Purpose: Functional dyspepsia (FD) is a chronic disorder characterized by upper abdominal symptoms in the absence of an identifiable organic cause. Although the efficacy of acotiamide has been demonstrated in adults with FD, its effectiveness in pediatric patients remains unclear. This study aimed to evaluate the efficacy of acotiamide in pediatric patients with FD. Methods: We conducted a retrospective analysis of 33 patients with FD, aged <16 years, who received acotiamide at a single children’s hospital between August 2013 and March 2022. Results: Symptomatic improvement was observed in 57.6% (19/33) of patients one month after acotiamide administration. The improvement rates were 63.6%, 20.0%, and 66.7% among patients with epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlap PDS-EPS, respectively. No statistically significant differences in symptomatic improvement rates were noted among the subtypes (p=0.213). Two patients discontinued acotiamide because of abdominal pain, but no serious adverse events were reported. Conclusion Acotiamide demonstrated efficacy in pediatric FD, which is consistent with previously reported outcomes in adults. Acotiamide may be a beneficial treatment option for pediatric FD across all subtypes.

Purpose: Functional dyspepsia (FD) is a chronic disorder characterized by upper abdominal symptoms in the absence of an identifiable organic cause. Although the efficacy of acotiamide has been demonstrated in adults with FD, its effectiveness in pediatric patients remains unclear. This study aimed to evaluate the efficacy of acotiamide in pediatric patients with FD. Methods: We conducted a retrospective analysis of 33 patients with FD, aged <16 years, who received acotiamide at a single children’s hospital between August 2013 and March 2022. Results: Symptomatic improvement was observed in 57.6% (19/33) of patients one month after acotiamide administration. The improvement rates were 63.6%, 20.0%, and 66.7% among patients with epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlap PDS-EPS, respectively. No statistically significant differences in symptomatic improvement rates were noted among the subtypes (p=0.213). Two patients discontinued acotiamide because of abdominal pain, but no serious adverse events were reported. Conclusion Acotiamide demonstrated efficacy in pediatric FD, which is consistent with previously reported outcomes in adults. Acotiamide may be a beneficial treatment option for pediatric FD across all subtypes.

Purpose: Functional dyspepsia (FD) is a chronic disorder characterized by upper abdominal symptoms in the absence of an identifiable organic cause. Although the efficacy of acotiamide has been demonstrated in adults with FD, its effectiveness in pediatric patients remains unclear. This study aimed to evaluate the efficacy of acotiamide in pediatric patients with FD. Methods: We conducted a retrospective analysis of 33 patients with FD, aged <16 years, who received acotiamide at a single children’s hospital between August 2013 and March 2022. Results: Symptomatic improvement was observed in 57.6% (19/33) of patients one month after acotiamide administration. The improvement rates were 63.6%, 20.0%, and 66.7% among patients with epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlap PDS-EPS, respectively. No statistically significant differences in symptomatic improvement rates were noted among the subtypes (p=0.213). Two patients discontinued acotiamide because of abdominal pain, but no serious adverse events were reported. Conclusion Acotiamide demonstrated efficacy in pediatric FD, which is consistent with previously reported outcomes in adults. Acotiamide may be a beneficial treatment option for pediatric FD across all subtypes.

Purpose: Functional dyspepsia (FD) is a chronic disorder characterized by upper abdominal symptoms in the absence of an identifiable organic cause. Although the efficacy of acotiamide has been demonstrated in adults with FD, its effectiveness in pediatric patients remains unclear. This study aimed to evaluate the efficacy of acotiamide in pediatric patients with FD. Methods: We conducted a retrospective analysis of 33 patients with FD, aged <16 years, who received acotiamide at a single children’s hospital between August 2013 and March 2022. Results: Symptomatic improvement was observed in 57.6% (19/33) of patients one month after acotiamide administration. The improvement rates were 63.6%, 20.0%, and 66.7% among patients with epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlap PDS-EPS, respectively. No statistically significant differences in symptomatic improvement rates were noted among the subtypes (p=0.213). Two patients discontinued acotiamide because of abdominal pain, but no serious adverse events were reported. Conclusion Acotiamide demonstrated efficacy in pediatric FD, which is consistent with previously reported outcomes in adults. Acotiamide may be a beneficial treatment option for pediatric FD across all subtypes.

Purpose: Functional dyspepsia (FD) is a chronic disorder characterized by upper abdominal symptoms in the absence of an identifiable organic cause. Although the efficacy of acotiamide has been demonstrated in adults with FD, its effectiveness in pediatric patients remains unclear. This study aimed to evaluate the efficacy of acotiamide in pediatric patients with FD. Methods: We conducted a retrospective analysis of 33 patients with FD, aged <16 years, who received acotiamide at a single children’s hospital between August 2013 and March 2022. Results: Symptomatic improvement was observed in 57.6% (19/33) of patients one month after acotiamide administration. The improvement rates were 63.6%, 20.0%, and 66.7% among patients with epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlap PDS-EPS, respectively. No statistically significant differences in symptomatic improvement rates were noted among the subtypes (p=0.213). Two patients discontinued acotiamide because of abdominal pain, but no serious adverse events were reported. Conclusion Acotiamide demonstrated efficacy in pediatric FD, which is consistent with previously reported outcomes in adults. Acotiamide may be a beneficial treatment option for pediatric FD across all subtypes.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10–20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0–32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10–20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0–32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.