CardioSource WorldNews December 2014 - Page 14

Adempas could mean moving from the couch to the kitchen Patients walked farther with Adempas at Week 12: results from Week 2 onward 36m improvement (mean) in 6-minute walk distance (6MWD) over placebo at Week 12 (95% Confidence Interval (CI): 20m-52m; p<0.0001) for PAH (WHO Group 1) patients. WHO FUNCTIONAL CLASS 50% more PAH patients improved WHO Functional Class vs placebo (p=0.0033; Adempas: n=53/254 [21%], placebo: n=18/125 [14%]) at Week 12. Deteriorated 4% for Adempas (n=9/254) 14% for placebo (n=18/125) Stable 76% for Adempas (n=192/254) 71% for placebo (n=89/125) PATENT-1: 443 PAH patients were studied. (Adempas 2.5 mg n=254, 1.5 mg n=63, placebo n=126) Baseline characteristics: – PAH defined as: pulmonary vascular resistance (PVR) >300 dyn·sec·cm-5, mean pulmonary arterial pressure (mPAP) >25 mm Hg – Mean age: 51 years (approximately 80% female) – PAH etiologies: idiopathic (61%), familial (2%), associated with connective tissue disease (25%), congenital heart disease (8%), portal hypertension (3%), or anorexigen or amphetamine use (1%) – Mean 6MWD was 363m – Concomitant medications: Oral anticoagulants, diuretics, digitalis, calcium channel blockers, and oxygen were allowed Patient population was: 50% treatment-naïve, 44% pretreated with an endothelin receptor antagonist (ERA), and 6% pretreated with a prostacyclin analogue (PCA). The majority of patients had WHO Functional Class II (42%) or III (54%) at baseline. Patients with systolic blood pressure <95 mm Hg were excluded. CONTRAINDICATIONS Adempas is contraindicated in: • Pregnancy. Adempas may cause fetal harm when administered to a pregnant woman. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus • Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form. • Concomitant administration with specific phosphodiesterase-5 (PDE-5) inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline). WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity. Adempas may cause fetal harm when administered during pregnancy and is contraindicated for use in women who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, advise use of acceptable contraception and obtain monthly pregnancy tests. For females, Adempas is only available through a restricted program under the Adempas REMS Program. Please see additional Important Safety Information, including Boxed Warning, throughout and Brief Summary of Prescribing Information at end of advertisement.