Lansoprazole: Package Insert and Label Information (Page 8 of 11)

14.3 Maintenance of Healed Duodenal Ulcers

Lansoprazole has been shown to prevent the recurrence of duodenal ulcers. Two independent, double-blind, multicenter, controlled trials were conducted in patients with endoscopically confirmed healed duodenal ulcers. Patients remained healed significantly longer and the number of recurrences of duodenal ulcers was significantly less in patients treated with lansoprazole than in patients treated with placebo over a 12 month period (Table 13) [see Indications and Usage (1.3)].

Table 13. 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	86	90%*	87%*	84%*
	Placebo	83	49%	41%	39%
#2	Lansoprazole 30 mg daily	18	94%*	94%*	85%*
	Lansoprazole 15 mg daily	15	87%*	79%*	70%*
	Placebo	15	33%	0%	0%

In trial #2, no significant difference was noted between lansoprazole 15 and 30 mg in maintaining remission.

14.4 Gastric Ulcer

In a U.S. multicenter, double-blind, placebo-controlled study of 253 patients with endoscopically documented gastric ulcer, the percentage of patients healed at four and eight weeks was significantly higher with lansoprazole 15 and 30 mg once a day than with placebo (Table 14) [see Indications and Usage (1.4)].

Table 14. Gastric Ulcer Healing Rates

* (p ≤ 0.05) vs placebo.
	Lansoprazole			Placebo
Week	15 mg daily (N = 65)	30 mg daily (N = 63)	60 mg daily (N = 61)	(N = 64)
4	64.6%*	58.1%*	53.3%*	37.5%
8	92.2%*	96.8%*	93.2%*	76.7%

Patients treated with any lansoprazole dose reported significantly less day and night abdominal pain along with fewer days of antacid use and fewer antacid tablets used per day than the placebo group.

Independent substantiation of the effectiveness of lansoprazole 30 mg was provided by a meta-analysis of published and unpublished data.

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 *

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

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 *

(p < 0.001) lansoprazole 15 mg daily vs placebo; lansoprazole 30 mg daily vs placebo; and misoprostol 200 mcg four times daily vs placebo.(p < 0.05) misoprostol 200 mcg four times daily vs lansoprazole 15 mg daily; and misoprostol 200 mcg four times daily vs lansoprazole 30 mg daily.
* % = Life Table Estimate.
Week	Lansoprazole 15 mg daily (N = 121)	Lansoprazole 30 mg daily (N = 116)	Misoprostol 200 mcg four times daily (N = 106)	Placebo (N = 112)
4	90%	92%	96%	66%
8	86%	88%	95%	60%
12	80%	82%	93%	51%

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

* (p < 0.01) vs placebo.
Variable	Placebo (n = 43)	Lansoprazole 15 mg (n = 80)	Lansoprazole 30 mg (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%*

Figure 1.

Figure 2.

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)].