Office and ambulatory blood pressure: a comparison between amlodipine and felodipine ER. 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. A total of 118 patients were allocated to a 12-week, double-blind treatment with either felodipine ER (n = 57) or amlodipine (n = 61). The anti-hypertensive effect was evaluated by measuring office blood pressure (BP) at baseline and after 4, 6, 8 and 12 weeks, together with 24 h 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 (+/- 15.7)/-11.8 (+/- 6.9) mmHg for felodipine ER (mean daily dose 11.2 mg) and -15.3 (+/- 17.0)/-12.9 (+/- 7.3) mm Hg for amlodipine (mean daily dose 7.4 mg). All BP reductions were significant (P < 0.01) with respect to time, but differences between treatment groups were not significant. The mean ambulatory BP changes from baseline to end of the study were -11.6 (+/- 5.2)/-10.0 (+/- 2.0) mmHg for felodipine ER and -16.3 (+/- 4.4)/-9.6 (+/- 3.0) mm Hg for amlodipine, both significant (P < 0.01). The fall in ambulatory SBP was significantly greater (P < 0.001) in the patients treated with amlodipine compared with felodipine ER whereas there was no difference between the groups with respect to ambulatory DBP. Both drgs were well tolerated with a withdrawl rate of 12% equally distributed.(ABSTRACT TRUNCATED AT 250 WORDS)
Høegholm
A
A
Department of Medicine, Noestved County Hospital, Denmark.
Wiinberg
N
N
Rasmussen
E
E
Nielsen
P E
PE
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018660:Blood Pressure Monitoring, Ambulatory; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics / Q000627:therapeutic use; D003971:Diastole / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015736:Felodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009819:Office Visits; D013599:Systole / Q000187:drug effects; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D017311:Amlodipine; D015736:Felodipine