Abstract

Introduction: Gastroesophageal Reflux Disease (GERD) is the regurgitation or rise of gastric or duodenal contents beyond the gastroesophageal junction, and its prevalence ranges from 15% to 30%. It has been underdiagnosed due to lack of consultation with a health professional and due to self-medication. Interventions include pharmacological ones, such as prokinetics and Proton Pump Inhibitors (PPIs)

Objective: To compare the clinical performance in real life and the safety of mosapride and esomeprazole in treating patients diagnosed with GER from primary care clinics in 12 Colombian cities.

Methods: We conducted an analytical cohort study, including patients older than 18, diagnosed with GER, who started treatment with mosapride 5 mg, or 10 mg and esomeprazole 10 mg, 20 mg, or 40 mg. The clinical outcomes were symptoms such as heartburn, reflux, epigastric pain, hoarseness, nausea, and the number of episodes of any of the symptoms in the last month. Measures of association between mosapride and esomeprazole were estimated.

Results: A total of 298 patients were analyzed. The cohort exposed to mosapride contained 84 (28.2%), and the esomeprazole cohort 214 (71.8%). The most frequent symptoms were reflux 282 (94.6%), nausea 210 (70.4%), and dysphonia 203 (68.1%). A decrease in symptoms was evidenced in both medications, such as heartburn, reflux, epigastric pain, nausea, dysphonia and episodes of symptoms (for all cases p<0.001). Finding that mosapride only had a better performance in improving epigastric pain (RR: 0.4 95% CI 0.2-0.7). Adherence to medical control, 270 (90.6%). No serious or non-serious adverse events were recorded.

Conclusion: This study made it possible to determine the clinical effectiveness of mosapride and esomeprazole in real-life conditions, impacting the improvement of symptoms before and after their use. The use of these drugs did not show serious or non-serious adverse events, and their adherence to medical control was higher than 80%.

Keywords: Gastroesophageal reflux; Heartburn; Abdominal pain; Digestive signs and symptoms; Proton pump inhibitors