On-Demand Therapy with Pantoprazole 20 mg as Effective Long-Term Management of Reflux Disease in Patients with Mild GERD: The ORION Trial

Abstract

Aims: To compare safety and efficacy of on-demand pantoprazole 20 mg/40 mg versus placebo in the long-term management of patients with mild gastroesophageal reflux disease (GERD) after heartburn relief. Methods: A total of 634 patients with endoscopically confirmed GERD grade 0/I and heartburn were included. During the acute phase, patients were treated with pantoprazole 20 mg once daily for 4 weeks. Those patients relieved from heartburn entered the long-term phase, and were randomly assigned to either treatment group pantoprazole 20 mg, 40 mg or placebo. Over 6 months, patients took study medication on demand (antacids as rescue medication) and discontinued the drug once symptoms abated. Results: After 4 weeks a total of 87.1%/90.0% of patients were free of heartburn (ITT/PP), and entered the subsequent long-term phase. The perceived average daily symptom load (placebo: 3.93, pantoprazole 20 mg: 2.91, pantoprazole 40 mg: 2.71, ITT) and the number of antacid tablets taken (average number, placebo: 0.68, pantoprazole 20 mg: 0.45, pantoprazole 40 mg: 0.33, ITT) were significantly higher in the placebo than in both pantoprazole groups (p < 0.0001), with no statistically significant difference between the two pantoprazole groups. The discontinuation rate due to insufficient control of heartburn was significantly lower in both pantoprazole groups compared to placebo (placebo: 10.9, pantoprazole 20 mg: 2.8, pantoprazole 40 mg: 0.9, ITT). Conclusions: Our findings favor on-demand treatment with pantoprazole 20 mg for the long-term management of heartburn in patients with uncomplicated GERD (grade 0/I) with superiority to placebo.

Pharmacological Dependency in Chronic Treatment of Gastroesophageal Reflux Disease: A Randomized Controlled Clinical Trial

“…Monotherapy results in mean daily consumptions of 0.3–1 tablet a day [11,12,21,22], whereas in combination with antacids, needs of <0.5 PPI tablet a day were reported [23,24,25,26,27]. In all these studies, first-time consulting patients were included and on-demand treatment was initiated after a short period of standard treatment, which is the most ideal situation for titrating PPI needs.…”

Medical treatment of gastroesophageal reflux disease

“…Moreover, a lower endoscopic recurrence rate was found in the group receiving the dose of 20 mg/day than in the group receiving the dose of 10 mg/day (7). On the other hand, in the study of Scholten et al (16), no difference was found between patients using pantoprazole at the standard dose and at the maintenance dose at the end of the 6 th month in terms of the mean symptom load (2.7 vs. 2.9, p>0.05). Similarly, at the end of the 6 th month, there was no difference between patients receiving esomeprazole at the standard dose and at the maintenance dose with regard to symptomatic remission rates (17).…”

Patients vote with their feet for ‘On demand’ rabeprazole in the maintenance treatment phase of reflux oesophagitis

“…3,4 Inhibition of STAT3 with several agents has also been shown to lead to growth inhibition and enhanced chemo-sensitivity in HCC cells, supporting the role of STAT3 in HCC development. [5][6][7] In conclusion, based on the above observations, it is reasonable to suggest a potential link between obesity and HCC via activation of STAT3. Although it is widely agreed that IL-6-and TNF-mediated STAT3 activation plays a major role in the development of HCC, the association with obesity still warrants further clinical investigation.…”

“…The study is instructive in three ways: first, although similar studies have been performed in Europe, [2][3][4][5][6] there is evidence of differences to responses to PPI [7][8][9] and indeed in the pathogenesis of GERD in different ethnic groups. 10 Therefore, it is essential to confirm that the findings from European studies are indeed applicable to the US population at large, which is ethnically different in make-up to the European population.…”