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Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease.
Dig Dis Sci. 2017 11; 62(11):3059-3068.DD

Abstract

BACKGROUND

Proton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents.

AIMS

To assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD.

METHODS

A phase 2, open-label, multicenter study was conducted in adolescents aged 12-17 years. After a 21-day screening period, adolescents with endoscopically confirmed NERD received a daily dose of 30-mg dexlansoprazole for 4 weeks. The primary endpoint was treatment-emergent adverse events (TEAEs) experienced by ≥5% of patients. The secondary endpoint was the percentage of days with neither daytime nor nighttime heartburn. Heartburn symptoms and severity were recorded daily in patient electronic diaries and independently assessed by the investigator, along with patient-reported quality of life, at the beginning and end of the study.

RESULTS

Diarrhea and headache were the only TEAEs reported by ≥5% of patients. Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn. Symptoms such as epigastric pain, acid regurgitation, and heartburn improved in severity for 73-80% of patients. Pediatric Gastroesophageal Symptom and Quality of Life Questionnaire-Adolescents-Short Form symptom and impact subscale scores (scaled 1-5) each decreased by an average of 0.7 units at week 4.

CONCLUSIONS

Use of 30-mg dexlansoprazole in adolescent NERD was generally well tolerated and had beneficial effects on improving heartburn symptoms and quality of life.

TRIAL REGISTRATION

This study has the ClinicalTrials.gov identifier NCT01642602.

Authors+Show Affiliations

Children's Center for Digestive Healthcare, LLC, 993D Johnson Ferry Rd. NE, Suite 440, Atlanta, GA, 30342, USA. bgold@gicareforkids.com.Takeda Development Center Americas, Inc, One Takeda Parkway, Deerfield, IL, 60015, USA.Department of Gastroenterology, Hepatology, Feeding Disorders and Paediatrics, The Children's Memorial Health Institute, Al. Dzieci Polskich 20, 04-730, Warsaw, Poland.Takeda Development Center Americas, Inc, One Takeda Parkway, Deerfield, IL, 60015, USA.Takeda Development Center Americas, Inc, One Takeda Parkway, Deerfield, IL, 60015, USA.Department of Pediatrics, College of Medicine, University of South Alabama, 1601 Center Street, Suite 1271, Mobile, AL, 36604, USA.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28916953

Citation

Gold, Benjamin D., et al. "Dexlansoprazole for Heartburn Relief in Adolescents With Symptomatic, Nonerosive Gastro-esophageal Reflux Disease." Digestive Diseases and Sciences, vol. 62, no. 11, 2017, pp. 3059-3068.
Gold BD, Pilmer B, Kierkuś J, et al. Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease. Dig Dis Sci. 2017;62(11):3059-3068.
Gold, B. D., Pilmer, B., Kierkuś, J., Hunt, B., Perez, M. C., & Gremse, D. (2017). Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease. Digestive Diseases and Sciences, 62(11), 3059-3068. https://doi.org/10.1007/s10620-017-4743-3
Gold BD, et al. Dexlansoprazole for Heartburn Relief in Adolescents With Symptomatic, Nonerosive Gastro-esophageal Reflux Disease. Dig Dis Sci. 2017;62(11):3059-3068. PubMed PMID: 28916953.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease. AU - Gold,Benjamin D, AU - Pilmer,Betsy, AU - Kierkuś,Jaroslaw, AU - Hunt,Barbara, AU - Perez,Maria Claudia, AU - Gremse,David, Y1 - 2017/09/15/ PY - 2017/04/13/received PY - 2017/08/30/accepted PY - 2017/9/17/pubmed PY - 2017/11/7/medline PY - 2017/9/17/entrez KW - Adolescent KW - GERD KW - Heartburn KW - NERD KW - Nonerosive KW - PPI SP - 3059 EP - 3068 JF - Digestive diseases and sciences JO - Dig. Dis. Sci. VL - 62 IS - 11 N2 - BACKGROUND: Proton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents. AIMS: To assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD. METHODS: A phase 2, open-label, multicenter study was conducted in adolescents aged 12-17 years. After a 21-day screening period, adolescents with endoscopically confirmed NERD received a daily dose of 30-mg dexlansoprazole for 4 weeks. The primary endpoint was treatment-emergent adverse events (TEAEs) experienced by ≥5% of patients. The secondary endpoint was the percentage of days with neither daytime nor nighttime heartburn. Heartburn symptoms and severity were recorded daily in patient electronic diaries and independently assessed by the investigator, along with patient-reported quality of life, at the beginning and end of the study. RESULTS: Diarrhea and headache were the only TEAEs reported by ≥5% of patients. Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn. Symptoms such as epigastric pain, acid regurgitation, and heartburn improved in severity for 73-80% of patients. Pediatric Gastroesophageal Symptom and Quality of Life Questionnaire-Adolescents-Short Form symptom and impact subscale scores (scaled 1-5) each decreased by an average of 0.7 units at week 4. CONCLUSIONS: Use of 30-mg dexlansoprazole in adolescent NERD was generally well tolerated and had beneficial effects on improving heartburn symptoms and quality of life. TRIAL REGISTRATION: This study has the ClinicalTrials.gov identifier NCT01642602. SN - 1573-2568 UR - https://www.unboundmedicine.com/medline/citation/28916953/Dexlansoprazole_for_Heartburn_Relief_in_Adolescents_with_Symptomatic_Nonerosive_Gastro_esophageal_Reflux_Disease_ L2 - https://doi.org/10.1007/s10620-017-4743-3 DB - PRIME DP - Unbound Medicine ER -