COMPARISON OF THE ANTIHYPERTENSIVE EFFICACY OF 5-MG AND 10-MG FELODIPINE IN PATIENTS WITH PRIMARY HYPERTENSION

Comparison of the antihypertensive efficacy of 5 and 10 mg felodipine in patients with primary hypertension. A double-blind, cross-over comparative study using automative ambulatory blood pressure measurement. The purpose of this double-blind cross-over-study was to investigate the antihypertensive 24-hour-efficacy and tolerability of two dosage-regimes of the calcium-antagonist felodipine ER (extended release) 5 mg and felodipine ER 10 mg once daily in mild to moderate hypertension both under casual conditions and using 24-hour ambulatory blood pressure monitoring (ABPM). After a one-week-lasting placebo-controlled run-in-period the patients (n = 24) were randomized to a one week treatment with felodipine 5 mg or felodipine 10 mg and another week on the resp. other dose. Both resting measurements of blood pressure before intake of medication and ABPM were performed at the end of the placebo period and after both treatment periods. Both preparations reduced lying systolic and diastolic blood pressure significantly compared to baseline. There was no difference between treatments regarding resting blood pressure. Both daytime (6-22 h) and night profile (22-6 h) of ABPM showed a significant reduction of systolic and diastolic and of mean arterial blood pressure compared to baseline. There was a significant reduction of BP at trough in the last 3 hours of ABPM (5-8 h) before next intake of medication regarding the systolic and mean arterial blood pressure with no significant difference between the treatments. The incidence (17%) and the profile of adverse reactions were in the scope of known data in the literature. Heart race increased slightly on both treatments compared to baseline but nor in a clinically relevant extension. The routine laboratory screen was not affected by either treatment. The two doses strengths of felodipine showed an antihypertensive effect throughout the entire dose interval. On the basis of these data it should be taken into consideration, to start the treatment of patients with mild to moderate hypertension as a first seep of adjustment with felodipine 5 mg.