VERAPAMIL AND TRANDOLAPRIL ALONE AND IN FIXED COMBINATION IN MODERATEESSENTIAL-HYPERTENSION - A MULTICENTER, DOUBLE-MASKED STUDY

We compared the efficacy of fixed combination therapy with verapamil s ustained release (SR)/trandolapril with that of each agent alone in a randomized, double-masked, parallel-group, multicenter study involving 310 patients (180 men and 130 women; mean age, 55.6 years) with moder ate essential hypertension (defined as sitting diastolic blood pressur e [DBP] greater than or equal to 100 and <110 mm Hg). After a 4-week p lacebo run-in period, patients were randomized to receive verapamil SR 180 mg (102 patients), trandolapril 2 mg (105 patients), and verapami l SR 180 mg/trandolapril 2 mg (103 patients) each once daily for 8 wee ks, Combination therapy produced a significantly greater mean reductio n in sitting DBP (13.2 mm Hg) than either verapamil. SR (9.6 mm Hg) or trandolapril (10.9 mm Hg) alone, The estimated adjusted mean contribu tion to the DBP-reducing effect of combination therapy was 2.3 mm Hg f or verapamil SR and 3.6 mm Hg for trandolapril. Overall, combination t herapy was significantly superior to monotherapy with either agent, At the last visit 50,5% of patients receiving combination therapy showed normalization of sitting DBP (<90 mm Hg) compared with 32.4% receivin g verapamil SR and 41,9% receiving trandolapril; response rates (norma lization of or reduction in DBP greater than or equal to 10 mm Hg) wer e 69.9% for patients receiving combination therapy, 49.0% for patients receiving verapamil SR, and 59.0% for patients receiving trandolapril , All three treatments mere safe and well tolerated. The profile of ad verse events with combination therapy was consistent with that known f or each component drug. Fixed low-dose combination therapy with verapa mil SE 180 mg/trandolapril 2 mg would be a suitable treatment option f or patients with moderate essential hypertension, including those who have not responded to other forms of therapy.