Comparison of six Generic Vancomycin Products for the Treatment of Methicillin-Resistant Staphylococcus aureus, Experimental Endocarditis in Rabbits.
Dec 2012
Tattevin P, Saleh-Mghir A, Davido B, Ghout I, Massias L, Garcia de la Maria C, Miró JM, Perronne C, Laurent F, Crémieux AC.
Source
Pontchaillou Univ. Hosp., Rennes, France.
Abstract
Concerns have recently emerged about the potency and the quality of generic vancomycin (VAN) products approved for use in humans, based on experiments in a neutropenic mouse thigh infection model. However, other animal models may be more appropriate to decipher VAN generics bactericidal activity in vivo, and to predict their efficacy in humans. We aimed to compare the bactericidal activity of six generic VAN products currently used in France (Mylan, Sandoz), Spain (Hospira), Switzerland (Teva), and United States (Akorn-Strides, and APP), in a rabbit model of aortic valve endocarditis induced by 8 × 10(7) CFU of methicillin-resistant S. aureus (MRSA) COL strain (VAN MIC, 1.5 μg/ml). In vitro, there were no significant differences in the time-kill curve studies performed with the six generic VAN products. Ten rabbits in each group were treated with i.v. VAN, 60 mg/kg b.i.d., during 4 days. Mean peak serum VAN levels, measured 45 mn after the last injection, ranged from 35.5 (APP) to 45.9 μg/ml (Teva). Mean trough serum VAN levels, measured 12 h after the last injection, ranged from 2.3 (Hospira) to 9.2 μg/ml (APP). All generic VAN products were superior to controls (no treatment) in terms of residual organisms in vegetations (P < 0.02 for each comparison), and in spleen (P < 0.005 for each comparison). Pairwise comparisons of generic VAN products found no significant differences. In conclusion, a stringent MRSA endocarditis model found no significant differences in the bactericidal activity of six generic VAN products currently used in Europe and America
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