22):e20061. doi: 10.1097/MD.0000000000020061.

Ridker PM, Danielson E, Fonseca FAH, Genest J, Gotto AM, Kastelein JJP, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(21):2195-207. doi: 10.1056/NEJMoa0807646.

Meaney E, Vela A, Ramos A, Alemao E, Yin D. Cholesterol goal attainment with lipid lowering drugs. The COMETA Mexico Trial. Gac Med Mex. 2004;140(5):493-501. Disponible en: https:// www.medigraphic.com/pdfs/gaceta/gm-2004/gm045c.pdf.

Agrawal D, Manchanda SC, Sawhney JPS, Kandpal B, Jain R, Mehta A, et al. To study the effect of high dose Atorvastatin 40mg versus 80mg in patients with dyslipidemia. Indian Heart J. 2018;70(Suppl 3):S8-12. doi: 10.1016/j.ihj.2018.01.034.

Perdices EV, Medina-Cáliz I, Hernando S, Ortega A, Martín-Ocaña F, Navarro JM, et al. Hepatotoxicity associated with statin use: analysis of the cases included in the Spanish Hepatotoxicity Registry. Rev Esp Enferm Dig. 2014;106(4):246- 54. Disponible en: https://scielo.isciii.es/pdf/diges/v106n4/original2.pdf.

Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group, Armitage J, Bowman L, Wallendszus K, Bulbulia R, Rahimi K, et al. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Lancet. 2010;376(9753):1658- 69. doi: 10.1016/S0140-6736(10)60310-8.

Herrett E, Williamson E, Beaumont D, Prowse D, Youssouf N, Brack K, et al. Study protocol for statin web-based investigation of side effects (StatinWISE): a series of randomised controlled N-of-1 trials comparing atorvastatin and placebo in UK primary care. BMJ Open. 2017;7(12):e016604. doi: 10.1136/ bmjopen-2017-016604.

González-Pliego JA, Gutiérrez-Díaz GI, Celis A, Gudiño-Amezcua DA. Registry of non-ST elevation acute coronary syndromes in a tertiary hospital (RESCATA-SEST registry). Arch Cardiol Mex. 2014;84(2):92-9. doi: 10.1016/j.acmx.2013.11.006.

Rivera-Silva G, Martínez-Fernández P, Papacristofilou-Riebeling B. Biobancos cardiovasculares. Rev Med Inst Mex Seguro Soc. 2020;58(4):508-510. doi: 10.24875/RMIMSS. M20000076.

Moctezuma-Paz A, Vázquez-Rodríguez CF, Benítez-González GA, Solís-Chavez P, Canche-Kauil N, Flores-Legorreta JP et al. Epidemiología en tiempos modernos. Rev Med Inst Mex Seguro Soc. 2021;59(5):358-9. Disponible en: http://revistamedica. imss.gob.mx/editorial/index.php/revista_medica/article/view/4426/4266.

García-Esquivel MA, Huerta-Liceaga F, Martínez-Garzón LA, Sandoval-Espadas RA, Salame-Khouri L. Infarto agudo al miocardio con elevación del segmento ST en época de COVID-19. Rev Med Inst Mex Seguro Soc. 2020;58 Supl 2:S268- 281. Disponible en: http://revistamedica.imss.gob.mx/ editorial/index.php/revista_medica/article/view/3738/4185.

Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JAC. «Chapter 8: Assessing risk of bias in a randomized trial.» In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). «Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022).» Cochrane, 2022. Disponible en: www.training. cochrane.org/handbook.

McGuinness, LA, Higgins, JPT. Risk-of-bias VISualization (robvis): An R package and Shiny web app for visualizing risk-of-bias assessments. Res Syn Meth. 2020;1-7. doi: 10.1002/ jrsm.1411.

Lee YH. An overview of meta-analysis for clinicians. Korean J Intern Med. 2018;33(2):277-83. doi: 10.3904/kjim.2016.195.

Andrade C. Understanding the Basics of Meta-Analysis and How to Read a Forest Plot: As Simple as It Gets. J Clin Psychiatry. 2020;81(5):20f13698. doi: 10.4088/JCP.20f13698.

Ranstam J, Wagner P. Systematic reviews, meta-analyses, randomized trials, and observational studies. Acta Orthop. 2022;93:1-2. doi: 10.1080/17453674.2021.1975398.

Rivas-Ruiz R, Castelán-Martínez OD, Pérez-Rodríguez M, Palacios-Cruz L, Noyola-Castillo ME, Talavera JO. Investigación clínica XXIII. Del juicio clínico a los metaanálisis. Rev Med Inst Mex Seguro Soc. 2014;52(5):558-65. Disponible en: http://www.redalyc.org/articulo.oa?id=457745484018.

Liu Z, Joerg H, Hao H, Xu J, Hu S, Li B, et al. Efficacy of High-Intensity Atorvastatin for Asian Patients Undergoing Percutaneous Coronary Intervention. Ann Pharmacother. 2016;50(9): 725-33. doi: 10.1177/1060028016654722.

Lu C, Jia H, Wang Z. High-dose atorvastatin reduces the risk of cardiovascular events in patients with percutaneous coronary intervention. Oncotarget. 2017;8(41):70356-65. doi: 10.18632/oncotarget.19701.

Bezerra CT, Grande AJ, Galvão VK, Santos DHMD, Atallah ÁN, Silva V. Assessment of the strength of recommendation and quality of evidence: GRADE checklist. A descriptive study. Sao Paulo Med J. 2022;140(6):829-36. doi: 10.1590/1516- 3180.2022.0043.R1.07042022.

Waters DD. Safety of high-dose atorvastatin therapy. Am J Cardiol. 2005;96(5A):69F-75F. doi: 10.1016/j.amjcard.2005.06.028.

Downloads

Published

2023-09-18

Issue

Vol. 61 No. Suplemento 3 (2023): CAIC

Section

Original Articles

License

Copyright (c) 2023 Revista Médica del Instituto Mexicano del Seguro Social

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Authors retain their copyright and grant the Revista Médica del IMSS the right of first publication. Articles are distributed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which allows sharing as long as the author and the original source are properly credited.