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PIII‐50
Author(s) -
Loebstein R.,
Halkin H.,
Dushenat M.,
Silverman B.,
Shalev V.,
Friedman N.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.258
Subject(s) - medicine , concomitant , adverse effect , clinical pharmacology , gastroenterology , pharmacology
BACKGROUND Concerns have been raised regarding potential increased risk of UGIT adverse effects with generic alendronate formulations. PATIENTS AND METHODS In a retrospective database analysis of health resource utilization related to UGITO, we compared rates of: new use of UGIT medications (H2 blockers and proton pump inhibitors), gastroenterology specialist (GE) visits, and UGIT endoscopies, and total hospital admissions, in patients treated for > 3 months with: brand alendronate 10 mg/d (n=2875), generic 1 (Teva, Israel) 10 mg/d (n=1244), generic 2 (Unipharm, Israel) 10 mg/d (n=1088) and brand alendronate 70 mg/week (n=6893). RESULTS Rates of new use of UGIT medications (5.7%, 4.7%, 4.9% and 4.0% respectively) and of GE visits (0.8%, 0.7%, 0.3% and 0.8%) respectively) were not significantly different among the 4 formulations (all comparisons adjusted for age and concomitant use of NSAIDs). Endoscopies totaled 58, respective rates were 0.3%, 0.7% 1.1% and 0.4%, with generic 2 significantly higher compared to brand 70 mg/weekly, O.R. (95% CL): 3.0 (1.4–6.5). The most common findings were hiatus hernia or mild‐moderate reflux esophagitis. Hospital admissions rates were not different: 4.9%, 5.2%, 4.5% and 3.6% respectively. CONCLUSIONS Our findings, expressed in 1/4 outcome variables, indicate possible variation in patient symptoms and/or physician responses, during treatment with different generic alendronate formulations. Clinical Pharmacology & Therapeutics (2005) 79 , P71–P71; doi: 10.1016/j.clpt.2005.12.258