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Tomohiko Takahashi, Satoru Hayata, Akihiro Kobayashi, Yuna Onaka, Takeshi Ebihara, Terufumi Hara
BACKGROUND AND OBJECTIVE: Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. METHODS: PAH patients aged 15 years or older were subjected to the analysis...
March 2018: Clinical Drug Investigation
Jean-Luc Vachiéry, Marius M Hoeper, Andrew J Peacock, Olivier Sitbon, Martino Cheli, Colin Church, Karen M Olsson, Massimiliano Palazzini, Brian Waterhouse, Jonathan Langley, Nazzareno Galié
BACKGROUND: The VOLibris Tracking (VOLT) Study was an open-label, prospective, observational, multicenter, post-marketing registry program designed to more fully characterize the safety profile of ambrisentan for the treatment of pulmonary arterial hypertension (PAH). The key outcome was the incidence of aminotransferase elevations >3× the upper limit of normal (ULN). METHODS: In total, 999 patients from 115 centers in 15 countries, who were prescribed ambrisentan for the treatment of PAH (Functional Class II and III) between 30 June 2008 and 13 May 2011, were enrolled...
April 2017: Journal of Heart and Lung Transplantation
Rebecca Spence, Arun Mandagere, Gennyne Walker, Christopher Dufton, Ramesh Boinpally
BACKGROUND: Ambrisentan is an oral, once-daily endothelin receptor antagonist (ERA) that is approved for the treatment of pulmonary arterial hypertension (PAH). Pregnancy is not recommended for women of childbearing potential with PAH, due to an increased risk of mortality. Additionally, the ERA class is teratogenic in animal studies. A highly effective method of contraception is therefore strongly recommended for women of childbearing potential who are treated with an ERA for PAH. OBJECTIVE: This study investigated the effect of ambrisentan on the pharmacokinetics (PK) of the oral contraceptive norethindrone (norethisterone) 1 mg/ethinylestradiol 35 microg (NT 1 mg/EE 35 microg)...
2010: Clinical Drug Investigation
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