Table 1: Erosive Esophagitis Healing Rates (Per Protocol)
A US multicenter, double-blind, placebo-controlled study of PROTONIX 10-mg, 20-mg, or 40-mg once daily was conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale). In this study, approximately 25% of enrolled patients had severe EE of grade 3, and 10% had grade 4.
Table 2: Erosive Esophagitis Healing Rates (Per Protocol)
PROTONIX 40-mg and 20-mg once daily were also compared with nizatidine 150-mg twice daily in a US multicenter, double-blind study of 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above.
Tables 3 & 4: Long-term Maintenance of Healing of Erosive Gastroesophageal Reflux Disease (GERD Maintenance): Percentage of Patients Who Remained Healed
Two independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed erosive esophagitis to demonstrate efficacy of PROTONIX in long-term maintenance of healing. The two US studies enrolled 386 and 404 patients, respectively, to receive either 10-mg, 20-mg, or 40-mg of PROTONIX Delayed-Release Tablets once daily or 150-mg of ranitidine twice daily.