Verapamil SR/trandolapril combination therapy for the elderly hypertensive patient. German VeraTran Hypertension Study Group.

A total of 254 elderly hypertensive patients (71 men and 183 women aged between 63 and 92 years, diastolic blood pressure (DBP) 95-115 mm Hg inclusive) were treated with the fixed combination of verapamil SR/trandolapril following a 4-week single-blind placebo run-in period. Treatment was started with a response dependent 3-step dose titration period. All patients were initiated at dose step 1 (verapamil SR/trandolapril 120/0.5 mg o.d.) and if not 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/trandolapril 180/2 mg o.d.) during the first 12 weeks. After 3 months of treatment all patients not normalised were excluded from further participation in the study. The total duration of the treatment period was 6 months. Routine safety investigations were performed prior, during and on completion of the treatment period. Verapamil SR/trandolapril was highly effective in reducing blood pressure. At individual last visit during active treatment (also taking the non-responders into account), the mean reduction in SBP/DBP was 21.9/17.1 mm Hg (95% CI 19.8-24.1/16.1-18.1 mm Hg), with most of this reduction occurring during the first 3 months of treatment. After 6 months, 81.9% of the patients enrolled showed normalisation of DBP (<90 mm Hg) and 85% were responders (normalisation and/or reduction in DBP by at least 10 mm Hg). Normalisation and responder rates appeared to be comparable when stratified by age subgroups (63-69, 70-79 and > or =80 years) and were all greater than 80%. Verapamil SR/trandolapril was very well tolerated and there was no evidence of any clinically relevant changes in routine laboratory safety variables or resting ECG. In conclusion, the fixed dose combination of verapamil SR/trandolapril is an effective and safe alternative treatment for the elderly hypertensive patient.

RCT Entities:   Population Interventions Outcomes