Omadacycline Noninferior to Linezolid in ABSSSI Patients With High BMI, Diabetes

cellulitis on the abdomen
cellulitis on the abdomen
The goal of this post-hoc analysis of OASIS-1 study was to determine if BMI or T2D had any effect on the efficacy or safety of omadacycline relative to linezolid.

This article is part of Infectious Disease Advisor’s in-depth coverage of IDWeek 2017™, which took place in San Diego, CA. Our staff will be reporting on the latest treatment advancements and research initiatives for skin infections. Check back regularly for highlights from IDWeek 2017.

Intravenous (IV) omadacycline (OMC) and once-per-day oral OMC have efficacy and tolerability profiles similar to those of IV and oral linezolid (LZD) in overweight/obese patients with diabetes and acute bacterial skin and skin structure infection (ABSSSI), according to findings from a randomized study presented at IDWeek 2017, held October 4-8, in San Diego, California.

Adults with ABSSSI were randomly assigned (n=655) to 2 groups. Group 1 received a total of 2 doses of 100 mg IV OMC every 12 hours followed by 100 mg IV OMC once a day. The second group received 600 mg IV LZD every 12 hours. Following ≥3 days of IV OMC or LZD, patients received oral doses of their assigned therapy (300 mg every 24 hours OMC vs 600 mg LZD every 12 hours).

Most of the people in this study had a body mass index (BMI) ≥25 (n=417) vs BMI <25 (n=228). Additionally, a total of 59 patients had a history of diabetes. Early clinical response rates were similar among all patients taking OMC, regardless of BMI. In patients treated with OMC, the clinical success rate was higher at posttreatment evaluation compared with patients who were assigned LZD.

In addition, patients treated with OMC experienced less frequent adverse events, such as nausea and vomiting, than those taking LZD. No differences were observed across subgroups.

“These data show that omadacycline is well tolerated and clinically effective in patients with high BMI or diabetes, with no need for dosage adjustment,” concluded the researchers.

Disclosures: The OASIS-1 study was funded by Paratek Pharmaceuticals, Inc. With the exception of Mark Wilcox, MD, the remaining authors are employees of Paratek Pharmaceuticals, Inc.

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Wilcox M, Cure-Bolt N, Chitra S, Tzanis E, McGovern P. Efficacy and safety of omadacycline in patients with acute bacterial skin and skin structure infections (ABSSSI) and high body mass index or type 2 diabetes: a subgroup analysis from the OASIS trial. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Poster 1838.