A randomised double-blind study comparing nifedipine GITS 20 mg and bendrofluazide 2.5 mg administered once daily in mild-to-moderate hypertension

A multicentre, randomised, double-blind, parallel group comparison of nifed ipine GITS 20 mg (Adalat(R) LA) once daily and bendrofluazide 2.5 mg once d aily in patients with mild-to-moderate hypertension was conducted. Two hund red patients with a diastolic blood pressure (BP) in the range 95 to 109 mm Hg were randomised to active treatment for 6 weeks. For the per-protocol e fficacy population, both treatments resulted in clinically significant mean reductions of trough diastolic BP (nifedipine GITS -8.9 mm Hg, bendrofluaz ide -7.9 mm Hg) and systolic BP (nifedipine GITS -10.4 mm Hg, bendrofluazid e -10.5 mm Hg). The study demonstrated that nifedipine GITS was 'at least e quivalent' to bendrofluazide in the reduction of trough diastolic BP (one-s ided upper 95% confidence limit, 0.5 mm Hg), where inequivalence had been p re-defined as a difference in mean diastolic BP of greater than or equal to 5 mm Hg. Both drugs were well tolerated, the overall incidence of adverse events in the nifedipine GITS treatment group being 34.0% (34/100) and in t he bendrofluazide treatment group being 29.0% (29/100). The commonest event s (incidence greater than or equal to 5%) were headache, constipation, 'flu syndrome and vasodilatation with nifedipine GITS and headache end nausea w ith bendrofluazide. An increased incidence of elevations of plasma urea and glucose was observed in patients treated with bendrofluazide (9.6% and 30. 4% respectively) compared to those treated with nifedipine GITS (3.1% and 1 8.8% respectively). Nifedipine GITS 20 mg once daily is 'at least equivalen t' to bendrofluazide 2.5 mg once daily in reduction of blood pressure in pa tients with mild-to-moderate hypertension.