Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study.
BACKGROUND
Although gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.


METHODS
This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.


RESULTS
Of the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (P < .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.


CONCLUSIONS
GERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.


BACKGROUND
D9614C00098; ClinicalTrials.gov Identifier NCT00241501.
Gunasekaran
Thirumazhisai
T
Lutheran General Children's Hospital, Park Ridge, IL 60068, USA. ts.gunasekaran-md@advocatehealth.com
Tolia
Vasundhara
V
Colletti
Richard B
RB
Gold
Benjamin D
BD
Traxler
Barry
B
Illueca
Marta
M
Crawley
Joseph A
JA
D000284:Administration, Oral; D000293:Adolescent; D002170:Canada; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D064098:Esomeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007558:Italy; D008297:Male; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
D004791:Enzyme Inhibitors; D064098:Esomeprazole