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Enterochromaffin-like (ECL) Cell Effects During lifetime exposure of rats with up to 150 mg/ kg/ day of lansoprazole dosed seven days per week, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats. (See PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility.) Gastric biopsy specimens from the body of the stomach from approximately 150 patients treated continuously with lansoprazole for at least one year did not show evidence of ECL cell effects similar to those seen in rat studies. Longer term data are needed to rule out the possibility of an increased risk of the development of gastric tumors in patients receiving long-term therapy with lansoprazole. Text Continues Below
Other Gastric Effects in Humans Lansoprazole did not significantly affect mucosal blood flow in the fundus of the stomach. Due to the normal physiologic effect caused by the inhibition of gastric acid secretion, a decrease of about 17% in blood flow in the antrum, pylorus, and duodenal bulb was seen. Lansoprazole significantly slowed the gastric emptying of digestible solids. Lansoprazole increased serum pepsinogen levels and decreased pepsin activity under basal conditions and in response to meal stimulation or insulin injection. As with other agents that elevate intragastric pH, increases in gastric pH were associated with increases in nitrate-reducing bacteria and elevation of nitrite concentration in gastric juice in patients with gastric ulcer. No significant increase in nitrosamine concentrations was observed. Serum Gastrin Effects In over 2100 patients, median fasting serum gastrin levels increased 50% to 100% from baseline but remained within normal range after treatment with lansoprazole given orally in doses of 15 mg to 60 mg. These elevations reached a plateau within two months of therapy and returned to pretreatment levels within four weeks after discontinuation of therapy. PREVACID Endocrine Effects Human studies for up to one year have not detected any clinically significant effects on the endocrine system. Hormones studied include testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), prolactin, cortisol, estradiol, insulin, aldosterone, parathormone, glucagon, thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), and somatotropic hormone (STH). Lansoprazole in oral doses of 15 to 60 mg for up to one year had no clinically significant effect on sexual function. In addition, lansoprazole in oral doses of 15 to 60 mg for two to eight weeks had no clinically significant effect on thyroid function. In 24-month carcinogenicity studies in Sprague-Dawley rats with daily dosages up to 150 mg/ kg, proliferative changes in the Leydig cells of the testes, including benign neoplasm, were increased compared to control rates. Other Effects No systemic effects of lansoprazole on the central nervous system, lymphoid, hematopoietic, renal, hepatic, cardiovascular or respiratory systems have been found in humans. No visual toxicity was observed among 56 patients who had extensive baseline eye evaluations, were treated with up to 180 mg/ day of lansoprazole and were observed for up to 58 months. Other rat-specific findings after lifetime exposure included focal pancreatic atrophy, diffuse lymphoid hyperplasia in the thymus, and spontaneous retinal atrophy. Microbiology Lansoprazole, clarithromycin and/ or amoxicillin have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Helicobacter Helicobacter pylori Pretreatment Resistance Clarithromycin pretreatment resistance (³2. 0 µg/ mL) was 9. 5% (91/ 960) by E-test and 11. 3% (12/ 106) by agar dilution in the dual and triple therapy clinical trials (M93-125, M93-130, M93-131, M95-392, and M95-399). Amoxicillin pretreatment susceptible isolates (£0. 25 µg/ mL) occurred in 97. 8% (936/ 957) and 98. 0% (98/ 100) of the patients in the dual and triple therapy clinical trials by E-test and agar dilution, respectively. Twenty-one of 957 patients (2. 2%) by E-test and 2 of 100 patients (2. 0%) by agar dilution had amoxicillin pretreatment MICs of >0. 25 µg/ mL. One patient on the 14-day triple therapy regimen had an unconfirmed pretreatment amoxicillin minimum inhibitory concentration (MIC) of >256 µg/ mL by E-test and the patient was eradicated of H. pylori. PREVACID Clarithromycin Susceptibility Test Results and Clinical/ Bacteriological Outcomes a Clarithromycin Pretreatment Results Clarithromycin Post-treatment Results H. pylori negative – eradicated H. pylori positive – not eradicated
