Lansoprazole (Page 9 of 12)

14.2 Eradication of H. pylori 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 lansoprazole in combination with amoxicillin and clarithromycin as triple 14 day therapy or in combination with amoxicillin 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: Lansoprazole 30 mg twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily

Dual therapy: Lansoprazole 30 mg three times daily/amoxicillin 1 g three times daily

All treatments were for 14 days. H. pylori eradication was defined as two negative tests (culture and histology) at four to six 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 lansoprazole 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 (Tables 11 and 12) [see Indications and Usage ( 1.2)]

Table 11. H. pylori Eradication Rates – Triple Therapy (lansoprazole/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 86
[80.0–97.7] [73.3–93.5]
(N=48) (N=55)
M95-392 14 days 86 § 83 §
[75.7–93.6] [72.0–90.8]
(N=66) (N=70)
M95-399 14 days 85 82
[77.0–91.0] [73.9–88.1]
(N=113) (N=126)
10 days 84 81
[76.0–89.8] [73.9–87.6]
(N=123) (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 lansoprazole/amoxicillin and lansoprazole/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.

Table 12 H. pylori Eradication Rates – 14 Day Dual Therapy (lansoprazole/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 70
[62.5–87.2] [56.8–81.2]
(N=51) (N=60)
M93-125 66 § 61 §
[51.9–77.5] [48.5–72.9]
(N=58) (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 lansoprazole alone. § (p<0.05) versus lansoprazole alone or amoxicillin alone.

14.3 Maintenance of Healed Duodenal Ulcers

Lansoprazole 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 lansoprazole than in patients treated with placebo over a 12-month period (Table 13) [see Indications and Usage ( 1.4)]

Table 13 Endoscopic Remission Rates
Trial Drug No. of Pts. Percent in Endoscopic Remission
0–3 mo. 0–6 mo. 0–12 mo.
#1 Lansoprazole 15 mg daily 86 90%* 87%* 84%*
Placebo 83 49% 41% 39%
#2 Lansoprazole 30 mg daily 18 94%* 94%* 85%*
Lansoprazole 15 mg daily 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 lansoprazole 15 mg and 30 mg in maintaining remission.

14.4 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 lansoprazole 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
Lansoprazole Placebo (N=64)
Week 15 mg daily (N=65) 30 mg daily (N=63) 60 mg daily (N=61)
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 lansoprazole 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 lansoprazole 30 mg was provided by a meta-analysis of published and unpublished data.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.