Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial
Identifieur interne : 000871 ( Main/Exploration ); précédent : 000870; suivant : 000872Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial
Auteurs : David J. Webb [Royaume-Uni] ; Blai Coll [États-Unis] ; Hiddo J. L. Heerspink [Pays-Bas] ; Dennis Andress [États-Unis] ; Yili Pritchett [États-Unis] ; John J. Brennan [États-Unis] ; Mark Houser [États-Unis] ; Ricardo Correa-Rotter [Mexique] ; Donald Kohan [États-Unis] ; Hirofumi Makino [Japon] ; Vlado Perkovic [Australie] ; Giuseppe Remuzzi [Italie] ; Sheldon W. Tobe ; Robert Toto [États-Unis] ; Robert Busch [États-Unis] ; Pablo Pergola [États-Unis] ; Hans-Henrik Parving [Danemark] ; Dick De Zeeuw [Pays-Bas]Source :
- Drugs in R&D [ 1174-5886 ] ; 2017.
Abstract
Fluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan.
We performed longitudinal assessments of thoracic bioimpedance in patients with type 2 diabetes mellitus and nephropathy to determine whether a decrease in bioimpedance accurately reflected fluid retention during treatment with atrasentan.
We conducted a randomized, double-blind, placebo-controlled study in 48 patients with type 2 diabetes mellitus and nephropathy who were receiving stable doses of renin angiotensin system inhibitors and diuretics.
Patients were randomized 1:1:1 to placebo, atrasentan 0.5 mg, or atrasentan 1.25 mg once daily for 8 weeks. Thoracic bioimpedance, vital signs, clinical exams, and serologies were taken at weeks 1, 2, 4, 6, and 8, with the exception of serum hemoglobin, which was not taken at week 1, and serum brain natriuretic peptide, which was only taken at baseline, week 4, and week 8.
Alterations in bioimpedance were more often present in those who received atrasentan than in those who received placebo, though overall differences were not statistically significant. Transient declines in thoracic bioimpedance during the first 2 weeks of atrasentan exposure occurred before or during peak increases in body weight and hemodilution (decreased serum hemoglobin).
We conclude that thoracic bioimpedance did not reflect changes in weight gain or edema with atrasentan treatment in this study. However, the sample size was small, and it may be of interest to explore the use of thoracic bioimpedance in a larger population to understand its potential clinical use in monitoring fluid retention in patients with chronic kidney disease who receive ET receptor antagonists.
Url:
DOI: 10.1007/s40268-017-0201-0
PubMed: 28831752
PubMed Central: 5629141
Affiliations:
- Australie, Danemark, Italie, Japon, Mexique, Pays-Bas, Royaume-Uni, États-Unis
- Groningue (province), Illinois, Maryland, Nouvelle-Galles du Sud, Texas, Utah, État de New York
- Groningue, Groningue (ville)
- Université de Groningue
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Le document en format XML
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</author>
<author><name sortKey="Makino, Hirofumi" sort="Makino, Hirofumi" uniqKey="Makino H" first="Hirofumi" last="Makino">Hirofumi Makino</name>
<affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 1302 4472</institution-id>
<institution-id institution-id-type="GRID">grid.261356.5</institution-id>
<institution>Okayama University Graduate School of Medicine,</institution>
</institution-wrap>
Okayama, Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Okayama</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Perkovic, Vlado" sort="Perkovic, Vlado" uniqKey="Perkovic V" first="Vlado" last="Perkovic">Vlado Perkovic</name>
<affiliation wicri:level="2"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id>
<institution-id institution-id-type="GRID">grid.1013.3</institution-id>
<institution>The University of Sydney,</institution>
</institution-wrap>
Sydney, NSW Australia</nlm:aff>
