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. 2023 Apr 18;67(4):e0239721.
doi: 10.1128/aac.02397-21. Epub 2023 Mar 14.

Evaluation of the Impact of Comorbidities on Omadacycline Pharmacokinetics

M Trang  1 , E A Lakota  1 , M C Safir  1 , S M Bhavnani  1 , L Friedrich  2 , J N Steenbergen  2 , P C McGovern  2 , E Tzanis  2 , C M Rubino  1
Affiliations

Evaluation of the Impact of Comorbidities on Omadacycline Pharmacokinetics

M Trang et al. Antimicrob Agents Chemother. .

Abstract

Omadacycline is approved in the United States for the treatment of patients with community-acquired bacterial pneumonia or acute bacterial skin and skin structure infections. Analyses were undertaken to evaluate pharmacokinetic differences among subjects or patients stratified by comorbidities. Differences in clearance by smoking status, history of diabetes mellitus, chronic lung disease, hypertension, heart failure, or coronary artery disease were evaluated using a Welch two-sample t test. Smoking was the only significant comorbidity after correction for sex, with a clinically insignificant difference of 13%. Omadacycline dose adjustments based on these comorbidities do not appear to be warranted.

Keywords: comorbidity; omadacycline; pharmacokinetics.

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Conflict of interest statement

The authors declare a conflict of interest. M.T., M.C.S., S.M.B., and C.M.R. are employees of the Institute for Clinical Pharmacodynamics, Inc., which has received research support from Paratek Pharmaceuticals, Inc. E.A.L. was an employee of ICPD at the time the analyses were conducted and is currently an employee of Vertex Pharmaceuticals, Inc. L.F. was an employee of Paratek Pharmaceuticals at the time the analyses were conducted and is currently an employee of AN2 Therapeutics. J.N.S. was an employee of Paratek Pharmaceuticals at the time the analyses were conducted and is currently an employee of Scientific and Medical Affairs Consulting, LLC. P.C.M. was an employee of Paratek Pharmaceuticals at the time the analyses were conducted and is currently an employee of Venatorx Pharmaceuticals, Inc. E.T. was an employee of Paratek Pharmaceuticals at the time the analyses were conducted and is currently an employee of Neuraptive Therapeutics, Inc.

Figures

FIG 1
FIG 1
Box-and-whisker plots showing the distribution of omadacycline clearance (CL) values, stratified by various comorbidities. Counts for each group are provided in the respective boxes.
FIG 2
FIG 2
Box-and-whisker plot showing the distribution of omadacycline clearance (CL) values, stratified by smoking status and sex. Counts for each group are provided in the respective boxes.
See this image and copyright information in PMC

References

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