Efficacy and safety of itopride SR for upper gastrointestinal symptoms in patients with diabetic gastroparesis: real-world evidence from Pakistan.

Background: Gastroparesis is a serious condition that can be caused by diabetes, surgery or infection, or can be idiopathic. When there is no mechanical obstruction, gastroparesis is characterized by delayed stomach emptying. Itopride, a prokinetic drug, inhibits acetylcholinesterase activity in addition to antagonizing dopamine D2 receptors.
Methods: This prospective, multicentre study is based on real-world data from 988 patients with a diagnosis of diabetic gastroparesis for index (PAGI-SYM2) evaluation at baseline and week 4 of treatment for upper gastrointestinal disorder symptoms.
Results: Upper gastrointestinal symptom severity scores improved significantly after 4 weeks of treatment ( p <0.001), with significant improvement across all categories of gastroparesis (very mild (37-58.6%), mild degree (24.6-31.6%), moderate (29.3-7.3%) and severe (8.8-2.6%).
Conclusion: Itopride SR (Nogerd SR) in a 150 mg once-daily dose showed promising results in reducing the severity of upper gastrointestinal disorder symptoms associated with diabetic gastroparesis. Both statistical and clinical effectiveness were observed. Moreover, the treatment demonstrated a favourable tolerability profile, with a low incidence of adverse effects.
Competing Interests: Disclosure and potential conflicts of interest: NM is a full-time employee of Helix Pharma Pvt. Ltd. All authors has received support for attending meetings and/or travel from Helix Pharma. The remuneration was given to the investigators for examining and entering the data during the study duration. The authors report no other conflicts. The honesty of the study was not traded for any monetary benefit. 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/2023/09/dic.2023-6-4-COI.pdf
(Copyright © 2023 Ramzan A, Memon GF, Shaikh AA, Khoso MM, Meher T, Ghafoor A, Shehzad NA, Ahmed S, Nawaz Z, Rehan M, Saeed T, Taj W, Abbass S, Khan R, Ehsan H, Alam A, Manzoor B, Khan MN, Yahya KM, Mukhtiar F, Javed MA, Sheikh MU, Janjua D, Jabeen S, Zafar J, Khokhar RH, Nazar M, Maheshwary N, Khan MA.)