THE EFFICACY AND SAFETY OF ONCE-DAILY NIFEDIPINE ADMINISTERED WITHOUTFOOD - THE COAT-CORE FORMULATION COMPARED WITH THE GASTROINTESTINAL THERAPEUTIC SYSTEM FORMULATION IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

A parallel-group, randomized, doubleblind, forced-titration, multicent er study was done to compare the efficacy and safety of once-daily nif edipine coat-core (NIF CC) and once-daily nifedipine gastrointestinal therapeutic system (NIF GITS) dosed in the fasting state in patients w ith mild-to-moderate essential hypertension. Both formulations have be en shown to effectively and safely lower blood pressure in placebo-con trolled trials. After a 4-week placebo run-in period, 228 patients wer e randomized to 4 weeks of treatment with either NIF CC 30 mg daily or NIF GITS 30 mg daily. This period was followed by a forced-titration period to nifedipine 60 mg daily for an additional 4 weeks of double-b lind therapy. After the 30-mg treatment period (the primary time point ), there were no statistically significant differences between treatme nt groups in mean change from baseline in trough supine diastolic bloo d pressure, the primary efficacy variable (NIF CC patients, -7.0 mm Hg ; NIF GITS patients, -8.4 mm Hg; P = 0.139). Also, because the upper b ound of the treatment difference confidence interval was <3.0 mm Hg, e quivalence-as defined in the protocol-was established. After the 60-mg treatment period, the change from baseline in trough supine diastolic blood pressure was significantly greater for patients treated with NI F GITS than for patients treated with NIF CC (NIF GITS patients, -12.0 mm Hg; NIF CC patients, -8.4 mm Hg; P < 0.001). Because the upper bou nd of the confidence interval was >3 mm Hg, equivalence cannot be clai med. No statistically significant differences were noted for the compa rison of mean 24-hour ambulatory blood pressure monitoring changes. Bo th formulations were well tolerated.