Famotidine (Page 5 of 6)

14.3 Symptomatic Gastroesophageal Reflux Disease (GERD)

Orally administered famotidine was compared to placebo in a U.S. trial that enrolled patients with symptoms of GERD and without endoscopic evidence of esophageal erosion or ulceration. As shown in Table 6, patients treated with famotidine 20 mg twice daily had greater improvement in symptomatic GERD than patients treated with 40 mg at bedtime or placebo.

Table 6: Patients with Improvement of Symptomatic GERD (N=376)

Famotidine 20 mg twice daily (N=154)

Famotidine 40 mg at bedtime (N=149)

Placebo at bedtime (N=73)

Week 6

82% a

69%

62%

a p≤0.01 vs. placebo

14.4 Erosive Esophagitis due to GERD

Healing of endoscopically verified erosion and symptomatic improvement were studied in a U.S. and an international double-blind trials. Healing was defined as complete resolution of all erosions visible with endoscopy. The U.S. trial comparing orally administered famotidine 40 mg twice daily to placebo and orally administered famotidine 20 mg twice daily showed a significantly greater percentage of healing of erosive esophagitis for famotidine 40 mg twice daily at Weeks 6 and 12 (Table 7).

Table 7: Patients with Endoscopic Healing of Erosive Esophagitis — U.S. Study (N=318)

Famotidine 40 mg twice daily (N=127)

Famotidine 20 mg twice daily (N=125)

Placebo twice daily (N=66)

Week 6

48% a,b

32%

18%

Week 12

69% a,c

54% a

29%

a p≤0.01 vs. placebo

b p≤0.01 vs. famotidine 20 mg twice daily

c p≤0.05 vs. famotidine 20 mg twice daily

As compared to placebo, patients in the U.S. trial who received famotidine had faster relief of daytime and nighttime heartburn, and a greater percentage of famotidine tablets-treated patients experienced complete relief of nighttime heartburn. These differences were statistically significant.

In the international trial, when orally administered famotidine 40 mg twice daily was compared to orally administered ranitidine 150 mg twice daily, a statistically significantly greater percentage of healing of erosive esophagitis was observed with famotidine 40 mg twice daily at Week 12 (Table 8). There was, however, no significant difference in symptom relief among treatment groups.

Table 8: Patients with Endoscopic Healing of Erosive Esophagitis — International Study (N=440)

Famotidine

40 mg twice daily (N=175)

Famotidine

20 mg twice daily (N=93)

Ranitidine

150 mg twice daily (N=172)

Week 6

48%

52%

42%

Week 12

71% a

68%

60%

a p≤0.05 vs ranitidine 150 mg twice daily

14.5 Pathological Hypersecretory Conditions

In trials of patients with pathological hypersecretory conditions such as Zollinger-Ellison syndrome with or without multiple endocrine neoplasias, famotidine significantly inhibited gastric acid secretion and controlled associated symptoms. Orally administered famotidine dosages from 20 mg to 160 mg every 6 hours maintained basal acid secretion below 10 mEq/hour; initial dosages were titrated to the individual patient need and subsequent adjustments were necessary with time in some patients.

14.6 Risk Reduction of Duodenal Ulcer Recurrence

Two randomized, double-blind, multicenter trials in patients with endoscopically confirmed healed DUs demonstrated that patients receiving treatment with orally administered famotidine 20 mg at bedtime had lower rates of DU recurrence, as compared with placebo.

  • In the U.S. trial, DU recurrence within 12 months was 2.4 times greater in patients treated with placebo than in the patients treated with famotidine. The 89 famotidine tablets-treated patients had a cumulative observed DU recurrence rate of 23%, compared to a 57% in the 89 patients receiving placebo (p<0.01).
  • In the international trial, the cumulative observed DU recurrence within 12 months in the 307 famotidine tablets-treated patients was 36%, compared to 76% in the 325 patients who received placebo (p<0.01).

Controlled trials have not extended beyond one year.

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