Key result
Felodipine dose-dependently reduces blood pressure vs placebo, achieving target diastolic BP in up to ~92%.
Why the study?
Does felodipine monotherapy reduce blood pressure in patients with mild and moderate hypertension?
RCT (n=109)
Double-blind
randomised
Yes
Does felodipine monotherapy reduce blood pressure in patients with mild and moderate hypertension?
Felodipine monotherapy effectively and dose-dependently lowers blood pressure in mild to moderate hypertension, though the highest dose (10 mg b.i.d.) is associated with increased adverse events leading to withdrawal.
Supports felodipine monotherapy in mild-moderate hypertension; confirms dose-dependent efficacy versus placebo in RCT.
The role of felodipine, a new calcium antagonist, in monotherapy for mild and moderate hypertension was investigated in a placebo-controlled double-blind study of 109 patients from 13 centres. The patients were randomised in a double-blind fashion to receive felodipine, 2.5 mg b.i.d. (32 patients), 5 mg b.i.d. (30 patients), 10 mg b.i.d. (24 patients), or placebo (23 patients). Two hours after the first tablet was administered, there was a reduction in systolic and diastolic blood pressure, both supine (p less than 0.05) and standing (p less than 0.001), that was significantly correlated with dose. Three and 8 weeks later, 2 h after dosage, this correlation was still apparent in both supine and standing blood pressure (p less than 0.001). One week after randomisation, at 12 hours after administration there was a significant correlation with dose in the standing systolic (p less than 0.05) and diastolic (p less than 0.01) blood pressure. After 8 weeks therapy, a significant correlation with dose occurred in both supine and standing systolic (p less than 0.05) and diastolic (p less than 0.01) blood pressure 12 h after therapy. The proportion of patients completing the study who achieved a supine diastolic blood pressure of 90 mm Hg or less after 8 weeks therapy at 2 h after dosage was 9% on placebo, 67% on felodipine 2.5 mg b.i.d., 57% on felodipine 5 mg b.i.d., and 92% on felodipine 10 mg b.i.d. Felodipine was generally well tolerated although 10 patients on the highest dose withdrew due to adverse experiences. Plasma felodipine levels were significantly correlated with dose.(ABSTRACT TRUNCATED AT 250 WORDS)
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Hamilton et al. (1987) conducted an RCT in Mild and moderate hypertension (n=109). Felodipine vs. Placebo was evaluated on Supine diastolic blood pressure of 90 mm Hg or less after 8 weeks therapy at 2 h after dosage. Felodipine dose-dependently reduced blood pressure, with 67% to 92% of treated patients achieving a supine diastolic blood pressure ≤90 mm Hg at 8 weeks compared to 9% on placebo.
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