PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets (二十四)
no statistically significant difference between PREVACID 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) versus the active control
Study #1
PREVACID
30 mg daily Active Control†
Week 4 60% (53/88) ‡ 28% (23/83)
Week 8 79% (62/79) ‡ 55% (41/74)
Study #2
PREVACID
30 mg daily Active Control†
Week 4 53% (40/75) 38% (31/82)
Week 8 77% (47/61) ‡ 50% (33/66)
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 4, 8, and 12 weeks was significantly higher with 15 or 30 mg of PREVACID 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 PREVACID 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 PREVACID
15 mg daily
(N=121) PREVACID
30 mg daily
(N=116) Misoprostol
200 mcg four times daily
(N=106) Placebo
(N=112)
(p<0.001) PREVACID 15 mg daily versus placebo; PREVACID 30 mg daily versus placebo; and misoprostol 200 mcg four times daily versus placebo.
(p<0.05) Misoprostol 200 mcg four times daily versus PREVACID 15 mg daily; and misoprostol 200 mcg four times daily versus PREVACID 30 mg daily.
* % = Life Table Estimate
4 90% 92% 96% 66%
8 86% 88% 95% 60%
12 80% 82% 93% 51%
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 8 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 8-week treatment period are presented in Table 17 and in Figures 1 and 2:
Table 17: Frequency of Heartburn Variable Placebo
(n=43) PREVACID
15 mg
(n=80) PREVACID
30 mg
(n=86)
Median
* (p
% 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%*
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 m |
