Multicenter Prospective Randomized, Double-Blind, Placebo-Controlled Pharmacodynamic Study of The Additional Antihypertensive Effect of the Drug in Patients With Uncontrolled Arterial Hypertension Against the Background of Taking Renin-Angiotensin-Aldosterone System Blockers.

Abstract

Aim     To evaluate the efficacy and safety of a single sublingual dose of captopril in patients with poor control of arterial hypertension (AH) despite continuous use of long-acting angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). The safety of a single additional dose of a short-acting ACE inhibitor to relieve elevations of blood pressure (BP) in AH patients on ACE inhibitors or ARBs has not been adequately studied.Material and methods            This was a multicenter, prospective, randomized, double-blind, placebo-controlled pharmacodynamic study. The study included men and women aged 18 to 65 years with an established diagnosis of AH and ineffective treatment, despite regular use of constant doses of antihypertensive drugs for at least 3 weeks before inclusion in the study, who have not missed doses during the previous 3 days. Patients were randomly assigned to a sublingual Capoten 25 mg group (captopril group) or a placebo group at a 1:1 ratio. If the effect was insufficient after 30 min, an additional dose of the study drug (Capoten 25 mg or the respective placebo) was administered in each group.Results            The study included 114 patients (57 patients in each group). At baseline, systolic BP (SBP) and diastolic BP (DBP) before the administration of the study drug did not differ significantly between the groups. At one hour after study drug dosing in the captopril group and the placebo group, mean decrease in SBP was 22.0 ± 10.7 and 11.8 ± 11.9 mm Hg, respectively (p < 0.001). At one hour after captopril dosing, the mean decrease in DBP was 14.1±8.3 and 7.5±5.8 mm Hg, respectively (p<0.001). The need for a second dose in the captopril group and the placebo group was 12.3 and 75.4%, respectively.Conclusion      The study confirmed the efficacy and safety of captopril compared to placebo in patients with a marked increase in BP in the absence of damage to target organs, which supports the validity of using captopril as a first-line drug in such clinical situations.