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).


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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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.


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


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.


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.


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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