[Efficacy and safety of OTC omeprazole]

Abstract

Background: Heartburn and acid regurgitation--cardinal symptoms of gastro-esophageal reflux disease (GERD)--rank among the most frequent gastrointestinal disorders. The high degree of suffering often requires a fast and effective symptom relief. Proton pump inhibitors (PPI) are the medication of choice for all manifestations of GERD. Since 2009 the PPI omeprazole is available for OTC-treatment (over the counter). The aim of this pharmacoepidemiologic observational study was to document efficacy and safety of omeprazole under daily-life conditions of self-medication. 2718 patients who had bought the omeprazole product Antra in the pharmacy for treatment of heartburn or acid regurgitation participated in this prospective non-interventional study.

Results: A large part of patients benefited from the PPI-treatment with fast and long lasting symptom relief: 44% of patients already experienced improvement of their symptoms within two to four hours, 71% of patients were completely symptom-free after the OTC treatment (max. 14 days). Overall the PPI was very well tolerated. Adverse events were rare (2.4%) and in accordance with previous experiences. 94% of patients indicated that in case of need they would take the product again. 40% of 178 patients who had been followed-up over a period of three months remained completely symptom-free.

Conclusion: The efficacy and safety of omeprazole known from clinical trials are confirmed for OTC-treatment under daily-life conditions by the results of this non-interventional study.