期刊
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
卷 41, 期 3, 页码 264-273出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/00365520510024197
关键词
AZD3582; cyclooxygenase (COX); COX-inhibiting nitric oxide donator (CINOD); gastrointestinal safety; naproxen; thromboxane B-2
Objective. The objective of this endoscopic study was to compare the effects on the gastroduodenal mucosa of healthy volunteers of different doses and dosing regimens of AZD3582, a cyclooxygenase-inhibiting nitric oxide donator (CINOD), with equimolar doses of naproxen. Material and methods. Healthy volunteers were enrolled in a single-centre, randomized, double-blind, crossover trial consisting of two 12-day treatment periods and employing six sequences. The groups were: AZD3582 750 mg daily versus 375 mg twice daily ( n = 25), AZD3582 375 mg twice daily versus 750 mg twice daily ( n = 25) and naproxen 250 mg twice daily versus 500 mg twice daily ( n = 25). Results. Gastroduodenal tract damage was similar with AZD3582 375 mg twice daily and 750 mg twice daily ( mean number of erosions and ulcers +/- SD: 2.889 +/- 3.95 versus 3.089 +/- 2.80, respectively; p = 0.824; 1 ulcer counted as 10 erosions). There was an indication of decreased gastroduodenal toxicity with AZD3582 750 mg daily compared with 375 mg twice daily (0.929 +/- 2.08 versus 2.719 +/- 4.75, respectively; p = 0.068). Gastroduodenal toxicity was significantly lower with AZD3582 375 mg twice daily than with naproxen 250 mg twice daily ( 2.889 +/- 3.95 versus 6.169 +/- 9.36; p < 0.05), and with AZD3582 750 mg twice daily versus naproxen 500 mg twice daily ( 3.089 +/- 2.80 versus 6.689 +/- 6.97; p < 0.05). Equimolar twice-daily doses of AZD3582 and naproxen resulted in similar naproxen plasma levels and serum thromboxane B-2 inhibition. Conclusions. AZD3582 has an improved gastroduodenal safety profile compared with equimolar doses of naproxen. The gastroduodenal effects of AZD3582 375 mg and AZD3582 750 mg twice daily are similar. A once-daily regimen of AZD3582 might be less gastrotoxic than a twice-daily regimen.
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