Effect of omeprazole on patient-reported outcome measures in uninvestigated heartburn: a multi-country, multi-center observational study

Lazebnik LB , Alekseenko SA , Tkach SM , Stepanov YM , Marakhouski Y , Zharskaya O


Background: Heartburn occurs predominantly in the upper gastrointestinal tract and is associated with gastroesophageal reflux disease (GERD) and gastritis. Omeprazole is the most prescribed proton pump inhibitor class of medication to treat heartburn related clinical conditions. To compare the efficacy of omeprazole 40 mg (as a total daily dose) and 20 mg using patient-reported outcome measures (PROMs) in patients with heartburn due to various aetiologies like non-erosive reflux disease, GERD, gastritis, dyspepsia, functional heartburn, gastro-duodenal ulcer.

Methods: Naïve patients presenting heartburn symptoms were treated with omeprazole. PROMs were assessed based on short-form-leeds dyspepsia questionnaires (SF-LDQ), work productivity activity impairment (WPAI), relief obtained using medication and, treatment satisfactory questionnaires (TSQ).

Results: A total of 18,724 patients with heartburn (GERD and gastritis; n=10,509) were treated with omeprazole (Dr. Reddy’s omeprazole [DO]/generic omeprazole [GO]/branded omeprazole [BO]) 40 mg (as a total daily dose) and 20 mg. Statistical comparative analysis showed significant improvement with omeprazole 40 mg (as a total daily dose) compared to omeprazole 20 mg in SF-LDQ, relief obtained using medication among patients with heartburn. DO 20 mg showed a greater improvement under the ‘a lot’ and ‘complete’ relief category.

Conclusions: Omeprazole 40 mg (as a total daily dose) presented better efficacy as compared to omeprazole 20 mg in patient reported outcomes. This study highlights omeprazole 40 mg as the preferred intervention for improving PROMs and quality of life in the treatment of heartburn related clinical conditions.


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