ONCE-DAILY TRANDOLAPRIL COMPARED WITH THE TWICE-DAILY FORMULATION IN THE TREATMENT OF MILD-TO-MODERATE ESSENTIAL-HYPERTENSION - ASSESSMENT BY CONVENTIONAL AND AMBULATORY BLOOD PRESSURES
L. Poirier et al., ONCE-DAILY TRANDOLAPRIL COMPARED WITH THE TWICE-DAILY FORMULATION IN THE TREATMENT OF MILD-TO-MODERATE ESSENTIAL-HYPERTENSION - ASSESSMENT BY CONVENTIONAL AND AMBULATORY BLOOD PRESSURES, Journal of clinical pharmacology, 33(9), 1993, pp. 832-836
A double-blind, crossover study was carried out to compare the antihyp
ertensive efficacy of the long-acting ACE inhibitor trandolapril 1 mg
administered once daily and 0.5 mg twice daily in 31 patients with mil
d to moderate essential hypertension. After randomization, patients en
tered a single-blind placebo period of 4 weeks. After a double-blind t
reatment of 4 weeks with either of the dosage regimens, patients were
then crossed over to the alternate regimen for the last 4 weeks of the
study. Conventional BP and heart rate were measured on each visit and
ambulatory BP monitoring was done at baseline and at the end of each
treatment phase. Conventional as well as 24-hour and awake ambulatory
systolic and diastolic BPs were significantly (P < 0.001) and almost i
dentically decreased by both once- and twice-daily formulations. Moreo
ver, the clinical response rates (reduction in seated diastolic BP gre
ater-than-or-equal-to 10% or diastolic BP less-than-or-equal-to 90 mm
Hg) were similar with both treatment regimens (42% vs. 45% with the on
ce- and twice-daily formulations, respectively). However, trandolapril
twice daily exerted a significantly (p = 0.03) greater antihypertensi
ve effect on systolic BP during sleep as compared with the once-daily
formulation. Due to the fact that the minimal effective dose was used
in this trial, further studies with higher doses should demonstrate ef
fective 24-hour control of BP as described with other long-acting ACE
inhibitors. In addition, our results suggest that ambulatory BP measur
ements should be done in dose-response studies.