We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone.
- Authors
Goldstein, J. L.; Hochberg, M. C.; Fort, J. G.; Zhang, Y.; Hwang, C.; Sostek, M.
- Abstract
Aliment Pharmacol Ther 2010; 32: 401–413 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).
- Subjects
NONSTEROIDAL anti-inflammatory agents; ULCERS; NAPROXEN; ESOMEPRAZOLE; CLINICAL trials
- Publication
Alimentary Pharmacology & Therapeutics, 2010, Vol 32, Issue 3, p401
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/j.1365-2036.2010.04378.x