Post-treatment susceptibility results
S b I b R b No MIC
Triple Therapy 14-Day (lansoprazole 30 mg b. i. d./ amoxicillin 1 gm b. i. d./ clarithromycin 500 mg b. i. d.) (M95-399, M93-131, M95-392) Susceptible b 112 105 7
Intermediate b 3 3
Resistant b 17 6 7 4
Triple Therapy 10-Day (lansoprazole 30 mg b. i. d./ amoxicillin 1 gm b. i. d./ clarithromycin 500 mg b. i. d.) (M95-399) Susceptible b 42 40 1 1
Intermediate b
Resistant b 4 1 3 a
Includes only patients with pretreatment clarithromycin susceptibility test results b
Susceptible (S) MIC £0. 25 µg/ mL, Intermediate (I) MIC 0. 5 -1. 0 µg/ mL, Resistant (R) MIC ³2 µg/ mL Patients not eradicated of H. pylori following lansoprazole/ amoxicillin/ clarithromycin triple therapy will likely have clarithromycin resistant H. pylori. Therefore, for those patients who fail therapy, clarithromycin susceptibility testing should be done when possible. Patients with clarithromycin resistant H. pylori should not be treated with lansoprazole/ amoxicillin/ clarithromycin triple therapy or with regimens which include clarithromycin as the sole antimicrobial agent. Amoxicillin Susceptibility Test Results and Clinical/ Bacteriological Outcomes In the dual and triple therapy clinical trials, 82. 6% (195/ 236) of the patients that had pretreatment amoxicillin susceptible MICs (£0. 25 µg/ mL) were eradicated of H. pylori. Of those with pretreatment amoxicillin MICs of >0. 25 µg/ mL, three of six had the H. pylori eradicated. A total of 30% (21/ 70) of the patients failed lansoprazole 30 mg t. i. d./ amoxicillin 1 gm t. i. d. dual therapy and a total of 12. 8% (22/ 172) of the patients failed the 10-and 14-day triple therapy regimens. Post-treatment susceptibility results were not obtained on 11 of the patients who failed therapy. Nine of the 11 patients with amoxicillin post-treatment MICs that failed the triple therapy regimen also had clarithromycin resistant H. pylori isolates. Susceptibility Test for Helicobacter pylori The reference methodology for susceptibility testing of H. pylori is agar dilution MICs. 1 One to three microliters of an inoculum equivalent to a No. 2 McFarland standard (1 x 10 7 – 1 x 10 8 CFU/ mL for H. pylori) are inoculated directly onto freshly prepared antimicrobial-containing Mueller-Hinton agar plates with 5% aged defibrinated sheep blood (³ 2 weeks old). The agar dilution plates are incubated at 35° C in a microaerobic environment produced by a gas generating system suitable for campylobacters. After 3 days of incubation, the MICs are recorded as the lowest concentration of antimicrobial agent required to inhibit growth of the organism. The clarithromycin and amoxicillin MIC values should be interpreted according to the following criteria:
Clarithromycin MIC (µg/ mL) a Interpretation
£0. 25 Susceptible (S) 0. 5-1. 0 Intermediate (I) ³2. 0 Resistant (R) Amoxicillin MIC (µg/ mL) b Interpretation
£0. 25 Susceptible (S) a These are tentative breakpoints for the agar dilution methodology and they should not be used to interpret results obtained using alternative methods.
b There were not enough organisms with MICs >0. 25 µg/ mL to determine a resistance breakpoint. Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard clarithromycin and amoxicillin powders should provide the following MIC values:
Microorganism Antimicrobial Agent MIC (µg/ mL) a
H. pylori ATCC 43504 Clarithromycin 0. 015-0. 12 µg/ mL
H. pylori ATCC 43504 Amoxicillin 0. 015-0. 12 µg/ mL a
These are quality control ranges for the agar dilution methodology and they should not be used to control test results obtained using alternative methods. Reference 1. National Committee for Clinical Laboratory Standards. Summary Minutes, Subcommittee on Antimicrobial Susceptibility Testing, Tampa, FL, January 11-13, 1998. CLINICAL STUDIES Duodenal Ulcer In a U. S. multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of PREVACID once daily) study of 284 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after two and four weeks was significantly higher with all doses of PREVACID than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with PREVACID 15 mg. Based on this study and the second study described below, the recommended dose of PREVACID in duodenal ulcer is 15 mg per day. PREVACID Duodenal Ulcer Healing Rates
PREVACID Placebo 15 mg q. d. 30 mg q. d. 60 mg q. d.
