Dexlansoprazole for Heartburn Relief
Gastro-esophageal reflux disease
(GERD) is a disorder involving troublesome symptoms associated with persistent reflux
of gastric contents into the esophagus. Symptoms include heartburn, cough,
epigastric pain, vomiting, and regurgitation.
GERD is proposed to have 5 distinct
presentations—nonerosive GERD (NERD), erosive esophagitis (EE), functional
heartburn, hypersensitive esophagus, and Barrett’s esophagus.
Lack of damage to the esophageal
mucosa in the presence of GERD symptoms suggests a NERD diagnosis.
Typically, management of GERD has
included lifestyle changes (for example, diet, weight loss, or sleeping
position), over-the-counter antacids, histamine-2 receptor antagonists (H2RAs),
and more recently, proton pump inhibitors (PPIs).
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Authors present the safety and
efficacy of dexlansoprazole for heartburn relief in adolescents with NERD.
PPIs are well-established therapies
for both adolescent and adult NERD, in particular, heartburn relief, and are
considered more effective than H2RAs.
Dexlansoprazole, an enantiomer of
lansoprazole, was approved for healing of EE at a 60-mg dose and at a 30-mg
dose for treatment of symptomatic NERD and maintenance of healed EE and relief
of heartburn for up to 6 months in adults and pediatric patients 12–17 years
old.
Modified release dexlansoprazole
capsules were designed to expand existing PPI treatment options for adolescents
by employing a modified release formulation with two different types of
granules that have a pH-dependent release profile: the first granule type is
released within 1–2 h of administration and is followed by release of the
second granule type within 4–5 h. This allows prolonged drug exposure and
an extended duration of acid suppression with once daily dosing.
In addition, dexlansoprazole does
not have food restrictions, whereas other commercially available FDA-approved
PPIs are taken 30 min before the first meal of the day.
Dexlansoprazole can improve the quality of life of adolescents with NERD. Dexlansoprazole reduced the frequency of additional reflux-related symptoms including throat irritation, dyspepsia, nausea, and epigastric pain experienced by adolescent patients, as well as reduced the subjective impact of these symptoms on the patient’s eating habits, fatigue, and mood.
In conclusion, this study shows that dexlansoprazole is safe and
effective for the treatment of adolescent NERD, in particular, relief of
heartburn symptoms.
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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.
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