Statin associated adverse reactions in Latin America: a scoping review

Objectives We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries. Design Scoping review. Methods A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a ma...

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Autores:
Urina-Jassir, Manuel
Pacheco-Paez, Tatiana
Paez-Canro, Carol
Urina-Triana, Miguel
Tipo de recurso:
Fecha de publicación:
2021
Institución:
Universidad Simón Bolívar
Repositorio:
Repositorio Digital USB
Idioma:
eng
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oai:bonga.unisimon.edu.co:20.500.12442/8603
Acceso en línea:
https://hdl.handle.net/20.500.12442/8603
http://dx.doi.org/10.1136/bmjopen-2021-050675
https://bmjopen.bmj.com/content/11/10/e050675.full?ijkey=xzdbEDxRN2rDqIc&keytype=ref
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openAccess
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Attribution-NonCommercial-NoDerivatives 4.0 Internacional
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dc.title.eng.fl_str_mv Statin associated adverse reactions in Latin America: a scoping review
title Statin associated adverse reactions in Latin America: a scoping review
spellingShingle Statin associated adverse reactions in Latin America: a scoping review
title_short Statin associated adverse reactions in Latin America: a scoping review
title_full Statin associated adverse reactions in Latin America: a scoping review
title_fullStr Statin associated adverse reactions in Latin America: a scoping review
title_full_unstemmed Statin associated adverse reactions in Latin America: a scoping review
title_sort Statin associated adverse reactions in Latin America: a scoping review
dc.creator.fl_str_mv Urina-Jassir, Manuel
Pacheco-Paez, Tatiana
Paez-Canro, Carol
Urina-Triana, Miguel
dc.contributor.author.none.fl_str_mv Urina-Jassir, Manuel
Pacheco-Paez, Tatiana
Paez-Canro, Carol
Urina-Triana, Miguel
description Objectives We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries. Design Scoping review. Methods A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design. Results Out of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statinversus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose.
publishDate 2021
dc.date.accessioned.none.fl_str_mv 2021-10-01T20:50:03Z
dc.date.available.none.fl_str_mv 2021-10-01T20:50:03Z
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dc.identifier.citation.spa.fl_str_mv Urina-Jassir M, Pacheco-Paez T, Paez-Canro C, et al. Statin associated adverse reactions in Latin America: a scoping review. BMJ Open 2021;11:e050675. doi:10.1136/ bmjopen-2021-050675
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identifier_str_mv Urina-Jassir M, Pacheco-Paez T, Paez-Canro C, et al. Statin associated adverse reactions in Latin America: a scoping review. BMJ Open 2021;11:e050675. doi:10.1136/ bmjopen-2021-050675
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spelling Urina-Jassir, Manuel0779f0c2-c8a3-4008-b112-03df056b9fb5Pacheco-Paez, Tatiana2c5c2bdb-5264-4cad-81c6-732767a525e4Paez-Canro, Caroldab21dff-667b-470a-803f-6656a33d12b4Urina-Triana, Migueld749d19c-0dae-4d0b-8e9a-6d623d682f9e2021-10-01T20:50:03Z2021-10-01T20:50:03Z2021Urina-Jassir M, Pacheco-Paez T, Paez-Canro C, et al. Statin associated adverse reactions in Latin America: a scoping review. BMJ Open 2021;11:e050675. doi:10.1136/ bmjopen-2021-05067520446055https://hdl.handle.net/20.500.12442/8603http://dx.doi.org/10.1136/bmjopen-2021-050675https://bmjopen.bmj.com/content/11/10/e050675.full?ijkey=xzdbEDxRN2rDqIc&keytype=refObjectives We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries. Design Scoping review. Methods A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design. Results Out of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statinversus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose.pdfengBMJ Publishing GroupAttribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2BMJ OpenVol. 11, No. 10 (2021)Statin associated adverse reactions in Latin America: a scoping reviewinfo:eu-repo/semantics/articleArtículo científicohttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_2df8fbb1Arnett DK, Blumenthal RS, Albert MA, 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 guidelinesGrundy SM, Stone NJ, Bailey AL, et al. 2018 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:e285–350.Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J 2020;41:111–88.Byrne P, Cullinan J, Smith SM. Statins for primary prevention of cardiovascular disease. BMJ 2019;8:l5674–5.Redberg RF, Katz MH. Statins for primary prevention: the debate is intense, but the data are weak. JAMA 2016;316:1979–81.Yebyo HG, Aschmann HE, Kaufmann M, et al. Comparative effectiveness and safety of statins as a class and of specific statins for primary prevention of cardiovascular disease: a systematic review, meta-analysis, and network meta-analysis of randomized trials with 94,283 participants. Am Heart J 2019;210:18–28.Koskinas KC, Siontis GCM, Piccolo R, et al. Effect of statins and non-statin LDL-lowering medications on cardiovascular outcomes in secondary prevention: a meta-analysis of randomized trials. Eur Heart J 2018;39:1172–80.Guglielmi V, Bellia A, Pecchioli S, et al. Effectiveness of adherence to lipid lowering therapy on LDL-cholesterol in patients with very high cardiovascular risk: a real-world evidence study in primary care. Atherosclerosis 2017;263:36–41.Hope HF, Binkley GM, Fenton S, et al. Systematic review of the predictors of statin adherence for the primary prevention of cardiovascular disease. PLoS One 2019;14:1–38.Kim MC, Cho JY, Jeong HC, et al. Impact of postdischarge statin withdrawal on long-term outcomes in patients with acute myocardial infarction. Am J Cardiol 2015;115:1–7.Ingersgaard MV, Helms Andersen T, Norgaard O, et al. Reasons for Nonadherence to Statins - A Systematic Review of Reviews. Patient Prefer Adherence 2020;14:675–91.Thompson PD, Panza G, Zaleski A, et al. Statin-associated side effects. J Am Coll Cardiol 2016;67:2395–410.Navar AM, Peterson ED, Li S, et al. Prevalence and management of symptoms associated with statin therapy in community practice: insights from the palm (patient and provider assessment of lipid management) registry. Circ Cardiovasc Qual Outcomes 2018;11:1–5.Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J 2014;168:6–15.Rivera-Andrade A, Luna MA. Trends and heterogeneity of cardiovascular disease and risk factors across Latin American and Caribbean countries. Prog Cardiovasc Dis 2014;57:276–85.Pagan E, Chatenoud L, Rodriguez T, et al. Comparison of trends in mortality from coronary heart and cerebrovascular diseases in North and South America: 1980 to 2013. Am J Cardiol 2017;119:862–71.Vinueza R, Boissonnet CP, Acevedo M, et al. Dyslipidemia in seven Latin American cities: CARMELA study. Prev Med 2010;50:106–11.Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol 2005;8:19–32.Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implementation Sci 2010;5:1–9.Tricco AC, Lillie E, Zarin W, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med 2018;169:467–73.Aronson JK, Ferner RE. Clarification of terminology in drug safety. Drug Saf 2005;28:851–70.Miller SA, Forrest JL. Enhancing your practice through evidencebased decision making: PICO, learning how to ask good questions. Journal of Evidence Based Dental Practice 2001;1:136–41.Ouzzani M, Hammady H, Fedorowicz Z, et al. Rayyan—a web and mobile APP for systematic reviews. Syst Rev 2016;5:1–11.Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009;6:e1000097Vattimo ACA, Fonseca FAH, Morais DC, et al. Efficacy and tolerability of a fixed-dose combination of rosuvastatin and ezetimibe compared with a fixed-dose combination of simvastatin and ezetimibe in Brazilian patients with primary hypercholesterolemia or mixed dyslipidemia: a multicenter, randomized trial. Curr Ther Res Clin Exp 2020;93:100595.Castaño G, Más R, Fernández JC, et al. Efficacy and tolerability of policosanol compared with lovastatin in patients with type II hypercholesterolemia and concomitant coronary risk factors. Curr Ther Res Clin Exp 2000;61:137–46Fernández JC, Más R, Castaño G, et al. Comparison of the efficacy, safety and tolerability of Policosanol versus fluvastatin in elderly hypercholesterolaemic women. Clin Drug Investig 2001;21:103–13.Talavera J-O, Martinez G, Cervantes J-L, et al. A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients. Curr Med Res Opin 2013;29:379–86Rodríguez-Roa E, Téllez R, Rodríguez F, et al. Evaluación comparativa de la efectividad clínica de DOS formulaciones de atorvastatina en pacientes Con O Sin enfermedad cardiovascular. Rev Latinoam Hipertens 2008;3:129–35 https://www.redalyc.org/ articulo.oa?id=170217040005Fonseca FAH, Ruiz A, Cardona-Muñoz EG, et al. The DISCOVERY PENTA study: a DIrect Statin COmparison of LDL-C Value--an Evaluation of Rosuvastatin therapY compared with atorvastatin. Curr Med Res Opin 2005;21:1307–15.Albert MA, Glynn RJ, Fonseca FAH, et al. Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin (JUPITER) trial. Am Heart J 2011;162:106–14Ridker PM, Danielson E, Fonseca FAH, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195–207Spalvieri MP, Oyola ME. Estatinas: incidencia de efectos adversos / statins: incidence of adverse effects / Estatinas: incidência de efeitos adversos. Acta Bioquím Clín Latinoam 2011;45:727–65 https://www. redalyc.org/articulo.oa?id=53521525005Smiderle L, Lima LO, Hutz MH, et al. Evaluation of sexual dimorphism in the efficacy and safety of simvastatin/atorvastatin therapy in a southern Brazilian cohort. Arq Bras Cardiol 2014;103:33–40.Ferreira Castro P, Ribeiro E, Lima Dorea E, et al. Factors associated with statin-related adverse muscular events in adult dyslipidemic outpatients. Bras J Pharm Sci 2017;53:e00199.Santos PCJL, Morgan AC, Jannes CE, et al. Presence and type of low density lipoprotein receptor (LDLR) mutation influences the lipid profile and response to lipid-lowering therapy in Brazilian patients with heterozygous familial hypercholesterolemia. Atherosclerosis 2014;233:206–10Bello-Chavolla OY, Aguilar-Salinas CA. 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Misinterpretation of trial evidence on statin adverse effects may harm patients. Eur J Prev Cardiol 2015;22:492–3.Hovingh GK, Gandra SR, McKendrick J, et al. Identification and management of patients with statin-associated symptoms in clinical practice: a clinician survey. Atherosclerosis 2016;245:111–7.Rosenson RS, Gandra SR, McKendrick J, et al. Identification and management of Statin-Associated symptoms in clinical practice: extension of a clinician survey to 12 further countries. Cardiovasc Drugs Ther 2017;31:187–95.Golomb BA, Evans MA. Statin adverse effects : a review of the literature and evidence for a mitochondrial mechanism. Am J Cardiovasc Drugs 2008;8:373–418.Bhardwaj S, Selvarajah S, Schneider EB. Muscular effects of statins in the elderly female: a review. Clin Interv Aging 2013;8:47–59Cham S, Evans MA, Denenberg JO, et al. Statin-associated muscle-related adverse effects: a case series of 354 patients. Pharmacotherapy 2010;30:541–53.Holbrook A, Wright M, Sung M, et al. Statin-associated rhabdomyolysis: is there a dose-response relationship? Can J Cardiol 2011;27:146–51.Rosenson RS. Trial designs for statin muscle intolerance. Curr Opin Lipidol 2017;28:488–94.Falk Delgado A, Falk Delgado A. The association of funding source on effect size in randomized controlled trials: 2013-2015 - a crosssectional survey and meta-analysis. Trials 2017;18:125.Lewis SC, Warlow CP. How to spot bias and other potential problems in randomised controlled trials. J Neurol Neurosurg Psychiatry 2004;75:181–7.Hemkens LG. How routinely collected data for randomized trials provide long-term randomized real-world evidence. JAMA Netw Open 2018;1:e186014.Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials 2017;18:122.Cuneo C, Kotliar C, Medrano JC, et al. Logro de Los objetivos de colesterol de lipoproteínas de Baja densidad en 18 países fuera de Europa occidental: estudio Internacional de prácticas de manejo del colesterol (ICLPS) sub análisis argentino. Rev Fed Arg Cardiol 2019;48:86–91 https://www.fac.org.ar/archivo/2/revista/19v48n2/ especial/01/cuneo.phpGabriel Bottaro E, Caravello Óscar, Gustavo Scapellato P, et al. Rosuvastatina para tratamiento de la dislipidemia en pacientes infectados Con VIH en tratamiento antirretroviral de gran actividad. Experiencia preliminar. Enferm Infecc Microbiol Clin 2008;26:325–9do Nascimento RCRM, Guerra AA, Alvares J, et al. Statin use in Brazil: findings and implications. Curr Med Res Opin 2018;34:1809–17.Zuluaga-Quintero N, Arcila-Hincapie L, Bedoya-Lopez DF, et al. Comportamiento del perfil lípidico en paciente Con dislipidemia tratados Con estatinas en Una iPS. CES Salud Pública 2015;6:63–9.Ruiz Álvaro J., Vargas-Uricoechea H, Urina-Triana M, et al. Las dislipidemias Y SU tratamiento en centros de alta complejidad en Colombia. Clin e Investig en Arterioscler 2020;32:101–10.Diaztagle JJ, Castro CA, Buitrago DC. Experiencia en la utilización de hipolipemiantes en una cohorte de pacientes en 12 ciudades colombianas. Rev Medicas UIS 2019;32:13–20Toro Escobar JM, Toro CMA, Maya GC. Prevalencia de alteraciones de la creatina-fosfoquinasa (CPK) sérica en pacientes que toman estatinas. 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