Esomeprazole in acute and maintenance treatment of reflux oesophagitis: a multicentre prospective study.
BACKGROUND
The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission.


METHODS
A total of 235 patients with endoscopically proven reflux oesophagitis were enrolled in this study, which consisted of two phases (healing and maintenance therapy). Patients who showed complete endoscopic and symptomatic healing at the end of 4 or 8 weeks were switched to maintenance treatment with esomeprazole 20 mg q.d. for 12 weeks. The primary efficacy endpoint was healing of reflux oesophagitis at week 8. Secondary assessments included the proportion of patients with symptomatic relapse in the maintenance phase.


RESULTS
At the end of week 8, 88% (95% life-table confidence intervals [CI]: 84%, 92%) of patients were healed endoscopically and 90.6% of the patients were asymptomatic. Patient age, gender and Helicobacter pylori status had no effect on the efficacy of treatment. During the 12-week maintenance treatment phase, symptomatic relapse ratios were 0.5%, 2.2%, and 0%, for the first, second, and third 4-week periods, respectively. The proportions of patients satisfied with treatment were 95% and 99.4% at the end of acute and maintenance treatment, respectively. The most common adverse effects were headache, upper respiratory tract infection and abdominal pain.


CONCLUSIONS
Esomeprazole is effective in the healing of reflux oesophagitis, the resolution of heartburn, and in maintaining symptomatic remission. The effectiveness of esomeprazole in patients with gastroesophageal reflux disease is not affected by the presence of H. pylori.
School of Medicine, Department of Gastroenterology, Marmara University, Istanbul, Turkey.
Ozlen
O
Atug
Adnan
A
Giral
Cem
C
Kalayci
Enver
E
Dolar
Fahri
F
Isitan
Dilek
D
Oguz
Oya
O
Ovunc
Orhan
O
Ozgur
Irfan
I
Soykan
Ilkay
I
Simsek
Selahattin
S
Unal
Necati
N
Yenice
D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D016145:Endoscopy, Digestive System; D064098:Esomeprazole / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D055815:Young Adult
D000897:Anti-Ulcer Agents; D064098:Esomeprazole