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

Adil Ramzan, Ghulam Fareed Memon, Asif Ali, Muhammad Masood, Tariq Meher, Adnan Ghafoor, Naveed Ahmed Shehzad, Safian Ahmed, Zunaira Nawaz, Muhammad Rehan, Tariq Saeed, Waqar Taj, Sakhawat Abbass, Ramiz Khan, Hamza Ehsan, Abubakkar Alam, Bilal Manzoor, Muhammad Nawaz Khan, Khalid Mahmood Yahya, Farhan Mukhtiar, Muhammad Asif Javed, Muhammad Usman Sheikh, Danish Janjua, Sumerah Jabeen, Junaid Zafar, Riaz Hussain Khokar, Madeeha Nazar, Neeta Maheshwary, Muhammad Athar Khan

Abstract

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.

Article Details

Article Type

Original Research

DOI

10.7573/dic.2023-6-4

Categories

Publication Dates

Accepted: ; Published: .

Citation

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. Efficacy and safety of itopride SR for upper gastrointestinal symptoms in patients with diabetic gastroparesis: real-world evidence from Pakistan. Drugs Context. 2023;12:2023-6-4. https://doi.org/10.7573/dic.2023-6-4

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