<country>Australie</country>
<placeName><region type="state">Nouvelle-Galles du Sud</region>
</placeName>
<wicri:cityArea>Sydney</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Remuzzi, Giuseppe" sort="Remuzzi, Giuseppe" uniqKey="Remuzzi G" first="Giuseppe" last="Remuzzi">Giuseppe Remuzzi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000000106678902</institution-id>
<institution-id institution-id-type="GRID">grid.4527.4</institution-id>
<institution>Azienda Ospedaliera Papa Giovanni XXIII and IRCCS-Istituto di Ricerche Farmacologiche Mario Negri,</institution>
</institution-wrap>
Bergamo, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Bergamo</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Tobe, Sheldon W" sort="Tobe, Sheldon W" uniqKey="Tobe S" first="Sheldon W." last="Tobe">Sheldon W. Tobe</name>
<affiliation><nlm:aff id="Aff10"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9743 1587</institution-id>
<institution-id institution-id-type="GRID">grid.413104.3</institution-id>
<institution>Sunnybrook Health Sciences Center,</institution>
</institution-wrap>
Toronto, ON Canada</nlm:aff>
<wicri:noCountry code="subfield">ON Canada</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Toto, Robert" sort="Toto, Robert" uniqKey="Toto R" first="Robert" last="Toto">Robert Toto</name>
<affiliation wicri:level="2"><nlm:aff id="Aff11"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9482 7121</institution-id>
<institution-id institution-id-type="GRID">grid.267313.2</institution-id>
<institution>University of Texas Southwestern Medical Center,</institution>
</institution-wrap>
Dallas, TX USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<wicri:cityArea>Dallas</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Busch, Robert" sort="Busch, Robert" uniqKey="Busch R" first="Robert" last="Busch">Robert Busch</name>
<affiliation wicri:level="2"><nlm:aff id="Aff12">The Endocrine Group, New York, NY USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
<wicri:cityArea>The Endocrine Group, New York</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Pergola, Pablo" sort="Pergola, Pablo" uniqKey="Pergola P" first="Pablo" last="Pergola">Pablo Pergola</name>
<affiliation wicri:level="2"><nlm:aff id="Aff13">Renal Associates, P.A., San Antonio, TX USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<wicri:cityArea>Renal Associates, P.A., San Antonio</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Parving, Hans Henrik" sort="Parving, Hans Henrik" uniqKey="Parving H" first="Hans-Henrik" last="Parving">Hans-Henrik Parving</name>
<affiliation wicri:level="1"><nlm:aff id="Aff14"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0646 7373</institution-id>
<institution-id institution-id-type="GRID">grid.4973.9</institution-id>
<institution>University Hospital of Copenhagen,</institution>
</institution-wrap>
Copenhagen, Denmark</nlm:aff>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Copenhagen</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="De Zeeuw, Dick" sort="De Zeeuw, Dick" uniqKey="De Zeeuw D" first="Dick" last="De Zeeuw">Dick De Zeeuw</name>
<affiliation wicri:level="4"><nlm:aff id="Aff3">Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen</wicri:regionArea>
<placeName><settlement type="city">Groningue</settlement>
<region nuts="2" type="province">Groningue (province)</region>
<settlement type="city">Groningue (ville)</settlement>
</placeName>
<orgName type="university">Université de Groningue</orgName>
</affiliation>
</author>
</analytic>
<series><title level="j">Drugs in R&D</title>
<idno type="ISSN">1174-5886</idno>
<idno type="eISSN">1179-6901</idno>
<imprint><date when="2017">2017</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p id="Par1">Fluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan.</p>
</sec>
