What are the considerations for using Vimovo (esomeprazole/naproxen) in adolescents?

Vimovo Use in Adolescents

Vimovo (naproxen/esomeprazole fixed-dose combination) can be safely used in adolescents aged 12-17 years with juvenile idiopathic arthritis, as demonstrated in clinical trials showing good tolerability and efficacy in this age group. 1

FDA-Approved Indications and Age Considerations

• Naproxen is FDA-approved for the relief of signs and symptoms of juvenile arthritis, establishing its use in pediatric populations 2
• The fixed-dose combination of naproxen/esomeprazole has been specifically studied in adolescents aged 12-16 years with juvenile idiopathic arthritis (JIA), demonstrating safety and tolerability over 6 months 1
• Naproxen is the preferred NSAID in pediatric rheumatic conditions due to its established efficacy and safety profile in children and adolescents 3

Dosing Strategy

Weight-based dosing should be used for the naproxen/esomeprazole combination in adolescents:

• Doses are determined by baseline body weight, with the fixed combination providing appropriate ratios of both components 1
• For adolescents 16 years and older, adult dosing protocols can be applied 4
• The combination provides 500 mg naproxen with either 20 mg esomeprazole in the marketed formulations 5, 6

Safety Profile in Adolescents

The safety profile in adolescents is generally favorable but differs slightly from adults:

• In the pivotal 6-month study of 46 adolescents with JIA, 80.4% experienced at least one treatment-emergent adverse event (TEAE), with most being mild to moderate 1
• The most frequent adverse events (≥5%) were upper respiratory tract infections and gastrointestinal symptoms 1
• Only 23.9% had adverse events considered related to study drug, and 8.7% discontinued due to adverse events 1
• Critical caveat: One serious adverse event of acute hepatitis occurred, requiring discontinuation 1

Pediatric-specific adverse event patterns differ from adults:

• Increased incidence of rash and prolonged bleeding times in pediatric patients compared to adults 2
• Similar incidence of gastrointestinal and central nervous system reactions as adults 2
• Lower incidence of other reactions compared to adults 2

Efficacy in Adolescent JIA

Clinical response rates are substantial:

• By month 6, ACR Pediatric-30, -50, -70, and -90 response rates were 47.1%, 38.2%, 32.4%, and 17.6%, respectively 1
• Response rates improved progressively over the 6-month treatment period 1
• Functional improvements occurred across multiple domains including arising, walking, activities, dressing, grooming, eating, hygiene, and grip 1

Gastroesophageal Protection Rationale

The esomeprazole component provides important gastroprotection:

• NSAIDs carry risk of gastric ulcers, which can be reduced by concomitant proton pump inhibitor administration 1
• Esomeprazole 20-40 mg daily has been demonstrated safe and well-tolerated in adolescents aged 12-17 years in multiple studies 7, 8
• The fixed-dose combination was specifically developed to reduce the risk of NSAID-associated gastric ulcers 1

Monitoring Requirements

Regular monitoring is essential:

• Assess for gastrointestinal symptoms (heartburn, abdominal pain, nausea, diarrhea) at each visit 1, 8
• Monitor for rash and bleeding complications, which occur more frequently in pediatric patients 2
• Evaluate liver function given the reported case of acute hepatitis 1
• Check for prolonged bleeding times periodically 2

Clinical Considerations

Important practice points:

• NSAID therapy should not delay initiation of disease-modifying antirheumatic drugs (DMARDs) when indicated for JIA 3
• An adequate trial period of at least 8 weeks is needed to assess NSAID response, given the time course to response of about 1 month 3
• The combination should be used at the lowest effective dose for the shortest duration consistent with treatment goals 2
• For adolescents with GERD symptoms, esomeprazole component provides dual benefit of gastroprotection and symptom relief 7, 8