Key result
Felodipine added to beta-blocker therapy significantly increased exercise duration at 4 hours post-dose after 12 weeks compared to placebo (increase 39 vs 3 seconds; 95% CI 1.01-1.16; P=0.02).
Why the study?
Does felodipine added to beta-blocker therapy improve exercise duration in patients with stable angina pectoris?
RCT (n=128)
Double-blind
randomized
Yes
Does felodipine added to beta-blocker therapy improve exercise duration in patients with stable angina pectoris?
Absolute Event Rate: 39% vs 3%
p-value: p=0.02
The addition of felodipine to beta-blocker therapy in patients with stable angina improves exercise duration at 4 hours post-dose, though the effect is not sustained at 24 hours.
Supports felodipine add-on to beta-blockers for peak exercise gains in stable angina; confirms 4-hour benefit but leaves 24-hour durability open.
The additional efficacy, duration of action and tolerability of felodipine were evaluated in patients with stable angina pectoris and a positive stress test who were already receiving therapy with a beta-adrenergic blocker. One hundred and twenty-eight patients were randomized to double-blind treatment with 5-10 mg felodipine once daily or matching placebo, and were evaluated by serial exercise testing during 12 weeks of treatment. Felodipine at 4 h significantly increased exercise duration assessed after 4 weeks of treatment (increase 34 +/- 65 s vs 18 +/- 71 s in placebo-treated patients; 95% confidence interval 1.01-1.11; P = 0.01), and after 12 weeks of treatment (increase 39 +/- 103 s vs 3 +/- 72 s; 95% confidence interval 1.01-1.16; P = 0.02). The time until onset of exercise-induced anginal pain and time until 1 mm ST depression assessed after 4 weeks of treatment also increased significantly with felodipine compared to placebo. No statistically significant changes in exercise test parameters evaluated 24 h after medication were observed. The addition of felodipine once daily demonstrated a sustained improvement in exercise duration in patients symptomatic despite treatment with a beta-blocker evaluated 4 h after drug intake. At 24 h post dose, no statistically significant effect was observed. Felodipine is well tolerated with a low incidence of side-effects and no adverse effect on quality of life.
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Rønnevik et al. (1995) conducted an RCT in stable angina pectoris (n=128). Felodipine vs. matching placebo was evaluated on exercise duration assessed after 12 weeks of treatment at 4 h (95% CI 1.01-1.16, p=0.02). Felodipine added to beta-blocker therapy significantly increased exercise duration at 4 hours post-dose after 12 weeks compared to placebo (increase 39 vs 3 seconds; 95% CI 1.01-1.16; P=0.02).
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