XXXX in primary care: an international study of different treatment strategies with @entity4546 . International GORD Study Group.

@entity1 @entity1109 @entity4546 @entity354
OBJECTIVE: To assess the efficacy of @entity4546 in @entity1 presenting with troublesome reflux symptoms. DESIGN: Randomized, double-blind, parallel-group, placebo-controlled comparison. SETTING: Primary care. SUBJECTS: @entity1 were recruited using a symptom-based questionnaire for diagnosis of @entity354 . INTERVENTIONS: After endoscopy, @entity1 without endoscopic @entity354 were randomized to @entity4546 20 mg (Ome20), @entity4546 10 mg (Ome10) or placebo once daily for 4 weeks (n = 261) and those with @entity354 (except circumferential/ulcerative) were randomized to receive either Ome20 or Ome10 once daily for 4 weeks (n = 277). @entity1 not symptom-free at 4 weeks received open treatment with Ome20 once daily for a further 4 weeks. Those symptom-free at 4-8 weeks were followed up for 6 months off treatment, to see whether their symptoms recurred. MAIN OUTCOME MEASURE: Complete upper GI symptom relief during week 4 on Ome20 or Ome10 in @entity1 with or without endoscopic @entity354 . RESULTS: Forty one percent of all @entity1 on Ome20 and 35% on Ome10 reported complete relief from @entity1109 during week 4, whilst 73% of the @entity1 on Ome20 and 62% on Ome10 obtained sufficient control. Complete relief during week 4 was reported by 19% of endoscopy-negative @entity1 on placebo, and sufficient control by 35%. Endoscopic healing at 4 weeks occurred in 76% of @entity354 @entity1 on Ome20 and in 56% on Ome10. After 6 months off treatment, 90% of @entity1 with @entity354 and 75% of endoscopy-negative @entity1 reported symptomatic relapse. CONCLUSION: Both 10 mg and 20 mg of @entity4546 gave effective relief of symptoms, although 20 mg gave superior healing in @entity1 with @entity354 . After cessation of treatment, symptomatic relapse was rapid and frequent in both endoscopy-positive and endoscopy-negative @entity1 .
