期刊
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
卷 32, 期 3, 页码 401-413出版社
WILEY
DOI: 10.1111/j.1365-2036.2010.04378.x
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资金
- AstraZeneca
- Given
- Logical Therapeutics
- Pfizer
- Takeda
- TAP
- Amgen
- Astellas
- GlaxoSmithKline
- Horizon
- Merck
- Novartis
- PLX
- Procter Gamble
- Wyeth
- Bayer HealthCare LLC
- Bioiberica
- CombinatoRx
- Eli Lilly
- Endo Pharmaceuticals
- Merck Serono International
- NicOx
- Sanofi-Aventis
- POZEN Inc
P>Background Gastroprotective co-therapy may reduce the risk of nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcers, but adherence is suboptimal. Aim To compare the incidence of gastric ulcers with PN 400 [enteric-coated (EC) naproxen 500 mg and immediate-release esomeprazole 20 mg], or EC naproxen. Methods Two randomized, double-blind, multicentre studies (PN400-301, PN400-302). Patients [stratified by low-dose aspirin (< 325 mg) use] aged >= 50 years or 18-49 years with a history of ulcer, received PN 400 BID (301, n = 218; 302, n = 210) or EC naproxen 500 mg BID (301, n = 216; 302, n = 210) for 6 months. The primary endpoint was the cumulative incidence of endoscopic gastric ulcers. Results The cumulative incidence of gastric ulcers was significantly lower with PN 400 vs. EC naproxen (301: 4.1% vs. 23.1%, P < 0.001; 302: 7.1% vs. 24.3%, P < 0.001). PN 400 was associated with a lower combined incidence of gastric ulcers vs. EC naproxen in low-dose aspirin users (n = 201) (3.0% vs. 28.4%, P < 0.001) and non-users (n = 653) (6.4% vs. 22.2%, P < 0.001). The incidence of, and discontinuations due to, upper gastrointestinal (UGI) AEs was significantly lower with PN 400 relative to EC naproxen (P < 0.01, both studies). Conclusions PN 400 significantly reduces the incidence of gastric ulcers, regardless of low-dose aspirin use, in at-risk patients, and is associated with improved UGI tolerability relative to EC naproxen (ClinicalTrials.gov, NCT00527782).
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