Cargando…

A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study

STUDY DESIGN: Double-blind, randomized cross-over placebo-controlled pilot study. OBJECTIVES: To determine the effects of tadalafil on systolic blood pressure (SBP), heart rate (HR), and dizziness of men with American Spinal Injury Association Impairment Scale-A (AIS-A) spinal cord injury (SCI) betw...

Descripción completa

Detalles Bibliográficos
Autores principales: Ethans, Karen D., Casey, Alan, Tarhoni, Mohamed, Nankar, Mayur, Entcheva, Stella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249218/
https://www.ncbi.nlm.nih.gov/pubmed/30479838
http://dx.doi.org/10.1038/s41394-018-0137-9
_version_ 1783372696574230528
author Ethans, Karen D.
Casey, Alan
Tarhoni, Mohamed
Nankar, Mayur
Entcheva, Stella
author_facet Ethans, Karen D.
Casey, Alan
Tarhoni, Mohamed
Nankar, Mayur
Entcheva, Stella
author_sort Ethans, Karen D.
collection PubMed
description STUDY DESIGN: Double-blind, randomized cross-over placebo-controlled pilot study. OBJECTIVES: To determine the effects of tadalafil on systolic blood pressure (SBP), heart rate (HR), and dizziness of men with American Spinal Injury Association Impairment Scale-A (AIS-A) spinal cord injury (SCI) between cervical-4 (C4) and thoracic-5 (T5) levels. SETTING: Outpatient rehabilitation clinic. DESIGN: Double-blind, randomized cross-over placebo-controlled pilot study. METHODS: 20 males with AIS-A SCI, C4-T5 received either tadalafil 20 mg or placebo for the first arm, and then were crossed-over after 1 week to the second arm. SBP, HR, and Visual Analogue Scale (VAS) for dizziness upon sitting up from lying were measured at baseline and again 1, 2, 4, 12, 22, 29, and 36 h post dose administration. The change in each outcome measure (SBP, HR, VAS dizziness) was observed from pre-dose to each time point. A change in VAS dizziness of 2 cm or greater (scale 0–10 cm) was considered positive. RESULTS: SBP did not change significantly in either group. However, HR increased significantly in the tadalafil group at several time points (12 h p < 0.05, 22 h p <0.05, 29 h p <0.01, and 36 h p <0.05), with no change in the placebo group. The VAS dizziness significantly increased (range 2–6 cm changes) at some time point in 1/4 of the subjects after tadalafil, but not in the placebo group; all reports of dizziness were at 12 h or later. CONCLUSIONS: Tadalafil use in people with SCI above T6 is safe with respect to not causing hypotension; hemodynamic changes that occurred 12–36 h post administration were compensated for by elevations in HR. SPONSORSHIP: The Manitoba Medical Services Foundation and the Health Sciences Centre Foundation.
format Online
Article
Text
id pubmed-6249218
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Nature Publishing Group UK
record_format MEDLINE/PubMed
spelling pubmed-62492182018-11-26 A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study Ethans, Karen D. Casey, Alan Tarhoni, Mohamed Nankar, Mayur Entcheva, Stella Spinal Cord Ser Cases Article STUDY DESIGN: Double-blind, randomized cross-over placebo-controlled pilot study. OBJECTIVES: To determine the effects of tadalafil on systolic blood pressure (SBP), heart rate (HR), and dizziness of men with American Spinal Injury Association Impairment Scale-A (AIS-A) spinal cord injury (SCI) between cervical-4 (C4) and thoracic-5 (T5) levels. SETTING: Outpatient rehabilitation clinic. DESIGN: Double-blind, randomized cross-over placebo-controlled pilot study. METHODS: 20 males with AIS-A SCI, C4-T5 received either tadalafil 20 mg or placebo for the first arm, and then were crossed-over after 1 week to the second arm. SBP, HR, and Visual Analogue Scale (VAS) for dizziness upon sitting up from lying were measured at baseline and again 1, 2, 4, 12, 22, 29, and 36 h post dose administration. The change in each outcome measure (SBP, HR, VAS dizziness) was observed from pre-dose to each time point. A change in VAS dizziness of 2 cm or greater (scale 0–10 cm) was considered positive. RESULTS: SBP did not change significantly in either group. However, HR increased significantly in the tadalafil group at several time points (12 h p < 0.05, 22 h p <0.05, 29 h p <0.01, and 36 h p <0.05), with no change in the placebo group. The VAS dizziness significantly increased (range 2–6 cm changes) at some time point in 1/4 of the subjects after tadalafil, but not in the placebo group; all reports of dizziness were at 12 h or later. CONCLUSIONS: Tadalafil use in people with SCI above T6 is safe with respect to not causing hypotension; hemodynamic changes that occurred 12–36 h post administration were compensated for by elevations in HR. SPONSORSHIP: The Manitoba Medical Services Foundation and the Health Sciences Centre Foundation. Nature Publishing Group UK 2018-11-21 /pmc/articles/PMC6249218/ /pubmed/30479838 http://dx.doi.org/10.1038/s41394-018-0137-9 Text en © The Author(s) 2018 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Ethans, Karen D.
Casey, Alan
Tarhoni, Mohamed
Nankar, Mayur
Entcheva, Stella
A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
title A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
title_full A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
title_fullStr A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
title_full_unstemmed A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
title_short A randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (Cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: A Pilot Study
title_sort randomized double-blind, placebo-controlled, cross-over trial assessing the effect of tadalafil (cialis) on the cardiovascular response in men with complete spinal cord injury above the sixth thoracic level: a pilot study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249218/
https://www.ncbi.nlm.nih.gov/pubmed/30479838
http://dx.doi.org/10.1038/s41394-018-0137-9
work_keys_str_mv AT ethanskarend arandomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT caseyalan arandomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT tarhonimohamed arandomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT nankarmayur arandomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT entchevastella arandomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT ethanskarend randomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT caseyalan randomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT tarhonimohamed randomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT nankarmayur randomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy
AT entchevastella randomizeddoubleblindplacebocontrolledcrossovertrialassessingtheeffectoftadalafilcialisonthecardiovascularresponseinmenwithcompletespinalcordinjuryabovethesixththoraciclevelapilotstudy