Efficacy of Rho-Kinase Inhibitor Fasudil in Secondary Raynaud’s Phenomenon
Identifieur interne : 003583 ( Pmc/Curation ); précédent : 003582; suivant : 003584Efficacy of Rho-Kinase Inhibitor Fasudil in Secondary Raynaud’s Phenomenon
Auteurs : Andrea Fava ; Peter K. Wung ; Fredrick M. Wigley ; Laura K. Hummers ; Natalie R. Daya ; Sharon R. Ghazarian ; Francesco BoinSource :
- Arthritis care & research [ 2151-464X ] ; 2012.
Abstract
The RhoA/Rho-kinase pathway plays a pivotal role in cold induced vasoconstriction, vascular smooth muscle cells function and vascular homeostasis. This study evaluates the efficacy of fasudil, a RhoA/Rho-kinase inhibitor, to reverse cold-induced vasospasm in patients with Raynaud’s phenomenon (RP) secondary to systemic sclerosis (SSc).
This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge. The fall in skin temperature after the cold challenge and time to recover 50% and 70% of pre-challenge digital skin temperature were used as primary outcomes. Digital blood flow assessed by Laser Doppler, time to minimum skin temperature, and rate of skin cooling were also measured.
Seventeen patients with SSc and RP completed the study. After cold challenge, skin temperatures and the average time (minutes) to recover 50% (placebo: 7.9, fasudil 40 mg: 7.5, and fasudil 80 mg: 8.2; p=.791) and 70% (placebo: 18.2, fasudil 40 mg: 15.0, and fasudil 80 mg: 17.1; p=.654) of pre-challenge skin temperature were not significantly different across the three groups. The digital blood flow measurements were higher in fasudil treated groups than placebo but differences were not significant (p=.693).
Fasudil administered at single oral dose of 40 mg or 80 mg was not associated with significant benefit in term of skin temperature recovery time and digital blood flow after cold challenge.
Url:
DOI: 10.1002/acr.21622
PubMed: 22275160
PubMed Central: 3343172
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<author><name sortKey="Fava, Andrea" sort="Fava, Andrea" uniqKey="Fava A" first="Andrea" last="Fava">Andrea Fava</name>
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<author><name sortKey="Wung, Peter K" sort="Wung, Peter K" uniqKey="Wung P" first="Peter K" last="Wung">Peter K. Wung</name>
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<author><name sortKey="Wigley, Fredrick M" sort="Wigley, Fredrick M" uniqKey="Wigley F" first="Fredrick M" last="Wigley">Fredrick M. Wigley</name>
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<author><name sortKey="Hummers, Laura K" sort="Hummers, Laura K" uniqKey="Hummers L" first="Laura K" last="Hummers">Laura K. Hummers</name>
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<author><name sortKey="Daya, Natalie R" sort="Daya, Natalie R" uniqKey="Daya N" first="Natalie R." last="Daya">Natalie R. Daya</name>
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<author><name sortKey="Ghazarian, Sharon R" sort="Ghazarian, Sharon R" uniqKey="Ghazarian S" first="Sharon R." last="Ghazarian">Sharon R. Ghazarian</name>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Objective</title>
<p id="P1">The RhoA/Rho-kinase pathway plays a pivotal role in cold induced vasoconstriction, vascular smooth muscle cells function and vascular homeostasis. This study evaluates the efficacy of fasudil, a RhoA/Rho-kinase inhibitor, to reverse cold-induced vasospasm in patients with Raynaud’s phenomenon (RP) secondary to systemic sclerosis (SSc).</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge. The fall in skin temperature after the cold challenge and time to recover 50% and 70% of pre-challenge digital skin temperature were used as primary outcomes. Digital blood flow assessed by Laser Doppler, time to minimum skin temperature, and rate of skin cooling were also measured.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Seventeen patients with SSc and RP completed the study. After cold challenge, skin temperatures and the average time (minutes) to recover 50% (placebo: 7.9, fasudil 40 mg: 7.5, and fasudil 80 mg: 8.2; p=.791) and 70% (placebo: 18.2, fasudil 40 mg: 15.0, and fasudil 80 mg: 17.1; p=.654) of pre-challenge skin temperature were not significantly different across the three groups. The digital blood flow measurements were higher in fasudil treated groups than placebo but differences were not significant (p=.693).</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">Fasudil administered at single oral dose of 40 mg or 80 mg was not associated with significant benefit in term of skin temperature recovery time and digital blood flow after cold challenge.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
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<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101518086</journal-id>
<journal-id journal-id-type="pubmed-jr-id">37048</journal-id>
<journal-id journal-id-type="nlm-ta">Arthritis Care Res (Hoboken)</journal-id>
