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Helidac

Clinical Pharmacology
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Clinical Pharmacology

Helidac

Graham et al. 19923 studied long-term outcome in patients treated for active duodenal ulcer by frequently monitoring for ulcer recurrence for up to 1 year after therapy. This study compared patients who received bismuth subsalicylate (BSS), metronidazole (MTZ), and tetracycline hydrochloride (TCN) for 2 weeks with ranitidine to those who received ranitidine alone. The ulcer recurrence rates at 6 months and 1 year regardless of post-treatment eradication status are summarized below for duodenal ulcer patients who were H. pylori positive at baseline.

Duodenal Ulcer Recurrence Rates at 6 Months†


Therapy All Patients H. pylori Negative
Patients
Post-Treatment
BSS/MTZ/TCN + Ranitidine 4% (1/25) 6% (1/18)
Ranitidine 85% (17/20) 100% (1/1)

Duodenal Ulcer Recurrence Rates at 1 Year†


Therapy All Patients H. pylori Negative
Patients
Post-Treatment
BSS/MTZ/TCN + Ranitidine 9% (2/22) 13% (2/16)
Ranitidine 95% (18/19) 100% (1/1)
† Includes all patients randomized to therapy who were H. pylori positive at baseline (by culture, histology, and/or urea breath test) who had ulcer healing and 24 or 48 weeks of endoscopic follow-up data.

Eradication of H. pylori in Patients with a History of Duodenal Ulcer Disease: A controlled, multicenter trial conducted by P&GP in the U.S. compared the rates of eradication of H. pylori following 14 days of treatment with HELIDAC Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride) or control (bismuth sub-salicylate, metronidazole placebo, and tetracycline placebo) in 103 patients infected with H. pylori who had a history of duodenal ulcer disease. No H2-receptor antagonist was used. The primary efficacy measurement was H. pylori eradication assessed by rapid urease testing, histology, and culture at least 4 weeks after the last dose. HELI-DAC Therapy was effective in eradicating H. pylori. The eradication rates are noted in the table below:

H. pylori Eradication Rates in Patients with a History of Duodenal Ulcer Disease


Population Evaluable Population† Intent-To-Treat Population‡
Therapy HELIDAC
Therapy		 Control HELIDAC
Therapy		 Control
Eradication Rate
(Number of Patients)		 71%
(40/56)		 7%
(2/30)		 72%
(41/57)		 6%
(2/32)
95% confidence interval 60, 83 0a , 16 60, 84 0a , 15
a The lower limit for this calculation was -2.2 but was truncated to 0 for reporting purposes.
† Evaluable patients were defined as having a history of a confirmed duodenal ulcer prior to treatment and having taken ≥ 70% of each component of HELIDAC Therapy (bismuth subsalicylate, metronida-zole, tetracycline hydrochloride) during the 14-day dosing period. Eradication was defined as no evidence of H. pylori infection by two or three diagnostic tests (culture, histology, and rapid urease test) from at least 4 weeks to 6 weeks post-treatment. Excluded from the evaluable population were patients who were non-compliant with medication, patients who were not infected with H. pylori at baseline, and patients without ulcer documentation. Three patients in the HELIDAC Therapy group and one patient in the Control group were included as eradication failures because they withdrew from the study due to treatment-related adverse events.
‡ Patients were included in the analysis if they had documented H. pylori infection at baseline and had confirmed duodenal ulcer disease. All dropouts were included as failures of therapy. Eradication was defined as no evidence of H. pylori infection by culture, histology, or rapid urease test.
Brand Name: Helidac
Generic Name: Bismuth Subsalicylate
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