Introduction
Objectives
Methods
Characteristics | Olmesartan (n = 282) | Placebo (n = 284) |
---|---|---|
Age (years) | 59.1 ± 8.1 | 59.2 ± 8.1 |
Japanese/Chinese, n
| 182:100 | 184:100 |
Male sex, n (%) | 199 (70.6) | 192 (67.6) |
Smoker, n (%) | 72 (25.5) | 72 (25.4) |
Weight (kg) | 66.7 ± 13.6 | 66.1 ± 12.0 |
Body mass index (kg/m2) | 25.3 ± 4.2 | 25.3 ± 3.8 |
Systolic blood pressure (mmHg) | 141.7 ± 17.0 | 140.8 ± 18.0 |
Diastolic blood pressure (mmHg) | 77.8 ± 10.4 | 77.2 ± 10.6 |
UACR (mg/mmol) | 192.3 (87.1–339.4) | 191.2 (98.4–352.9) |
Urinary protein/creatinine ratio (mg/mmol) | 247.7 (112.0–437.8) | 231.9 (124.4–429.9) |
Serum creatinine (μmol/l) | 143.21 ± 28.29 | 143.21 ± 30.94 |
Serum potassium (mmol/l) | 4.61 ± 0.43 | 4.61 ± 0.41 |
HbA1c
| ||
% | 7.11 ± 1.20 | 7.05 ± 1.24 |
mmol/mol | 57.1 ± 12.5 | 56.4 ± 12.9 |
Total cholesterol (mmol/l) | 5.41 ± 1.38 | 5.36 ± 1.18 |
Blood haemoglobin (g/l) | 124 ± 20 | 121 ± 19 |
Uric acid (mmol/l) | 434.24 ± 95.18 | 428.29 ± 89.23 |
Medical history, n (%) | ||
Diabetic retinopathy | 228 (80.9) | 233 (82.0) |
Diabetic neuropathy | 144 (51.1) | 154 (54.2) |
Cardiovascular disease | 60 (21.3) | 33 (11.6) |
MI | 11 (3.9) | 5 (1.8) |
Coronary revascularisation | 24 (8.5) | 8 (2.8) |
HF | 12 (4.3) | 9 (3.2) |
Peripheral arterial disease | 33 (11.7) | 19 (6.7) |
Stroke or TIA | 41 (14.5) | 42 (14.8) |
Severe orthostatic hypotension | 3 (1.1) | 5 (1.8) |
Medications, n (%) | ||
Insulin | 139 (49.3) | 153 (53.9) |
Oral glucose-lowering drugs | 165 (58.5) | 175 (61.6) |
Lipid regulating drugs | 155 (55.0) | 149 (52.5) |
Erythropoietin | 10 (3.5) | 6 (2.1) |
Aspirin | 58 (20.6) | 55 (19.4) |
Antihypertensive agents | 262 (92.9) | 269 (94.7) |
Diuretics | 108 (38.3) | 99 (34.9) |
Calcium channel blockers | 186 (66.0) | 198 (69.7) |
ACEI | 205 (72.7) | 209 (73.6) |
α Blockers | 41 (14.5) | 41 (14.4) |
β Blockers | 54 (19.1) | 42 (14.8) |
Others | 37 (13.1) | 38 (13.4) |
Results
Outcome |
n (%) | Olmesartan vs placebo | |
---|---|---|---|
Olmesartan | Placebo | HR (95% CI) (covariates: SCr, ACR and region) | |
All patients group (olmesartan n = 282, placebo n = 284) | |||
Renal composite outcome | 116 (41.1) | 129 (45.4) | 0.97 (0.75, 1.24)†
|
Doubling of SCr | 106 (37.6) | 120 (42.3) | 0.94 (0.73, 1.23) |
ESRD | 74 (26.2) | 78 (27.5) | 1.08 (0.78, 1.49) |
Death from any cause | 19 (6.7) | 20 (7.0) | 0.99 (0.53, 1.86) |
Outcome |
n (%) | Olmesartan vs placebo | ||
---|---|---|---|---|
Olmesartan | Placebo | HR (95% CI) (covariates: ACR and age) | Adjusted HR (95% CI) (covariates: ACR, age and cardiovascular history) | |
All patients group (olmesartan n = 282, placebo n = 284) | ||||
Cardiovascular composite outcome | 40 (14.2) | 53 (18.7) | 0.73 (0.48, 1.09)† | 0.64 (0.43, 0.98)‡ |
Cardiovascular death | 10 (3.5) | 3 (1.1) | 3.38 (0.93, 12.29) | 2.81 (0.76, 10.38) |
Non-fatal stroke | 8 (2.8) | 11 (3.9) | 0.73 (0.29, 1.82) | 0.73 (0.29, 1.83) |
Non-fatal myocardial infarction | 3 (1.1) | 7 (2.5) | 0.43 (0.11, 1.66) | 0.45 (0.11, 1.75) |
Hospitalisation with unstable angina | 5 (1.8) | 3 (1.1) | 1.67 (0.40, 6.98) | 1.37 (0.31, 6.00) |
Hospitalisation with heart failure | 18 (6.4) | 25 (8.8) | 0.71 (0.39, 1.30) | 0.59 (0.32, 1.10) |
Coronary, carotid or peripheral revascularisation | 8 (2.8) | 21 (7.4) | 0.37 (0.16, 0.84) | 0.35 (0.15, 0.80) |
Amputation | 4 (1.4) | 0 (0.0) | – (–) | – (–) |