15183
document
Esomeprazole resolves chronic heartburn in patients without erosive oesophagitis . BACKGROUND Patients with chronic heartburn but with no endoscopic evidence of erosive oesophagitis require gastric acid suppression to relieve symptoms . AIM To assess the efficacy and safety of esomeprazole in patients with frequent heartburn for > or = 6 months and no evidence of erosive oesophagitis on endoscopy . METHODS Two randomized , double-blind , 4-week , multi-centre trials with identical methodology compared once-daily esomeprazole , 40 mg ( n = 241 ) or 20 mg ( n = 234 ) , with placebo ( n = 242 ) for the rigorous end-point of complete resolution of heartburn . Secondary end-points included the percentage of heartburn-free days and the time to first and sustained resolution of heartburn . RESULTS Patients treated with either dose of esomeprazole were two to three times more likely to achieve complete resolution of heartburn than patients treated with placebo ( P < 0.001 ) . The percentage of heartburn-free days was significantly higher with esomeprazole 40 mg ( 63 % , 66 % ) or 20 mg ( 63 % , 68 % ) than with placebo ( 46 % , 36 % ; P < or = 0.001 ) in each of the two studies . Esomeprazole was associated with a significantly shorter mean time to first ( 6-7 days ) and sustained ( 12-17 days ) resolution of heartburn compared with placebo ( first , 10-12 days ; sustained , 21-22 days ; P < or = 0.008 ) . The spectrum and frequency of adverse events with esomeprazole were similar to those with placebo . CONCLUSIONS Esomeprazole , at daily doses of 40 mg or 20 mg , is effective and safe for the treatment of chronic heartburn in patients without erosive oesophagitis .
15184
Intervention_Pharmacological
Esomeprazole
15185
Intervention_Pharmacological
esomeprazole
15186
Intervention_Pharmacological
esomeprazole
15187
Intervention_Control
placebo
15188
Intervention_Pharmacological
esomeprazole
15189
Intervention_Pharmacological
esomeprazole
15190
Intervention_Pharmacological
Esomeprazole
15191
Intervention_Pharmacological
esomeprazole
15192
Intervention_Pharmacological
Esomeprazole
15193
Outcome_Physical
chronic heartburn
15194
Outcome_Physical
relieve symptoms
15195
Outcome_Other
efficacy and safety
15196
Outcome_Physical
frequent heartburn
15197
Outcome_Physical
complete resolution of heartburn
15198
Outcome_Physical
percentage of heartburn-free days
15199
Outcome_Physical
time to first and sustained resolution of heartburn
15200
Outcome_Physical
complete resolution of heartburn
15201
Outcome_Physical
percentage of heartburn-free days
15202
Outcome_Physical
resolution of heartburn
15203
Outcome_Adverse-effects
spectrum and frequency of adverse events
15204
Outcome_Other
effective and safe
15205
Outcome_Physical
chronic heartburn
15206
Participant_Condition
without erosive oesophagitis
15207
Participant_Condition
chronic heartburn
15208
Participant_Condition
frequent heartburn for > or = 6 months
15209
Participant_Sample-size
241
15210
Participant_Sample-size
234
15211
Participant_Sample-size
242