Riociguat for the treatment of pulmonary arterial hypertension
| Autor: | Ghofrani, Ha, Galiè, N, Grimminger, F, Grünig, E, Humbert, M, Jing, Zc, Keogh, Am, Langleben, D, Kilama, Mo, Fritsch, A, Neuser, D, Rubin, Lj, 1 Study Group including Bortman G, Patent, Keogh, A, Kermeen, F, Feenstra, J, Williams, T, Reeves, G, Kilpatrick, D, Lang, I, Kahler, C, Mascherbauer Steringer, R, Vachiery, Jl, Delcroix, M, Meyer, G, Arakaki, J, Santana, M, Waetge, D, Granton, J, Helmersen, D, He, J, Jing, Z, Zhou, D, Huang, Y, Wang, C, Jansa, P, Neilsen Kudsk JE, Hachulla, E, De Groote, P, Frachon, I, Bourdin, A, Pison, C, Bauer, F, Dromer, C, Marquette, Ch, Degano, B, Neurohr, C, Wilkens, H, Hoffken, G, Hoeper, M, Ghofrani, A, Wirtz, H, Rosenkranz, S, Ewert, R, Orfanos, S, Kramer, M, Ben Gal, T, Scelsi, L, Vizza, C, Harari, S, Confalonieri, M, Albera, Carlo, Fukumoto, Y, Sano, M, Hatano, M, Saji, T, Tanaka, S, Takeda, Y, Takehara, K, Matsubara, H, Kihara, Y, Shiohira, Y, Kawai, H, Homma, S, Satoh, T, Tokunaga, T, Ishizaki, T, Diaz, C, Zamudio, T, De Los Rios, M, Estupian, S, Cacho, Jr, Gamba, M, Beckert, L, Torbicki, A, Castro, G, Reis, A, Agapito, A, Martins, S, Kim, H, Lee, S, Chang, H, Song, Y, Chazova, I, Moiseeva, O, Lim, S, Yip, J, Barbera, J, Roman, A, Palma Jdel, C, Reitan, O, Soderberg, S, Jansson, K, Speich, R, Hsu, Hh, Lin, Hy, Cheng, Cc, Phrommintikul, A, Jaimchariyatam, N, Sayin, T, Kultursay, H, Ongen, G, Pepke Zaba, J, Coghlan, G, Peacock, A, Gibbs, J, Wagoner, L, Badesch, D, Frost, A, Hill, N, Allen, R, Waxman, A, Sood, N, Torres, F, Minai, O, Shapiro, S, Klinger, J, Engel, P, Garcia, H, Schuller, D, Poch, D, Rosenzweig, E, Mcconnell, J, Rischard, F, Olschewski, H, Haverkamp, W, Lehmacher, W, Hoischen, S, Collamati, S, Dehay, J, Hallmann, M, Menezes, F. |
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| Přispěvatelé: | Ghofrani HA, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ, PATENT-1 Study Group |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
business.industry General Medicine Placebo medicine.disease Pulmonary hypertension Riociguat law.invention Surgery Clinical trial chemistry.chemical_compound medicine.anatomical_structure Randomized controlled trial chemistry DRUG THERAPY law Anesthesia riociguat pulmonary arterial hypertension Clinical endpoint Vascular resistance Medicine business Macitentan medicine.drug |
| Popis: | Riociguat, a soluble guanylate cyclase stimulator, has been shown in a phase 2 trial to be beneficial in the treatment of pulmonary arterial hypertension. METHODS: In this phase 3, double-blind study, we randomly assigned 443 patients with symptomatic pulmonary arterial hypertension to receive placebo, riociguat in individually adjusted doses of up to 2.5 mg three times daily (2.5 mg-maximum group), or riociguat in individually adjusted doses that were capped at 1.5 mg three times daily (1.5 mg-maximum group). The 1.5 mg-maximum group was included for exploratory purposes, and the data from that group were analyzed descriptively. Patients who were receiving no other treatment for pulmonary arterial hypertension and patients who were receiving endothelin-receptor antagonists or (nonintravenous) prostanoids were eligible. The primary end point was the change from baseline to the end of week 12 in the distance walked in 6 minutes. Secondary end points included the change in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, World Health Organization (WHO) functional class, time to clinical worsening, score on the Borg dyspnea scale, quality-of-life variables, and safety. RESULTS: By week 12, the 6-minute walk distance had increased by a mean of 30 m in the 2.5 mg-maximum group and had decreased by a mean of 6 m in the placebo group (least-squares mean difference, 36 m; 95% confidence interval, 20 to 52; P |
| Databáze: | OpenAIRE |
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