EFFICACY AND TOLERABILITY OF EXTENDED-RELEASE FELODIPINE AND EXTENDED-RELEASE NIFEDIPINE IN PATIENTS WITH MILD-TO-MODERATE ESSENTIAL-HYPERTENSION

The efficacy and tolerability of extended-release felodipine (felodipi ne-ER) and nifedipine gastrointestinal therapeutic system (nifedipine GITS) were compared in a multicenter, prospective, open-label clinical trial of 277 patients with mild-to-moderate uncomplicated essential h ypertension (sitting diastolic blood pressure [SiDBP] greater-than-or- equal-to95 and less-than-or-equal-to115 mm Hg). After a 3-week washout period, patients were randomized to receive felodipine-ER (5 mg once daily) or nifedipine GITS (30 mg once daily); during a subsequent 6-we ek titration phase, the once-daily felodipine-ER dose could be increas ed to 10 mg and the nifedipine GITS dose to 60 or 90 mg in an attempt to achieve adequate blood pressure response (SiDBP less-than-or-equal- to90 mm Hg, or <100 mm Hg with a >10-mm Hg reduction from baseline, as measured 24 hours after dosing [trough]). At the end of titration, th e mean daily doses of felodipine-ER and nifedipine GITS were 8 and 50 mg, respectively. Mean changes in sitting systolic blood pressure (SiS BP)/SiDBP were -14/-12 and -16/-13 mm Hg, respectively. All reductions were significant when compared with baseline (P < 0.01), but there we re no significant differences between treatment groups. Adequate blood pressure response occurred in 77% of the felodipine-ER group and 80% of the nifedipine GITS group; this difference was not significant. Blo od pressure changes were similar among sex and race subgroups. A highe r percentage of older patients (>55 years of age) than younger patient s (less-than-or-equal-to55 years of age) reached goal SiDBP with both drugs. Patients with adequate SiDBP response continued receiving their assigned medication for an additional 6-week maintenance period. Redu ctions in SiDBP and SiSBP from baseline continued to be significant in both treatment groups. No clinically important changes in heart rate were noted. A total of 28 patients (15 in the felodipine-ER group and 13 in the nifedipine GITS group) withdrew from the study because of in adequate blood pressure response. At least one adverse experience occu rred in 55% of the felodipine-ER group and 63% of the nifedipine GITS group, prompting withdrawal of 14 patients (10%) and 16 patients (11%) , respectively. Headache and edema were the most common adverse experi ences. The incidence and pattern of adverse experiences did not differ significantly between treatments. The results of this study demonstra te that once-daily felodipine-ER and nifedipine GITS are similarly hig hly effective and generally well tolerated in patients with essential hypertension.