<sec><title>Objective</title>
<p id="Par2">We performed longitudinal assessments of thoracic bioimpedance in patients with type 2 diabetes mellitus and nephropathy to determine whether a decrease in bioimpedance accurately reflected fluid retention during treatment with atrasentan.</p>
</sec>
<sec><title>Study Design</title>
<p id="Par3">We conducted a randomized, double-blind, placebo-controlled study in 48 patients with type 2 diabetes mellitus and nephropathy who were receiving stable doses of renin angiotensin system inhibitors and diuretics.</p>
</sec>
<sec><title>Methods</title>
<p id="Par4">Patients were randomized 1:1:1 to placebo, atrasentan 0.5 mg, or atrasentan 1.25 mg once daily for 8 weeks. Thoracic bioimpedance, vital signs, clinical exams, and serologies were taken at weeks 1, 2, 4, 6, and 8, with the exception of serum hemoglobin, which was not taken at week 1, and serum brain natriuretic peptide, which was only taken at baseline, week 4, and week 8.</p>
</sec>
<sec><title>Results</title>
<p id="Par5">Alterations in bioimpedance were more often present in those who received atrasentan than in those who received placebo, though overall differences were not statistically significant. Transient declines in thoracic bioimpedance during the first 2 weeks of atrasentan exposure occurred before or during peak increases in body weight and hemodilution (decreased serum hemoglobin).</p>
</sec>
<sec><title>Conclusions</title>
<p id="Par6">We conclude that thoracic bioimpedance did not reflect changes in weight gain or edema with atrasentan treatment in this study. However, the sample size was small, and it may be of interest to explore the use of thoracic bioimpedance in a larger population to understand its potential clinical use in monitoring fluid retention in patients with chronic kidney disease who receive ET receptor antagonists.</p>
</sec>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="De Zeeuw, D" uniqKey="De Zeeuw D">D de Zeeuw</name>
</author>
<author><name sortKey="Coll, B" uniqKey="Coll B">B Coll</name>
</author>
<author><name sortKey="Andress, D" uniqKey="Andress D">D Andress</name>
</author>
<author><name sortKey="Brennan, Jj" uniqKey="Brennan J">JJ Brennan</name>
</author>
<author><name sortKey="Tang, H" uniqKey="Tang H">H Tang</name>
</author>
<author><name sortKey="Houser, M" uniqKey="Houser M">M Houser</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Galie, N" uniqKey="Galie N">N Galie</name>
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<author><name sortKey="Olschewski, H" uniqKey="Olschewski H">H Olschewski</name>
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<author><name sortKey="Oudiz, Rj" uniqKey="Oudiz R">RJ Oudiz</name>
</author>
<author><name sortKey="Torres, F" uniqKey="Torres F">F Torres</name>
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</author>
<author><name sortKey="Ghofrani, Ha" uniqKey="Ghofrani H">HA Ghofrani</name>
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</biblStruct>
<biblStruct><analytic><author><name sortKey="Khanna, D" uniqKey="Khanna D">D Khanna</name>
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<author><name sortKey="Wen, S" uniqKey="Wen S">S Wen</name>
</author>
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</biblStruct>
<biblStruct><analytic><author><name sortKey="Rubin, Lj" uniqKey="Rubin L">LJ Rubin</name>
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<author><name sortKey="Yancy, Cw" uniqKey="Yancy C">CW Yancy</name>
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<biblStruct><analytic><author><name sortKey="Tsai, Yc" uniqKey="Tsai Y">YC Tsai</name>
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</biblStruct>
<biblStruct><analytic><author><name sortKey="Holmes, Sj" uniqKey="Holmes S">SJ Holmes</name>
</author>
