A real-world retrospective study of omeprazole-domperidone combination in managing acid peptic disease with PRoton-pump Inhibitors in patients with type 2 DiabEtes mellitus (PRIDE-2).

Autor:	Saboo B; Department of Diabetology, Prayas Diabetes Centre, Indore, Madhya Pradesh, India., Mulwani N; Department of Diabetology, Dr. Nimmi's Diabetes Care, Chandkheda, Ahmedabad, Gujarat, India., Petare AU; Medical Affairs, Dr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India., Veligandla KC; Medical Affairs, Dr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India., Pinto CS; Medical Affairs, Dr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India., Mane A; Medical Affairs, Dr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India., Rathod R; Medical Affairs, Dr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India., Kotak B; Medical Affairs, Dr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India.
Jazyk:	angličtina
Zdroj:	Drugs in context [Drugs Context] 2023 Feb 13; Vol. 12. Date of Electronic Publication: 2023 Feb 13 (Print Publication: 2023).
DOI:	10.7573/dic.2022-10-3
Abstrakt:	Background: Proton-pump inhibitors, along with a prokinetic agent, are widely used to provide symptomatic relief amongst patients with acid peptic disease (APD). This article evaluates the effectiveness and safety of the omeprazole-domperidone combination amongst patients with type 2 diabetes mellitus for the management of APD. Methods: PRIDE-2 (PRoton-pump Inhibitor in patients with type 2 DiabEtes mellitus) is a retrospective study reviewing electronic medical records of patients with type 2 diabetes mellitus and APD who were receiving the omeprazole-domperidone combination and visiting multiple Indian healthcare settings between March 2018 and April 2021. The effectiveness outcome of the therapy was evaluated in terms of resolution of APD symptoms at visit 5 (120 days after baseline visit) compared with visit 1 (baseline visit). Safety was determined in terms of reported adverse events (AEs) during the treatment period (120 days). Results: A total of 174 patients were included in the study. The mean age of the patients was 51.5±9.6 years, with the majority (59.8%) being men. A significant proportion of patients reported relief from APD symptoms, including abdominal pain (91.6%), epigastric burning (68.7%), nausea (89.5%), flatulence (100.0%), loss of appetite (93.6%), and altered bowel movements (94.7%) ( p <0.001 for each) at visit 5 compared with visit 1. No serious AEs were reported. Conclusion: Omeprazole-domperidone combination was beneficial in providing symptomatic relief to patients with diabetes and APD. The combination therapy was well tolerated, with few reports of minor AEs. Competing Interests: Disclosure and potential conflicts of interest: AUP, KCV and CSP are the Medical Advisor, Team Lead and Clinical Research Specialist, respectively, at Medical Affairs Department, Dr. Reddy’s Laboratories Ltd, Hyderabad. AM, RR and BK are Medical Cluster Head, Head Ideation & Clinical Research and Head Medical Affairs, respectively, at the Medi-cal Affairs Department, Dr. Reddy’s Laboratories Ltd, Hyderabad. BS and NM have no conflicts of interest to disclose. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2023/01/dic.2022-10-3-COI.pdf (Copyright © 2023 Saboo B, Mulwani N, Petare AU, Veligandla KC, Pinto CS, Mane A, Rathod R, Kotak B.)
Databáze:	MEDLINE
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