Efficacy of XXXX for resolution of symptoms of heartburn and acid regurgitation in continuous users of non-steroidal anti-inflammatory drugs.

@entity1 @entity1537 @entity1066 @entity344 @entity490 @entity5616 @entity2275
BACKGROUND: The use of non-steroidal anti-inflammatory drugs (NSAIDs) is often associated with @entity344 such as heartburn and acid regurgitation. AIM: To assess the efficacy of @entity1537 20 and 40 mg for resolution of heartburn and acid regurgitation in continuous NSAIDs. METHODS: A post hoc analysis of five clinical trials was performed. Two identically designed, placebo-controlled, 4-week studies (NASA1, SPACE1) enrolled non-ulcer, NSAIDs-treated @entity1 with upper @entity490 , discomfort or burning. PLUTO and VENUS were identically designed, placebo-controlled, 6-month studies that enrolled @entity1 at risk of NSAIDs-induced @entity1066 . Study 285 was an 8-week comparative study with @entity5616 (300 mg/day) in @entity1 with NSAIDs-induced @entity2275 . Resolution of investigator-assessed heartburn and acid regurgitation was defined as symptom severity of 'none' in the last 7 days. RESULTS: In NASA1/SPACE1, heartburn resolved in 61% and 62% of @entity1 taking @entity1537 20 and 40 mg, respectively (vs. 36% on placebo, P < 0.001), and acid regurgitation resolved in 65% and 67% (vs. 48%, P < 0.001). Resolution of both symptoms was greater with @entity1537 than with placebo in PLUTO/VENUS (P <or= 0.001), and than with @entity5616 in study 285 (P < 0.05 for @entity1537 20 mg). CONCLUSION: Heartburn and regurgitation are common in @entity1 taking NSAIDs and @entity1537 is efficacious for resolution of these symptoms.
