Abstract

Background: Randomized trials established statins as an agent for prevention of coronary heart disease (CHD). We assessed the hypothesis that standard-dose statin therapy had a beneficial effect in diabetic CHD patients with normal cholesterol levels. Methods and Results: To evaluate the effect of statins after percutaneous coronary intervention (PCI) on subsequent cardiovascular events, a prospective, randomized, open, blinded-endpoint trial conducted from 2002 to 2004 at 55 hospitals in Japan. A total of 1,016 patients (301 patients with diabetes mellitus [DM] and 715 non-DM patients) whose total cholesterol levels ranged from 180 to 240 mg/dL was enrolled and randomly assigned to receive any available standard-dose statins within 96 hours after PCI. Clinical parameters were comparable between DM group and non-DM group. The low-density lipoprotein cholesterol (LDL-C) levels were equally decreased after statin treatment in 2 groups (Table ). However, event rate for the primary end point was particularly lower in DM patients with statin treatment than those without statin treatment (Figure). Conclusions: Standard-dose statin therapy provides incremental clinical benefit in DM patients with normal cholesterol levels compared with that in non-DM patients. These data suggest that DM patients derive pleiotropic effect from statins, irrespective of lowering effect of LDL-C levels. Serial changes of LDL cholesterol levels

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