4.3 Article

Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies

期刊

FUTURE MICROBIOLOGY
卷 16, 期 8, 页码 -

出版社

FUTURE MEDICINE LTD
DOI: 10.2217/fmb-2021-0042

关键词

acute bacterial skin and skin structure infections; ceftobiprole; community-acquired pneumonia; elderly; hospital-acquired pneumonia; older; Phase III

资金

  1. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response [HSO100201600002C]
  2. Biomedical Advanced Research and Development Authority (BARDA) [HSO100201600002C]
  3. Basilea Pharmaceutica International Ltd, Basel, Switzerland

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The study evaluated the efficacy and safety of the novel antibiotic ceftobiprole in patients aged 65 and older. Results showed that ceftobiprole offered similar benefits to established antibiotics in older patients with skin infections or pneumonia, with some evidence suggesting a quicker response in older patients. Overall, ceftobiprole was well tolerated and a useful treatment option for infections in older patients.
Lay abstract Infections are a common cause of severe disease and death in older patients. Antibiotic treatment may also be complicated by age-related changes within the body. The present study analyzed results from three large clinical trials that assessed the benefits of the novel antibiotic ceftobiprole in the older population. In patients aged over 65 years with skin infections or with pneumonia acquired either in the community or in a hospital setting, ceftobiprole offered similar benefits to established antibiotics. There was also some preliminary evidence that older patients may respond more quickly to ceftobiprole compared with the other antibiotics used in these studies. Overall, ceftobiprole was well tolerated and will be a useful treatment option for infections in older patients. Aim: To evaluate the efficacy and safety of ceftobiprole in patients aged >= 65 years. Materials & methods: We conducted a post hoc analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Results: Findings for patients aged >= 65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged >= 75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16.3% [95% CI:1.8-30.8]). The safety profile was similar between treatment groups in all studies. Conclusion: This analysis further supports the efficacy and safety of ceftobiprole in older patients with acute bacterial skin and skin structure infections or pneumonia. Clinicaltrials.gov trial identifiers: , , ,

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