Abstract

Introduction: Control of blood pressure (BP) is associated with decreased risk of cardiovascular (CV) events in patients with type 2 diabetes mellitus (T2DM). Lowering the level of low-density lipoprotein cholesterol (LDL-C) by statins is also effective to reduce CV events in T2DM patients with hyperlipidemia. In this study, we examined whether the effectiveness of statin lipid-lowering therapy was affected by baseline BP level in T2DM patients in a primary prevention setting. Methods: The EMPATHY study was a randomized controlled trial investigating the effects of statin intensive therapy targeting LDL-C <70 mg/dL compared to standard therapy targeting LDL-C ≥100 to <120 mg/dL in T2DM patients with diabetic retinopathy and hyperlipidemia without known CV diseases. In this post-hoc subgroup analysis, a total of 4980 patients were divided into two groups based on baseline BP: high BP (systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg) and non-high BP (systolic BP <130 mmHg and diastolic BP <80 mmHg) groups. CV events were defined as composite of cardiac, cerebral, renal, and vascular events. Results: At baseline, mean systolic and diastolic BP values were 141.7 and 78.3 mmHg in high BP group (n=3335) and 120.2 and 67.9 mmHg in non-high BP group (n=1645). Compared to non-high BP group, the proportion of patients with diabetic nephropathy (55.5 % vs 46.6 %), body mass index (26.1 kg/m 2 vs 24.8 kg/m 2 ), HbA1c (7.82 % vs 7.67 %), and LDL-C (131.3 mg/dL vs 129.6 mg/dL) were significantly higher in high BP group. During a median follow-up of 36.8 months, 281 CV events were observed. In high BP group, statin intensive therapy was associated with low risk of CV events (HR 0.70, 95% CI 0.54-0.92, p=0.011) compared to standard therapy after adjustment. In non-high BP group, no such association was observed. Interaction between BP group and statin therapy was significant in CV events (p=0.036). Conclusion: Compared to statin standard therapy, statin intensive therapy targeting LDL-C <70 mg/dL significantly reduced CV events in the primary prevention setting among T2DM patients with BP ≥130/80 mmHg, but not among those with BP <130/80 mmHg.

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