Double-blind comparison of the efficacy and safety of trandolapril 2 mg and hydrochlorothiazide 25 mg in patients with mild-to-moderate essential hypertension. Investigator Study Group.
This multicenter international trial recruited 205 patients from 16 investigators. After a 4-week, single-blind placebo run-in, patients were randomized to receive 16 weeks of trandolapril 2 mg/day (68 patients), hydrochlorothiazide (HCTZ) 25 mg/day (68 patients), or the combination (69 patients). Morning predosing supine diastolic blood pressure (DBP) was the primary efficacy measurement. Intention-to-treat analysis showed significant decreases in all three groups in mean (+/- SEM) supine DBP throughout the study, with no significant differences at week 16 between trandolapril (-10.6 +/- 1.3 mm Hg) and HCTZ (-10.9 +/- 1.3 mm Hg). The combination gave a significantly greater reduction than either drug alone (-15.1 +/- 1.13 mm Hg). Blood pressure was normalized in the combination group in 67% of patients, a significantly higher proportion than either trandolapril (63%) or HCTZ (60%; p = 0.04). Each treatment was well tolerated. The incidence of adverse events was similar in all three groups. Trandolapril 2 mg once daily is an effective antihypertensive agent, comparable to HCTZ. Furthermore, the combination of the two drugs was shown to enhance the antihypertensive effect of the two compounds alone.
Meyer
B H
BH
University of Orange Free State, Bloemfontein, South Africa.
Pauly
N C
NC
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
D000806:Angiotensin-Converting Enzyme Inhibitors; D007211:Indoles; D006852:Hydrochlorothiazide; C052035:trandolapril