G. Mancia et al., EFFECTS OF VERAPAMIL SR, TRANDOLAPRIL, AND THEIR FIXED COMBINATION ON24-H BLOOD-PRESSURE - THE VERATRAN STUDY, American journal of hypertension, 10(5), 1997, pp. 492-499
The Veratran study investigated the antihypertensive efficacy of verap
amil sustained release (SR) (180 mg), trandolapril(1 mg), and their fi
xed combination during a 24-h period. After a 4-week placebo run-in pe
riod, 272 patients (age 49 +/- 9 years, mean +/- SD) with essential hy
pertension and a clinic diastolic blood pressure greater than or equal
to 100 mm Hg were randomized to verapamil, trandolapril, their fixed
combination, or placebo for 8 weeks, according to a multicenter double
-blind parallel group study design. Clinic and semiautomatic blood pre
ssure at trough and 24-h ambulatory blood pressure were measured at th
e end of run-in period and after 8 weeks of treatment. In the 234 pati
ents included in the efficacy analysis, run-in clinic and semiautomati
c blood pressures were reduced by verapamil, trandolapril, and combine
d verapamil and trandolapril significantly more than by placebo. The r
eductions obtained with the combination were significantly greater tha
n those obtained by verapamil alone. Twenty-four-hour average blood pr
essures were not modified by placebo and were reduced by 8/6 mm Hg (sy
stolic/diastolic) by verapamil, 11/7 mm Hg by trandolapril, and 14/11
mm Hg by the combination of the two drugs. The differences between the
effect of the combination and the combination components were, in mos
t instances, statistically significant. The verapamil-trandolapril com
bination was more effective also on day average blood pressure and sup
erior to the monotherapies for the trough-to-peak ratio of the antihyp
ertensive effect as well. Twenty-four-hour heart rate was slightly but
significantly reduced by verapamil and the reduction was manifest in
the group taking verapamil plus trandolapril. Thus, the antihypertensi
ve treatment with the fixed verapamil SR-trandolapril combination is m
ore effective and balanced over the 24 hours than the effect of the co
mbination components administered alone. (C) 1997 American Journal of
Hypertension, Ltd.