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Continuous subcutaneous treprostinil for treatment of pulmonary arterial hypertension |
HAYES, Inc |
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Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc. Continuous subcutaneous treprostinil for treatment of pulmonary arterial hypertension. Lansdale: HAYES, Inc. Healthcare Technology Brief Publication. 2017 Authors' conclusions Pulmonary arterial hypertension (PAH) refers to the vascular remodeling of the small pulmonary arteries that is associated with elevated pulmonary arterial pressure (PAP) and eventually right ventricular failure (RVF). Symptoms of PAH begin as shortness of breath at exertion, later progressing to dyspnea with normal activities, and ultimately dyspnea at rest. Patients with advanced PAH are unable to perform any activity without shortness of breath or chest pain. PAH is an inexorable, progressive, and lethal disease. Incidence estimates vary and suggest a range of 5 to 52 cases per 1 million persons. Patients who remain untreated have an estimated survival rate of 2.8 years with 1-, 3-, and 5-year survival rates of 68%, 48%, and 34%, respectively. Current therapy may yield average survival after diagnosis of 5 to 7 years in adults.
Description of Technology: This health technology assessment focuses on the use of treprostinil sodium (Remodulin) as a continuous subcutaneous (SC) infusion for adults with World Health Organization (WHO) Group 1 PAH with WHO or New York Heart Association (NYHA) functional classes II to IV (mild to severe
symptoms). Treprostinil is a tricyclic benzindene analog of prostacyclin with similar antiplatelet and vasodilatory actions, including acute pulmonary vasodilation. Treprostinil exhibits an absolute bioavailability of 100% after SC infusion. Continuous SC administration of treprostinil achieves steady-state plasma concentrations after approximately 10 hours when given at rates from 1.25 nanograms per kilogram per minute (ng/kg/min) to 22 ng/kg/min. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, it is recommended to reduce the infusion rate to 0.625 ng/kg/min. Patient Population: Treprostinil sodium (Remodulin) is indicated in patients with PAH categorized as WHO Group 1 with WHO or NYHA functional class II to IV symptoms and etiologies of idiopathic or heritable PAH, PAH associated with congenital systemic-to-pulmonary shunts, or PAH associated with connective tissue
diseases. Treprostinil is indicated for symptom reduction.
Clinical Alternatives: Alternatives to treprostinil include prostacyclin derivatives (epoprosteno, oral or inhalant treprostinil, and iloprost), endothelin receptor antagonists (bosentan and ambrisentan), phosphodiesterase-5 inhibitors (sildenafil and tadalafil), and nitric oxide. Patients with PAH who fail drug therapies may undergo
surgical procedures including lung transplantation or an atrial septostomy. Indexing Status Subject indexing assigned by CRD MeSH Epoprostenol; Familial Primary Pulmonary Hypertension; Humans; Hypertension, Pulmonary Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32017000180 Date abstract record published 04/04/2017 |
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