A total of 254 elderly hypertensive patients (71 men and 183 women aged bet
ween 63 and 92 years, diastolic blood pressure (DBP) 95-115 mm Hg inclusive
) were treated with the fixed combination of verapamil SR/trandolapril foll
owing a 4-week single-blind placebo run-in period. Treatment was started wi
th a response dependent 3-step dose titration period. All patients were ini
tiated at dose step 1 (verapamil SR/trandolapril 120/0.5 mg o.d.) and if no
t normalised (DBP <90 mm Hg) titrated at 4-weekly intervals over dose step
2 (verapamil SR/trandolapril 180/1 mg o.d.) to dose step 3 (verapamil SR/tr
andolapril 180/2 mg o.d.) during the first 12 weeks. After 3 months of trea
tment all patients not normalised were excluded from further participation
in the study. The total duration of the treatment period was 6 months. Rout
ine safety investigations were performed prior, during and on completion of
the treatment period. Verapamil SR/trandolapril was highly effective in re
ducing blood pressure. At individual last visit during active treatment (al
so taking the non-responders into account), the mean reduction in SBP/DBP w
as 21.9/17.1 mm Hg (95% CI 19.8-24.1/16.1-18.1 mm Hg), with most of this re
duction occurring during the first 3 months of treatment. After 6 months, 8
1.9% of the patients enrolled showed normalisation of DBP (<90 mm Hg) and 8
5% were responders (normalisation and/or reduction in DBP by at least 10 mm
Hg). Normalisation and responder rates appeared to be comparable when stra
tified by age subgroups (63-69, 70-79 and greater than or equal to 80 years
) and were all greater than 80%. Verapamil SR/trandolapril was very well to
lerated and there was no evidence of any clinically relevant changes in rou
tine laboratory safety variables or resting EGG. In conclusion, the fixed d
ose combination of verapamil SR/trandolapril is an effective and safe alter
native treatment for the elderly hypertensive patient.