PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets (二十三)
active or within one year) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest, histology and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. † Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within one year). All dropouts were included as failures of therapy. ‡ (p<0.05) versus PREVACID alone. § (p<0.05) versus PREVACID alone or amoxicillin alone.
M93-131 77‡
[62.5-87.2]
(N=51) 70‡
[56.8-81.2]
(N=60)
M93-125 66§
[51.9-77.5]
(N=58) 61§
[48.5-72.9]
(N=67)
Long-Term Maintenance Treatment of Duodenal Ulcers
PREVACID 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 PREVACID than in patients treated with placebo over a 12-month period (Table 13) [see Indications and Usage (1.3)].
Table 13: Endoscopic Remission Rates Drug No. of Pts. Percent in Endoscopic Remission
Trial 0-3 mo. 0-6 mo. 0-12 mo.
%=Life Table Estimate
* (p≤0.001) versus placebo.
#1 PREVACID 15 mg daily 86 90%* 87%* 84%*
Placebo 83 49% 41% 39%
#2 PREVACID 30 mg daily 18 94%* 94%* 85%*
PREVACID 15 mg daily 15 87%* 79%* 70%*
Placebo 15 33% 0% 0%
In trial #2, no significant difference was noted between PREVACID 15 mg and 30 mg in maintaining remission.
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 PREVACID 15 mg and 30 mg once a day than with placebo (Table 14) [see Indications and Usage (1.4)].
Table 14: Gastric Ulcer Healing Rates PREVACID Placebo
(N=64)
Week 15 mg daily
(N=65) 30 mg daily
(N=63) 60 mg daily
(N=61)
* (p≤0.05) versus placebo.
4 64.6%* 58.1%* 53.3%* 37.5%
8 92.2%* 96.8%* 93.2%* 76.7%
Patients treated with any PREVACID 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 PREVACID 30 mg was provided by a meta-analysis of published and unpublished data.
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 8 weeks was statistically significantly higher with 30 mg of PREVACID 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 |
