B008: Baseline characteristics of the hypertensive cohort of the appropriate blood pressure control in diabetes trial-part 2 with valsartan (ABCD-2V)

ABCD-2V, the 5-year continuation of ABCD, is a prospective, randomized clinical trial to compare the effects of intensive versus moderate blood pressure control on nephropathy and vascular complications in hypertensive and normotensive subjects with type 2 diabetes. At the end of the ABCD trial in June 1998, 772 normotensive and hypertensive patients were enrolled. Those in the hypertensive cohort were continued as previously randomized to either intensive (diastolic BP goal 75 mmHg) or moderate (diastolic BP goal 80–89 mmHg) control groups. Valsartan, an angiotensin receptor blocker (ARB), is the primary antihypertensive agent in this trial. By May 1999 enrollment into the hypertensive cohort was complete with 215 subjects. Groups are comparable for age, height, body mass index (BMI), duration of diabetes and hypertension and smoking history. Mean diastolic BP was significantly lower in the intensive control group than in the moderate control group. Risk factor and end-organ damage data for the group includes: Cholesterol 200.7 ± 41.1 mg/dL, LDL-C 119.8 ± 33.3 mg/dL, HDL-C 41.7 ± 11.6 mg/dL, % of patients with Estes Score (ECG) >4 = 51.2%, HbA1c 8.4 ± 1.4% and Urinary Albumin Excretion 298.2 ± 705.1 mg/L/24h. These data indicate that the hypertensive cohort of ABCD-2V is at a relatively high risk for cardiovascular events and the progression of nephropathy. (See Table) Intensive (n = 116) Moderate (n = 99) Age (years) 64.1 ± 8.2 64.3 ± 7.8 DBP (mmHg)* 79.3 ± 8.1 83.4 ± 8.5 SBP (mmHg) 137.8 ± 17.9 141.6 ± 17.7 BMI (kg/m2) 32.1 ± 5.5 31.7 ± 5.3 Duration of Diabetes (years) 15.6 ± 7.0 15.7 ± 7.4 Duration of Htn (years) 19.1 ± 10.4 19.1 ± 11.1 Smoking History (pk-yrs) 18.8 ± 34.2 15.5 ± 21.4 *p = 0.004.