RABEPRAZOLE SODIUM (Page 9 of 10)

14.3 Treatment of Symptomatic GERD in Adults

Two U.S., multicenter, double-blind, placebo controlled studies were conducted in 316 adult patients with daytime and nighttime heartburn. Patients reported 5 or more periods of moderate to very severe heartburn during the placebo treatment phase the week prior to randomization. Patients were confirmed by endoscopy to have no esophageal erosions.

The percentage of heartburn free daytime and/or nighttime periods was greater with 20 mg Rabeprazole Sodium delayed-release tablets compared to placebo over the 4 weeks of study in Study RAB-USA-2 (47% vs. 23%) and Study RAB-USA-3 (52% vs. 28%). The mean decreases from baseline in average daytime and nighttime heartburn scores were significantly greater for Rabeprazole Sodium delayed-release tablets 20 mg as compared to placebo at week 4. Graphical displays depicting the daily mean daytime and nighttime scores are provided in Figures 2 to 5.

Figure 2: Mean Daytime Heartburn Scores RAB-USA-2
(click image for full-size original)
Figure 3: Mean Nighttime Heartburn Scores RAB-USA-2
(click image for full-size original)
Figure 4: Mean Daytime Heartburn Scores RAB-USA-3
(click image for full-size original)
Figure 5: Mean Nighttime Heartburn Scores RAB-USA-3
(click image for full-size original)

In addition, the combined analysis of these two studies showed 20 mg of Rabeprazole Sodium delayed-release tablets significantly improved other GERD-associated symptoms (regurgitation, belching, and early satiety) by week 4 compared with placebo (all p values < 0.005).

A dose of 20 mg Rabeprazole Sodium delayed-release tablets also significantly reduced daily antacid consumption versus placebo over 4 weeks (p<0.001).

The recommended dosage of Rabeprazole Sodium delayed-release tablets is 20 mg once daily for 4 weeks.

14.4 Healing of Duodenal Ulcers in Adults

In a U.S., randomized, double-blind, multicenter study assessing the effectiveness of 20 mg and 40 mg of Rabeprazole Sodium delayed-release tablets once daily versus placebo for healing endoscopically defined duodenal ulcers, 100 patients were treated for up to four weeks. Rabeprazole Sodium delayed-release tablets were significantly superior to placebo in producing healing of duodenal ulcers. The percentages of patients with endoscopic healing are presented below:

Table 11: Healing of Duodenal Ulcers Percentage of Patients Healed
*
p≤0.001 versus placebo

Week

Rabeprazole Sodium Delayed-Release Tablets

Placebo N=33

20 mg once daily N=34

40 mg once daily N=33

2

44%

42%

21%

4

79% *

91% *

39%

At Weeks 2 and 4, significantly more patients in the Rabeprazole Sodium delayed-release tablets 20 and 40 mg groups reported complete resolution of ulcer pain frequency (p≤0.018), daytime pain severity (p≤0.023), and nighttime pain severity (p≤0.035) compared with placebo patients. The only exception was the 40 mg group versus placebo at Week 2 for duodenal ulcer pain frequency (p=0.094). Significant differences in resolution of daytime and nighttime pain were noted in both Rabeprazole Sodium delayed-release tablets groups relative to placebo by the end of the first week of the study. Significant reductions in daily antacid use were also noted in both Rabeprazole Sodium delayed-release tablets groups compared to placebo at Weeks 2 and 4 (p<0.001).

An international randomized, double-blind, active-controlled trial was conducted in 205 patients comparing 20 mg Rabeprazole Sodium delayed-release tablets once daily with 20 mg omeprazole once daily. The study was designed to provide at least 80% power to exclude a difference of at least 10% between Rabeprazole Sodium delayed-release tablets and omeprazole, assuming four-week healing response rates of 93% for both groups. In patients with endoscopically defined duodenal ulcers treated for up to four weeks, Rabeprazole Sodium delayed-release tablets were comparable to omeprazole in producing healing of duodenal ulcers. The percentages of patients with endoscopic healing at two and four weeks are presented below:

Table 12: Healing of Duodenal Ulcers Percentage of Patients Healed

Week

Rabeprazole Sodium Delayed-Release Tablets 20 mg once daily N=102

Omeprazole 20 mg once daily N=103

95% Confidence Interval for the Treatment Difference (Rabeprazole Sodium Delayed-Release Tablets — Omeprazole)

2

69%

61%

(–6%, 22%)

4

98%

93%

(–3%, 15%)

Rabeprazole Sodium delayed-release tablets and omeprazole were comparable in providing complete resolution of symptoms.

The recommended dosage of Rabeprazole Sodium delayed-release tablets is 20 mg once daily for 4 weeks.

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