Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F16%3A10329106" target="_blank" >RIV/00179906:_____/16:10329106 - isvavai.cz</a>
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=3TLz-oU2W8" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=3TLz-oU2W8</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1001/jama.2016.5258" target="_blank" >10.1001/jama.2016.5258</a>
Alternative languages
Result language
angličtina
Original language name
Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials
Original language description
IMPORTANCE Digital ulcers in patients with systemic sclerosis are associated with pain and poor quality of life. Endothelin-1 promotes vasculopathy in systemic sclerosis after macitentan, an endothelin-1 blocker. OBJECTIVE To evaluate the efficacy of macitentan in reducing the number of new digital ulcers in patients with systemic sclerosis. DESIGN, SETTING, AND PARTICIPANTS Two international, randomized, double-blind, placebo-controlled trials (DUAL-1, DUAL-2) were conducted between January 2012 and February 2014. Participants were patients with systemic sclerosis and active digital ulcers at baseline. Target enrollment for each study was 285 patients. INTERVENTIONS Patients were randomized (1:1:1) to receive oral doses of 3mg of macitentan, 10mg of macitentan, or placebo once daily and stratified according to number of digital ulcers at baseline (3 or >3). MAIN OUTCOMES AND MEASURES The primary outcome for each trialwas the cumulative number of new digital ulcers from baseline to week 16. Treatment effect was expressed as the ratio between treatment groups.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30226 - Rheumatology
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JAMA: The Journal of the American Medical Association
ISSN
0098-7484
e-ISSN
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Volume of the periodical
315
Issue of the periodical within the volume
18
Country of publishing house
US - UNITED STATES
Number of pages
14
Pages from-to
1975-1988
UT code for WoS article
000375461100015
EID of the result in the Scopus database
2-s2.0-84968808222