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

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.