The Annals of pharmacotherapy · 2022
Omadacycline and Clostridioides difficile: A Systematic Review of Preclinical and Clinical Evidence.
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Garey Kevin W, Rose Warren, Gunter Kyle, Serio Alisa W, Wilcox Mark H
Аннотация
OBJECTIVE: The objective of this systematic review is to summarize in vitro, preclinical, and human data related to omadacycline and Clostridioides difficile infection (CDI).
DATA SOURCES: PubMed and Google Scholar were searched for "omadacycline" AND ("Clostridium difficile" OR "C difficile" OR "Clostridioides difficile") for any studies published before February 15, 2022. The US Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) was searched for omadacycline (for reports including "C. difficile" or "CDI" or "gastrointestinal infection"). The publications list publicly available at Paratek Pharmaceuticals, Inc. Web site was reviewed.
STUDY SELECTION AND DATA EXTRACTION: Publications presenting primary data on omadacycline and C. difficile published in English were included.
DATA SYNTHESIS: Preclinical and clinical evidence was extracted from 14 studies. No case reports in indexed literature and no reports on FDA AERS were found. Omadacycline has potent in vitro activity against many C. difficile clinical strains and diverse ribotypes. In phase 3 studies, there were no reports of CDI in patients who received omadacycline for either community-acquired bacterial pneumonia or acute bacterial skin and skin structure infection.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Omadacycline should be considered a low-risk antibiotic regarding its propensity to cause CDI.
CONCLUSIONS: Reducing the burden of CDI on patients and the health care system should be a priority. Patients with appropriate indications who are at heightened risk of CDI may be suitable candidates for omadacycline therapy. In these patients, omadacycline may be preferable to antibiotics with a high CDI risk.
DATA SOURCES: PubMed and Google Scholar were searched for "omadacycline" AND ("Clostridium difficile" OR "C difficile" OR "Clostridioides difficile") for any studies published before February 15, 2022. The US Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) was searched for omadacycline (for reports including "C. difficile" or "CDI" or "gastrointestinal infection"). The publications list publicly available at Paratek Pharmaceuticals, Inc. Web site was reviewed.
STUDY SELECTION AND DATA EXTRACTION: Publications presenting primary data on omadacycline and C. difficile published in English were included.
DATA SYNTHESIS: Preclinical and clinical evidence was extracted from 14 studies. No case reports in indexed literature and no reports on FDA AERS were found. Omadacycline has potent in vitro activity against many C. difficile clinical strains and diverse ribotypes. In phase 3 studies, there were no reports of CDI in patients who received omadacycline for either community-acquired bacterial pneumonia or acute bacterial skin and skin structure infection.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Omadacycline should be considered a low-risk antibiotic regarding its propensity to cause CDI.
CONCLUSIONS: Reducing the burden of CDI on patients and the health care system should be a priority. Patients with appropriate indications who are at heightened risk of CDI may be suitable candidates for omadacycline therapy. In these patients, omadacycline may be preferable to antibiotics with a high CDI risk.