VALUE[16] | ASCOT-BPLA[17] | AdaPT | ||||||
---|---|---|---|---|---|---|---|---|
Valsartan | Amlodipine | Amlodipine | Atenolol | Ramipril | Placebo | ACEi | Diuretic | |
(n = 7649) | (n = 7596) | (n = 9639) | (n = 9618) | (n = 2.623) | (n = 2.646) | (n = 1.353) | (n = 662) | |
Study design | RCT | RCT | RCT | Observational study | ||||
Endpoint | New onset diabetes (secondary objective) | New onset diabetes (tertiary objective) | New onset diabetes or death (primary endpoint) | New onset diabetes (primary evaluation criterion) | ||||
Inclusion criteria | ||||||||
Age (years) | ≥ 50 | 40–79 | ≥ 30 | ≥ 45 | ||||
Hypertension | 160–210/<115 mmHg | ≥ 160/100 mmHg | n.a. | ≥ 140/90 mmHg | ||||
Fasting plasma glucose | normal | Normal | 110–125 mg/dl [6.1–7.0 mmol/l] | 110–125 mg/dl [6.1–7.0 mmol/l] | ||||
Impaired glucose tolerance | normal | Normal | 140–199 mg/dl [7.8–11.0 mmol/l] | no inclusion criterion | ||||
Exclusion criteria | ||||||||
Diabetes | exclusion (for diabetes endpoint) | exclusion (for diabetes endpoint) | exclusion | exclusion | ||||
Cardiovascular disease | possible | Possible | exclusion | possible | ||||
Follow-up (years) | 4.2 (mean) | 5.5 (median) | 3.0 (median) | 4 (planned) | ||||
HR new-onset diabetes | 0.77 [95%CI 0.69–0.86] | 0.70 [95%CI 0.63–0.78] | 0.91 [95%CI 0.80–1.03] | n.a. |