What is the recommended dose of acotiamide (prokinetic agent) for functional dyspepsia?

Acotiamide Dosing for Functional Dyspepsia

The recommended dose of acotiamide for functional dyspepsia is 100 mg three times daily, taken before meals. 1, 2

Standard Dosing Regimen

• Acotiamide 100 mg three times daily (TID) is the established therapeutic dose that has demonstrated consistent efficacy in multiple randomized controlled trials for treating postprandial distress syndrome (PDS) symptoms of functional dyspepsia. 2, 3

• The medication should be administered before meals to optimize its prokinetic effects on gastric emptying and accommodation. 3

• This dosing regimen has been validated across clinical studies in Europe, Japan, and the USA, showing superior efficacy compared to other doses tested. 2, 4

Alternative Extended-Release Formulation

• An extended-release formulation of acotiamide 300 mg once daily has been developed and shown comparable efficacy and safety to the standard 100 mg TID regimen in a phase 3 trial. 1

• The once-daily ER formulation demonstrated a 92.66% responder rate for overall treatment effect at 4 weeks, non-inferior to the TID formulation (94.39% responder rate). 1

• This option may improve adherence for patients who prefer once-daily dosing, though availability varies by region. 1

Clinical Context and Positioning

• Acotiamide is positioned as a first-line prokinetic agent for functional dyspepsia, particularly for patients with postprandial distress syndrome characterized by postprandial fullness, early satiation, and upper abdominal bloating. 5, 4

• The British Society of Gastroenterology guidelines note that prokinetics like acotiamide are well-tolerated options, though the quality of evidence is rated as low with a weak recommendation. 5

• Acotiamide specifically benefits PDS symptoms (postprandial fullness, early satiation, bloating) but does not show efficacy for epigastric pain syndrome symptoms. 2, 4

Safety Profile

• Long-term safety data up to 1 year shows no treatment-related severe or serious adverse events, with the majority of patients (81.6%) maintaining treatment for >50 weeks. 6

• Adverse events occur in 7.9-9.2% of patients, with headache being the most common, and rates are not significantly different from placebo. 1, 2

• No clinically significant laboratory abnormalities or deaths have been reported in long-term studies. 6

Mechanism Supporting This Dose

• The 100 mg TID dose enhances acetylcholine release in the enteric nervous system through dual mechanisms: muscarinic receptor antagonism and acetylcholinesterase inhibition. 3

• This dosing achieves therapeutic effects on gastric accommodation and gastric emptying in functional dyspepsia patients, though interestingly it does not affect gastric emptying in healthy volunteers. [3, @11@]

Treatment Duration Expectations

• Symptomatic improvement typically begins within 1-2 weeks, with clinically important changes in postprandial fullness and early satiation observed at weeks 1 and 2. 6

• Treatment can be safely continued for up to 1 year with sustained benefit on quality of life and work productivity. 6