Safety and Tolerability of Thrombin Inhibition in Scleroderma‐Associated Interstitial Lung Disease
Identifieur interne : 000871 ( Main/Exploration ); précédent : 000870; suivant : 000872Safety and Tolerability of Thrombin Inhibition in Scleroderma‐Associated Interstitial Lung Disease
Auteurs : R. M. Silver ; D. A. Wilson ; T. Akter ; I. Atanelishvili ; J. T. Huggins ; K. Kajdasz ; K. B. Highland ; P. J. Nietert ; G. S. BogatkevichSource :
- Acr Open Rheumatology [ 2578-5745 ] ; 2019.
Abstract
Interstitial lung disease (
We performed a prospective, single‐center, open‐label treatment trial with the direct thrombin inhibitor, dabigatran, in patients with
Of 15 patients with
Dabigatran appears to be safe and well tolerated in patients with
Url:
DOI: 10.1002/acr2.11049
PubMed: 31777820
PubMed Central: 6858036
Affiliations:
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Le document en format XML
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<author><name sortKey="Silver, R M" sort="Silver, R M" uniqKey="Silver R" first="R. M." last="Silver">R. M. Silver</name>
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<author><name sortKey="Bogatkevich, G S" sort="Bogatkevich, G S" uniqKey="Bogatkevich G" first="G. S." last="Bogatkevich">G. S. Bogatkevich</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety and Tolerability of Thrombin Inhibition in Scleroderma‐Associated Interstitial Lung Disease</title>
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<author><name sortKey="Akter, T" sort="Akter, T" uniqKey="Akter T" first="T." last="Akter">T. Akter</name>
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<author><name sortKey="Atanelishvili, I" sort="Atanelishvili, I" uniqKey="Atanelishvili I" first="I." last="Atanelishvili">I. Atanelishvili</name>
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<author><name sortKey="Huggins, J T" sort="Huggins, J T" uniqKey="Huggins J" first="J. T." last="Huggins">J. T. Huggins</name>
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<author><name sortKey="Kajdasz, K" sort="Kajdasz, K" uniqKey="Kajdasz K" first="K." last="Kajdasz">K. Kajdasz</name>
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<author><name sortKey="Highland, K B" sort="Highland, K B" uniqKey="Highland K" first="K. B." last="Highland">K. B. Highland</name>
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<author><name sortKey="Nietert, P J" sort="Nietert, P J" uniqKey="Nietert P" first="P. J." last="Nietert">P. J. Nietert</name>
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<author><name sortKey="Bogatkevich, G S" sort="Bogatkevich, G S" uniqKey="Bogatkevich G" first="G. S." last="Bogatkevich">G. S. Bogatkevich</name>
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<series><title level="j">Acr Open Rheumatology</title>
<idno type="eISSN">2578-5745</idno>
<imprint><date when="2019">2019</date>
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<front><div type="abstract" xml:lang="en"><sec id="acr211049-sec-0001"><title>Objective</title>
<p>Interstitial lung disease (<styled-content style="fixed-case" toggle="no">ILD</styled-content>
) is a frequent complication of systemic sclerosis (<styled-content style="fixed-case" toggle="no">SS</styled-content>
c) (scleroderma) and the leading cause of scleroderma‐related deaths. There exists an unmet need for a new drug therapy for <styled-content style="fixed-case" toggle="no">ILD</styled-content>
‐complicated <styled-content style="fixed-case" toggle="no">SS</styled-content>
c. Substantial evidence supports an important role for thrombin in the pathogenesis of <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐associated <styled-content style="fixed-case" toggle="no">ILD</styled-content>
(hereafter <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐<styled-content style="fixed-case" toggle="no">ILD</styled-content>
), and targeting thrombin with a direct thrombin inhibitor could prove to be a novel and effective treatment strategy. As a first step toward designing a clinical trial to test the efficacy of thrombin inhibition in <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐<styled-content style="fixed-case" toggle="no">ILD</styled-content>
, we conducted this study to test the safety and tolerability of dabigatran in patients with <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐<styled-content style="fixed-case" toggle="no">ILD</styled-content>
.</p>
</sec>
<sec id="acr211049-sec-0002"><title>Methods</title>
<p>We performed a prospective, single‐center, open‐label treatment trial with the direct thrombin inhibitor, dabigatran, in patients with <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐<styled-content style="fixed-case" toggle="no">ILD</styled-content>
. Any patient with a history of gastrointestinal hemorrhage or gastric antral vascular ectasia was excluded. Blood monitoring was performed monthly, and patient‐reported outcomes, pulmonary function tests, and skin scores were obtained at baseline and at 3‐ and 6‐month visits. Bronchoscopy with bronchoalveolar lavage (<styled-content style="fixed-case" toggle="no">BAL</styled-content>
) was performed at baseline and at 6 months for measurement of lung thrombin activity.</p>
</sec>
<sec id="acr211049-sec-0003"><title>Results</title>
<p>Of 15 patients with <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐<styled-content style="fixed-case" toggle="no">ILD</styled-content>
, 14 completed 6 months of treatment with dabigatran at 75 mg taken orally twice daily. Adverse events were uncommon and usually mild or unrelated to the study medication. No serious adverse event was observed. Dabigatran was well tolerated, and we observed no significant gastrointestinal, pulmonary, or other safety issues or intolerability. <styled-content style="fixed-case" toggle="no">BAL</styled-content>
fluid thrombin activity decreased or remained stable in 13 of 14 (92.8%) subjects.</p>
</sec>
<sec id="acr211049-sec-0004"><title>Conclusion</title>
<p>Dabigatran appears to be safe and well tolerated in patients with <styled-content style="fixed-case" toggle="no">SS</styled-content>
c‐<styled-content style="fixed-case" toggle="no">ILD</styled-content>
. A larger randomized controlled trial to test the efficacy of direct thrombin inhibition with dabigatran can be considered.</p>
</sec>
</div>
</front>
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<tree><noCountry><name sortKey="Akter, T" sort="Akter, T" uniqKey="Akter T" first="T." last="Akter">T. Akter</name>
<name sortKey="Atanelishvili, I" sort="Atanelishvili, I" uniqKey="Atanelishvili I" first="I." last="Atanelishvili">I. Atanelishvili</name>
<name sortKey="Bogatkevich, G S" sort="Bogatkevich, G S" uniqKey="Bogatkevich G" first="G. S." last="Bogatkevich">G. S. Bogatkevich</name>
<name sortKey="Highland, K B" sort="Highland, K B" uniqKey="Highland K" first="K. B." last="Highland">K. B. Highland</name>
<name sortKey="Huggins, J T" sort="Huggins, J T" uniqKey="Huggins J" first="J. T." last="Huggins">J. T. Huggins</name>
<name sortKey="Kajdasz, K" sort="Kajdasz, K" uniqKey="Kajdasz K" first="K." last="Kajdasz">K. Kajdasz</name>
<name sortKey="Nietert, P J" sort="Nietert, P J" uniqKey="Nietert P" first="P. J." last="Nietert">P. J. Nietert</name>
<name sortKey="Silver, R M" sort="Silver, R M" uniqKey="Silver R" first="R. M." last="Silver">R. M. Silver</name>
<name sortKey="Wilson, D A" sort="Wilson, D A" uniqKey="Wilson D" first="D. A." last="Wilson">D. A. Wilson</name>
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