Once-Daily Monotherapy of Hypertension with Nifedipine Sustained Release (20mg to 100mg)

Abstract

A 2-centre double-blind randomised clinical study was conducted to evaluate the efficacy and tolerability of fixed doses of a new sustained release (SR) formulation of nifedipine compared with placebo in 207 patients with mild to moderate uncomplicated essential hypertension. After a 3- to 6-week placebo washout period, patients were randomised to receive either placebo, nifedipine SR 20mg, nifedipine SR 50mg or nifedipine SR 100mg. All doses were taken once daily in the morning without food. Among the 157 patients who completed 6 weeks of active therapy, the mean diastolic blood pressure reductions from baseline at 24 hours postdose were 5.3mm Hg, 9.3mm Hg, 9.7mm Hg and 11.1mm Hg in the placebo and nifedipine SR 20mg, 50mg and 100mg groups, respectively (p < 0.01). Nifedipine SR given in fixed doses once daily produced a relatively uniform antihypertensive effect throughout the 24-hour dosing interval, as determined by ambulatory blood pressure monitoring. All 3 dosages of nifedipine SR were generally well tolerated. A major finding of this study was the efficacy and safety of the once-daily 20mg dose.