<author><name sortKey="Espiner, Ea" uniqKey="Espiner E">EA Espiner</name>
</author>
<author><name sortKey="Richards, Am" uniqKey="Richards A">AM Richards</name>
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</author>
<author><name sortKey="Hofstra, L" uniqKey="Hofstra L">L Hofstra</name>
</author>
<author><name sortKey="Kroon, Aa" uniqKey="Kroon A">AA Kroon</name>
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<author><name sortKey="De Leeuw, Pw" uniqKey="De Leeuw P">PW de Leeuw</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Danemark</li>
<li>Italie</li>
<li>Japon</li>
<li>Mexique</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Groningue (province)</li>
<li>Illinois</li>
<li>Maryland</li>
<li>Nouvelle-Galles du Sud</li>
<li>Texas</li>
<li>Utah</li>
<li>État de New York</li>
</region>
<settlement><li>Groningue</li>
<li>Groningue (ville)</li>
</settlement>
<orgName><li>Université de Groningue</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Tobe, Sheldon W" sort="Tobe, Sheldon W" uniqKey="Tobe S" first="Sheldon W." last="Tobe">Sheldon W. Tobe</name>
</noCountry>
<country name="Royaume-Uni"><noRegion><name sortKey="Webb, David J" sort="Webb, David J" uniqKey="Webb D" first="David J." last="Webb">David J. Webb</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Illinois"><name sortKey="Coll, Blai" sort="Coll, Blai" uniqKey="Coll B" first="Blai" last="Coll">Blai Coll</name>
</region>
<name sortKey="Andress, Dennis" sort="Andress, Dennis" uniqKey="Andress D" first="Dennis" last="Andress">Dennis Andress</name>
<name sortKey="Brennan, John J" sort="Brennan, John J" uniqKey="Brennan J" first="John J." last="Brennan">John J. Brennan</name>
<name sortKey="Busch, Robert" sort="Busch, Robert" uniqKey="Busch R" first="Robert" last="Busch">Robert Busch</name>
<name sortKey="Houser, Mark" sort="Houser, Mark" uniqKey="Houser M" first="Mark" last="Houser">Mark Houser</name>
<name sortKey="Kohan, Donald" sort="Kohan, Donald" uniqKey="Kohan D" first="Donald" last="Kohan">Donald Kohan</name>
<name sortKey="Pergola, Pablo" sort="Pergola, Pablo" uniqKey="Pergola P" first="Pablo" last="Pergola">Pablo Pergola</name>
<name sortKey="Pritchett, Yili" sort="Pritchett, Yili" uniqKey="Pritchett Y" first="Yili" last="Pritchett">Yili Pritchett</name>
<name sortKey="Toto, Robert" sort="Toto, Robert" uniqKey="Toto R" first="Robert" last="Toto">Robert Toto</name>
</country>
<country name="Pays-Bas"><region name="Groningue (province)"><name sortKey="Heerspink, Hiddo J L" sort="Heerspink, Hiddo J L" uniqKey="Heerspink H" first="Hiddo J. L." last="Heerspink">Hiddo J. L. Heerspink</name>
</region>
<name sortKey="De Zeeuw, Dick" sort="De Zeeuw, Dick" uniqKey="De Zeeuw D" first="Dick" last="De Zeeuw">Dick De Zeeuw</name>
</country>
<country name="Mexique"><noRegion><name sortKey="Correa Rotter, Ricardo" sort="Correa Rotter, Ricardo" uniqKey="Correa Rotter R" first="Ricardo" last="Correa-Rotter">Ricardo Correa-Rotter</name>
</noRegion>
</country>
<country name="Japon"><noRegion><name sortKey="Makino, Hirofumi" sort="Makino, Hirofumi" uniqKey="Makino H" first="Hirofumi" last="Makino">Hirofumi Makino</name>
</noRegion>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Perkovic, Vlado" sort="Perkovic, Vlado" uniqKey="Perkovic V" first="Vlado" last="Perkovic">Vlado Perkovic</name>
</region>
</country>
<country name="Italie"><noRegion><name sortKey="Remuzzi, Giuseppe" sort="Remuzzi, Giuseppe" uniqKey="Remuzzi G" first="Giuseppe" last="Remuzzi">Giuseppe Remuzzi</name>
</noRegion>
</country>
<country name="Danemark"><noRegion><name sortKey="Parving, Hans Henrik" sort="Parving, Hans Henrik" uniqKey="Parving H" first="Hans-Henrik" last="Parving">Hans-Henrik Parving</name>
</noRegion>
</country>
</tree>
</affiliations>
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