Delayed-release oral suspension of omeprazole for the treatment of erosive esophagitis and gastroesophageal reflux disease in pediatric patients: a review

Figures & data

Table 1 Clinical trials testing delayed-release omeprazole in children

Author	Study design	Trial data (country, center)	No of treated children	Age	Formulation	Dosage	Duration of therapy	Measured parameters
Cucchiara^Citation27	RCT	Italy, single-center	12	6 mo–13.4 y	capsule content or capsule	40 mg/1.73 m^2/die	8 wk	symptoms, esophageal and gastric pH monitoring, endoscopic and histological degree of esophagitis
Moore^Citation41	RCT, double-blind, placebo controlled, crossover	Australia, multi-center	15	3–12 mo	microspheres in apple juice	5–10 kg: 10 mg/die; >10 kg: 10 mg/bid	2 wk	symptoms, esophageal pH monitoring
Hassal^Citation42	CT, open-label	Multinational, multi-center	57	1–16 y	capsule or granules in weakly acid vehicle for children unable to swallow intact capsule	0.7–3.5 mg/kg/die	12 wk	symptoms, endoscopic degree of esophagitis
Alliët^Citation18	CT, open-label	Belgium, single-center	12	2–3.8 mo	capsule content in milk or water	0.5 mg/kg/die = 20 mg/1.73 m^2/die	6 wk	symptoms, gastric pH monitoring, endoscopic and histological degree of esophagitis
Bishop^Citation17	CT, open-label	UK, single-center	10	1.25–20 mo	multiple unit pellet system dissolved in alkaline vehicle	0.7–2.8 mg/kg/die	2 wk	symptoms, esophageal and gastric pH monitoring
Cucchiara^Citation43	CT, open-label	Italy, single-center	22	19 mo–12 y	content of the capsule in acid vehicle as grapefruit or orange juice	1 mg/kg/die = 40 mg/1.73 m^2/die	8 wk	symptoms, endoscopic degree of esophagitis
Kato^Citation22	CT, open-label	Japan, single-center	5	3–18 y	enteric coated preparation	0.3–1.6 mg/kg/die	2–8 wk	symptoms, gastric pH monitoring, endoscopic degree of esophagitis
De Giacomo^Citation44	CT, open-label	Italy, single-center	10	2–9 y	capsule content	<30 kg: 20 mg/die; >30 kg: 40 mg/bid	12 wk	symptoms, esophageal pH monitoring, endoscopic and histological degree of esophagitis
Karjoo^Citation45	CT, open-label	USA, single-center	38	6–18 y	capsule content	20–60 mg/die	8 wk	symptoms
Gunasekaran^Citation25	CT, open-label	Canada, single-center	15	0.8–17 y	capsule or granules in weakly acid vehicle for children unable to swallow intact capsule	0.7–3.3 mg/kg/die = 10–60 mg/die	24 wk	symptoms, esophageal pH monitoring, endoscopic degree of esophagitis
Boccia^Citation46	CT, open-label	Italy, single-center	48	2.7–14.2 y	capsule or granules in weakly acid vehicle for children unable to swallow intact capsule	1.4 mg/kg/die	12 wk	symptoms, endoscopic degree of esophagitis
Strauss^Citation26	CT, open-label	USA, single-center	18	2–17 y	capsule content	0.26–1.35 mg/kg/die	8–12 wk	symptoms, endoscopic and histological degree of esophagitis

Abbreviations: CT, controlled trial; die, once daily; RCT, randomized controlled trial.

Figure 1 Symptom resolution rates in the 10 studies reporting percentage of asymptomatic children after treatment.

Table 2 Studies evaluating esophageal and/or gastric pH-monitoring

Author	No of treated children	Esophageal pH-monitoring % of time of esophageal pH < 4	Gastric pH-monitoring % of time of gastric pH < 4
Cucchiara^Citation27	12	before treatment 9 after treatment 3.1 Δ −5.9	before treatment 90.3 after treatment 60.3 Δ −30
Moore^Citation41	15	before treatment 9.9 after treatment 1 Δ −8.9
Alliët^Citation18	12		before treatment 90.3 after treatment 21.3 Δ −69
Bishop^Citation17	10	before treatment 18.5 after treatment 1.6 Δ −16.9	before treatment 71.9 after treatment 13.2 Δ −58.7
Kato^Citation22	5		after treatment 72.2
De Giacomo^Citation44	10	before treatment 17 after treatment 5.4 Δ −11.6
Gunasekaran^Citation25	15	before treatment range 11–88 after treatment ≤6

Table 3 Studies evaluating rates of endoscopic and/or histological healing of esophagitis

Author	Duration of therapy	Endoscopic healing	Histological healing
Cucchiara^Citation27	8 wk	9/11 (82%)	9/12 (75%)
Hassal^Citation42	12 wk	54/57 (95%)
Alliët^Citation18	6 wk	12/12 (100%)	8/12 (67%)
Cucchiara^Citation43	8 wk	13/17 (76%)
Kato^Citation22	2–8 wk	4/5 (80%)
De Giacomo^Citation44	12 wk	9/10 (90%)	0/10
Gunasekaran^Citation25	24 wk	6/6 (100%)
Boccia^Citation46	12 wk	46/48 (96%)
Strauss^Citation26	8–12 wk	1/1 (100%)	6/14 (43%)

Notes: In 115 of 121 children treated for 12 weeks or longer endoscopic healing rate was 95% (95% CI 89–98). In 38 of 45 children treated for 8 weeks or shorter endoscopic healing rate was 84% (95% CI 71–93).

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