Brand Name: Protonix
Active Ingredient: pantoprazole sodium
Indication: Short-term (up to 16 weeks) treatment of erosive esophagitis
Company Name: American Home Products Corporation
Availability: Tablet form approved by the FDA on February 3, 2000
Nearly 60 million Americans experience symptoms of gastroesophageal reflux disease (GERD), which if left uncontrolled can progress to stricture, hemorrhage, Barrett’s esophagus, or esophageal cancer. Proton pump inhibitors are a class of drugs introduced in the late 1980s that have vastly improved the treatment of GERD.
Protonix (pantoprazole sodium) is the newest proton pump inhibitor to be approved by the FDA. Manufactured by American Home Products Corporation, Protonix is indicated as short-term (up to 16 weeks) treatment to promote healing and provide symptomatic relief in patients with erosive esophagitis (EE), one of the most serious forms of gastroesophageal reflux disease. The recommended dosage is one 40 mg delayed-release tablet once daily.
How It Works
Protonix suppresses the final step in gastric acid production by binding to two sites of the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists for longer than 24 hours.
Protonix (pantoprazole): Clinical Study Results
The efficacy of Protonix for the treatment of EE was established in more than 100 clinical trials worldwide in more than 11,000 patients. One multicenter study in the US compared 10 mg, 20 mg, or 40 mg Protonix once daily to placebo in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or higher. At both 4 and 8 weeks of follow-up, patients who took Protonix experienced significantly greater healing rates and relief of symptoms than those who took placebo.
For example, at week 4, healing rates in the 10 mg, 20 mg, and 40 mg Protonix groups were 45.6%, 58.4%, and 75.0%, respectively, compared to 14.3% for placebo. The corresponding rates for week 8 were 66.0%, 83.5%, and 92.6% for the Protonix groups, versus 39.7% for placebo. A significantly greater proportion of patients taking the 40 mg Protonix dose experienced relief of daytime and nighttime heartburn and the absence of regurgitation starting from the first day of treatment, compared to placebo. Moreover, patients taking Protonix consumed fewer antacid tablets each day.
Another multicenter US study compared Protonix (20 mg and 40 mg) with nizatidine (150 mg twice daily) in 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or higher. Protonix was significantly more effective for improving healing and relieving symptoms than nizatidine. At week 4, healing rates in the 20 mg and 40 mg Protonix groups were 61.4% and 64.0%, respectively, compared to 22.2% for nizatidine. The corresponding rates for week 8 were 79.2% and 82.9% for the Protonix groups, versus 41.4% for nizatidine. A significantly greater proportion of patients taking Protonix experienced complete relief of nighttime heartburn and regurgitation starting from the first day of treatment, compared to the nizatidine group. Moreover, patients taking Protonix consumed fewer antacid tablets each day than the nizatidine patients.
Protonix (pantoprazole sodium) has also been shown to be effective in healing duodenal ulcer (DU). A Brazilian study compared 40 mg Protonix to 300 mg ranitidine in 222 patients with DU. After two weeks of treatment, significantly more patients taking Protonix experienced ulcer healing (97.1% for Protonix, 74.5% for ranitidine) and remission of symptoms (97.6% for Protonix, 77.5% for ranitidine).
What the Patient Should Know
Adverse events reported by patients taking Protonix are similar to those associated with other proton pump inhibitors, and include headache, diarrhea, and flatulence. Protonix should be used by pregnant or nursing women only if clearly needed, as determined by the physician.