Serious adverse events reported in the COPE trial

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Serious adverse events reported in the COPE trial Patients with CKD (n=834) Patients without CKD (n=1996) P value Beni + ARB Beni + BB Beni + TD P value Total Beni + ARB Beni + BB Beni + TD P value Total Angina pectoris 2(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 obliterans 2(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 failure 1(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 operation 1(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 hemorrhage 2(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 cancer 2(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 infarction 4(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 malignant 1(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 infarction 2(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 Pneumonia 4(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 cancer 3(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 stroke 1(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 attack 1(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 Supplemental data Abbreviations: Beni=benidipine , ARB =angiotensin receptor blocker, BB = β-blocker, TD = thiazide diuretic, Data are shown as number of patients (%).

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Supplemental data. Serious adverse events reported in the COPE trial. Abbreviations: Beni=benidipine , ARB =angiotensin receptor blocker, BB = β- blocker, TD = thiazide diuretic, Data are shown as number of patients (%). Supplemental data. Adverse events reported in the COPE trial. - PowerPoint PPT Presentation

Transcript of Serious adverse events reported in the COPE trial

  • 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

  • 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%)