Clinical and endoscopic evaluantion of gastroesophageal reflux disease in patients successfully treated with esomeprazole

Abstract

-Background -Esomeprazole, an S-isomer of omeprazole, is the first proton pump inhibitor developed as an optical isomer, and it has shown high healing rates in erosive esophagitis. Aim -To evaluate the efficacy and tolerability of esomeprazole in subjects with erosive esophagitis, according to the Los Angeles classification study design: an open, multi-center clinical study. Material and Methods -Two hundred and eighteen subjects with reflux esophagitis confirmed by endoscopy were included in an open, multi-center study in Brazil. All of them received esomeprazole 40 mg, once daily, for a 4-week period. Subjects who had unhealed esophagitis by week 4 continued the treatment for another 4 weeks. The primary efficacy endpoint was the healing rates by weeks 4 and 8. The secondary endpoints were the number of patients with symptom resolution by week 4, the number of days to sustained symptom resolution, number of symptom-free days and nights and safety and tolerability of the drug. Results -Healing rates by weeks 4 and 8 were 82% (confidence interval: 77.4%-87.6%) and 96.1% (confidence interval: 93.5% -98.8%), respectively. Ninety-nine (99%) of the patients had heartburn resolution by week 2. The most common adverse events were headache (4%), diarrhea (2.6%) and epigastric pain (2.2%). Conclusion -For the studied period, esomeprazole was shown to be a safe and well-tolerated drug, providing significant healing rates of mucosal breaks, regardless of LA classification, in patients with erosive esophagitis. Esomeprazole was also shown to be effective in quickly relieving symptoms.

Clinical, endoscopic and histologic evaluation of gastroesophageal reflux disease in patients treated with proton pump inhibitor: a prospective study

“…is ndings are consistent with the study done by Edson Pedro et al where at the end of 4 th week of treatment with esomeprazole, 10% patients had heartburn. 8 Biswjit Dutt, in his study, had shown resolution of heartburn by omeprazole in 76% patients. 9 David and Pierre, in a randomized control comparison study, showed that PPI (pantoprazole) resulted in higher complete resolution of heartburn compared to placebo therapy in GERD patients but relief of heartburn was not signi cantly di erent between the erosive and nonerosive GERD.…”

“…Edson pedro et al, in their study found that at the end of 4 th week of treatment with esomeprazole, 10% patients had regurgitation. 8 Carlsson et al showed that after 4 weeks of treatment with omeprazole, symptoms of acid regurgitation, epigastric pain, nausea and dysphagia were resolved more often in endoscopy positive patients than in those without endoscopic nding. 11 Bishwajit D. showed that acid regurgitation improved in 90% of patients in both endoscopy positive and negative groups.…”

“…12 Edson et all found that the healing rate was 82.5% at 4 th week and 93.6% at 8 th week of treatment with once daily 40 mg esomeprazole treatment. 8 Proton pump inhibitor therapy has been reported to reduce proliferative changes of esophagus signi cantly in GERD. In this study, proliferative changes of the squamous epithelium was assessed histologically by measuring thickness of basal cell layer and elongation of the papilla as percentage of whole epithelial thickness.…”