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Aciphex
Clinical Pharmacology
Aciphex
Clarithromycin Susceptibility Test Results and Clinical/Bacteriologic Outcomes: For the U.S. multicenter study, the baseline H. pylori clarithromycin susceptibility results and the H. pylori eradication results post-treatment are shown in the table below:
| Clarithromycin Susceptibility Test Results and Clinical/Bacteriologic Outcomes a for a Three Drug Regimen (Rabeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 7 or 10 days) | |||||||
| Days of RAC Therapy | Clarithromycin Pretreatment Results | Total Number | H. pylori Negative (Eradicated) | H. pylori Positive (Persistent) Post-Treatment Susceptibility Results | |||
| S b | I b | R b | No MIC | ||||
| 7 | Susceptible b | 129 | 103 | 2 | 0 | 1 | 23 |
| 7 | Intermediate b | 0 | 0 | 0 | 0 | 0 | 0 |
| 7 | Resistant b | 16 | 5 | 2 | 1 | 4 | 4 |
| 10 | Susceptible b | 133 | 111 | 3 | 1 | 2 | 16 |
| 10 | Intermediate b | 0 | 0 | 0 | 0 | 0 | 0 |
| 10 | Resistant b | 9 | 1 | 0 | 0 | 5 | 3 |
| a Includes only patients with pretreatment and
post-treatment clarithromycin susceptibility test results. b Susceptible (S) MIC < 0.25 (xg/mL, Intermediate (I) MIC = 0.5 (xg/mL, Resistant (R) MIC > 1 |xg/mL |
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Patients with persistent H. pylori infection following rabeprazole, amoxicillin, and clarithromycin therapy will likely have clarithromycin resistant clinical isolates. Therefore, clarithromycin susceptibility testing should be done when possible. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
Amoxicillin Susceptibility Test Results and Clinical/Bacteriological Outcomes: In the U.S. multicenter study, a total of > 99% (558/560) of patients had H. pylori isolates which were considered to be susceptible (MIC ≤ 0.25 µg/mL) to amoxicillin at baseline. The other 2 patients had baseline H. pylori isolates with an amoxicillin MIC of 0.5 µg/mL, and both isolates were clarithromycin-resistant at baseline; in one case the H. pylori was eradicated. In the 7- and 10-day treatment groups 75% (107/145) and 79% (112/142), respectively, of the patients who had pretreatment amoxicillin susceptible MICs (≤ 0.25 µg/mL) were eradicated of H. pylori. No patients developed amoxicillin-resistant H. pylori during therapy.
CLINICAL STUDIES
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
In a U.S., multicenter, randomized, double-blind, placebo-controlled study, 103 patients were treated for up to eight weeks with placebo, 10 mg, 20 mg or 40 mg ACIPHEX® QD. For this and all studies of GERD healing, only patients with GERD symptoms and at least grade 2 esophagitis (modified Hetzel-Dent grading scale) were eligible for entry. Endoscopic healing was defined as grade 0 or 1. Each rabeprazole dose was significantly superior to placebo in producing endoscopic healing after four and eight weeks of treatment. The percentage of patients demonstrating endoscopic healing was as follows:
Healing of Erosive or Ulcerative Gastroesophageal Reflux
Disease (GERD)
Percentage of Patients Healed
| Week | 10 mg ACIPHEX® QD N=27 |
20 mg ACIPHEX® QD N=25 |
40 mg ACIPHEX® QD N=26 |
Placebo N=25 |
| 4 | 63%* | 56%* | 54%* | 0% |
| 8 | 93%* | 84%* | 85%* | 12% |
| *(p<0.001 versus placebo) | ||||
Generic Name: Rabeprazole Sodium
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