Safety and symptom improvement with esomeprazole in adolescents with gastroesophageal reflux disease.
OBJECTIVE
The primary objective was to assess the safety of esomeprazole 20 or 40 mg once daily in adolescents with clinically diagnosed gastroesophageal reflux disease (GERD). A secondary aim was to assess changes in GERD symptoms after esomeprazole therapy.


METHODS
In this multicenter, randomized, double-blind study, adolescents ages 12 to 17 years inclusive received esomeprazole 20 or 40 mg once daily for 8 weeks. Adverse events and changes in clinical parameters (eg, physical examination, laboratory measurements) were evaluated to assess safety. Patients or their parents or guardians scored symptom severity daily, and investigators scored overall GERD symptom severity every 2 weeks using a 4-point scale.


RESULTS
In the 148 adolescents with safety data, treatment-related and non-treatment-related adverse events were reported by 75% and 78% of patients in the esomeprazole 20- and 40-mg groups, respectively. Twenty-two patients (14.9%) experienced adverse events that were considered related to treatment; the most common were headache (8%, 12/148), abdominal pain (3%, 4/148), nausea (2%, 3/148), and diarrhea (2%, 3/148). No serious adverse events or clinically important findings in other safety assessments were observed. At baseline, 68% (100/147) had heartburn, 63% (93/147) had epigastric pain, 57% (84/147) had acid regurgitation, and 15% (22/147) had vomiting symptoms. Symptom scores decreased significantly in both the esomeprazole 20-mg and 40-mg groups by the final study week (P < 0.0001). Investigators rated 63.1% (94/149) of the patients as having moderate or severe symptoms at baseline; at the final visit, this percentage decreased significantly to 9.3% (13/140; P < .0001).


CONCLUSIONS
In adolescent patients with GERD, esomeprazole 20 or 40 mg daily for 8 weeks was well tolerated, and GERD-related symptoms were significantly reduced from baseline values in both groups.
Gold
Benjamin D
BD
Division of Pediatric Gastroenterology and Nutrition, Emory University School of Medicine, 2015 Uppergate Dr, Atlanta, GA 30322, USA. bgold@emory.edu
Gunasekaran
Thirumazhisai
T
Tolia
Vasundhara
V
Wetzler
Graciela
G
Conter
Howard
H
Traxler
Barry
B
Illueca
Marta
M
D015746:Abdominal Pain / Q000139:chemically induced; D000293:Adolescent; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced; D006356:Heartburn / Q000150:complications; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014839:Vomiting / Q000150:complications
D000897:Anti-Ulcer Agents; D064098:Esomeprazole