BACKGROUND: Some patients do not tolerate or respond to high-intensity statin monotherapy. Lower-intensity statin combined with nonstatin medication may be an alternative, but the benefits and risks compared with those of higher-intensity statin monotherapy are unclear. PURPOSE: To compare the clinical benefits, adherence, and harms of lower-intensity statin combination therapy with those of higher-intensity statin monotherapy among adults at high risk for atherosclerotic cardiovascular disease (ASCVD). DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to July 2013, with an updated MEDLINE search through November 2013. STUDY SELECTION: Randomized, controlled trials published in English. DATA EXTRACTION: Two reviewers extracted information on study design, population characteristics, interventions, and outcomes (deaths, ASCVD events, low-density lipoprotein [LDL] cholesterol level, adherence, and adverse events). Two independent reviewers assessed risk of bias. DATA SYNTHESIS: A total of 36 trials were included. Low-intensity statin plus bile acid sequestrant decreased LDL cholesterol level 0% to 14% more than mid-intensity monotherapy among high-risk hyperlipidemic patients. Mid-intensity statin plus ezetimibe decreased LDL cholesterol level 5% to 15% and 3% to 21% more than high-intensity monotherapy among patients with ASCVD and diabetes mellitus, respectively. Evidence was insufficient to evaluate LDL cholesterol for fibrates, niacin, and ω-3 fatty acids. Evidence was insufficient for long-term clinical outcomes, adherence, and harms for all regimens. LIMITATION: Many trials had short durations and high attrition rates, lacked blinding, and did not assess long-term clinical benefits or harms. CONCLUSION: Clinicians could consider using lower-intensity statin combined with bile acid sequestrant or ezetimibe among high-risk patients intolerant of or unresponsive to statins; however, this strategy should be used with caution given the lack of evidence on long-term clinical benefits and harms. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
BACKGROUND: Some patients do not tolerate or respond to high-intensity statin monotherapy. Lower-intensity statin combined with nonstatin medication may be an alternative, but the benefits and risks compared with those of higher-intensity statin monotherapy are unclear. PURPOSE: To compare the clinical benefits, adherence, and harms of lower-intensity statin combination therapy with those of higher-intensity statin monotherapy among adults at high risk for atherosclerotic cardiovascular disease (ASCVD). DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to July 2013, with an updated MEDLINE search through November 2013. STUDY SELECTION: Randomized, controlled trials published in English. DATA EXTRACTION: Two reviewers extracted information on study design, population characteristics, interventions, and outcomes (deaths, ASCVD events, low-density lipoprotein [LDL] cholesterol level, adherence, and adverse events). Two independent reviewers assessed risk of bias. DATA SYNTHESIS: A total of 36 trials were included. Low-intensity statin plus bile acid sequestrant decreased LDL cholesterol level 0% to 14% more than mid-intensity monotherapy among high-risk hyperlipidemic patients. Mid-intensity statin plus ezetimibe decreased LDL cholesterol level 5% to 15% and 3% to 21% more than high-intensity monotherapy among patients with ASCVD and diabetes mellitus, respectively. Evidence was insufficient to evaluate LDL cholesterol for fibrates, niacin, and ω-3 fatty acids. Evidence was insufficient for long-term clinical outcomes, adherence, and harms for all regimens. LIMITATION: Many trials had short durations and high attrition rates, lacked blinding, and did not assess long-term clinical benefits or harms. CONCLUSION: Clinicians could consider using lower-intensity statin combined with bile acid sequestrant or ezetimibe among high-risk patients intolerant of or unresponsive to statins; however, this strategy should be used with caution given the lack of evidence on long-term clinical benefits and harms. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
Authors: Abel A Pavía-López; Marco A Alcocer-Gamba; Edith D Ruiz-Gastelum; José L Mayorga-Butrón; Roopa Mehta; Filiberto A Díaz-Aragón; Jorge A Aldrete-Velasco; Nitzia López-Juárez; Ivette Cruz-Bautista; Adolfo Chávez-Mendoza; Nikos C Secchi-Nicolás; Francisco J Guerrero-Martínez; Jorge E Cossio-Aranda; Victoria Mendoza-Zubieta; Guillermo Fanghänel-Salmon; Martha Valdivia-Proa; Luis Olmos-Domínguez; Carlos A Aguilar-Salinas; Luis Dávila-Maldonado; Armando Vázquez-Rangel; Vanina Pavia-Aubry; María de Los A Nava-Hernández; Carlos A Hinojosa-Becerril; Juan C Anda-Garay; Manuel O de Los Ríos-Ibarra; Ana C Berni-Betancourt; Julio López-Cuellar; Diego Araiza-Garaygordobil; Romina Rivera-Reyes; Gabriela Borrayo-Sánchez; Mónica Tapia-Hernández; Claudia V Cano-Nigenda; Arturo Guerra-López; Josué Elías-López; Marco A Figueroa-Morales; Bertha B Montaño-Velázquez; Liliana Velasco-Hidalgo; Ana L Rodríguez-Lozano; Claudia Pimentel-Hernández; María M Baquero-Hoyos; Felipe Romero-Moreno; Mario Rodríguez-Vega Journal: Arch Cardiol Mex Date: 2022