Published: 2021-05-27

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

Leonid B. Lazebnik, Sergey A. Alekseenko, Sergii M. Tkach, Yuriy M. Stepanov, Yury Marakhouski, Olga Zharskaya, Baurzhan I. Samikovich, Negreanu Lucian, Thein Myint, Amit Garg, Hardik Pathak, Nadezhda Pavlova


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.


Heartburn, Gastroesophageal reflux disease, Gastritis, Omeprazole, Patient-reported outcome measures

Full Text:



Kato H, Ishii T, Akimoto T, Urita Y, Sugimoto M. Prevalence of linked angina and gastroesophageal reflux disease in general practice. World J Gastroenterol. 2009;15(14):1764-8.

Clarrett DM, Hachem C. Gastroesophageal Reflux Disease (GERD). Mo Med. 2018;115(3):214-8.

Nobakht H. Association between Pattern of Gastritis and Gastroesophageal Reflux Disease in Patients with Helicobacter Pylori Infection. Middle East J Dig Dis. 2016;8(3):206-11.

Gisbert JP, Cooper A, Karagiannis D, Hatlebakk J, Agréus L, Jablonowski H, et al. Impact of gastroesophageal reflux disease on work absenteeism, presenteeism and productivity in daily life: a European observational study. Health Qual Life Outcomes. 2009;7:90.

Chen T, Lu M, Wang X, Yang Y, Zhang J, Jin L, et al. Prevalence and risk factors of gastroesophageal reflux symptoms in a Chinese retiree cohort. BMC Gastroenterol. 2012;12(1):161.

Frazzoni M, de Bortoli N, Frazzoni L, Tolone S, Savarino V, Savarino E. Impedance-pH Monitoring for Diagnosis of Reflux Disease: New Perspectives. Dig Dis Sci. 2017;62(8):1881-9.

Yamasaki T, Hemond C, Eisa M, Ganocy S, Fass R. The Changing Epidemiology of Gastroesophageal Reflux Disease: Are Patients Getting Younger? J Neurogastroenterol Motil. 2018;24(4):559-69.

Sipponen P, Maaroos H-I. Chronic gastritis. Scand J Gastroenterol. 2015;50(6):657-67.

Maradey-Romero C, Fass R. New and Future Drug Development for Gastroesophageal Reflux Disease. J Neurogastroenterol Motil. 2014;20(1):6-16.

Peura DA, Berardi RR, Gonzalez J, Brunetti L. The Value of Branded Proton Pump Inhibitors. P T. 2011;36(7):434-45.

Gallelli L. Safety and efficacy of generic drugs with respect to brand formulation. J Pharmacol Pharmacother. 2013;4(1):110-4.

Insights CM. Global Omeprazole Market to Surpass US$ 4.1 Billion by 2026 - Coherent Market Insights [Internet]. GlobeNewswire News Room. 2018. Available at: Accessed on 16 April 2021.

Wahlqvist P. Validity of a Work Productivity and Activity Impairment Questionnaire for Patients with Symptoms of Gastro-Esophageal Reflux Disease (WPAI-GERD)—Results from a Cross-Sectional Study. Value in Health. 2002;5(2):106-13.

Zhang W, Bansback N, Boonen A, Young A, Singh A, Anis AH. Validity of the work productivity and activity impairment questionnaire - general health version in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):177.

Coyne KS, Wiklund I, Schmier J. Development and validation of a disease-specific treatment satisfaction questionnaire for gastro-oesophageal reflux disease. Aliment Pharmacol Therap. 2003;18(9):907-15.

Fraser A, Delaney BC. The Short-Form Leeds Dyspepsia Questionnaire validation study. Aliment Pharmacol Therap. 2007;25(4):477-86.

Mitchell RJ, Bates P. Measuring Health-Related Productivity Loss. Popul Health Manag. 2011;14(2):93-8.

Richter JE, Peura D. Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. Arch Intern Med. 2000;160(12):1810-6.

Yacyshyn BR, Thomson ABR. The Clinical Importance of Proton Pump Inhibitor Pharmacokinetics. Digestion. 2002;66(2):67-78.

Junghard O, Wiklund IK. Effect of baseline symptom severity on patient-reported outcomes in gastroesophageal reflux disease. Eur J Gastroenterol Hepatol. 2007;19(7):555-60.

Bitwayiki R, Orikiiriza JT, Kateera F, Bihizimana P, Karenzi B, Kyamanywa P, et al. Dyspepsia prevalence and impact on quality of life among Rwandan healthcare workers: A cross-sectional survey. S Afr Med J. 2015;105(12):1064.

Coyne KS, Wiklund I, Schmier J. Development and validation of a disease-specific treatment satisfaction questionnaire for gastro-oesophageal reflux disease. Aliment Pharmacol Therap. 2003;18(9):907-15.

Van Zanten SV. Patient satisfaction with medication for gastroesophageal reflux disease: A systematic review. Can J Gastroenterol. 2012;26(4):196-204.