Comparative effects of amlodipine and felodipine ER on office and ambulatory blood pressure in patients with mild to moderate hypertension. Danish Multicentre Group.
The anti-hypertensive efficacy and safety of extended-release (ER) felodipine (5, 10 or 20 mg) and amlodipine (5 or 10 mg) once daily were compared in patients with mild to moderate essential hypertension in a double-blind, double-dummy, randomised, comparative study. One hundred and eighteen patients were randomised to receive either felodipine ER (n = 57) or amlodipine (n = 61) for 12 weeks. Efficacy was assessed by measuring office blood pressure (BP) at baseline and after 4, 6, 8 and 12 weeks, together with 24h ambulatory blood pressure monitoring (ABPM) at baseline, on day 1 of treatment and at the end of the study. The mean office BP changes from baseline to week 12 were -13.4/-11.8 mmHg for felodipine ER (mean daily dose 11.2 mg) and -15.3/-12.9 mm Hg for amlodipine (mean daily dose 7.4 mg). Changes in office BP between treatment groups were not significant. The mean 24h ambulatory BP changes from baseline to end of the study were -11.6/-10.0 mm Hg for felodipine ER and -16.3/-9.6 mm Hg for amlodipine, both significant (P < 0.01). The fall in systolic ambulatory BP was significantly greater (P < 0.001) in the amlodipine-compared with felodipine ER-treated patients but there was no difference between the groups with respect to diastolic ambulatory BP. Both drugs were well tolerated with only seven patients withdrawing because of side-effects, equally distributed between treatment groups. Headache and flushing were significantly (P < 0.05) more frequent in the felodipine ER group. Amlodipine appears to be more potent on a milligram to milligram basis and induces fewer side-effects than does felodipine ER.
Høegholm
A
A
Department of Medicine, Naestved County Hospital, Denmark.
Wiinberg
N
N
Rasmussen
E
E
Nielsen
P E
PE
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D004311:Double-Blind Method; D015736:Felodipine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged
D017311:Amlodipine; D015736:Felodipine