Key result
Four weeks of treatment with 25 mg and 50 mg daily doses of rofecoxib did not significantly impair endothelial-dependent or independent vasodilator responses compared to placebo in patients with severe coronary artery disease taking aspirin.
Why the study?
Does rofecoxib 25 mg or 50 mg daily impair endothelial function in patients with severe CAD taking concomitant aspirin?
RCT (n=34)
Single-blind
Randomized
No
Does rofecoxib 25 mg or 50 mg daily impair endothelial function in patients with severe CAD taking concomitant aspirin?
p-value: p=>0.05
Four weeks of treatment with standard (25 mg) or high (50 mg) doses of rofecoxib did not impair endothelial function or alter hs-CRP levels in patients with severe CAD on concomitant aspirin therapy.
Rofecoxib does not impair endothelial function in severe CAD on aspirin; confirms neutral short-term vascular effects of COX-2 inhibition.
In this study, we investigated the effects of both 25 and 50 mg daily doses of rofecoxib on the endothelial functions of patients with coronary artery disease (CAD). For this purpose, 34 patients with documented severe CAD and who were under aspirin treatment (300 mg/day) were randomized to receive 4 weeks of treatment with a placebo (n = 10, group I), rofecoxib 25 mg/day (n = 12, group II), and rofecoxib 50 mg/day (n = 12, group III). Brachial artery vasodilator responses were measured in order to evaluate endothelial function. The percentage of change in endothelial-dependent vasodilation in groups I, II, and III were similar at the baseline level and showed no significant change after treatment (6.2+/-3.9% vs. 5.9+/-3.1% and 5.8+/-3.3% vs. 5.6+/-3.8% and 6.1+/-4.5% vs. 5.8+/-4.1%, respectively; P > 0.05). Compared with the baseline, endothelium-independent vasodilatation, as assessed by nitroglycerine (NTG), remained unchanged after the treatment period (11.2+/-6.9% vs. 10.3+/-7.1% and 11.2+/-6.3% vs. 9.9+/-5.1% and 9.5+/-4.9% and 8.8+/-4.6%, respectively; P> 0.05). Treatment with both doses also showed no significant effects on high-sensitivity C-reactive protein (hs-CRP) levels and resting arterial diameters (P > 0.05). In conclusion, 4 weeks of treatment with standard and high doses of rofecoxib showed no significant effects on either endothelial-dependent or independent vasodilator response or plasma hs-CRP levels in patients with severe CAD taking concomitant aspirin.
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Tıkız et al. (2005) conducted an RCT in Coronary artery disease (n=34). Rofecoxib vs. Placebo was evaluated on Percentage of change in endothelial-dependent vasodilation (p=>0.05). Four weeks of treatment with 25 mg and 50 mg daily doses of rofecoxib did not significantly impair endothelial-dependent or independent vasodilator responses compared to placebo in patients with severe coronary artery disease taking aspirin.
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