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Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study

Vixotrigine is a state‐ and use‐dependent Nav1.7 channel blocker being investigated for the treatment of neuropathic pain conditions. This randomized, double‐blind, placebo‐controlled crossover trial was designed to evaluate changes in blood pressure with the administration of vixotrigine using ambu...

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Autores principales: Fong, Regan, Ballow, Charles H., Naik, Himanshu, Steiner, Deb, Palmer, Joanne, White, William B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6586067/
https://www.ncbi.nlm.nih.gov/pubmed/30144099
http://dx.doi.org/10.1002/jcph.1298
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author Fong, Regan
Ballow, Charles H.
Naik, Himanshu
Steiner, Deb
Palmer, Joanne
White, William B.
author_facet Fong, Regan
Ballow, Charles H.
Naik, Himanshu
Steiner, Deb
Palmer, Joanne
White, William B.
author_sort Fong, Regan
collection PubMed
description Vixotrigine is a state‐ and use‐dependent Nav1.7 channel blocker being investigated for the treatment of neuropathic pain conditions. This randomized, double‐blind, placebo‐controlled crossover trial was designed to evaluate changes in blood pressure with the administration of vixotrigine using ambulatory blood pressure monitoring (ABPM). Eligible participants were healthy adults 18 to 65 years of age without evidence of baseline systolic blood pressure (SBP) persistently > 140 mm Hg or diastolic blood pressure (DBP) persistently > 90 mm Hg. Vixotrigine (400 mg [men], 300 mg [women]) or placebo was administered orally twice daily for 36 days. Following a 7‐day washout period, participants crossed over to the other treatment. Each dosing period was preceded by 1 inpatient visit and 1 outpatient baseline visit. Two 14‐hour inpatient ABPM sessions occurred on days 14 and 35, with a return to the clinic the morning of days 15 and 36 for initiation of outpatient ABPM, which assessed blood pressure and heart rate every 15 minutes. Adverse events were collected throughout the study. The primary end point was the change from baseline in 24‐hour mean SBP and DBP on day 36. Sixty participants were enrolled; 10 withdrew from the study owing to adverse events, investigator discretion, or withdrawal of consent. From baseline to day 36, mean changes in average SBP and DBP (vixotrigine treated) were ‐0.33 and 0.20 mm Hg, respectively. Adverse event rates were comparable for vixotrigine and placebo; the most common adverse events were headache, dizziness, and nausea. Vixotrigine administration is not associated with a clinically important increase in blood pressure.
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spelling pubmed-65860672019-07-02 Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study Fong, Regan Ballow, Charles H. Naik, Himanshu Steiner, Deb Palmer, Joanne White, William B. J Clin Pharmacol Therapeutics Vixotrigine is a state‐ and use‐dependent Nav1.7 channel blocker being investigated for the treatment of neuropathic pain conditions. This randomized, double‐blind, placebo‐controlled crossover trial was designed to evaluate changes in blood pressure with the administration of vixotrigine using ambulatory blood pressure monitoring (ABPM). Eligible participants were healthy adults 18 to 65 years of age without evidence of baseline systolic blood pressure (SBP) persistently > 140 mm Hg or diastolic blood pressure (DBP) persistently > 90 mm Hg. Vixotrigine (400 mg [men], 300 mg [women]) or placebo was administered orally twice daily for 36 days. Following a 7‐day washout period, participants crossed over to the other treatment. Each dosing period was preceded by 1 inpatient visit and 1 outpatient baseline visit. Two 14‐hour inpatient ABPM sessions occurred on days 14 and 35, with a return to the clinic the morning of days 15 and 36 for initiation of outpatient ABPM, which assessed blood pressure and heart rate every 15 minutes. Adverse events were collected throughout the study. The primary end point was the change from baseline in 24‐hour mean SBP and DBP on day 36. Sixty participants were enrolled; 10 withdrew from the study owing to adverse events, investigator discretion, or withdrawal of consent. From baseline to day 36, mean changes in average SBP and DBP (vixotrigine treated) were ‐0.33 and 0.20 mm Hg, respectively. Adverse event rates were comparable for vixotrigine and placebo; the most common adverse events were headache, dizziness, and nausea. Vixotrigine administration is not associated with a clinically important increase in blood pressure. John Wiley and Sons Inc. 2018-08-24 2019-01 /pmc/articles/PMC6586067/ /pubmed/30144099 http://dx.doi.org/10.1002/jcph.1298 Text en © 2018, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Therapeutics
Fong, Regan
Ballow, Charles H.
Naik, Himanshu
Steiner, Deb
Palmer, Joanne
White, William B.
Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study
title Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study
title_full Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study
title_fullStr Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study
title_full_unstemmed Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study
title_short Effects of a State‐ and Use‐Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study
title_sort effects of a state‐ and use‐dependent nav1.7 channel blocker on ambulatory blood pressure: a randomized, controlled crossover study
topic Therapeutics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6586067/
https://www.ncbi.nlm.nih.gov/pubmed/30144099
http://dx.doi.org/10.1002/jcph.1298
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