OB/GYN News - Protonix
(pantoprazole, American Home Products)
A proton pump inhibitor (PPI) for erosive esophagitis associated with gastroesophageal reflux disease (GERD). The fourth PPI approved.
* Recommended Dosage: 40 mg once a day for up to 8 weeks; consider another 8-week course for those who don’t heal within that time, according to the drug’s labeling.
* Special Considerations: Safety and efficacy as maintenance therapy not established. Tablets are delayed-release and should be swallowed whole. Generally well tolerated in clinical trials.
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* Comment: In a study of patients with reflux symptoms and endoscopically confirmed erosive esophagitis, 93% of the 162 patients on the 40-mg dose had healed by the 8th week of treatment, compared with 40% of the 68 patients on placebo. Significantly more of those on 40 mg had no regurgitation and complete relief of daytime and nighttime heartburn beginning with the first day of treatment and took significantly fewer antacid tablets, compared with those on placebo.
In another study of similar patients that compared 40 mg of Protonix to 150 mg of nizatidine (Axid) twice a day, 83% of those on the PPI had healed by 8 weeks vs. 42% of those on nizatidine, which is sold over the counter.
Protonix, which works by suppressing the final step in gastric acid production, will not be available until the second quarter of this year, according to American Home Products.
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