Serious adverse events reported in the COPE trial
description
Transcript of Serious adverse events reported in the COPE trial
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 TotalBeni +
ARBBeni + 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 (%).
Supplemental data
Patients with CKD (n=834) Patients without CKD (n=1996)P valueBeni +
ARBBeni + BB Beni + TD P value Total
Beni + ARB
Beni + BB Beni + TD P value Total
Alanine aminotransferase increased
7(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 increased
7(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 pain 1(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 increased
6(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 increased 7(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%) <0.001Blood urea increased 10(3.5%) 6(2.1%) 9(3.4%) 0.566 25(3.0%) 2(0.3%) 5(0.8%) 5(0.7%) 0.478 12(0.6%) <0.001Bradycardia 0(0.0%) 9(3.2%) 0(0.0%) <0.001 9(1.1%) 3(0.5%) 32(4.9%) 1(0.1%) <0.001 36(1.8%) 0.156 Bronchitis 15(5.2%) 5(1.8%) 10(3.8%) 0.084 30(3.6%) 13(2.0%) 16(2.5%) 15(2.2%) 0.832 44(2.2%) 0.036 Diabetes mellitus 6(2.1%) 13(4.6%) 9(3.4%) 0.252 28(3.4%) 15(2.3%) 25(3.9%) 19(2.8%) 0.229 59(3.0%) 0.588 Eczema 4(1.4%) 2(0.7%) 2(0.8%) 0.646 8(1.0%) 4(0.6%) 3(0.5%) 4(0.6%) 0.930 11(0.6%) 0.230 Gamma-glutamyltransferase increased
2(0.7%) 3(1.1%) 1(0.4%) 0.641 6(0.7%) 7(1.1%) 4(0.6%) 10(1.5%) 0.319 21(1.1%) 0.400
Gastroenteritis 2(0.7%) 0(0.0%) 6(2.3%) 0.021 8(1.0%) 4(0.6%) 5(0.8%) 6(0.9%) 0.847 15(0.8%) 0.583 Glycosylated hemoglobin increased
4(1.4%) 1(0.4%) 5(1.9%) 0.237 10(1.2%) 5(0.8%) 6(0.9%) 9(1.3%) 0.574 20(1.0%) 0.650
Hypercholesterolemia 5(1.7%) 7(2.5%) 3(1.1%) 0.499 15(1.8%) 16(2.4%) 15(2.3%) 25(3.7%) 0.256 56(2.8%) 0.114 Hyperglycemia 4(1.4%) 2(0.7%) 3(1.1%) 0.725 9(1.1%) 4(0.6%) 7(1.1%) 9(1.3%) 0.417 20(1.0%) 0.863 Hyperkalemia 8(2.8%) 1(0.4%) 1(0.4%) 0.009 10(1.2%) 3(0.5%) 5(0.8%) 2(0.3%) 0.457 10(0.5%) 0.045 Hyperlipidemia 7(2.4%) 11(3.9%) 9(3.4%) 0.610 27(3.2%) 17(2.6%) 14(2.2%) 17(2.5%) 0.872 48(2.4%) 0.217 Hypertriglyceridemia 7(2.4%) 9(3.2%) 5(1.9%) 0.628 21(2.5%) 15(2.3%) 22(3.4%) 19(2.8%) 0.475 56(2.8%) 0.654 Hyperuricemia 10(3.5%) 4(1.4%) 28(10.6%) <0.001 42(5.0%) 7(1.1%) 12(1.9%) 47(6.9%) <0.001 66(3.3%) 0.031 Hypokalemia 1(0.3%) 1(0.4%) 5(1.9%) 0.076 7(0.8%) 5(0.8%) 0(0.0%) 20(2.9%) <0.001 25(1.3%) 0.337 Hypotension 2(0.7%) 3(1.1%) 0(0.0%) 0.266 5(0.6%) 3(0.5%) 4(0.6%) 5(0.7%) 0.807 12(0.6%) 0.988 Nasopharyngitis 6(2.1%) 8(2.8%) 10(3.8%) 0.491 24(2.9%) 13(2.0%) 17(2.6%) 13(1.9%) 0.614 43(2.2%) 0.257 Osteoarthritis 3(1.0%) 0(0.0%) 0(0.0%) 0.057 3(0.4%) 6(0.9%) 7(1.1%) 6(0.9%) 0.922 19(1.0%) 0.100 Pharyngitis 5(1.7%) 1(0.4%) 5(1.9%) 0.213 11(1.3%) 3(0.5%) 7(1.1%) 17(2.5%) 0.004 27(1.4%) 0.932 Proteinuria 4(1.4%) 5(1.8%) 4(1.5%) 0.935 13(1.6%) 3(0.5%) 5(0.8%) 9(1.3%) 0.221 17(0.9%) 0.097 Upper respiratory tract inflammation
9(3.1%) 6(2.1%) 7(2.7%) 0.751 22(2.6%) 13(2.0%) 15(2.3%) 9(1.3%) 0.390 37(1.9%) 0.189
Vertigo 0(0.0%) 7(2.5%) 4(1.5%) 0.033 11(1.3%) 4(0.6%) 9(1.4%) 12(1.8%) 0.157 25(1.3%) 0.897
Adverse events reported in the COPE trial
Abbreviations: ALT=alanine aminotransferase, Beni=benidipine , ARB =angiotensin receptor blocker, BB = β-blocker, TD = thiazide diuretic,Data are shown as number of patients (%).