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.
Lay abstract Pneumonia is a major cause of morbidity and mortality in East Asia and treatment is complicated by increasing rates of antibiotic resistance in this region. This study analyzed results from two clinical trials that assessed the benefits of the novel antibiotic ceftobiprole in patients from mainland China, Hong Kong, Taiwan and South Korea. In East Asian patients with either community- or hospital-acquired pneumonia, outcomes following ceftobiprole treatment were similar to those achieved with established antibiotics. There was also an indication that ceftobiprole may improve the rate at which causative bacteria were eradicated and may potentially reduce mortality rates compared with other antibiotics. Ceftobiprole was well tolerated in this population and will be a useful option for the treatment of pneumonia in East Asia.