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Nexium Drugs Approved by the FDA
Article
Drug Name: Nexium (esomeprazole magnesium)
The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.
Company: AstraZeneca
Approval Status: Approved February 2001
Treatment for: Duodenal ulcer disease, erosive esophagitis, and gastroesophageal reflux disease
General Information
Nexium has been approved by the FDA for the relief of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and for the healing of erosive esophagitis, a potentially serious condition associated with GERD. The FDA also approved Nexium for maintenance of healing of erosive esophagitis and, in combination with amoxicillin and clarithromycin, for the eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Nexium is derived from Prilosec (omeprazole). Prilosec contains a racemic mixture of the D- and L- forms (isomers) of omeprazole. Nexium contains only one of the isomers. Both Prilosec and Nexium are known as proton pump inhibitors (PPIs).
As many as 25 million adults experience heartburn on a daily basis. Although heartburn is the most common symptom of GERD, the condition is also often marked by other symptoms - such as a sour taste in the mouth or difficulty swallowing - related to the backing up of harsh stomach acid into the esophagus. When this acid reflux damages the lining of the esophagus, it may lead to a potentially more serious condition called erosive esophagitis that can lead to narrowing or ulceration of the esophagus.
Clinical Results
Four multicenter, double blind, randomized trials evaluated the healing rates of Nexium 40 mg, Nexium 20 mg, and omeprazole 20 mg in subjects with endoscopically diagnosed erosive esophagitis. Healing rates were evaluated at week four and eight. At week eight, healing rates were higher with Nexium treatment compared to omeprazole in all four studies.
Two multicenter, randomized, double blind, placebo controlled 4 arm trials evaluated the long term maintenance of healing of erosive esophagitis. The trials included subjects with endoscopically confirmed, healed erosive esophagitis, and they evaluated Nexium 40 mg, 20 mg and 10 mg once daily over six months of treatment. Subjects remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in subjects treated with Nexium compared to placebo.
Nexium's effectiveness in the resolution of GERD symptoms was evaluated in two multicenter, randomized, double blind, placebo controlled trials. These trials were conducted in a total of 717 subjects, and they compared four weeks of treatment with Nexium 20 mg or 40 mg once daily versus placebo. The percentage of subjects who were symptom free of heartburn was significantly higher in the Nexium groups compared to placebo at all follow up visits (weeks 1, 2 and 4).
In three European symptomatic GERD trials, no significant treatment related differences were observed between Nexium 20 mg and 40 mg and omeprazole 20 mg.
Nexium in combination with amoxicillan and clarithromycin was tested in two multicenter, randomized, double blind trials for the eradication of Helicobacter pylori (H. pylori) in subjects with duodenal ulcer disease. H. pylori eradication rates at four weeks post therapy were significantly higher in the Nexium plus amoxicillin and clarithromycin group than in a Nexium plus clarithromycin or Nexium alone group.
Nexium Side Effects
Side effects reported with Nexium use include (but are not limited to) the following:
- Headache
- Diarrhea
- Abdominal pain
Safety and effectiveness have not yet been established in pediatric (having to do with children) patients.
Please consult your physician for further information on side effects or to discuss the individual appropriateness of Nexium treatment.
Mechanism of Action
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion. (Nexium Prescribing Information)
Additional Information
Nexium is produced in a delayed release capsule formulation, with dosages of 20 mg or 40 mg.
Back to Nexium and Proton Pump Inhibitors Articles
References:
www.centerwatch.com/patient/drugs/dru665.html
www.centerwatch.com
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