81018
document
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 .
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Intervention_Pharmacological
trandolapril
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Intervention_Pharmacological
hydrochlorothiazide
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Intervention_Control
single-blind placebo
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Intervention_Pharmacological
trandolapril
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Intervention_Pharmacological
hydrochlorothiazide ( HCTZ )
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Intervention_Other
or the combination
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Outcome_Other
efficacy and safety
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Outcome_Physical
Morning predosing supine diastolic blood pressure ( DBP )
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Outcome_Physical
supine DBP
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Outcome_Physical
Blood pressure
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Outcome_Adverse-effects
adverse events
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Outcome_Physical
antihypertensive effect
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Participant_Condition
patients with mild-to-moderate essential hypertension .