干旱区生态环境知识资源中心(Arid): Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections

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DOI	10.1093/jac/dkaa558
	Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections
	Pai, Manjunath P.; Wilcox, Mark H.; Chitra, Surya; McGovern, Paul C.
通讯作者	Pai, MP (corresponding author), Univ Michigan, Coll Pharm, Dept Clin Pharm, Ann Arbor, MI 48109 USA.
来源期刊	JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
ISSN	0305-7453
EISSN	1460-2091
出版年	2021
卷号	76 期号:5 页码:1315-1322
英文摘要	Objectives: The objectives of this post-hoc analysis were to examine the safety and efficacy of omadacycline by BMI categories and diabetes history in adults with acute bacterial skin and skin structure infections (ABSSSI) from two pivotal Phase III studies. Patients and methods: OASIS-1 (ClinicalTrials.gov identifier NCT02378480): patients were randomized 1:1 to IV omadacycline or linezolid for 7-14 days, with optional transition to oral medication. OASIS-2 (ClinicalTrials.gov identifier NCT02877927): patients received once-daily oral omadacycline or twice-daily oral linezolid for 7-14 days. Early clinical response (ECR) was defined as >= 20% reduction in lesion size 48-72 h after the first dose. Clinical success at post-treatment evaluation (PTE; 7-14 days after the last dose) was defined as symptom resolution such that antibacterial therapy was unnecessary. Safety was assessed by treatment-emergent adverse events and laboratory measures. Between-treatment comparisons were made with regard to WHO BMI categories and diabetes history. Results: Patients were evenly distributed among healthy weight, overweight and obese groups. Clinical success for omadacycline-treated patients at ECR and PTE was similar across BMI categories. Outcomes by diabetes status were similar in omadacycline- and linezolid-treated patients: at ECR, clinical success rates were lower for those with diabetes; at PTE, clinical success was similar between treatment groups regardless of diabetes history. The safety of omadacycline and linezolid was largely similar across BMI groups and by diabetes history. Conclusions: Omadacycline efficacy in patients with higher BMI and in patients with diabetes was consistent with results from two pivotal Phase III ABSSSI trials. Fixed-dose omadacycline is an appropriate treatment for ABSSSI in adults regardless of BMI.
类型	Article
语种	英语
开放获取类型	hybrid, Green Published
收录类别	SCI-E
WOS记录号	WOS:000648949700028
WOS关键词	OBESE ; VANCOMYCIN
WOS类目	Infectious Diseases ; Microbiology ; Pharmacology & Pharmacy
WOS研究方向	Infectious Diseases ; Microbiology ; Pharmacology & Pharmacy
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/350660
作者单位	[Pai, Manjunath P.] Univ Michigan, Coll Pharm, Dept Clin Pharm, Ann Arbor, MI 48109 USA; [Wilcox, Mark H.] Univ Leeds, Leeds LS2 9JT, W Yorkshire, England; [Wilcox, Mark H.] Leeds Teaching Hosp, Leeds LS2 9JT, W Yorkshire, England; [Chitra, Surya; McGovern, Paul C.] Paratek Pharmaceut Inc, King Of Prussia, PA 19406 USA; [McGovern, Paul C.] Venatorx Pharmaceut, Malvern, PA 19355 USA
推荐引用方式 GB/T 7714	Pai, Manjunath P.,Wilcox, Mark H.,Chitra, Surya,et al. Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections[J],2021,76(5):1315-1322.
APA	Pai, Manjunath P.,Wilcox, Mark H.,Chitra, Surya,&McGovern, Paul C..(2021).Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections.JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY,76(5),1315-1322.
MLA	Pai, Manjunath P.,et al."Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections".JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY 76.5(2021):1315-1322.