dexlansoprazole and Diarrhea

In gastroesophageal reflux disease (GERD), the frequency of heartburn symptoms and erosive esophagitis (EE) increases with age in children and adolescents. Proton pump inhibitor, dexlansoprazole, is approved for healing EE of all grades, maintenance of healed EE, relief of heartburn, and treatment of symptomatic non-erosive GERD in patients ≥ 12 years.. To assess safety and efficacy of dexlansoprazole dual delayed-release capsule in healing of EE and maintenance of healed EE in adolescents.. A multicenter, phase 2, 36-week study was conducted in 62 adolescents (12-17 years) with endoscopically confirmed EE. Patients received dexlansoprazole 60 mg once daily (QD) during open-label healing phase. Those with confirmed healing at week 8 were randomized to dexlansoprazole 30 mg QD or placebo during 16-week, double-blind maintenance phase, with subsequent treatment-free follow-up of ≥ 12 weeks. Primary endpoints were treatment-emergent adverse events (TEAEs) in ≥ 5% of patients during treatment. Secondary endpoints included percentages of patients with healing of EE and with maintenance of healed EE.. 88% of patients achieved EE healing, and 61.3% reported a TEAE [headache (12.9%), oropharyngeal pain (8.1%), diarrhea (6.5%), and nasopharyngitis (6.5%)]. During maintenance phase, healing was maintained in 82% and 58% of dexlansoprazole and placebo groups, respectively. 72.0% of dexlansoprazole-treated patients reported TEAEs, which included headache (24.0%), abdominal pain (12.0%), nasopharyngitis (12.0%), pharyngitis (12.0%), sinusitis (12.0%), bronchitis (8.0%), upper respiratory tract infection (8.0%), and insomnia (8.0%); 61.5% experienced a TEAE with placebo.. Dexlansoprazole is safe and efficacious for healing EE and maintenance of healed EE in adolescents.

Topics: Abdominal Pain; Adolescent; Child; Delayed-Action Preparations; Dexlansoprazole; Diarrhea; Double-Blind Method; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Headache; Humans; Maintenance Chemotherapy; Male; Nasopharyngitis; Oropharynx; Pain; Pharyngitis; Proton Pump Inhibitors; Sleep Initiation and Maintenance Disorders; Treatment Outcome

Recently, the eradication rate of. A total of 50 treatment-naïve patients with active. Seven out of the 50 patients (29 men and 21 women; mean age, 57 years) dropped out during the study. The total eradication rate was 52% (26/50), and that for those with a compliance rate of over 90% was 68.4% (26/38).. High and frequent doses of proton pump inhibitor-amoxicillin dual therapy were not effective in eradicating

Topics: Amoxicillin; Anti-Bacterial Agents; Breath Tests; Dexlansoprazole; Diarrhea; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Prospective Studies; Proton Pump Inhibitors