Aciphex (Page 8 of 11)

14 CLINICAL STUDIES

14.1 Healing of Erosive or Ulcerative GERD in Adults

In a U.S., multicenter, randomized, double-blind, placebo-controlled study, 103 patients were treated for up to eight weeks with placebo, 10 mg, 20 mg, or 40 mg ACIPHEX delayed-release tablets once daily. For this and all studies of GERD healing, only patients with GERD symptoms and at least grade 2 esophagitis (modified Hetzel-Dent grading scale) were eligible for entry. Endoscopic healing was defined as grade 0 or 1. Each rabeprazole dose was significantly superior to placebo in producing endoscopic healing after four and eight weeks of treatment. The percentage of patients demonstrating endoscopic healing was as follows:

Table 7: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Percentage of Patients Healed
ACIPHEX delayed-release tablets
Week 10 mg once dailyN=27 20 mg once dailyN=25 40 mg once dailyN=26 PlaceboN=25
*
(p<0.001 versus placebo)
4 63%* 56%* 54%* 0%
8 93%* 84%* 85%* 12%

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, the percentage of patients healed at endoscopy after four and eight weeks of treatment was statistically superior in the patients treated with ACIPHEX delayed-release tablets compared to ranitidine:

Table 8: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Percentage of Patients Healed
Week 20 mg ACIPHEX delayed-release tablets once dailyN=167 Ranitidine 150 mg four times dailyN=169
*
(p<0.001 versus ranitidine)
4 59%* 36%
8 87%* 66%

A dose of 20 mg once daily of ACIPHEX delayed-release tablets was significantly more effective than ranitidine 150 mg four times daily in the percentage of patients with complete resolution of heartburn at Weeks 4 and 8 (p<0.001). ACIPHEX was also more effective in complete resolution of daytime heartburn (p≤0.025), and nighttime heartburn (p≤0.012) at both Weeks 4 and 8, with significant differences by the end of the first week of the study.

The recommended dosage of ACIPHEX delayed-release tablets is 20 mg once daily for 4 to 8 weeks.

14.2 Long-Term Maintenance of Healing of Erosive or Ulcerative GERD in Adults

The long-term maintenance of healing in patients with erosive or ulcerative GERD previously healed with gastric antisecretory 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 delayed-release tablets once daily or placebo. As demonstrated in Tables 10 and 11 below, patients treated with ACIPHEX delayed-release tablets were 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. The recommended dosage of ACIPHEX delayed-release tablets is 20 mg once daily.

Table 9: Percent of Patients in Endoscopic Remission
ACIPHEX delayed-release tablets Placebo
10 mg once daily 20 mg once daily
*
(p<0.001 versus placebo)
Study 1 N=66 N=67 N=70
Week 4 83%* 96%* 44%
Week 13 79%* 93%* 39%
Week 26 77%* 93%* 31%
Week 39 76%* 91%* 30%
Week 52 73%* 90%* 29%
Study 2 N=93 N=93 N=99
Week 4 89%* 94%* 40%
Week 13 86%* 91%* 33%
Week 26 85%* 89%* 30%
Week 39 84%* 88%* 29%
Week 52 77%* 86%* 29%
COMBINED STUDIES N=159 N=160 N=169
Week 4 87%* 94%* 42%
Week 13 83%* 92%* 36%
Week 26 82%* 91%* 31%
Week 39 81%* 89%* 30%
Week 52 75%* 87%* 29%
Table 10: Percent of Patients Without Relapse in Heartburn Frequency and Daytime and Nighttime Heartburn Severity at Week 52
ACIPHEX delayed-release tablets Placebo
10 mg once daily 20 mg once daily
*
p≤0.001 versus placebo
0.001<p<0.05 versus placebo
Heartburn Frequency
Study 1 46/55 (84%)* 48/52 (92%)* 17/45 (38%)
Study 2 50/72 (69%)* 57/72 (79%)* 22/79 (28%)
Daytime Heartburn Severity
Study 1 61/64 (95%)* 60/62 (97%)* 42/61 (69%)
Study 2 73/84 (87%) 82/87 (94%)* 67/90 (74%)
Nighttime Heartburn Severity
Study 1 57/61 (93%)* 60/61 (98%)* 37/56 (66%)
Study 2 67/80 (84%) 79/87 (91%) 64/87 (74%)

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