Lansoprazole: Package Insert and Label Information (Page 9 of 11)

14.8 Erosive Esophagitis

In a U.S., multicenter, double-blind, placebo-controlled study of 269 patients entering with an endoscopic diagnosis of esophagitis with mucosal grading of two or more and grades three and four signifying erosive disease, the percentages of patients with healing are presented in Table 18:

Table 18. Erosive Esophagitis Healing Rates
*
(p ≤ 0.001) vs placebo.
(p ≤ 0.05) vs lansoprazole 15 mg.

Lansoprazole

Placebo

Week

15 mg daily

(N = 69)

30 mg daily

(N = 65)

60 mg daily

(N = 72)

(N = 63)

4

67.6%*

81.3%*

80.6%*

32.8%

6

87.7%*

95.4%*

94.3%*

52.5%

8

90.9%*

95.4%*

94.4%*

52.5%

In this study, all lansoprazole groups reported significantly greater relief of heartburn and less day and night abdominal pain along with fewer days of antacid use and fewer antacid tablets taken per day than the placebo group. Although all doses were effective, the earlier healing in the higher two doses suggests 30 mg daily as the recommended dose.

Lansoprazole was also compared in a U.S., multicenter, double-blind study to a low dose of ranitidine in 242 patients with erosive reflux esophagitis. Lansoprazole at a dose of 30 mg was significantly more effective than ranitidine 150 mg twice daily as shown below (Table 19).

Table 19. Erosive Esophagitis Healing Rates
*
(p ≤ 0.001) vs ranitidine.

Week

Lansoprazole

30 mg daily

(N = 115)

Ranitidine

150 mg twice daily

(N = 127)

2

66.7%*

38.7%

4

82.5%*

52.0%

6

93.0%*

67.8%

8

92.1%*

69.9%

In addition, patients treated with lansoprazole reported less day and nighttime heartburn and took less antacid tablets for fewer days than patients taking ranitidine 150 mg twice daily.

Although this study demonstrates effectiveness of lansoprazole in healing erosive esophagitis, it does not represent an adequate comparison with ranitidine because the recommended ranitidine dose for esophagitis is 150 mg four times daily, twice the dose used in this study.

In the two trials described and in several smaller studies involving patients with moderate to severe erosive esophagitis, lansoprazole produced healing rates similar to those shown above.

In a U.S., multicenter, double-blind, active-controlled study, 30 mg of lansoprazole was compared with ranitidine 150 mg twice daily in 151 patients with erosive reflux esophagitis that was poorly responsive to a minimum of 12 weeks of treatment with at least one H2 -receptor antagonist given at the dose indicated for symptom relief or greater, namely, cimetidine 800 mg/day, ranitidine 300 mg/day, famotidine 40 mg/day or nizatidine 300 mg/day. Lansoprazole 30 mg was more effective than ranitidine 150 mg twice daily in healing reflux esophagitis, and the percentage of patients with healing were as follows. This study does not constitute a comparison of the effectiveness of histamine H2 -receptor antagonists with lansoprazole, as all patients had demonstrated unresponsiveness to the histamine H2 -receptor antagonist mode of treatment. It does indicate, however, that lansoprazole may be useful in patients failing on a histamine H2 -receptor antagonist (Table 20) [see Indications and Usage (1.7)].

Table 20. Reflux Esophagitis Healing Rates in Patients Poorly Responsive to Histamine H2 -Receptor Antagonist Therapy
*
(p ≤ 0.001) vs ranitidine.

Week

Lansoprazole

30 mg daily

(N = 100)

Ranitidine

150 mg twice daily

(N = 51)

4

74.7%*

42.6%

8

83.7%*

32.0%

14.9 Maintenance of Healing of Erosive Esophagitis

Two independent, double-blind, multicenter, controlled trials were conducted in patients with endoscopically confirmed healed esophagitis. Patients remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in patients treated with lansoprazole than in patients treated with placebo over a 12 month period (Table 21).

Table 21. Endoscopic Remission Rates
% = Life Table Estimate.
*
(p ≤ 0.001) vs placebo.

Trial

Drug

No. of Pts.

Percent in Endoscopic Remission

0-3 mo.

0-6 mo.

0-12 mo.

#1

Lansoprazole 15 mg daily

59

83%*

81%*

79%*

Lansoprazole 30 mg daily

56

93%*

93%*

90%*

Placebo

55

31%

27%

24%

#2

Lansoprazole 15 mg daily

50

74%*

72%*

67%*

Lansoprazole 30 mg daily

49

75%*

72%*

55%*

Placebo

47

16%

13%

13%

Regardless of initial grade of erosive esophagitis, lansoprazole 15 and 30 mg were similar in maintaining remission.

In a U.S., randomized, double-blind study, lansoprazole 15 mg daily (n = 100) was compared with ranitidine 150 mg twice daily (n = 106), at the recommended dosage, in patients with endoscopically-proven healed erosive esophagitis over a 12 month period. Treatment with lansoprazole resulted in patients remaining healed (Grade 0 lesions) of erosive esophagitis for significantly longer periods of time than those treated with ranitidine (p < 0.001). In addition, lansoprazole was significantly more effective than ranitidine in providing complete relief of both daytime and nighttime heartburn. Patients treated with lansoprazole remained asymptomatic for a significantly longer period of time than patients treated with ranitidine [see Indications and Usage (1.9)].

14.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In open studies of 57 patients with pathological hypersecretory conditions, such as Zollinger-Ellison syndrome (ZES) with or without multiple endocrine adenomas, lansoprazole significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia and pain. Doses ranging from 15 mg every other day to 180 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery and below 5 mEq/hr in patients with prior gastric surgery.

Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients [see Dosage and Administration (2.1)]. Lansoprazole was well-tolerated at these high-dose levels for prolonged periods (greater than four years in some patients). In most ZES patients, serum gastrin levels were not modified by lansoprazole. However, in some patients, serum gastrin increased to levels greater than those present prior to initiation of lansoprazole therapy [see Indications and Usage (1.10)].

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