denal ulcer disease (defined as an active ulcer or history of an ulcer within one year) eva luated 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 twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily
Dual therapy: PREVACID 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 4 to 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 (Tables 11 and 12) [see Indications and Usage (1.2)].
Table 11 H. pylori Eradication Rates – Triple Therapy (PREVACID/amoxicillin/clarithromycin) Percent of Patients Cured [95% Confidence Interval] (Number of patients) Study Duration Triple Therapy
eva luable Analysis* Triple Therapy
Intent-to-Treat Analysis†
* Based on eva luable 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 eva luable 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 eva luable analysis and (-9.7, 9.1) in the 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)
M95-399¶ 14 days 85
[77.0-91.0]
(N=113) 82
[73.9-88.1]
(N=126)
10 days 84
[76.0-89.8]
(N=123) 81
[73.9-87.6]
(N=135)
Table 12 H. pylori Eradication Rates – 14-Day Dual Therapy (PREVACID/amoxicillin) Percent of Patients Cured [95% Confidence Interval] (Number of patients) Study Dual Therapy
eva luable Analysis* Dual Therapy
Intent-to-Treat Analysis†
* Based on eva luable patients with confirmed duodenal ulcer ( |
