ArticleCureus2021
Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study.
Article in Cureus, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed, 0 citations in OpenAlex.
- Efficacy of Acotiamide in Pediatric Patients with Functional Dyspepsia.Pediatric gastroenterology, hepatology & nutrition · 2025Article
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Authors and funding
10 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAcotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS.
methodsIn this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks. The primary efficacy endpoint was responder rates for the overall treatment effect (OTE) at end of week 4. Secondary efficacy endpoints included OTE at each week, elimination rate of postprandial fullness, upper abdominal bloating and early satiation, improvement of individual symptom scores, and quality of life (QoL). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs).
resultsThe responder rate for OTE at the end of the four week period, in acotiamide ER 300 mg OD versus acotiamide 100 mg TID group was 92.66% and 94.39% (97.5% CI -8.3,4.8), respectively, in per-protocol (PP) population and 92.66% and 92.73% (97.5% CI -7.0,6.8), respectively, in intent to treat (ITT) population. All other secondary efficacy endpoints, including QoL, were significantly improved with acotiamide ER 300 mg. Both the formulations of acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD. Adverse events were reported by 7.9% of patients in acotiamide ER 300 mg and 9.2% in acotiamide 100 mg patients; the most common adverse event reported was a headache.
conclusionsThe efficacy and safety of acotiamide ER 300 mg once daily were observed to be comparable to acotiamide immediate release 100 mg thrice daily. A significant improvement in QoL over a four-week treatment period in FD-PDS patients was observed.
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