LDL-cholesterol lowering efficacy of atorvastatin® in primary prevention. Real-world experience in a developing country; a program based on evidence, personalization, and empowerment

Main Article Content

Enrique C. Morales-Villegas Abigail Vega-Velasco Gualberto Moreno-Virgen

Abstract

Despite the iconoclasts of the LDL-centric principle and the net benefit of statins, the plurality, quantity, and especially the scientific quality of the evidence that supports the causal role of low-density lipoprotein cholesterol (LDL-C) in atherosclerosis, as well as the net benefit of statins in its prevention, make these two concepts, universal principles accepted by all guidelines worldwide.


The efficacy, safety, and cost-effectiveness of statins have been confirmed in multiple randomized and controlled clinical trials. However, paradoxically, and especially in developing countries like Mexico, the use of this therapeutic class is suboptimal. The reasons to explain this paradox are multiple and are analyzed in this article, which has the purpose of confirming the efficacy, safety, and significant potential impact of statins in the "real developing world." To fulfill this purpose, this article presents our center experience using statins, especially atorvastatin®, in patients without atherosclerotic cardiovascular disease (ASCVD). Founded on an evidence-based, personalization, and empowerment program, our results in almost four hundred patients in primary cardiovascular prevention are as follows. In intermediate-risk patients, atorvastatin® 10 mg/day with a baseline LDL-C of 111.6 mg/dL (±25.1), reduced LDL-C by 38.0% (±13.9); atorvastatin® 20 mg/day with a baseline LDL-C of 124.4 mg/dL (±25.3), reduced LDL-C by 44.9% (±15.0) (p <0.005 for both). In the atorvastatin® 10/20 mg/day cohort (a total of 294 patients), 87.7% (258 patients) achieved a ≥30% LDL-C reduction, and 36.7% (108 patients) a ≥50% reduction. In the atorvastatin 10/20 mg/day cohort, with an average baseline LDL-C of 122.6 mg/dL (±25.6), 92.5 and 55.7% achieved LDL-C of ≤100 and ≤70 mg/dL, respectively. In high-risk patients, atorvastatin® 40 mg/day with a baseline LDL-C of 151.7 mg/dL (±31.6), there was an LDL-C average reduction of 54.7% (±12.2). Atorvastatin 80mg/day with a baseline LDL-C of 160.2 mg/dL (±41.5) produced an LDL-C average reduction of 62.5% (±10.8) (P <0.005 for both). In the atorvastatin® 40/80 mg/day cohort (89 patients), 98.8% (88 patients) achieved a ≥30% LDL-C reduction, and 76.4% (68 patients) achieved a ≥50% reduction. In the atorvastatin 40/80 mg/day cohort, with an average baseline LDL-C of 153.0 mg/dL (±33.2), 95.8 and 62.9% achieved LDL-C of ≤100 and ≤70 mg/dL, respectively.

Article Details

How to Cite
MORALES-VILLEGAS, Enrique C.; VEGA-VELASCO, Abigail; MORENO-VIRGEN, Gualberto. LDL-cholesterol lowering efficacy of atorvastatin® in primary prevention. Real-world experience in a developing country; a program based on evidence, personalization, and empowerment. Medical Research Archives, [S.l.], v. 9, n. 11, nov. 2021. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/2607>. Date accessed: 25 apr. 2024. doi: https://doi.org/10.18103/mra.v9i11.2607.
Section
Research Articles

