Antihypertensive effect and tolerability of felodipine extended release (ER) tablets in comparison with felodipine plain tablets (PT) and placebo in hypertensives on a diuretic. Canadian Study Group.
Antihypertensive efficacy and tolerability of felodipine extended release (ER) (o.d.), felodipine plain tablet (PT) (b.i.d.), and placebo were compared in mild to moderate hypertensives whose seated diastolic blood pressure (DBP) was > or = 95 mm Hg while on hydrochlorothiazide 25 mg od. In addition to the diuretic, patients were randomised to felodipine ER 5 mg od (n = 50), PT 2.5 mg bid (n = 50), or placebo (n = 48) for 6 weeks, with clinic visits every 2 weeks. If seated DBP was > or = 90 mm Hg at any visit, daily dosage of felodipine was doubled to a maximum of 20 mg. The mean difference between ER and placebo was 5.1 mm Hg (p = 0.003); for PT vs. placebo the difference was 5.3 mm Hg (p = 0.002). Seated systolic blood pressure (SBP) was reduced by a mean difference of 6.8 mm Hg in the felodipine PT group compared with placebo (p = 0.03). Fourteen patients were withdrawn: 4 from the placebo group, 4 from the felodipine ER group, and 6 from the felodipine PT group. The most commonly reported adverse event was peripheral edema. In patients not adequately controlled on diuretic alone, felodipine ER o.d. and felodipine PT b.i.d. were superior to placebo in reducing seated DBP.
Carruthers
S G
SG
Victoria General Hospital, Halifax, Nova Scotia.
Vint-Reed
C
C
D000328:Adult; D000368:Aged; D001794:Blood Pressure; D001835:Body Weight; D002170:Canada; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004562:Electrocardiography; D015736:Felodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006339:Heart Rate; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos
D003692:Delayed-Action Preparations; D010919:Placebos; D006852:Hydrochlorothiazide; D015736:Felodipine