An Open-Label Observational Study Assessing the Efficacy and Safety of Levopraid Injection 25mg (levosulpiride)  in Three Tertiary Care Hospitals in Pakistan

Dyspepsia is referred to as discomfort arising from proximal GIT, leads to other conditions such as Gastroesophageal Reflux Disease (GERD), Nausea and Vomiting (NV), and Irritable Bowel Syndrome (IBS), which pose significant challenges in primary care and affects patient quality of life. In spite of many treatment options, gastroprokinetic drugs are still considered as profound treatment options, this study aimed to assess the efficacy and safety of levosulpiride injection, an antidopaminergic gastrointestinal prokinetic. Study conducted between January and March 2023 across three tertiary care hospitals in Pakistan, this open-label observational study evaluated the use of levosulpiride in the treatment of epigastric functional dyspepsia (EGFD), GERD, NV, and IBS in 137 patients aged 13-83. Patients’ symptoms were monitored over several visits after receiving levosulpiride 25mg IM/IV injections, with symptom resolution times ranging from 1 to 5 days. Results demonstrated a significant difference in mean symptom duration across the hospitals, with a decrease in symptom resolution time associated with a dosage increase. The regression analysis yielded a mathematical model for the relationship between dosage and symptom resolution time. Meanwhile, the findings suggest the potential therapeutic benefits of levosulpiride. Further research is needed to investigate the recurrence of symptoms and the long-term safety and efficacy of this treatment option.

Key Words: Functional dyspepsia, Levosulpiride injectable, Gastroesophageal Reflux Disease (GERD), Nausea and Vomiting (NV), Irritable Bowel Syndrome (IBS)