Lansoprazole (Page 10 of 12)

14.5 Healing of NSAID-Associated Gastric Ulcer

In two U.S. and Canadian multicenter, double-blind, active-controlled studies in patients with endoscopically confirmed NSAID-associated gastric ulcer who continued their NSAID use, the percentage of patients healed after eight weeks was statistically significantly higher with 30 mg of lansoprazole than with the active control. A total of 711 patients were enrolled in the study, and 701 patients were treated. Patients ranged in age from 18 to 88 years (median age 59 years), with 67% female patients and 33% male patients. Race was distributed as follows: 87% Caucasian, 8% Black, 5% Other. There was no statistically significant difference between lansoprazole 30 mg daily and the active control on symptom relief (i.e., abdominal pain) ( Table 15) [see Indications and Usage ( 1.5)].

Table 15. NSAID-Associated Gastric Ulcer Healing Rates*
Study #1
Lansoprazole 30 mg daily Active Control
Week 4 60% (53/88) 28% (23/83)
Week 8 79% (62/79) 55% (41/74)
Study #2
Lansoprazole 30 mg daily Active Control
Week 4 53% (40/75) 38% (31/82)
Week 8 77% (47/61) 50% (33/66)

* Actual observed ulcer(s) healed at time points ± 2 days
Dose for healing of gastric ulcer (p≤0.05) versus the active control

14.6 Risk Reduction of NSAID-Associated Gastric Ulcer

In one large U.S., multicenter, double-blind, placebo- and misoprostol-controlled (misoprostol blinded only to the endoscopist) study in patients who required chronic use of an NSAID and who had a history of an endoscopically documented gastric ulcer, the proportion of patients remaining free from gastric ulcer at four, eight, and 12 weeks was significantly higher with 15 or 30 mg of lansoprazole than placebo. A total of 537 patients were enrolled in the study, and 535 patients were treated. Patients ranged in age from 23 to 89 years (median age 60 years), with 65% female patients and 35% male patients. Race was distributed as follows: 90% Caucasian, 6% Black, 4% other. The 30 mg dose of lansoprazole demonstrated no additional benefit in risk reduction of the NSAID-associated gastric ulcer than the 15 mg dose (Table 16) [see Indications and Usage ( 1.6)].

Table 16. Proportion of Patients Remaining Free of Gastric Ulcers*
Week Lansoprazole 15 mg daily Lansoprazole 30 mg daily Misoprostol 200 mcg four times daily Placebo
(N=121) (N=116) (N=106) (N=112)
4 90% 92% 96% 66%
8 86% 88% 95% 60%
12 80% 82% 93% 51%

* % = Life Table Estimate
(p<0.001) lansoprazole 15 mg daily versus placebo; lansoprazole 30 mg daily versus placebo; and misoprostol 200 mcg four times daily versus placebo. (p<0.05) Misoprostol 200 mcg four times daily versus lansoprazole 15 mg daily; and misoprostol 200 mcg four times daily versus lansoprazole 30 mg daily.

14.7 Symptomatic Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD: In a U.S. multicenter, double-blind, placebo-controlled study of 214 patients with frequent GERD symptoms, but no esophageal erosions by endoscopy, significantly greater relief of heartburn associated with GERD was observed with the administration of lansoprazole 15 mg once daily up to eight weeks than with placebo. No significant additional benefit from lansoprazole 30 mg once daily was observed.

The intent-to-treat analyses demonstrated significant reduction in frequency and severity of day and night heartburn. Data for frequency and severity for the eight week treatment period are presented in Table 17 and in Figures 1 and 2:

Table 17. Frequency of Heartburn
Placebo Lansoprazole 15 mg Lansoprazole 30 mg
Variable (n=43) (n=80) (n=86)
Median
% of Days without Heartburn
Week 1 0% 71%* 46%*
Week 4 11% 81%* 76%*
Week 8 13% 84%* 82%*
% of Nights without Heartburn
Week 1 17% 86%* 57%*
Week 4 25% 89%* 73%*
Week 8 36% 92%* 80%*

*(p<0.01) versus placebo.

Figure 1

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Figure 2

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In two U.S., multicenter double-blind, ranitidine-controlled studies of 925 total patients with frequent GERD symptoms, but no esophageal erosions by endoscopy, lansoprazole 15 mg was superior to ranitidine 150 mg (twice daily) in decreasing the frequency and severity of day and night heartburn associated with GERD for the eight week treatment period. No significant additional benefit from lansoprazole 30 mg once daily was observed [see Indications and Usage ( 1.7)]

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
Week Lansoprazole Placebo
15 mg daily 30 mg daily 60 mg daily
(N=69) (N=65) (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%

*(p≤0.001) versus placebo. (p≤0.05) versus lansoprazole 15 mg.

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
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%

*(p≤0.001) versus ranitidine.

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 H 2 -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 H 2 -receptor antagonists with lansoprazole, as all patients had demonstrated unresponsiveness to the histamine H 2 -receptor antagonist mode of treatment. It does indicate, however, that lansoprazole may be useful in patients failing on a histamine H 2 -receptor antagonist (Table 20) [see Indications and Usage ( 1.7)]

Table 20. Reflux Esophagitis Healing Rates in Patients Poorly Responsive to Histamine H 2 -Receptor Antagonist Therapy
Week Lansoprazole 30 mg daily (N=100) Ranitidine 150 mg twice daily (N=51)
4 74.7%* 42.6%
8 83.7%* 32.0%

*(p≤0.001) versus ranitidine.

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