Blood Pressure Response to Zofenopril or Irbesartan Each Combined with Hydrochlorothiazide in High-Risk Hypertensives Uncontrolled by Monotherapy: A Randomized, Double-Blind, Controlled, Parallel Group, Noninferiority Trial

Table 3

Summary measures for cardiac (LVMI, left ventricular mass index), renal (urine protein), and vascular (IMT, intima-media thickness) damage for the intention-to-treat population and for the two study treatment groups. For any measure the baseline value (±SD), the adjusted reduction (and 95% confidence interval), and the absolute () and relative (%) frequency of patients with damage at baseline showing regression with treatment are reported. Adjustment was made by the baseline value and other potentially confounding variables (age, gender, abdominal obesity, HDL cholesterol, family history for premature cardiovascular disease, baseline blood pressure, and blood pressure changes with treatment). The value refers to the statistical significance of the intertreatment difference.

	Zofenopril 30–60 mg + HCTZ 12.5 mg	Irbesartan 150–300 mg + HCTZ 12.5 mg	value
Cardiac damage
Baseline LVMI (g/m^2)	118.3 ± 35.3	124.6 ± 44.9
LVMI reduction with treatment LVMI (g/m^2)	7.9 (17.4, +1.5)	10.7 (19.7, 1.6)	0.467
Patients with LVH at baseline showing LVH regression at study end (, %)	20/84 (23.8)	24/86 (27.9)	0.648
Renal damage
Albumin/creatinine ratio (mg/g)
Baseline	14.0 ± 23.4	10.3 ± 20.3
Reduction with treatment	3.2 (10.3, +3.9)	5.3 (11.8, +1.2)	0.490
Microalbuminuria over the 24 hours (mg/24 h)
Baseline	21.1 ± 33.0	23.2 ± 37.1
Reduction with treatment	+0.9 (20.8, +22.6)	+8.2 (14.1, +30.5)	0.387
Semiquantitative assessment of microalbuminuria by dipstick (mg)
Baseline	14.2 ± 23.4	19.3 ± 31.3
Reduction with treatment	12.3 (20.0, 4.6)	11.6 (18.7, 4.4)	0.801
Patients with renal damage at baseline showing regression at study end (, %)	9/17 (52.9)	15/22 (68.2)	0.404
Vascular damage (maximum IMT in all districts)
Baseline IMT (mm)	1.22 ± 0.47	1.21 ± 0.47	—
IMT reduction with treatment (mm)	0.07 (0.15, +0.01)	0.03 (0.11, +0.05)	0.143
Patients with carotid plaque at baseline showing regression at study end (, %)	18/57 (31.6)	9/56 (16.1)	0.047