Healing of EE

In 3 of the 4 pivotal trials,

92%–94% of patients with EE healed—that’s the efficacy of NEXIUM 40 mg

Healing vs omeprazole

Healing of erosive esophagitis data for NEXIUM vs omeprazole
  • In another study, 92% of patients were healed with NEXIUM 40 mg QD (n=576) vs 90% with omeprazole 20 mg QD (n=572) (P=NS)†4
  • In an additional study with NEXIUM 20 mg (n=587), 91% on NEXIUM 20 mg were healed compared to 88% on omeprazole 20 mg (n=588) P=NS†5

NEXIUM 40 mg, NEXIUM 20 mg, and omeprazole 20 mg are the FDA-approved doses for the healing of EE.

*Varying grades of EE defined as LA grades A, B, C, and D erosive esophagitis.

†Data from multicenter, randomized, double-blind trials comparing oral doses of NEXIUM vs omeprazole, administered once daily to patients with endoscopically diagnosed EE.1-5

Healing vs lansoprazole

Healing of erosive esophagitis data for NEXIUM vs lansoprazole

‡Varying grades of EE defined as LA grades A, B, C, and D erosive esophagitis.

§Primary end point from a multicenter, randomized, double-blind, parallel-group, 8-week trial comparing oral doses of NEXIUM 40 mg with lansoprazole 30 mg, administered once daily to patients with endoscopically diagnosed EE.6

//Moderate-to-severe EE defined as LA grades C and D erosive esophagitis.

Primary end point from a multicenter, randomized, double-blind, parallel-group, 8-week trial comparing oral doses of NEXIUM 40 mg with lansoprazole 30 mg. administered once daily to patients with endoscopically diagnosed EE.7

NEXIUM 40 mg, NEXIUM 20 mg, and lansoprazole 30 mg are the FDA-approved doses for the healing of EE.

Next: Maintenance of Healing of Erosive Esophagitis

1000104-2067505 Last updated 2/13

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Important Safety Information

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • Symptomatic response to therapy does not rule out the presence of gastric malignancy
  • Atrophic gastritis has occasionally been noted with long-term therapy with omeprazole
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea
  • Avoid concomitant use of NEXIUM with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using NEXIUM consider alternative anti-platelet therapy
  • Long-term and multiple daily dose proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy 
  • Concomitant use of NEXIUM and St. John’s wort or rifampin can substantially decrease NEXIUM concentrations. Avoid concomitant use
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
  • Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • NEXIUM may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction
  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate
  • In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain
  • The ARs reported at a frequency of 1% or greater with NEXIUM I.V. in clinical trials were headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation, and pruritus
  • In pediatric patients 1 to 17 years of age, the most frequently reported ARs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence

Indications

NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Prescribing Information with Medication Guide for NEXIUM. (PDF – 303 KB)

Prescribing Information for NEXIUM I.V. (PDF – 72 KB)

References

1.     Prescribing Information for NEXIUM, AstraZeneca Pharmaceuticals LP, Wilmington, DE.

2.     Richter JE, Kahrilas PJ, Johanson J, et al. Am J Gastroenterol. 2001;96:656–665.

3.     Kahrilas PJ, Falk GW, Johnson DA, et al. Aliment Pharmacol Ther. 2000;14:1249–1258.

3.     Schmitt C, Lightdale CJ, Hwang C, et al. Dig Dis Sci. 2006;51:844–850.

4.     Lightdale CJ, Schmitt C, Hwang C, et al. Dig Dis Sci. 2006;51:852–857.

5.     Castell DO, Kahrilas PJ, Richter JE, et al. Am J Gastroenterol. 2002;97:575–583.

6.     Fennerty MB, Johanson JF, Hwang C, et al. Aliment Pharmacol Ther. 2005;21:455–463.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.