Twenty-four-hour blood pressure monitoring during treatment with extended-release felodipine versus slow-release nifedipine in elderly patients with mild to moderate hypertension: a randomized, double-blind, cross-over study.
OBJECTIVE
This double-blind, placebo-controlled randomized study was designed to compare the antihypertensive effect and tolerability of extended-release felodipine and slow-release nifedipine retard in elderly hypertensive patients.


METHODS
Thirty patients of both sexes (mean age 71 years) with mild to moderate essential hypertension were recruited from our hypertension outpatient clinic. After a 2-week placebo period, felodipine extended-release (felodipine ER), 10 mg once daily, nifedipine slow-release retard (nifedipine SR), 20 mg twice daily or placebo were administered to each patient for 2 weeks according to a 3 x 3 latin-square design. At the end of each treatment period, the patients underwent 24-h noninvasive blood pressure monitoring.


RESULTS
All of the patients completed the trial and no serious adverse experience was reported. In comparison with placebo, felodipine and nifedipine decreased mean 24-h diastolic blood pressure by 6.7 and 4.3 mmHg, respectively, with no significant difference between the two drugs. Mean 24-h systolic blood pressure also decreased after felodipine and nifedipine, with no difference between the two drugs. Both drugs reduced blood pressure variability, lowering the 24-h mean standard deviation of mean hourly blood pressure values. The trough:peak ratio for felodipine was 80% for systolic and 75% for diastolic blood pressure.


CONCLUSIONS
Felodipine ER once daily lowers blood pressure in elderly hypertensives and is as effective as nifedipine SR twice daily. The high trough:peak ratio suggests that the dose and the between-dose interval of felodipine provides adequate therapeutic coverage.
Bonaduce
D
D
Institute of Internal Medicine, Cardiology and Heart Surgery, Naples, Italy.
Canonico
V
V
Petretta
M
M
Forgione
L
L
Ianniciello
A
A
Cavallaro
V
V
Bertocchi
F
F
Rengo
F
F
D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory / Q000379:methods; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015736:Felodipine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D009543:Nifedipine / Q000008:administration & dosage*
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D009543:Nifedipine; D015736:Felodipine