Sixty-one patients (41 men, 20 women) aged 29-73 years, with moderate to severe hypertension, were enrolled in a multicentre study to compare the efficacy, safety, and tolerability of dilevalol (D) and captopril (C). At the end of the baseline period, supine diastolic blood pressure (SuDBP) was 105-140 mm Hg on hydrochlorothiazide (HCTZ) 25 mg once daily and placebo t.i.d. Patients were randomly assigned to D + HCTZ (n = 29) or C + HCTZ (n = 32) and entered phase II titration of D (100-800 mg b.i.d.) or C (12.5 mg b.i.d. to 50 mg t.i.d.). If SuDBP was >99 mm Hg, hydralazine was added (25 mg once daily to 50 mg b.i.d.). If SuDBP was ≤ 99 mm Hg, patients entered phase III, a 3-month maintenance period. Demographic profiles were not significantly different between the two groups. Baseline supine BP (mean ± SEM) was similar in the two groups (D + HCTZ: 182 ± 3/112 ± 1; C + HCTZ: 179 ± 4/113 ± 1 mm Hg), as was baseline standing BP (D + HCTZ: 175 ± 3/114 ± 2; C ± HCTZ: 173 ± 4/113 ± 1 mm Hg). At the end of phase II, there were no significant differences between treatments with respect to the changes in BP from baseline. At the treatment endpoints (end study drug + HCTZ and end of study), statistically significant (p < 0.05) greater decreases were observed for SUDBP and standing DBP for the D + HCTZ group (supine, 15 ± 2,16 ± 2 mm Hg; standing, 16 ± 2,16 ± 2 mm Hg) than for the C + HCTZ group (supine, 10 ± 2,11 ± 2 mm Hg; standing, 9 ± 2,11 ± 2 mm Hg). Heart rate (HR) was reduced significantly in the D + HCTZ group. Similar numbers of patients achieved the treatment goal of SuDBP ≤ 99 mm Hg: 18 (62%) in the D + HCTZ group and 17 (53%) in the C + HCTZ group at end of study. Adverse experiences resulted in early termination in four of the D + HCTZ group and seven of the C + HCTZ group. In patients with moderate to severe hypertension, uncontrolled on HCTZ, the vasodilator β-blocker dilevalol is at least as effective and as well tolerated as captopril for the dose ranges used in this study
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