In addition, there was a statistically significant difference in favor of the ACIPHEX® 10 mg, 20 mg, and 40 mg doses compared to placebo at Weeks 4 and 8 regarding complete resolution of GERD heartburn frequency (p≤ 0.026). All ACIPHEX® groups reported significantly greater rates of complete resolution of GERD daytime heartburn severity compared to placebo at Weeks 4 and 8 (p≤ 0.036). Mean reductions from baseline in daily antacid dose were statistically significant for all ACIPHEX® groups when compared to placebo at both Weeks 4 and 8 (p≤ 0.007).

In a North American multicenter, randomized, double-blind, active-controlled study of 336 patients, ACIPHEX® was statistically superior to ranitidine with respect to the percentage of patients healed at endoscopy after four and eight weeks of treatment (see table below):

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
Percentage of Patients Healed

ACIPHEX® 20 mg once daily was significantly more effective than ranitidine 150 mg QID in the percentage of patients with complete resolution of heartburn at Weeks 4 and 8 (p<0.001). ACIPHEX® 20 mg once daily was also more effective in complete resolution of daytime heartburn (p≤ 0.025), and night time heartburn (p≤ 0.012) at both Weeks 4 and 8, with significant differences by the end of the first week of the study.

Long-term Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance)

The long-term maintenance of healing in patients with erosive or ulcerative GERD previously healed with gastric anti-secretory therapy was assessed in two U.S., multicenter, randomized, double-blind, placebo-controlled studies of identical design of 52 weeks duration. The two studies randomized 209 and 285 patients, respectively, to receive either 10 mg or 20 mg of ACIPHEX® QD or placebo. As demonstrated in the tables below, ACIPHEX® was significantly superior to placebo in both studies with respect to the maintenance of healing of GERD and the proportions of patients remaining free of heartburn symptoms at 52 weeks:

Long-term Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance)
Percent of Patients in Endoscopic Remission

Long-term Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance):
Percent of Patients Without Relapse in Heartburn Frequency and Daytime and Nighttime Heartburn Severity at Week 52

Symptomatic Gastroesophageal Reflux Disease (GERD)

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