Serious adverse events reported in the COPE trial
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Serious adverse events reported in the COPE trialSupplemental dataAbbreviations: Beni=benidipine , ARB =angiotensin receptor blocker, BB = -blocker, TD = thiazide diuretic,Data are shown as number of patients (%).
Patients with CKD (n=834)Patients without CKD (n=1996)P valueBeni + ARBBeni + BBBeni + TDP valueTotalBeni + ARBBeni + BBBeni + TDP valueTotalAngina pectoris2(0.7%)5(1.8%)3(1.1%)0.499 10(1.2%)4(0.6%)6(0.9%)7(1.0%)0.689 17(0.9%)0.393 Arteriosclerosis obliterans2(0.7%)0(0.0%)2(0.8%)0.354 4(0.5%)3(0.5%)1(0.2%)1(0.1%)0.440 5(0.3%)0.328 Cardiac failure1(0.3%)1(0.4%)4(1.5%)0.180 6(0.7%)3(0.5%)2(0.3%)2(0.3%)0.858 7(0.4%)0.189 Cataract operation1(0.3%)0(0.0%)4(1.5%)0.057 5(0.6%)1(0.2%)4(0.6%)3(0.4%)0.407 8(0.4%)0.482 Cerebral hemorrhage2(0.7%)2(0.7%)0(0.0%)0.394 4(0.5%)3(0.5%)7(1.1%)2(0.3%)0.150 12(0.6%)0.688 Gastric cancer2(0.7%)2(0.7%)1(0.4%)0.854 5(0.6%)3(0.5%)4(0.6%)1(0.1%)0.385 8(0.4%)0.482 Lacunar infarction4(1.4%)2(0.7%)0(0.0%)0.154 6(0.7%)4(0.6%)3(0.5%)2(0.3%)0.690 9(0.5%)0.375 Lung neoplasm malignant1(0.3%)1(0.4%)2(0.8%)0.731 4(0.5%)2(0.3%)0(0.0%)2(0.3%)0.379 4(0.2%)0.205 Myocardial infarction2(0.7%)0(0.0%)3(1.1%)0.220 5(0.6%)3(0.5%)2(0.3%)1(0.1%)0.586 6(0.3%)0.248 Pneumonia4(1.4%)3(1.1%)2(0.8%)0.770 9(1.1%)1(0.2%)2(0.3%)2(0.3%)0.823 5(0.3%)0.004 Prostate cancer3(1.0%)1(0.4%)2(0.8%)0.618 6(0.7%)1(0.2%)2(0.3%)6(0.9%)0.113 9(0.5%)0.375 Thrombotic stroke1(0.3%)1(0.4%)1(0.4%)0.998 3(0.4%)2(0.3%)3(0.5%)2(0.3%)0.844 7(0.4%)0.976 Transient ischemic attack1(0.3%)3(1.1%)1(0.4%)0.466 5(0.6%)1(0.2%)3(0.5%)3(0.4%)0.569 7(0.4%)0.358
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Supplemental dataAdverse events reported in the COPE trialAbbreviations: ALT=alanine aminotransferase, Beni=benidipine , ARB =angiotensin receptor blocker, BB = -blocker, TD = thiazide diuretic,Data are shown as number of patients (%).
Patients with CKD (n=834)Patients without CKD (n=1996)P valueBeni + ARBBeni + BBBeni + TDP valueTotalBeni + ARBBeni + BBBeni + TDP valueTotalAlanine aminotransferase increased7(2.4%)8(2.8%)8(3.0%)0.911 23(2.8%)20(3.0%)7(1.1%)25(3.7%)0.009 52(2.6%)0.834 Aspartate aminotransferase increased7(2.4%)8(2.8%)7(2.7%)0.959 22(2.6%)19(2.9%)10(1.5%)19(2.8%)0.212 48(2.4%)0.731 Back pain1(0.3%)2(0.7%)6(2.3%)0.070 9(1.1%)7(1.1%)5(0.8%)4(0.6%)0.615 16(0.8%)0.479 Blood alkaline phosphatase increased6(2.1%)1(0.4%)2(0.8%)0.111 9(1.1%)8(1.2%)4(0.6%)11(1.6%)0.235 23(1.2%)0.857 Blood creatinine increased7(2.4%)5(1.8%)13(4.9%)0.076 25(3.0%)1(0.2%)1(0.2%)5(0.7%)0.117 7(0.4%)