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Symptom Relief

In patients with Erosive Esophagitis (EE)...

NEXIUM: day and night symptom relief over 24 hours1-3

Daytime Heartburn Relief:

In 5037 erosive esophagitis (EE) patients…

  • 90% of patients taking NEXIUM 40 mg QD (n=2521) reported daily heartburn relief at week 4,* and 89% of patients experienced daily heartburn relief with lansoprazole 30 mg QD (n=2516; P=NS)*†1,2

* Secondary endpoint from a multicenter, randomized, double-blind study (n=5037), comparing NEXIUM 40 mg with lansoprazole 30 mg administered once daily to patients with endoscopically diagnosed erosive esophagitis (EE).1,2 Primary endpoint was healing of EE at week 8.
Heartburn relief defined as investigator-recorded symptom of “none” or “mild.”

Nighttime Heartburn Relief:

In 1860 EE patients…

  • 92% of patients taking NEXIUM 40 mg QD (n=909) reported heartburn-free nights at week 4, and 90% of patients experienced heartburn-free nights with lansoprazole 30 mg QD (n=951; P=NS)§1,3

Secondary endpoint from a multicenter, randomized, double-blind study (n=1860), comparing NEXIUM 40 mg with lansoprazole 30 mg administered once daily to patients with endoscopically diagnosed EE.1,3 Primary endpoint was healing of EE at week 8.
§ Heartburn-free nights defined as patient-recorded symptom of “none.”

93% of patients taking NEXIUM 40mg QD vs. 89% of patients taking lansoprazole 30mg QD experienced healing of EE through 8 weeks (n=5241, P=.0001)//

//Primary endpoint from a multicenter, randomized, double-blind, parallel-group, 8-week trial comparing oral doses of NEXIUM 40mg with lansoprazole 30mg administered once daily to patients with endoscopically diagnosed EE.

  • NEXIUM 40 mg and NEXIUM 20 mg are the FDA-approved doses for the healing of EE

     

NEXIUM Data

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Approved Uses

Healing of Erosive Esophagitis (EE)

NEXIUM 40 mg and NEXIUM 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed EE.

Maintenance of Healing of EE

NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE. Controlled studies did not extend beyond 6 months.

Symptomatic GERD

NEXIUM 20 mg is indicated for the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Pediatric Use

NEXIUM is indicated for the short-term treatment (up to 8 weeks) of GERD (symptomatic GERD and healing of EE) in patients 1 to 17 years of age. Pediatric use is supported by extrapolation of results from studies that supported the approval for NEXIUM for adults and safety and pharmacokinetic studies performed in pediatric and adolescent patients.

Effectiveness has not been demonstrated in patients less than 1 year of age. Safety and effectiveness for other pediatric uses have not been established.

Important Safety Information

References
  1. Castell DO, Kahrilas PJ, Richter JE, et al. Am J Gastroenterol. 2002;97:575-583.
  2. Data on file, eSTaR #267459.
  3. Data on file, eSTaR #267438.