<journal-id journal-id-type="iso-abbrev">Arthritis Care Res (Hoboken)</journal-id>
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<article-id pub-id-type="manuscript">NIHMS351521</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
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</article-categories>
<title-group><article-title>Efficacy of Rho-Kinase Inhibitor Fasudil in Secondary Raynaud’s Phenomenon</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Fava</surname>
<given-names>Andrea</given-names>
</name>
<degrees>M.D.</degrees>
<aff id="A1">Johns Hopkins University School of Medicine, Baltimore, MD</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Wung</surname>
<given-names>Peter K</given-names>
</name>
<degrees>M.D.</degrees>
<aff id="A2">Instructor of Medicine, Johns Hopkins, University School of Medicine, Baltimore, MD</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Wigley</surname>
<given-names>Fredrick M</given-names>
</name>
<degrees>M.D.</degrees>
<aff id="A3">Professor of Medicine, Johns Hopkins, University School of Medicine, Baltimore, MD</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Hummers</surname>
<given-names>Laura K</given-names>
</name>
<degrees>M.D.</degrees>
<aff id="A4">Assistant Professor of Medicine, Johns Hopkins, University School of Medicine, Baltimore, MD</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Daya</surname>
<given-names>Natalie R.</given-names>
</name>
<degrees>B.S.</degrees>
<aff id="A5">Emory University, Biostatistics and Bioinformatics Department, Atlanta, GA</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Ghazarian</surname>
<given-names>Sharon R.</given-names>
</name>
<degrees>PhD</degrees>
<aff id="A6">Johns Hopkins University School of Medicine, Baltimore, MD</aff>
</contrib>
<contrib contrib-type="author"><name><surname>Boin</surname>
<given-names>Francesco</given-names>
</name>
<degrees>M.D.</degrees>
<aff id="A7">Assistant Professor of Medicine, Johns Hopkins, University School of Medicine, Baltimore, MD</aff>
</contrib>
</contrib-group>
<author-notes><corresp id="FN1">Corresponding Author: Francesco Boin, M.D., Assistant Professor of Medicine, Division of Rheumatology, Johns Hopkins University School of Medicine, 5200 Eastern Avenue, MFL Center Tower Suite 4100, Baltimore, MD 21224</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>24</day>
<month>1</month>
<year>2012</year>
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<pub-date pub-type="epub"><day>24</day>
<month>1</month>
<year>2012</year>
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<pub-date pub-type="ppub"><month>6</month>
<year>2012</year>
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<pub-date pub-type="pmc-release"><day>01</day>
<month>6</month>
<year>2013</year>
</pub-date>
<volume>64</volume>
<issue>6</issue>
<fpage>925</fpage>
<lpage>929</lpage>
<abstract><sec id="S1"><title>Objective</title>
<p id="P1">The RhoA/Rho-kinase pathway plays a pivotal role in cold induced vasoconstriction, vascular smooth muscle cells function and vascular homeostasis. This study evaluates the efficacy of fasudil, a RhoA/Rho-kinase inhibitor, to reverse cold-induced vasospasm in patients with Raynaud’s phenomenon (RP) secondary to systemic sclerosis (SSc).</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge. The fall in skin temperature after the cold challenge and time to recover 50% and 70% of pre-challenge digital skin temperature were used as primary outcomes. Digital blood flow assessed by Laser Doppler, time to minimum skin temperature, and rate of skin cooling were also measured.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Seventeen patients with SSc and RP completed the study. After cold challenge, skin temperatures and the average time (minutes) to recover 50% (placebo: 7.9, fasudil 40 mg: 7.5, and fasudil 80 mg: 8.2; p=.791) and 70% (placebo: 18.2, fasudil 40 mg: 15.0, and fasudil 80 mg: 17.1; p=.654) of pre-challenge skin temperature were not significantly different across the three groups. The digital blood flow measurements were higher in fasudil treated groups than placebo but differences were not significant (p=.693).</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">Fasudil administered at single oral dose of 40 mg or 80 mg was not associated with significant benefit in term of skin temperature recovery time and digital blood flow after cold challenge.</p>
</sec>
</abstract>
<kwd-group><kwd>Raynaud’s phenomenon</kwd>
<kwd>rho-kinase inhibitor</kwd>
<kwd>fasudil</kwd>
<kwd>systemic sclerosis</kwd>
</kwd-group>
<funding-group><award-group><funding-source country="United States">National Institute of Arthritis and Musculoskeletal and Skin Diseases : NIAMS</funding-source>
<award-id>K23 AR055667-05 || AR</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
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