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Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy

Tetracycline‐class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second‐generation tetracycline‐class antibiotics, including doxycycline and minocycline, may be reduced by co‐administration with food, resulting in potent...

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Autores principales: Grada, Ayman, Del Rosso, James Q., Graber, Emmy, Bunick, Christopher G., Stein Gold, Linda, Moore, Angela Y., Baldwin, Hilary, Obagi, Zaidal, Damiani, Giovanni, Carrothers, Timothy, McNamee, Brian, Hanze, Eva
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286649/
https://www.ncbi.nlm.nih.gov/pubmed/34923732
http://dx.doi.org/10.1111/dth.15275
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author Grada, Ayman
Del Rosso, James Q.
Graber, Emmy
Bunick, Christopher G.
Stein Gold, Linda
Moore, Angela Y.
Baldwin, Hilary
Obagi, Zaidal
Damiani, Giovanni
Carrothers, Timothy
McNamee, Brian
Hanze, Eva
author_facet Grada, Ayman
Del Rosso, James Q.
Graber, Emmy
Bunick, Christopher G.
Stein Gold, Linda
Moore, Angela Y.
Baldwin, Hilary
Obagi, Zaidal
Damiani, Giovanni
Carrothers, Timothy
McNamee, Brian
Hanze, Eva
author_sort Grada, Ayman
collection PubMed
description Tetracycline‐class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second‐generation tetracycline‐class antibiotics, including doxycycline and minocycline, may be reduced by co‐administration with food, resulting in potentially lower clinical efficacy. Development of novel compounds and formulations that are not impacted by diet could improve compliance, absorption, and effectiveness among patients. The objective of this study is to investigate weight‐based dosing protocols and the impact of food intake, including high‐fat meals, on the absorption, and clinical efficacy of sarecycline, a novel oral narrow‐spectrum third‐generation tetracycline‐class antibiotic approved by the Food and Drug Administration for acne vulgaris treatment. Data from 12 clinical studies were analyzed using population pharmacokinetic modeling, exposure–response modeling and pharmacodynamics to evaluate sarecycline dosing recommendations. The extent of exposure is estimated to decrease by 21.7% following co‐administration of a sarecycline tablet with a high‐fat meal. Based on the PopPK‐PD model, this is equivalent to a decrease in efficacy of 0.9 inflammatory lesions, which is not clinically meaningful. Sarecycline can be administered using weight‐based dosing with or without food. Co‐administration with high‐fat food has a limited impact on clinical efficacy. The pharmacokinetics of oral sarecycline may provide added convenience and support ease of use and improved compliance for acne vulgaris patients.
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spelling pubmed-92866492022-07-19 Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy Grada, Ayman Del Rosso, James Q. Graber, Emmy Bunick, Christopher G. Stein Gold, Linda Moore, Angela Y. Baldwin, Hilary Obagi, Zaidal Damiani, Giovanni Carrothers, Timothy McNamee, Brian Hanze, Eva Dermatol Ther Original Articles Tetracycline‐class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second‐generation tetracycline‐class antibiotics, including doxycycline and minocycline, may be reduced by co‐administration with food, resulting in potentially lower clinical efficacy. Development of novel compounds and formulations that are not impacted by diet could improve compliance, absorption, and effectiveness among patients. The objective of this study is to investigate weight‐based dosing protocols and the impact of food intake, including high‐fat meals, on the absorption, and clinical efficacy of sarecycline, a novel oral narrow‐spectrum third‐generation tetracycline‐class antibiotic approved by the Food and Drug Administration for acne vulgaris treatment. Data from 12 clinical studies were analyzed using population pharmacokinetic modeling, exposure–response modeling and pharmacodynamics to evaluate sarecycline dosing recommendations. The extent of exposure is estimated to decrease by 21.7% following co‐administration of a sarecycline tablet with a high‐fat meal. Based on the PopPK‐PD model, this is equivalent to a decrease in efficacy of 0.9 inflammatory lesions, which is not clinically meaningful. Sarecycline can be administered using weight‐based dosing with or without food. Co‐administration with high‐fat food has a limited impact on clinical efficacy. The pharmacokinetics of oral sarecycline may provide added convenience and support ease of use and improved compliance for acne vulgaris patients. John Wiley & Sons, Inc. 2021-12-30 2022-03 /pmc/articles/PMC9286649/ /pubmed/34923732 http://dx.doi.org/10.1111/dth.15275 Text en © 2021 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Grada, Ayman
Del Rosso, James Q.
Graber, Emmy
Bunick, Christopher G.
Stein Gold, Linda
Moore, Angela Y.
Baldwin, Hilary
Obagi, Zaidal
Damiani, Giovanni
Carrothers, Timothy
McNamee, Brian
Hanze, Eva
Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
title Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
title_full Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
title_fullStr Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
title_full_unstemmed Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
title_short Sarecycline treatment for acne vulgaris: Rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
title_sort sarecycline treatment for acne vulgaris: rationale for weight‐based dosing and limited impact of food intake on clinical efficacy
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286649/
https://www.ncbi.nlm.nih.gov/pubmed/34923732
http://dx.doi.org/10.1111/dth.15275
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