کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5987259 | 1578235 | 2015 | 10 صفحه PDF | دانلود رایگان |

BackgroundIn PATENT-1, riociguat significantly improved 6-minute walking distance (6MWD) and a range of secondary end-points in patients with pulmonary arterial hypertension (PAH). We investigated whether riociguat increased the proportion of patients achieving clinically relevant responder thresholds compared with placebo during PATENT-1.MethodsIn PATENT-1, a randomized, double-blind study, treatment-naïve patients or patients on background PAH-targeted therapy with symptomatic PAH received 12 weeks of treatment with placebo, riociguat up to 2.5 mg 3 times daily, or riociguat up to 1.5 mg 3 times daily. Increases in 6MWD â¥40 m, 6MWD â¥380 m, cardiac index â¥2.5 liter/min/m2, mixed venous oxygen saturation â¥65%, World Health Organization functional class I/II, N-terminal pro-brain natriuretic peptide <1,800 pg/ml, and right atrial pressure <8 mm Hg were chosen as threshold criteria of a positive response.ResultsRiociguat increased the proportion of treatment-naïve patients and patients on background PAH-targeted therapy with 6MWD â¥380 m at Week 12 (+21% and +15%, respectively), whereas there was a small reduction in 6MWD in placebo-treated patients for both sub-groups. Riociguat also increased the proportion of treatment-naïve patients and patients on background PAH-targeted therapy achieving World Health Organization functional class I/II (+12% and +19%, respectively) and cardiac index â¥2.5 liter/min/m2 (+30% and +33%, respectively) at Week 12, whereas there was little change in the respective placebo groups.ConclusionsCompared with placebo, riociguat increased the proportion of treatment-naïve patients and patients on background PAH-targeted therapy who fulfilled criteria defining a positive response to therapy.
Journal: The Journal of Heart and Lung Transplantation - Volume 34, Issue 3, March 2015, Pages 338-347