The efficacy and safety of itopride as an add-on therapy to a proton pump inhibitor in the treatment of gastroesophageal reflux disease.

Introduction: The primary objective was to demonstrate the efficacy and safety of itopride as an add-on therapy to a proton pump inhibitor (PPI) in the treatment of gastroesophageal reflux disease.

Aim: Reflux disease affects the largest percentage of the population worldwide, symptoms overlap with many other conditions which hamper diagnostic and therapy presenting challenges in treating patients and prompting an intensive search for new, more effective therapeutic regimens.

Material and methods: A retrospective study was undertaken with 140 enrolled patients with reflux disease, confirmed by 24-hour pH impedance previously treated with PPIs without any significant improvement. Itopride was added to the PPI therapy in a dose of 150 mg/day, after which the severity of reflux disease symptoms was reassessed.

Results: The greatest improvement after the combined treatment (p < 0.001) was experienced in the context of heartburn, nausea and laryngopharyngeal symptoms. There was also a high percentage of statistically significant (p < 0.01) improvement in burning in the oesophagus and stomach and regarding postprandial fullness, gastric retention and swallowing disorders. No adverse effects were noted.

Conclusions: The presented study clearly demonstrates that in patients ineffectively treated with PPIs, the addition of itopride to the therapy for 8 weeks without changing the PPI dose, significantly improves the efficacy of treatment of reflux disease and thus shortens the need for medication usage and reduces the costs of therapy, potential side effects of PPI, improves the patient's quality of life and decreases the frequency of medical appointments.