PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets (二十六)
eceptor Antagonist Therapy Week PREVACID
30 mg daily
(N=100) Ranitidine
150 mg twice daily
(N=51)
* (p≤0.001) versus ranitidine.
4 74.7%* 42.6%
8 83.7%* 32.0%
Long-Term Maintenance Treatment of Erosive Esophagitis
Two independent, double-blind, multicenter, controlled trials were conducted in patients with endoscopically confirmed healed esophagitis. Patients remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in patients treated with PREVACID than in patients treated with placebo over a 12-month period (Table 21).
Table 21: Endoscopic Remission Rates Percent in Endoscopic Remission
Trial Drug No. of Pts. 0-3 mo. 0-6 mo. 0-12 mo.
%=Life Table Estimate
* (p≤0.001) versus placebo.
PREVACID 15 mg daily 59 83%* 81%* 79%*
#1 PREVACID 30 mg daily 56 93%* 93%* 90%*
Placebo 55 31% 27% 24%
PREVACID 15 mg daily 50 74%* 72%* 67%*
#2 PREVACID 30 mg daily 49 75%* 72%* 55%*
Placebo 47 16% 13% 13%
Regardless of initial grade of erosive esophagitis, PREVACID 15 mg and 30 mg were similar in maintaining remission.
In a U.S., randomized, double-blind, study, PREVACID 15 mg daily (n = 100) was compared with ranitidine 150 mg twice daily (n = 106), at the recommended dosage, in patients with endoscopically-proven healed erosive esophagitis over a 12-month period. Treatment with PREVACID resulted in patients remaining healed (Grade 0 lesions) of erosive esophagitis for significantly longer periods of time than those treated with ranitidine (p<0.001). In addition, PREVACID was significantly more effective than ranitidine in providing complete relief of both daytime and nighttime heartburn. Patients treated with PREVACID remained asymptomatic for a significantly longer period of time than patients treated with ranitidine [see Indications and Usage (1.8)].
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
In open studies of 57 patients with pathological hypersecretory conditions, such as Zollinger-Ellison syndrome (ZES) with or without multiple endocrine adenomas, PREVACID significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia and pain. Doses ranging from 15 mg every other day to 180 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery and below 5 mEq/hr in patients with prior gastric surgery.
Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients [see Dosage and Administration (2.1)]. PREVACID was well tolerated at these high dose levels for prolonged periods (greater than four years in some patients). In most ZES patients, serum gastrin levels were not modified by PREVACID. However, in some patients, serum gastrin increased to levels greater than those present prior to initiation of lansoprazole therapy [see Indications and Usage (1.9)].
15 REFERENCES
1. National Committee for Clinical Laboratory Standards. Summary Minutes, Subcommittee on Antimicrobial Susceptibility Testing, Tampa, FL, January 11-13, 1998.
16 HOW SUPPLIED/STORAGE AND HANDLING
PREVACID Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with "TAP" and "PREVACID 15" imprinted on the capsules. The 30 mg capsules are opaque, ha |
