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Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler
Background: Clinical studies on medical cannabis (MC) treatment have shown sex-related differences, including higher susceptibility to adverse events among women and greater analgesia among men. Here, we used the Syqe metered-dose inhaler (MDI) and a single chemovar to analyze sex differences. Metho...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610259/ https://www.ncbi.nlm.nih.gov/pubmed/37895897 http://dx.doi.org/10.3390/ph16101426 |
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author | Aviram, Joshua Glezerman, Marek Hayam, Eytan Belobrov, Rostislav Procaccia, Shiri Meiri, David Eisenberg, Elon |
author_facet | Aviram, Joshua Glezerman, Marek Hayam, Eytan Belobrov, Rostislav Procaccia, Shiri Meiri, David Eisenberg, Elon |
author_sort | Aviram, Joshua |
collection | PubMed |
description | Background: Clinical studies on medical cannabis (MC) treatment have shown sex-related differences, including higher susceptibility to adverse events among women and greater analgesia among men. Here, we used the Syqe metered-dose inhaler (MDI) and a single chemovar to analyze sex differences. Methods: A total of 1249 Israeli chronic pain patients were assessed for pain intensity, sleep and adverse events (AEs) over 240 days. Results: Following the first two weeks, no significant sex differences were found in the effectiveness or safety of MC treatment (p > 0.05). Inhaled Δ(9)-THC doses did not vary significantly between sexes (p > 0.05) except in the first month of treatment. Pain reduction and sleep improvement were similar for both sexes (p > 0.05). The overall rate of AEs was equal and relatively low at 10% (n = 65, 10% of women and n = 60, 10% of men; χ(2) (1) = 0.05, p = 0.820). A secondary analysis of pharmacokinetic data showed no significant differences between sexes in Δ(9)-THC and its metabolite pharmacokinetics, cardiovascular measures, or AE severity (p > 0.05). Conclusions: Uniform MC treatment via the Syqe MDI showed no sex differences in short-term effectiveness, safety and pharmacokinetics, nor in long-term effects, under “real-life” conditions. These findings provide insights into MC treatment which may inform clinical practice and policy-making in the field. |
format | Online Article Text |
id | pubmed-10610259 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-106102592023-10-28 Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler Aviram, Joshua Glezerman, Marek Hayam, Eytan Belobrov, Rostislav Procaccia, Shiri Meiri, David Eisenberg, Elon Pharmaceuticals (Basel) Article Background: Clinical studies on medical cannabis (MC) treatment have shown sex-related differences, including higher susceptibility to adverse events among women and greater analgesia among men. Here, we used the Syqe metered-dose inhaler (MDI) and a single chemovar to analyze sex differences. Methods: A total of 1249 Israeli chronic pain patients were assessed for pain intensity, sleep and adverse events (AEs) over 240 days. Results: Following the first two weeks, no significant sex differences were found in the effectiveness or safety of MC treatment (p > 0.05). Inhaled Δ(9)-THC doses did not vary significantly between sexes (p > 0.05) except in the first month of treatment. Pain reduction and sleep improvement were similar for both sexes (p > 0.05). The overall rate of AEs was equal and relatively low at 10% (n = 65, 10% of women and n = 60, 10% of men; χ(2) (1) = 0.05, p = 0.820). A secondary analysis of pharmacokinetic data showed no significant differences between sexes in Δ(9)-THC and its metabolite pharmacokinetics, cardiovascular measures, or AE severity (p > 0.05). Conclusions: Uniform MC treatment via the Syqe MDI showed no sex differences in short-term effectiveness, safety and pharmacokinetics, nor in long-term effects, under “real-life” conditions. These findings provide insights into MC treatment which may inform clinical practice and policy-making in the field. MDPI 2023-10-08 /pmc/articles/PMC10610259/ /pubmed/37895897 http://dx.doi.org/10.3390/ph16101426 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Aviram, Joshua Glezerman, Marek Hayam, Eytan Belobrov, Rostislav Procaccia, Shiri Meiri, David Eisenberg, Elon Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler |
title | Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler |
title_full | Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler |
title_fullStr | Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler |
title_full_unstemmed | Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler |
title_short | Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients Treated with Cannabis by a Metered-Dose Inhaler |
title_sort | evaluating sex differences in efficacy, safety and pharmacokinetics in patients treated with cannabis by a metered-dose inhaler |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610259/ https://www.ncbi.nlm.nih.gov/pubmed/37895897 http://dx.doi.org/10.3390/ph16101426 |
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