OBJECTIVES: To evaluate the efficacy of acid-suppressive maintenance therapy for gastroesophageal reflux disease (GERD) in children, after the healing of reflux esophagitis. METHODS:Forty-eight children (median age 105 months, range 32-170) with erosive reflux esophagitis were initially treated with omeprazole 1.4 mg/kg/day for 3 months. Patients in endoscopic remission were assigned in a randomized, blinded manner by means of a computer-generated list to three groups of 6-month maintenance treatment: group A (omeprazole at half the starting dose, once daily before breakfast), group B (ranitidine 10 mg/kg/day, divided in two doses), and group C (no treatment). Endoscopic, histological, and symptomatic scores were evaluated at: T0, enrollment; T1, assessment for remission at 3 months after enrollment (healing phase); T2, assessment for effective maintenance at 12 months after T0 (3 months after the completion of the maintenance phase). Relapse was defined as the recurrence of macroscopic esophageal lesions. After the completion of the maintenance phase, patients without macroscopic esophagitis relapse were followed up for GERD symptoms for a further period of 30 months. RESULTS:Of 48 initially treated patients, 46 (94%) healed and entered the maintenance study. For all patients, in comparison to T0, the histological, endoscopic, and symptomatic scores were significantly reduced both at T1 and T2 (P<0.0001, for each). No significant difference was found in these three scores, comparing group A, B, and C at T1 and T2. A relapse occurred in one patient only, who presented with macroscopic esophageal lesions at T2. Three months after the completion of the maintenance phase, 12 (26%) patients complained of symptoms sufficiently mild to discontinue GERD therapy, excluding the patient who showed macroscopic esophagitis relapse. Three of 44 (6.8%) patients reported very mild GERD symptoms within a period of 30 months after maintenance discontinuation. CONCLUSIONS: Our pediatric population showed a low rate of erosive esophagitis relapse and GERD symptom recurrence long term after healing with omeprazole, irrespective of the maintenance therapy.
RCT Entities:
OBJECTIVES: To evaluate the efficacy of acid-suppressive maintenance therapy for gastroesophageal reflux disease (GERD) in children, after the healing of reflux esophagitis. METHODS: Forty-eight children (median age 105 months, range 32-170) with erosive reflux esophagitis were initially treated with omeprazole 1.4 mg/kg/day for 3 months. Patients in endoscopic remission were assigned in a randomized, blinded manner by means of a computer-generated list to three groups of 6-month maintenance treatment: group A (omeprazole at half the starting dose, once daily before breakfast), group B (ranitidine 10 mg/kg/day, divided in two doses), and group C (no treatment). Endoscopic, histological, and symptomatic scores were evaluated at: T0, enrollment; T1, assessment for remission at 3 months after enrollment (healing phase); T2, assessment for effective maintenance at 12 months after T0 (3 months after the completion of the maintenance phase). Relapse was defined as the recurrence of macroscopic esophageal lesions. After the completion of the maintenance phase, patients without macroscopic esophagitis relapse were followed up for GERD symptoms for a further period of 30 months. RESULTS: Of 48 initially treated patients, 46 (94%) healed and entered the maintenance study. For all patients, in comparison to T0, the histological, endoscopic, and symptomatic scores were significantly reduced both at T1 and T2 (P<0.0001, for each). No significant difference was found in these three scores, comparing group A, B, and C at T1 and T2. A relapse occurred in one patient only, who presented with macroscopic esophageal lesions at T2. Three months after the completion of the maintenance phase, 12 (26%) patients complained of symptoms sufficiently mild to discontinue GERD therapy, excluding the patient who showed macroscopic esophagitis relapse. Three of 44 (6.8%) patients reported very mild GERD symptoms within a period of 30 months after maintenance discontinuation. CONCLUSIONS: Our pediatric population showed a low rate of erosive esophagitis relapse and GERD symptom recurrence long term after healing with omeprazole, irrespective of the maintenance therapy.
Authors: Jaroslaw Kierkus; Grzegorz Oracz; Bartosz Korczowski; Edyta Szymanska; Anna Wiernicka; Marek Woynarowski Journal: Drug Saf Date: 2014-05 Impact factor: 5.606