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 5

Summary measures for cardiac (LVMI, left ventricular mass index), renal (urine protein), and vascular (IMT, intima-media thickness) damage after 48 weeks of treatment with zofenopril 60 mg + hydrochlorothiazide (HCTZ) or irbesartan 300 mg + HCTZ. Data are shown for the intention-to-treat population. 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 60 mg + HCTZ 12.5 mg	Irbesartan 300 mg + HCTZ 12.5 mg	value
Cardiac damage
Baseline LVMI (g/m^2)	118.8 ± 40.3	132.0 ± 50.3
LVMI reduction with treatment LVMI (g/m^2)	23.3 (40.6, 6.0)	27.0 (44.3, 9.6)	0.445
Patients with LVH at baseline showing LVH regression at study end (, %)	35/44 (79.5)	39/49 (79.6)	0.989
Renal damage
Albumin/creatinine ratio (mg/g)
Baseline	12.2 ± 16.7	2.3 ± 3.6
Reduction with treatment	+9.0 (+2.1, +15.9)	+11.7 (+3.9, +19.5)	0.348
Microalbuminuria over the 24 hours (mg/24 h)
Baseline	25.5 ± 41.2	19.4 ± 32.3
Reduction with treatment	24.8 (72.8, +23.2)	0.22 (50.6, +50.1)	0.191
Semiquantitative assessment of microalbuminuria by dipstick (mg)
Baseline	10.2 ± 11.3	24.7 ± 42.9
Reduction with treatment	6.1 (15.1, +2.9)	6.5 (15.0, +2.0)	0.924
Patients with renal damage at baseline showing regression at study end (, %)	1/8 (12.5)	2/9 (22.2)	0.617
Vascular damage (maximum IMT in all districts)
Baseline IMT (mm)	1.27 ± 0.53	1.23 ± 0.49
IMT reduction with treatment (mm)	+0.24 (0.05, +0.52)	+0.28 (0.01, +0.57)	0.693
Patients with carotid plaque at baseline showing regression at study end (, %)	6/32 (18.8)	8/26 (30.8)	0.190