Patients were excluded from the study if they had refused endoscopic examination, their GERD was accompanied by severe esophagitis (Grade C or D by LA classification) 12 those with severe cardiovascular or respiratory failure or other kind of heart arrhythmia, local malignancies, hepatic or renal dysfunction/disease, any other clinically significant medical condition, or a history of alcohol or drug abuse within the previous 6 months, pregnant or breastfeeding women, or women of childbearing age not using effective contraception. All patients provided signed informed consent prior to the start of the study. It was performed in accordance with the Declaration of Helsinki and Good Clinical Practice and was approved by the local ethics committee. The study was conducted in Belarus during the period December 2013 to July 2014. Endoscopic evidence of esophagitis healing was an efficacy measure of interest by the physician.Īdult outpatients (aged 18–70 years) with mild to moderate GERD accompanied by heartburn at least twice a week before enrollment and with an endoscopic diagnosis of reflux esophagitis (Los Angeles grades A-B) were enrolled in the study. It studied the combination of omeprazole (20 mg) enteric coated and domperidone (30 mg) sustained release capsule for treating patients with GERD. The active drug was administered for 8 weeks. The study was an open-label, comparative, parallel, randomized controlled, late-phase study of 12 weeks duration conducted for the first time in the Belarus region. The aim of this study was to compare the efficacy and safety of omeprazole-domperidone combination vs omeprazole monotherapy in GERD. It may also improve patient’s quality of life. Previous clinical trials have suggested increased efficacy of combination therapy in terms of symptomatic and endoscopic responses relative to PPI alone. It has been frequently used earlier and is proven to have added therapeutic benefit in patients with GERD. 11Ī combination therapy comprising a PPI and a prokinetic agent is rational, attractive, and effective treatment modality in patients with GERD. Omeprazole and domperidone given in combination did not have any clinically relevant pharmacokinetic interactions. Domperidone is a prokinetic which blocks the effects of endogenous dopamine in the gut and speeds up gastrointestinal peristalsis and causes prolactin release. Omeprazole is a highly effective inhibitor of gastric acid secretion it inhibits the H+/K+-adenosine triphosphatase in the proton pump of gastric parietal cells. Prokinetic agents act by increasing lower esophageal sphincter pressure, enhancing esophageal peristalsis, gastric emptying, and bowel motility. Therefore, their rapid transit to the upper intestine is beneficial. Retention of PPIs in the stomach for longer time due to dysmotility and delayed gastric emptying in patients with GERD may result in an impaired acid suppression. 2, 7 Proton pump inhibitors, as on-demand therapy, might be suitable for long-term management of patients with GERD 8 they have a slower onset of action and they do not act on the nonacid component which is also a contributing factor in causing reflux. 6 However, there was no effective symptomatic resolution in patients treated alone with PPI as observed in previous studies. Proton pump inhibitors (PPIs) have been considered as the cornerstone of the GERD treatment as compared with antacids, prokinetics, and H2 receptor blockers as per the American College of Gastroenterology Guidelines, 2013 5 and World Gastroenterology Organisation Global Guidelines. The diagnosis of GERD is challenging-symptom evaluation and invasive investigations-with endoscopy being the common tool. The disease severity and the wide symptomatic diversity have led to the need for more individualized therapeutic approach. 2 It has a huge impact on patient’s quality of life. 1 It is a common condition with a prevalence of less than 5% in Asia and 10% to 20% in Europe and the United States. Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications such as heartburn or acid indigestion.
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