Patients walked farther with Adempas at Week 16: results from Week 2 onward
46m
improvement (mean) in 6MWD over placebo at Week 16
(95% CI: 25m-67m; p<0.0001) for CTEPH* (WHO Group 4) patients.
WHO FUNCTIONAL CLASS
2x
as many CTEPH patients
improved WHO Functional
Class vs placebo (p=0.0026;
Adempas: n=57/173 [33%],
placebo: n=13/87 [15%])
at Week 16.
Deteriorated
5% for Adempas
(n=9/173)
7% for placebo
(n=6/87)
Stable
62% for Adempas
(n=107/173)
78% for placebo
(n=68/87)
CHEST-1: 261 CTEPH patients were studied. (Adempas n=173, placebo n=88)
Baseline characteristics:
*Inoperable or recurrent/persistent CTEPH after surgery.
– Mean age: 59 years (range: 18–80)
– Mean 6MWD was 347m
– Concomitant medications: Stable dosages of oral anticoagulants, diuretics,
digitalis, calcium channel blockers, and oxygen were allowed, but not nitric
oxide donors, endothelin receptor antagonists, prostacyclin analogues,
specific phosphodiesterase (PDE)-5 inhibitors (such as sildenafil, tadalafil,
or vardenafil), and nonspecific PDE inhibitors (for example, dipyridamole
or theophylline)
Patient population was: 72% inoperable by pulmonary
endarterectomy (PEA) (pulmonary vascular resistance
[PVR] >300 dyn·sec·cm-5 and mean pulmonary arterial
pressure >25 mm Hg measured at least 90 days after
the start of full anticoagulation); 28% recurrent or
persisting pulmonary hypertension (PH) following PEA
(PVR >300 dyn·sec·cm-5 measured at least 180 days
following PEA). The majority of patients were WHO
Functional Class II (31%) or III (64%) at baseline.
Patients with systolic blood pressure <95 mm Hg
were excluded.
WARNINGS AND PRECAUTIONS
Adempas REMS Program. Females can only receive Adempas through the
Adempas REMS Program, a restricted distribution program.
Important requirements of the Adempas REMS program include the following:
• Prescribers must be certified with the program by enrolling and
completing training.
• All females, regardless of reproductive potential, must enroll in the
Adempas REMS Program prior to initiating Adempas. Male patients
are not enrolled in the Adempas REMS Program.
• Female patients of reproductive potential must comply with
the pregnancy testing