A COMPARISON OF FELODIPINE AND NIFEDIPINE AS MONOTHERAPY IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

Felodipine is a vascular-selective calcium antagonist developed for th e treatment of hypertension. The purpose of this study was to investig ate whether felodipine extended release (ER) has benefit as monotherap y when compared with the established, widely used dihydropyridine, nif edipine retard (R). One hundred thirty-four patients with uncomplicate d mild-to-moderate primary hypertension (seated diastolic blood pressu re [DBP], 95 to 115 mm Hg) entered this multicenter, comparative, rand omized, double-blind, parallel-group study of the efficacy and tolerab ility of felodipine ER versus nifedipine R. Following a 4-week run-in period, patients were randomized to receive either felodipine ER 5 mg once in the morning or nifedipine R 10 mg twice daily. If seated DBP w as >90 mm Hg after 2 weeks of treatment, the doses were doubled and tr eatment continued for another 2 weeks. After 4 weeks of treatment, sea ted mean DBP values had decreased from 105 +/- 6 mm Hg to 89 +/- 7 mm Hg in the felodipine ER group and from 105 +/- 6 mm Hg to 92 +/- 8 mm Hg in the nifedipine R group. The mean reduction was 3 mm Hg greater w ith felodipine ER than with nifedipine R (95% confidence interval = -5 .7 to -0.03; P = 0.03). Sixty-five percent of the patients in the felo dipine ER group achieved a seated DBP less-than-or-equal-to 90 mm Hg v ersus 59% in the nifedipine R group. Thirteen patients discontinued th e study because of adverse events (five patients in the felodipine gro up and eight patients in the nifedipine group, one of whom died). The pattern of adverse events was similar in the two groups and they were generally mild. In this study, felodipine ER 5 to 10 mg once in the mo rning was shown to be more effective than nifedipine R 10 to 20 mg twi ce daily in reducing seated blood pressure and caused fewer patients t o discontinue treatment.