Methods | Multicentre, controlled, randomized, 2 x 2 factorial design. The ABCD‐H trial included hypertensive (DBP ≥90.0 mmHg) non insulin‐dependent diabetic participants (NIDDM). Participants were randomized to one of four arms: intensive treatment with nisoldipine, intensive treatment with enalapril, moderate treatment with nisoldipine, or moderate treatment with enalapril. Participants and investigators were not masked to blood pressure goal. The follow‐up was 5 years |
Participants | Adults with NIDDM aged between 40 and 74 years and a minimum DBP ≥ 90.0 mmHg were recruited. Exclusion criteria included MI, unstable angina or CVA within the previous six months, CABG surgery within the previous three months, Class III‐IV NYHA CHF, absolute need for therapy with ACEI or CCBs, haemodialysis or peritoneal dialysis, or serum creatinine concentration > 3 mg/dL (265 mmol/L). Country: USA |
Interventions | Standard (moderate) target: DBP 80.0 to 89.0 mmHg Intensive target: DBP ≤ 75.0 mmHg |
Outcomes | The primary endpoint was the effect of intensive or moderate blood pressure control on the change in the 24 hour creatinine clearance, which was assessed every six months. Secondary end points included the effect of intensive as compared with moderate blood pressure control on the incidence of cardiovascular events, retinopathy, clinical neuropathy, urinary albumin excretion, and left ventricular hypertrophy. All cardiovascular events were reviewed by an independent endpoints committee blinded to the patients’ assigned treatment groups. Cardiovascular outcomes were defined as death due to cardiovascular events (sudden death, progressive heart failure, fatal MI, fatal arrhythmias, CVAs, or ruptured aortic aneurysm); non fatal MI; non fatal CVA; heart failure requiring hospital admission; or pulmonary infarction |
Notes | The trial included a number unspecified participants with basal angina in the published article. Authors were contacted to clarify this issue but no definite answer was received before publication of this review. After 67 months of study, the committee recommended the discontinuation of nisoldipine therapy among the participants with hypertension |