Week (N= 68) (N= 74) (N= 70) (N= 72)
2 42. 4% * 35. 6% * 39. 1% * 11. 3%
4 89. 4% * 91. 7% * 89. 9% * 46. 1% *
(p£0. 001) versus placebo. PREVACID 15 mg was significantly more effective than placebo in relieving day and nighttime abdominal pain and in decreasing the amount of antacid taken per day. In a second U. S. multicenter study, also double-blind, placebo-controlled, dose-comparison (15 and 30 mg of PREVACID once daily), and including a comparison with ranitidine, in 280 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after four weeks was significantly higher with both doses of PREVACID than with placebo. There was no evidence of a greater or earlier response with the higher dose of PREVACID. Although the 15 mg dose of PREVACID was superior to ranitidine at 4 weeks, the lack of significant difference at 2 weeks and the absence of a difference between 30 mg of PREVACID and ranitidine leaves the comparative effectiveness of the two agents undetermined. Duodenal Ulcer Healing Rates
PREVACID Ranitidine Placebo 15 mg q. d. 30 mg q. d. 300 mg h. s.
Week (N= 80) (N= 77) (N= 82) (N= 41)
2 35. 0% 44. 2% 30. 5% 34. 2%
4 92. 3%** 80. 3%* 70. 5%* 47. 5% *
(p£0. 05) versus placebo. ** (p£0. 05) versus placebo and ranitidine. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the U. S. in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) evaluated the efficacy of PREVACID in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy or in combination with amoxicillin capsules as dual 14-day therapy for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of two different eradication regimens were established:
Triple therapy: PREVACID 30 mg b. i. d./ amoxicillin 1 gm b. i. d./
clarithromycin 500 mg b. i. d. Dual therapy: PREVACID 30 mg t. i. d./
amoxicillin 1 gm t. i. d. PREVACID All treatments were for 14 days. H. pylori eradication was defined as two negative tests (culture and histology) at 4-6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. A randomized, double-blind clinical study performed in the U. S. in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) compared the efficacy of PREVACID triple therapy for 10 and 14 days. This study established that the 10-day triple therapy was equivalent to the 14-day triple therapy in eradicating H. pylori.
H. pylori Eradication Rates – Triple Therapy (PREVACID/ amoxicillin/ clarithromycin)
Percent of Patients Cured [95% Confidence Interval]
(Number of patients) Study Duration Triple Therapy Evaluable Analysis * Triple Therapy Intent-to-Treat Analysis #
M93-131 14 days 92 *
[80. 0-97. 7]
(N= 48) 86 *
[73. 3-93. 5]
(N= 55) M95-392 14 days 86 *
[75. 7-93. 6]
(N= 66) 83 *
[72. 0-90. 8]
(N= 70) 14 days 85
[77. 0-91. 0]
(N= 113) 82
[73. 9-88. 1]
(N= 126) M95-399 + 10 days 84
[76. 0-89. 8]
(N= 123) 81
[73. 9-87. 6]
(N= 135) *
Based on evaluable patients with confirmed duodenal ulcer (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 evaluable 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/ amoxicillin and PREVACID/ clarithromycin dual therapy
* (p< 0. 05) versus clarithromycin/ amoxicillin dual therapy
+ The 95% confidence interval for the difference in eradication rates, 10-day minus 14-day is (-10. 5, 8. 1) in the evaluable analysis and (-9. 7, 9. 1) in the intent-to-treat analysis. PREVACID H. pylori Eradication Rates – 14-Day Dual Therapy (PREVACID/ amoxicillin)
Percent of Patients Cured [95% Confidence Interval]
(Number of patients)
Study Dual Therapy Evaluable Analysis * Dual Therapy Intent-to-Treat Analysis #
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) *
Based on evaluable patients with confirmed duodenal ulcer (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. 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. Endoscopic Remission Rates
Percent in Endoscopic Remission Trial Drug No. of Pts. 0-3 mo. 0-6 mo. 0-12 mo.
#1 PREVACID 15 mg q. d. 86 90% * 87% * 84% *
Placebo 83 49% 41% 39% #2 PREVACID 30 mg q. d. 18 94% * 94% * 85% *
PREVACID 15 mg q. d. 15 87% * 79% * 70% *
Placebo 15 33% 0% 0%
%= Life Table Estimate *
(p£0. 001) versus placebo. In trial #2, no significant difference was noted between PREVACID 15 mg and 30 mg in maintaining remission. PREVACID
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. Gastric Ulcer Healing Rates PREVACID Placebo
15 mg q. d. 30 mg q. d. 60 mg q. d.
