Reviews/Evaluations

Esomeprazole (Nexium®)

Esomeprazole is a proton pump inhibitor that was approved in February 2001. Esomeprazole is the S-isomer of omeprazole, which comes off patent later this year. It works like other proton pump inhibitors, by binding to the gastric acid pump and preventing acid release into the stomach.(4) Esomeprazole has been proven to be an effective agent when treating erosive esophagitis and GERD, but does not offer any significant benefit over traditional proton pump inhibitor therapy.

Esomeprazole is similar to omeprazole except that it has increased biovailability but his does not translate to superior clinical efficacy.(4) It was evaluated for the treatment of erosive esophagitis and GERD, maintenance healing and H.pylori eradication.

Esomeprazole was evaluated in an 8-week, randomized, double-blind trial involving 2425 patients with erosive esophagitis.(5) Healing rates were 93.7% in the esomeprazole 40mg group compared to 84.2% in the omeprazole 20mg group. These results were statistically significant but probably not clinically significant, because this was a large study and small clinical differences could translate into statically significant differences.

A second study compared esomeprazole 40mg, esomeprazole 20mg and omeprazole 20mg in 1960 patients with reflux esophagitis.(6) At week 8; there was a statistically significant higher healing rate in the esomeprazole groups versus omeprazole 20mg.

Another study was done to evaluate esomeprazole in maintenance healing. 318 patients were randomized to esomeprazole 40mg, esomprazole 20mg, esomeprazole 10mg or placebo.(8) Healing was maintained in 93.6% in the esomeprazole 40mg group, 93.2% in the esomeprazole 20mg group, 57.1% in the esomeprazole 10mg group and 29.0% in the placebo group after 6 months.

Lastly, esomeprazole was used for the eradication of H.pylori. Patients received one of three treatment regimens for 10 days: 1) esomeprazole 40mg qd, amoxicillin 1g bid, and clarithromycin 500mg bid (EAC) 2) esomeprazole 40mg daily and clarithromycin 500mg bid (EC) or 3) esomeprazole 40mg alone (E).(9) The highest eradication rate was seen in the EAC group, which was 77% effective. This is not as effective as other regimens for H.pylori, which demonstrate 80-90% eradication.

Cost Comparison

Esomeprazole is an effective agent in the treatment and maintenance healing of GERD and erosive esophagitis. No studies have compared esomeprazole 40mg to omeprazole 40mg. Although esomeprazole has increased bioavailability and is metabolized more slowly than omeprazole, treatment with esomeprazole appears to offer minimal clinical advantages.

4. Nexium package insert. Wilmington, DE; AstraZeneca; February 2001.
5. Richter J., et al. Efficacy and Safety of Esomeprazole Compared With Omeprazole in GERD Patients With Erosive Esophagitis: A Randomized Controlled Trial. Am J of Gastroenterology 2001; 96:656-665.
6. Kahrilas P., et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. Aliment Pharmacol Ther 2000; 14:1249-1258.
7. Lind T., et al. Esomeprazole provides improved acid control vs. omeprazole in patients with symptoms of gastro-oesophageal reflux disease. Ailment Pharmacol Ther 2000; 14:861-867.
8. Johnson D., et al. Esomeprazole Once Daily for 6 Months Is Effective Therapy for Maintaining Healed Erosive Esophagitis and for Controlling Gastroesophageal Reflux Disease Symptoms: A Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety. Am J of Gastroenterology 2001; 96:27-34.
9. Laine L., et al. Esomeprazole-Based Helicobacter pylori Eradication Therapy and the Effect of Antibiotic Resistance: Results of Three US Multicenter, Double-Blind Trials. Am J of Gastroenterology 2000; 95:3393-3398.