Efficacy and Safety of Acotiamide Versus Mosapride in Patients With Functional Dyspepsia Associated With Meal-Induced Postprandial Distress Syndrome: A Phase III Randomized Clinical Trial

Abstract

Background: Acotiamide is a novel prokinetic drug that acts by enhancing the release of acetylcholine and is used in the treatment of functional dyspepsia-postprandial distress syndrome (FD-PDS). Mosapride is indicated to FD-PDS as per the Rome III treatment guidelines. Mosapride 5 mg three times daily (TID) is approved by the Drugs Controller General of India (DCGI) for the treatment of FD-PDS. The objective of this study was to determine the efficacy and safety of Acotiamide in comparison with Mosapride on FD-PDS.Methods: The 220 patients of either gender (aged 18-64 years) with active PDS included in the study were centrally randomized 1:1 to receive either 100 mg Acotiamide (test product) or 5 mg Mosapride (reference product) TID for four weeks. Responder rates for the overall treatment effect (OTE) at the end of four weeks were the primary efficacy endpoint. Secondary efficacy endpoints included the elimination rate of postprandial fullness, upper abdominal bloating, and early satiation. The study also evaluated the OTE at each week, individual symptom scores, and quality of life (QoL) assessed by the Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs).Results: At the end of four weeks, the responders in the Acotiamide versus Mosapride group for OTE was 98% versus 93.27% in the per-protocol (PP) population. Among the intent to treat (ITT) population, the comparison of Acotiamide versus Mosapride stood at 95.15% versus 89.81%. Secondary efficacy endpoints were significantly improved with 100 mg TID Acotiamide, which was evident from the improvement in postprandial fullness (14.56%), upper abdominal bloating (15.53%), early satiation (10.68%), and QoL (13.7 ± 4.67).Conclusions: Our study results demonstrated that Acotiamide is effective, safe, and well-tolerated and had significantly improved the QoL over a four-week treatment period in FD-PDS patients. The efficacy and safety profiles of Acotiamide were similar to Mosapride.

Prokinetics for the treatment of functional dyspepsia: an updated systematic review and network meta-analysis

“…1 ). Four additional studies were included [ 3 , 4 , 11 , 12 ]. Noticeably, this review included 24 studies from the original systematic review [ 2 ].…”

“…There were nine studies from China with 1,665 participants [ 3 , 14 – 21 ], five studies from Belgium with 269 participants [ 22 – 26 ], one study from Germany with 548 participants [ 27 ], two studies from India with 280 participants [ 28 ] [ 12 ], six studies from Japan with 1778 participants [ 11 , 13 , 29 – 31 ], one study from Korea with 28 participants [ 32 ], one study from Denmark, Germany, France, Sweden, and the UK, with 566 participants [ 33 ], one study from Spain with 20 participants [ 4 ], and two studies from the US with 636 participants [ 34 , 35 ].…”

“…Three studies did not report the sex of 508 participants [ 18 , 21 , 23 ]. Most of the participants (n = 5,510) were diagnosed with FD, while the remaining 280 participants had postprandial distress syndrome, which was also classified as FD [ 12 , 19 ].…”

“…Six studies compared itopride with domperidone [ 14 , 16 – 18 , 20 , 21 ] and two studies compared itopride with placebo [ 27 , 34 ]. Seven studies compared mosapride with domperidone [ 15 ], itopride [ 28 ], acotiamide [ 12 ] and placebo [ 19 , 24 , 32 , 33 ]. The treatment duration ranged from 2 to 8 weeks.…”

Bioequivalence Study of Azilsartan in Healthy Chinese Subjects

“…Clinical trials have shown that ARB drugs can reduce the proportion of hypertensive patients who develop type 2 diabetes, and can signi cantly improve the prognosis of patients with high-risk hypertension, heart failure and diabetic nephropathy [6][7][8]. As a novel ARB drug, Azilsartan is mainly used for the treatment of adult hypertension [9]. As it binds to the angiotensin type II1 receptor (AT 1 ), which antagonizes angiotensin II and exhibits antihypertensive effects by mainly inhibiting the aldosterone secretion, strong vasoconstriction and other hypertensive effects, and by reducing the peripheral vascular resistance.…”