Week (N= 65) (N= 63) (N= 61) (N= 64)
4 64. 6% * 58. 1% * 53. 3% * 37. 5%
8 92. 2% * 96. 8% * 93. 2% * 76. 7% *
(p£0. 05) versus placebo. 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 no statistically significant difference between PREVACID 30 mg q. d. and the active control on symptom relief (i. e., abdominal pain). NSAID-Associated Gastric Ulcer Healing Rates 1
Study #1 PREVACID Active Control 2 30 mg q. d. Week 4 60% (53/ 88) 3 28% (23/ 83)
Week 8 79% (62/ 79) 3 55% (41/ 74)
Study #2 PREVACID Active Control 2 30 mg q. d. Week 4 53% (40/ 75) 38% (31/ 82)
Week 8 77% (47/ 61) 3 50% (33/ 66) 1
Actual observed ulcer( s) healed at time points + 2 days 2
Dose for healing of gastric ulcer 3
(p£0. 05) versus the active control PREVACID 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.
NSAID-Associated Gastric Ulcer Risk Reduction Rates
% of Patients Remaining Gastric Ulcer-Free 1 PREVACID PREVACID Misoprostol Placebo
15 mg q. d. 30 mg q. d. 200 µg q. i. d. Week (N= 121) (N= 116) (N= 106) (N= 112)
4 90% 92% 96% 66% 8 86% 88% 95% 60%
12 80% 82% 93% 51% 1
% = Life Table Estimate
(p< 0. 001) PREVACID 15 mg q. d. versus placebo; PREVACID 30 mg q. d. versus placebo; and misoprostol
200 µg q. i. d. versus placebo. (p< 0. 05) Misoprostol 200 µg q. i. d. versus PREVACID 15 mg q. d.; and misoprostol 200 µg q. i. d. versus PREVACID 30 mg q. d. 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 were as follows: PREVACID
Frequency of Heartburn
Variable Placebo (n= 43) PREVACID 15 mg (n= 80) PREVACID 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% *
* (p< 0. 01) versus placebo. PREVACID 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 (b. i. d.) 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. PREVACID
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 were as follows: Erosive Esophagitis Healing Rates PREVACID Placebo
15 mg q. d. 30 mg q. d. 60 mg q. d.
Week (N= 69) (N= 65) (N= 72) (N= 63)
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% *
(p£0. 001) versus placebo. *
(p£0. 05) versus PREVACID 15 mg. 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 q. d. 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 b. i. d. as shown below. Erosive Esophagitis Healing Rates
Week
PREVACID 30 mg q. d.
(N= 115)
Ranitidine 150 mg b. i. d.
(N= 127)
2 66. 7% * 38. 7%
4 82. 5% * 52. 0%
6 93. 0% * 67. 8%
8 92. 1% * 69. 9% * (p£0. 001) versus ranitidine. 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 b. i. d. 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 q. i. d., 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 b. i. d. 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 b. i. d. 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.
Reflux Esophagitis Healing Rates in Patients Poorly Responsive to Histamine H2-Receptor Antagonist Therapy
Week
PREVACID 30 mg q. d.
(N= 100)
Ranitidine 150 mg b. i. d.
(N= 51)
4 74. 7% * 42. 6%
8 83. 7% * 32. 0% *
(p£0. 001) versus ranitidine. 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. Endoscopic Remission Rates Percent in Endoscopic Remission Trial Drug No. of Pts. 0-3 mo. 0-6 mo. 0-12 mo.
#1 PREVACID 15 mg q. d. 59 83% * 81% * 79% *
PREVACID 30 mg q. d. 56 93% * 93% * 90% *
Placebo 55 31% 27% 24% #2 PREVACID 15 mg q. d. 50 74% * 72% * 67% *
PREVACID 30 mg q. d. 49 75% * 72% * 55% *
Placebo 47 16% 13% 13%
%= Life Table Estimate *
(p£0. 001) versus placebo. 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 q. d. (n = 100) was compared with ranitidine 150 mg b. i. d (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. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome In open studies of 57 patients with pathological hypersecretory conditions, such as Zollinger-Ellison (ZE) syndrome 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.) PREVACID was well tolerated at these high dose levels for prolonged periods (greater than four years in some patients). In most ZE 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. Page: << Prev | 1 | 2 | 3 | 4 | 5
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