Macitentan (Opsumit) for long-Term treatment of pulmonary arterial hypertension
Pulmonary arterial hypertension (PAH; also classified as Group 1 pulmonary hypertension [PH]) is a rare, debilitating, progressive, and life-threatening disease of the pulmonary vasculature, characterized by vascular proliferation and remodelling of small pulmonary arteries. PAH is defined by an inc...
| Corporate Author: | |
|---|---|
| Format: | eBook |
| Language: | English |
| Published: |
Ottawa (ON)
Canadian Agency for Drugs and Technologies in Health
2015 Jul, 2015
|
| Series: | Common drug review
|
| Subjects: | |
| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | Pulmonary arterial hypertension (PAH; also classified as Group 1 pulmonary hypertension [PH]) is a rare, debilitating, progressive, and life-threatening disease of the pulmonary vasculature, characterized by vascular proliferation and remodelling of small pulmonary arteries. PAH is defined by an increase in mean pulmonary arterial pressure (mPAP) e 25 mm Hg and a pulmonary wedge pressure of d 15 mm Hg. If left untreated, it can lead to right heart failure and premature death. Prior to the availability of PAH drug therapies, the median survival time was 2.8 years, with survival rates of 68%, 48%, and 34% at one, three, and five years following diagnosis, respectively. The survival of patients with PAH has improved since the introduction of advanced PAH therapy, with current average survival in adults reaching from five to seven years following diagnosis. In Canada, macitentan is indicated for the long-term treatment of PAH (WHO Group I) to reduce morbidity in patients whose WHO Functional Class (FC) is II or III, whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease. Macitentan is available as 10 mg film-coated tablets and is to be taken orally at a dose of 10 mg once daily, with or without food. The objective of this review was to evaluate the beneficial and harmful effects of macitentan (Opsumit) as monotherapy or in combination with other drugs for the treatment of PAH patients (WHO Group 1) of WHO FC II or III. Recent survival data for patients with idiopathic PAH (IPAH) or familial PAH (FPAH), which are the two largest subgroups of PAH, from an American registry estimate the one-, three-, five-, and seven-year survival rates to be 85%, 68%, 57%, and 49%, respectively. Health Canada has approved eight treatment options covering four different classes of drugs for PAH, World Health Organization (WHO) Group 1: 1. Prostanoids (epoprostenol, treprostinil) 2. Endothelin receptor antagonists (ERAs) (bosentan, ambrisentan, macitentan) 3. Phosphodiesterase type 5 (PDE-5) inhibitors (sildenafil, tadalafil) 4. Soluble guanylate cyclase (sGC) stimulator (riociguat). Macitentan is an orally active, non-peptide, potent dual ERA (ETA and ETB). |
|---|---|
| Physical Description: | 1 online resource illustrations |