Abstract
BackgroundEvidences support the benefits of moderate- to high-intensity statins for patients with acute myocardial infarction (AMI) except for those with type 2 diabetes mellitus (T2DM) on dialysis after AMI. This study was aimed to investigate the safety and efficacy of secondary prevention of cardiovascular diseases using moderate- to high-intensity statins in T2DM patients on dialysis after AMI.MethodsA simulated prospective cohort study was conducted between January 1st, 2001 and December 31st, 2013 utilizing data from the Taiwan National Health Insurance Research Database. A total of 882 patients with T2DM on dialysis after AMI were selected as the study cohort. Cardiovascular efficacy and safety of moderate- to high-intensity statins were evaluated by comparing outcomes of 441 subjects receiving statins after AMI to 441 matched subjects not receiving statins after AMI. The primary composite outcome included cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.ResultsThe Kaplan–Meier event rate for the primary composite outcomes at 8 years was 30.2% (133 patients) in the statin group compared with 25.2% (111 patients) in the non-statin group (hazard ratio [HR], .98; 95% confidence interval [CI] .76–1.27). Significantly lower risks of non-fatal ischemic stroke (HR, .58; 95% CI .35–.98) and all-cause mortality (HR, .70; 95% CI .59–.84) were found in the statin group.ConclusionsIn T2DM patients on dialysis after AMI, the use of moderate- to high-intensity statins has neutral effects on composite cardiovascular events but may reduce risks of non-fatal ischemic stroke and all-cause mortality.
Highlights
Evidences support the benefits of moderate- to high-intensity statins for patients with acute myocar‐ dial infarction (AMI) except for those with type 2 diabetes mellitus (T2DM) on dialysis after AMI
For patients on dialysis, guidelines of the 2013 kidney disease: improving global outcomes (KDIGO) and the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) work groups advise that statins treatment should not be administered routinely [14, 15], because the results of major trials such as the Die Deutsche Diabetes Dialyse (4-D), a study to evaluate the use of rosuvastatin in subjects on regular hemodialysis: an assessment of survival and cardiovascular events (AURORA), and the study of heart and renal protection (SHARP), revealed no definite clinical benefits with statins treatment in patients on dialysis [7, 16, 17]
Study population A total of 2,179,849 T2DM patients were initially enrolled between January 1st, 2001 and December 31st, 2013, among whom 3827 T2DM patients on dialysis were
Summary
Evidences support the benefits of moderate- to high-intensity statins for patients with acute myocar‐ dial infarction (AMI) except for those with type 2 diabetes mellitus (T2DM) on dialysis after AMI. Current evidence indicates that moderate- to high-intensity statins should be initiated if patients not receiving dialysis have clinical atherosclerotic cardiovascular disease (ASCVD) such as acute coronary syndromes [11]. For patients on dialysis, guidelines of the 2013 kidney disease: improving global outcomes (KDIGO) and the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) work groups advise that statins treatment should not be administered routinely [14, 15], because the results of major trials such as the Die Deutsche Diabetes Dialyse (4-D), a study to evaluate the use of rosuvastatin in subjects on regular hemodialysis: an assessment of survival and cardiovascular events (AURORA), and the study of heart and renal protection (SHARP), revealed no definite clinical benefits with statins treatment in patients on dialysis [7, 16, 17]. Post-hoc analysis of the AURORA trial found that rosuvastatin significantly reduced rates of cardiac events (including cardiac death and non-fatal myocardial infarction) by 32% (HR .68; 95% CI .51–.90) in diabetic patients [18]
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