References

1. Lanas F, Avezum A, Bautista L et al. Risk factors for acute myocardial infarction in Latin America: the INTERHEART Latin American study. Circulation. 2007; 115: 1067-1074.
2. Meaney A, Ceballos-Reyes G, Gutiérrez-Salmeán G et al. Cardiovascular risk factors in a Mexican middle-class urban population. The Lindavista Study. Baseline data. Arch Cardiol Mex. 2013; 83: 249-256.
3. Estrada-García T, Meaney A, López-Hernández D et al. Hypertension and lipid triad are the most important attributable risks for myocardial infarction in a middle class urban Mexican population. Nutr & Metabol. 2013; 63: 1343.
4. Rivas-Gomez B, Almeda-Valdés P, Tussié-Luna M et al. Dyslipidemia in Mexico, a call for action. Rev Invest Clin. 2018; 70: 211-216.
5. Hernández-Alcaraz C, Aguilar-Salinas CA, Mendoza-Herrera K et al. Dyslipidemia prevalence, awareness, treatment and control in Mexico: results of the ENSANUT 2012. Salud Publica Mex. 2020; 62: 137-146.
6. Borrayo-Sánchez G. Epidemiology and burden of morbidity and mortality in dyslipidemias and atherosclerosis. Cardiovasc Met Sci.2021; 32 (s3): s143-s146.
7. Morales-Villegas E. Cardio Prevención Primaria. Las siete preguntas en el Consultorio Médico. Primera Edición 2015. Editorial Atheros-CIC. ISBN 978-607-00-9327-2.
8. Kay-Tee Khaw. Rose´s Strategy of Preventive Medicine. Oxford University Press. USA; Updated Edition (15 March 2008).
9. Grundy SM, Stone NJ, Bailey AL et al. AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA. Guideline on the Management of Blood Cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019; 73 (24) 3168.
10. https://www.saludario.com/cambiar-medicinas-en-farmacias-problema-de-todos-y-de-nadie/. Accessed August 14, 2021.
11.https://altonivel.com.mx/economia/que-tan-rico-es-méxico-asi-está-su-PIB-per-capita-respecto-al-mundo. Accessed August 14, 2021.
12. Brown MS and Goldstein JL. A receptor-mediated pathway for cholesterol homeostasis. Nobel Lecture, 9 December 1985. https://www.nobelprize.org/prizes/medicine/1985/summary/
13. Goldstein JL, Brown MS. The LDL Receptor. History of Discovery. Arterioscler Thromb Vasc Biol. 2009; 29:431-38.
14. Brown MS, Goldstein JL. A tribute to Akira Endo, discoverer of a “Penicillin” for cholesterol. Atherosclerosis. 2004; 5:13-16.
15. Endo A, Kuroda M, Tsujita Y. ML-236A, ML-236B and ML-236C, new inhibitors of cholesterogenesis produced by Penicillium Citrinum. J Antibiotics. 1976; 26:1346.
16. Yamamoto A, Sudo H, Endo A. Therapeutic effects of ML-236B in primary hypercholesterolemia. Atherosclerosis. 1980; 305:259-66.
17. Mabushi H, Haba T, Tatami R et al. Effects of an inhibitor of 3-hydroxy-3methylglutaryl coenzyme A reductase on serum lipoproteins and ubiquinone-10 levels in patients with familial hypercholesterolemia. N Engl J Med. 1981; 305:478-82.
18. Cholesterol Treatment Trialist´s (CTT) Collaboration. Efficacy and safety of cholesterol lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomized trials of statins. Lancet. 2005; 366:1267-1278.
19. Cholesterol Treatments Trialist´s (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomized trials. Lancet. 2010; 376:1670-1681.
20. Yusuf S, Bosch J, Degenais G et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016; 376:2021-31.
21. Morales-Villegas E, Ray KK. Statin treatment. The evidence and role in primary and secondary prevention. Cardiovasc Metab Sci. 2021; 32 (s3): s212-s216.
22. Wood FA, Howard JP, Finegold JA et al. N-of-1 trial of a statin, placebo, or no treatment to assess side effects. N Engl J Med 383: 22. NEJM.ORG. November 26, 2020. DOI:10.1056/NEJMc2031173.
23. Herret E, Williamson E, Brack K et al. Statin treatment and muscle symptoms: series of randomized, placebo-controlled n-og-1 trials. BMJ 2021; 372: n135. DOI:10.1136/bmj. n135.
24. Robinson JG. The neuropsychology of statin intolerance. www.nature.com/nrcardio. https://doi.org/101038/s41569-020-00502-3.
25. Ravnkov U, de Lorgeril M, Diamond DM et al. LDL-C does not cause cardiovascular disease: a comprehensive review of the current literature. Expert Review of Clinical Pharmacology. 11.10, 959-970.
26.- Meaney E, Fernandez-Barros CL, Enciso-Muñoz JM et al. The attempt to demolish the science and practice of preventive cardiovascular medicine. Part 1. Addendum to the positioning around the diagnosis and treatment of dyslipidemias of ANCAM and the joint group of associated medical societies. Rev Mex Cardiol. 2018; 29:173-187.
27. Robinson JG, Joyanna MB, Bairey Merz CN, Stone NJ. Clinical implications of the log linear Association between LDL-C lowering and cardiovascular risk reduction. Greatest benefits when LDL-C >100 mg/dL. PLoSONE 15(10): e0240166. https://doi.org/10.1371/journal.pone.0240166.
28. Wilkins JT, Lloyd-Jones DM. Novel lipid-lowering therapies to reduce cardiovascular risk. JAMA. July 20, 2021, Volume 326, Number 3.
29.https://www.gob.mx/cofepris/es/articulos/reglas-para-la-produccion-de-medicamentos-genericos-en-beneficio-de-la-poblacion. Accessed August 15, 2021.
30.https://codigof.mx/la-cofepris-avala-el-uso-de-18-plantas-medicinales. Accessed August 15, 2021.
31. Francois Mach, Colin Baigent, Alberico Catapano et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart Journal (2019) 00, 1-78. doi:10.1093/eurheartj/ehz455.
32. https://www.inegi.org.mx/contenidos/programas/ccpv/2020/doc/censo2020. Presentación de resultados. Estados Unidos Mexicanos (inegi.org.mx). Accessed August 15, 2021