700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies
BACKGROUND: The risk of serious infections and poor treatment outcomes is reported to be higher in patients with diabetes compared with the general population. Omadacycline (OMC) is an intravenous (IV) and oral aminomethylcycline antibiotic approved in the US to treat acute bacterial skin and skin s...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Oxford University Press
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6811084/ http://dx.doi.org/10.1093/ofid/ofz360.768 |
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author | Pai, Manjunath P Wilcox, Mark H Curran, Marla Chitra, Surya Garrity-Ryan, Lynne McGovern, Paul C |
author_facet | Pai, Manjunath P Wilcox, Mark H Curran, Marla Chitra, Surya Garrity-Ryan, Lynne McGovern, Paul C |
author_sort | Pai, Manjunath P |
collection | PubMed |
description | BACKGROUND: The risk of serious infections and poor treatment outcomes is reported to be higher in patients with diabetes compared with the general population. Omadacycline (OMC) is an intravenous (IV) and oral aminomethylcycline antibiotic approved in the US to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults. Here we assessed safety and efficacy results from OMC Phase 3 studies (ABSSSI: Omadacycline in Acute Skin and skin structure Infections Study [OASIS]-1 and OASIS-2; CABP: Omadacycline for Pneumonia Treatment In the Community study [OPTIC]), by diabetes history. METHODS: In OASIS-1 (IV to optional oral medication) and OASIS-2 (oral only), patients were randomized to OMC or linezolid (LZD) for 7–14 days. In OPTIC, patients were randomized to IV OMC or moxifloxacin (MOX) for 7–14 days, with optional transition to oral medication. Data from OASIS-1 and OASIS-2 were pooled, and patient subgroups were defined by any medical history of diabetes (type 1, type 2, or unspecified), or no medical history of diabetes. Efficacy outcomes were early clinical response (ECR) and investigator’s assessment of clinical response at post-treatment evaluation (PTE), as defined for each indication. Safety was assessed by treatment-emergent adverse events (TEAEs) and laboratory measures, and data were pooled across the three studies. RESULTS: A total of 2,150 patients were included, of whom 238 (11.1%) had any history of diabetes (n = 105 for ABSSSI, n = 133 for CABP). In the pooled ABSSSI studies and the CABP study, clinical success at ECR and PTE was similar between patients with or without diabetes, and between OMC and the respective comparator (figure). TEAEs and serious TEAEs, respectively, were reported in similar numbers of OMC-, LZD-, and MOX-treated patients with diabetes (41.8–49.3%, 4.5–7.0%) and without (41.2–48.3%, 1.6–6.9%). Rates of nausea and vomiting, respectively, in patients with diabetes were similar across treatment arms: OMC (5.0%, 5.0%), LZD (7.5%, 6.0%), MOX (7.0%, 2.8%). CONCLUSION: Omadacycline efficacy and safety were similar and consistent in patients with or without diabetes. [Image: see text] DISCLOSURES: All authors: No reported disclosures. |
format | Online Article Text |
id | pubmed-6811084 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-68110842019-10-28 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies Pai, Manjunath P Wilcox, Mark H Curran, Marla Chitra, Surya Garrity-Ryan, Lynne McGovern, Paul C Open Forum Infect Dis Abstracts BACKGROUND: The risk of serious infections and poor treatment outcomes is reported to be higher in patients with diabetes compared with the general population. Omadacycline (OMC) is an intravenous (IV) and oral aminomethylcycline antibiotic approved in the US to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults. Here we assessed safety and efficacy results from OMC Phase 3 studies (ABSSSI: Omadacycline in Acute Skin and skin structure Infections Study [OASIS]-1 and OASIS-2; CABP: Omadacycline for Pneumonia Treatment In the Community study [OPTIC]), by diabetes history. METHODS: In OASIS-1 (IV to optional oral medication) and OASIS-2 (oral only), patients were randomized to OMC or linezolid (LZD) for 7–14 days. In OPTIC, patients were randomized to IV OMC or moxifloxacin (MOX) for 7–14 days, with optional transition to oral medication. Data from OASIS-1 and OASIS-2 were pooled, and patient subgroups were defined by any medical history of diabetes (type 1, type 2, or unspecified), or no medical history of diabetes. Efficacy outcomes were early clinical response (ECR) and investigator’s assessment of clinical response at post-treatment evaluation (PTE), as defined for each indication. Safety was assessed by treatment-emergent adverse events (TEAEs) and laboratory measures, and data were pooled across the three studies. RESULTS: A total of 2,150 patients were included, of whom 238 (11.1%) had any history of diabetes (n = 105 for ABSSSI, n = 133 for CABP). In the pooled ABSSSI studies and the CABP study, clinical success at ECR and PTE was similar between patients with or without diabetes, and between OMC and the respective comparator (figure). TEAEs and serious TEAEs, respectively, were reported in similar numbers of OMC-, LZD-, and MOX-treated patients with diabetes (41.8–49.3%, 4.5–7.0%) and without (41.2–48.3%, 1.6–6.9%). Rates of nausea and vomiting, respectively, in patients with diabetes were similar across treatment arms: OMC (5.0%, 5.0%), LZD (7.5%, 6.0%), MOX (7.0%, 2.8%). CONCLUSION: Omadacycline efficacy and safety were similar and consistent in patients with or without diabetes. [Image: see text] DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2019-10-23 /pmc/articles/PMC6811084/ http://dx.doi.org/10.1093/ofid/ofz360.768 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Abstracts Pai, Manjunath P Wilcox, Mark H Curran, Marla Chitra, Surya Garrity-Ryan, Lynne McGovern, Paul C 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies |
title | 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies |
title_full | 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies |
title_fullStr | 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies |
title_full_unstemmed | 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies |
title_short | 700. Safety and Efficacy of Omadacycline in Patients with Diabetes in Phase 3 Clinical Studies |
title_sort | 700. safety and efficacy of omadacycline in patients with diabetes in phase 3 clinical studies |
topic | Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6811084/ http://dx.doi.org/10.1093/ofid/ofz360.768 |
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