A prospective multicentric postmarketing observational study to characterize the patient population with reduced gastrointestinal motility among indian diabetic patients receiving itopride: The progress study

Abstract

Aims: This study was intended to assess the clinical profile of Indian diabetic patients with reduced gastrointestinal (GI) motility and to understand the role of itopride in addressing reduced GI motility (gastroparesis) symptoms and maintaining glycemic control. Material and Methods: Patients with established reduced GI motility (scintigraphy), with varying degree of GI symptoms, receiving itopride 150 mg as per physicians' discretion were enrolled. Clinical profile, changes in symptom severity, glycemic indices, tolerability, and quality of life (QoL) after 8-week therapy (Patient assessment of upper GI disorders-QoL [PAGI-QoL]) were assessed. Results: Mean ± standard deviation age of enrolled population ( n = 41) was 51.8 ± 12.39 years. Average duration of gastroparesis since underlying etiology was 67.7 ± 59.76 months. Common symptoms reported at baseline were bloating (68.3%), postprandial fullness (61.0%), nausea (51.2%), early satiety (41.5%), heartburn (39.0%), and vomiting (9.8%). Itopride therapy resulted in significant improvement in all symptoms ( P < 0.001), which correlated with improved QoL (PAGI-QoL score reduction: 13.8 ± 11.48; P < 0.0001). Moreover, significant improvement in glycemic indicators was also evident (mean change from baseline hemoglobinA1c –0.5 ± 1.18; fasting plasma glucose –15.3 ± 43.61; postprandial plasma glucose –24.6 ± 57.20). Conclusions: Itopride showed effectiveness in addressing symptoms of reduced GI motility in diabetics, with improved QoL. Significant improvement in glycemic indices was also evident posttreatment with itopride. This study sheds light on the role of prokinetics, not only for symptom relief but also for improving glycemic control in diabetic patients with reduced GI motility, thus providing a holistic approach for the management of these patients.

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

“…Following treatment with itopride, there was a remarkable and statistically significant improvement in all of these symptoms ( p <0.001). 21 Saxena et al found that itopride and levosulpiride were equally effective in ameliorating different symptoms of functional dyspepsia at the end of 4 weeks of treatment. There was a significant reduction in the mean Global Symptom Score and mean duration score and the mean score of severity in follow-up visits at weeks 2 and 4 from the day of presentation.…”

Prokinetics

“…Так, в проспективном многоцентровом рандомизированном исследовании R.R. Rai et al (2019) показана эффективность итоприда в устранении симптомов снижения моторики ЖКТ с улучшением качества жизни у пациентов с СД, при этом отмечено значительное улучшение гликемических показателей, что демонстрирует роль прокинетиков не только для облегчения симптомов, но и для улучшения гликемического контроля у пациентов с СД со сниженной моторикой ЖКТ, что обеспечивает целостный подход к ведению этих пациентов [7].…”

Role and safety of prokinetic drugs in the treatment of upper gastrointestinal motility disorders: an Indian perspective

“…27 Significant improvement in glycemic indices and improved quality of life has also been associated with itopride use. 28…”

“…Prokinetics like itopride remain the mainstay for treatment of DGP based on results from the PROGRESS study in India wherein an improvement in GI symptoms, glycemic control, and quality of life was observed with itopride use. 28 Diagnosis of GP is based on gastric scintigraphy, which involves gastric emptying of solids and remains the gold standard for diagnosis of DGP. Lack of testing facilities as well as the infrastructure in India make diagnosis challenging.…”