A post hoc analysis of two Phase III trials showing the efficacy and tolerability of ceftobiprole in East Asian patients

Haihui Huang, Lei Gao, Marc Engelhardt, Mikael Saulay, Kamal Hamed, Haihui Huang, Lei Gao, Marc Engelhardt, Mikael Saulay, Kamal Hamed

Abstract

Aim: To evaluate the efficacy and safety of ceftobiprole in patients from East Asia. Materials & methods: A post hoc analysis was conducted of two randomized, double-blind, Phase III studies in patients with community- or hospital-acquired pneumonia. Results: Findings for East Asian patients were consistent with the overall study populations. A trend toward higher microbiological eradication rates and numerically lower rates of all-cause mortality were reported for ceftobiprole versus comparators (all-cause mortality [intent-to-treat]: community-acquired pneumonia, 1.5 vs 2.8%; hospital-acquired pneumonia excluding ventilator-associated pneumonia, 5.9 vs 11.4%). The incidence of adverse events was similar between treatment groups. Conclusion: This post hoc analysis supports the efficacy and tolerability of ceftobiprole in East Asian patients. ClinicalTrials.gov trial identifiers: NCT00326287, NCT00210964, NCT00229008.

Keywords: East Asia; Phase III; ceftobiprole; community-acquired pneumonia; hospital-acquired pneumonia.

Source: PubMed

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