COMPARISON OF THE ANTIHYPERTENSIVE EFFICA CY 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 comp arative study using automative ambulatory blood pressure measurement. The purpose of this double-blind cross-over-study was to investigate t he antihypertensive 24-hour-efficacy and tolerability of two dosage-re gimes of the calcium-antagonist felodipine ER (extended release) 5 mg and felodipine ER 10 mg once daily in mild to moderate hypertension bo th 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 perio d and after both treatment periods. Both preparations reduced lying sy stolic and diastolic blood pressure significantly compared to baseline . There was no difference between treatments regarding resting blood p ressure. Both daytime (6-22 h) and night profile (22-6 h) of ABPM show ed a significant reduction of systolic and diastolic and of mean arter ial blood pressure compared to baseline. There was a significant reduc tion of BP at trough in the last 3 hours of ABPM (5-8 h) before next i ntake of medication regarding the systolic and mean arterial blood pre ssure with no significant difference between the treatments. The incid ence (17%) and the profile of adverse reactions were in the scope of k nown data in the literature. Heart race increased slightly on both tre atments compared to baseline but nor in a clinically relevant extensio n. The routine laboratory screen was not affected by either treatment. The two doses strengths of felodipine showed an antihypertensive effe ct 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.