The safety of ceftobiprole has been evaluated in single-dose and multiple-dose pharmacokinetic studies and in 2 Phase 3 clinical trials of cSSSIs.[33,34,42,43] In the single-dose study, 8 of 30 subjects experienced adverse effects. Of these 8 subjects, 10 adverse effects were reported, the most common (n = 7) being caramel-like taste disturbance due to ceftobiprole medocaril being rapidly metabolized to diacetyl. Other adverse effects reported were nausea (2) and vomiting (1). No reaction was considered serious or needed treatment. In addition, no electrocardiographic, vital sign, or laboratory changes were found. Similar results were shown in the multiple-dose study (n = 12), where the most frequent adverse effects were nausea, headache, and dysgeusia, all classified as mild to moderate in severity. Minor laboratory changes (increased serum creatinine and alanine aminotransferase) occurred but were not considered clinically significant.
Phase 3 clinical trials have confirmed the relative safety of ceftobiprole. One trial found no significant differences between total adverse events (52% for ceftobiprole vs 51% for vancomycin), total serious adverse events (6% vs 6%), discontinuation of drug (4% vs 6%), or abnormal laboratory values between treatment groups. However, more patients in the ceftobiprole group experienced nausea (14% vs 8%; p < 0.05), vomiting (7% vs 4%; NS), and dysgeusia (8% vs 1%; NS), whereas more patients in the vancomycin group experienced pruritus (6% vs 3%; NS). Similar safety results were replicated in the other cSSSI clinical trial ( Table 4 ). Laboratory values at baseline compared with those at the end of therapy were not significantly different in the ceftobiprole groups.[42,43] There were 3 total deaths in the ceftobiprole groups, but none was considered to be related to the study drug.[42,43]
The Annals of Pharmacotherapy. 2008;42(6):806-816. © 2008 Harvey Whitney Books Company
Cite this: Ceftobiprole: An Extended-Spectrum Anti–Methicillin-Resistant Staphylococcus aureus Cephalosporin - Medscape - Jun 01, 2008.