Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)

Background:
In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms.We aimed to compare the efficacy of different drugs for the treatment of uninvestigated uppergastrointestinal symptoms.
Methods:
This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylorinegative,endoscopically uninvestigated patients [greater than or equal to] 20 years of age with upper gastrointestinalsymptoms of at least moderate severity (Global Overall Symptom score [GOS] [greater than or equal to] 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily),famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg threetimes daily). The primary endpoint was sufficient relief of upper gastrointestinal symptomsafter 4 weeks of treatment (GOS [less than or equal to] 2). UMIN clinical trial registration number:UMIN000005399.
Results:
Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks oftreatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazolegroup, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenonegroups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverseevents. Conclusions: The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated uppergastrointestinal symptoms support its use as first-line treatment in this patient group in Japan.Patients who show no improvement in symptoms despite PPI use, and those with alarmsymptoms (such as vomiting, GI bleeding or acute weight loss) should receive furtherinvestigation, including prompt referral for endoscopy.Trial registrationUMIN000005399

Source: http://www.biomedcentral.com/1471-230X/12/42

auto sport medical rehab