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Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials
JAMA, 315 (2016), 18; 1975-1988. https://doi.org/10.1001/jama.2016.5258
(Dual-1, Dual-2) Khanna, Dinesh; Denton, Christopher P.; Merkel, Peter A.; Krieg, Thomas; Le Brun, Franck-Olivier; Anić, Branimir; Martinović Kaliterna, Dušanka; Morović Vergles, Jadranka; Novak, Srđan; Prus, Vesna

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Khanna, D., Denton, C. P., Merkel, P. A., Krieg, T., Le Brun, F. O., Anić, B. ... Prus, V. (2016). Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials. JAMA, 315. (18), 1975-1988. doi: 10.1001/jama.2016.5258

Khanna, Dinesh, et al. "Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials." JAMA, vol. 315, br. 18, 2016, str. 1975-1988. https://doi.org/10.1001/jama.2016.5258

Khanna, Dinesh, Christopher P. Denton, Peter A. Merkel, Thomas Krieg, Franck Olivier Le Brun, Branimir Anić, Dušanka Martinović Kaliterna, Jadranka Morović Vergles, Srđan Novak i Vesna Prus. "Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials." JAMA 315, br. 18 (2016): 1975-1988. https://doi.org/10.1001/jama.2016.5258

Khanna, D., et al. (2016) 'Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials', JAMA, 315(18), str. 1975-1988. doi: 10.1001/jama.2016.5258

Khanna D, Denton CP, Merkel PA, Krieg T, Le Brun FO, Anić B, i sur.. Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials. JAMA [Internet]. 2016. [pristupljeno 26.02.2025.];315(18):1975-1988. doi: 10.1001/jama.2016.5258

D. Khanna, et al., "Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials", JAMA, vol. 315, br. 18, str. 1975-1988, 2016. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:184:412669. [Citirano: 26.02.2025.]

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Naslov (engleski)Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL-1 and DUAL-2 Randomized Clinical Trials
Naslov (engleski)Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis
AutorDinesh Khanna
AutorChristopher P. Denton
AutorPeter A. Merkel
AutorThomas Krieg
AutorFranck-Olivier Le Brun
AutorBranimir Anić
AutorDušanka Martinović Kaliterna
AutorJadranka Morović Vergles
AutorSrđan Novak
AutorVesna Prus
KolaboracijaDual-1
KolaboracijaDual-2
Autorova ustanovaSveučilište u Rijeci
Medicinski fakultet
(Katedra za internu medicinu)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Temeljne medicinske znanosti
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Interna medicina
Sažetak (engleski)
MPORTANCE 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... Više 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 3 mg of macitentan, 10 mg 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 trial was the cumulative number of new digital ulcers from baseline to week 16. Treatment effect was expressed as the ratio between treatment groups. RESULTS In DUAL-1, among 289 randomized patients (mean age 51.2 years ; 85.8% women), 226 completed the study. The adjusted mean number of new digital ulcers per patient over 16 weeks was 0.94 in the 3-mg macitentan group (n = 95) and 1.08 in the 10-mg macitentan group (n = 97) compared with 0.85 in the placebo group (n = 97) (absolute difference, 0.09 [95% CI, −0.37 to 0.54] for 3 mg of macitentan vs placebo and 0.23 [−0.27 to 0.72] for 10 mg of macitentan vs placebo). Among 265 patients randomized in DUAL-2 (mean age 49.6 years ; 81.9% women), 216 completed the study. In DUAL- 2, the adjusted mean number of new digital ulcers was 1.44 in the 3-mg macitentan group (n = 88) and 1.46 in the 10-mg macitentan group (n = 88) compared with 1.21 in the placebo group (n = 89) (absolute difference, 0.23 [95% CI, −0.35 to 0.82] for 3 mg of macitentan vs placebo and 0.25 [95% CI, −0.34 to 0.84] for 10 mg of macitentan vs placebo). Adverse events more frequently associated with macitentan than with placebo were headache, peripheral edema, skin ulcer, anemia, upper respiratory tract infection, diarrhea, and nasopharyngitis. CONCLUSIONS AND RELEVANCE Among patients with systemic sclerosis and active ischemic digital ulcers, treatment with macitentan did not reduce new digital ulcers over 16 weeks. These results do not support the use of macitentan for the treatment of digital ulcers in this patient population. Sakrij dio sažetka
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaJAMA
Brojčani podacivol. 315, br. 18, str. 1975-1988
p-ISSN0098-7484
DOIhttps://doi.org/10.1001/jama.2016.5258
URN:NBNurn:nbn:hr:184:412669
Datum objave publikacije2016
URL dokumentahttp://bib.irb.hr/1030759
Vrsta resursaTekst
Prava pristupaZatvoreni pristup
Uvjeti korištenjaIkona licence Zaštićeno autorskim pravom.
Datum i vrijeme pohrane2022-02-17 15:55:02
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