PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets (二十五)
g (twice daily) in decreasing the frequency and severity of day and night heartburn associated with GERD for the 8-week treatment period. No significant additional benefit from lansoprazole 30 mg once daily was observed [see Indications and Usage (1.7)].
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 2 or more and grades 3 and 4 signifying erosive disease, the percentages of patients with healing are presented in Table 18:
Table 18: Erosive Esophagitis Healing Rates Week PREVACID Placebo
(N=63)
15 mg daily
(N=69) 30 mg daily
(N=65) 60 mg daily
(N=72)
* (p≤0.001) versus placebo. † (p≤0.05) versus PREVACID 15 mg.
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 PREVACID 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.
PREVACID was also compared in a U.S. multicenter, double-blind study to a low dose of ranitidine in 242 patients with erosive reflux esophagitis. PREVACID 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 PREVACID
30 mg daily
(N=115) Ranitidine
150 mg twice daily
(N=127)
* (p≤0.001) versus ranitidine.
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 PREVACID 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 PREVACID 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, PREVACID produced healing rates similar to those shown above.
In a U.S. multicenter, double-blind, active-controlled study, 30 mg of PREVACID 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. PREVACID 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 PREVACID, as all patients had demonstrated unresponsiveness to the histamine H2-receptor antagonist mode of treatment. It does indicate, however, that PREVACID 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-R |
