CardioSource WorldNews December 2014 | Page 16

More than 90% of Adempas
patients survived at 2 years*
*Data from CHEST-2 and PATENT-2 open-label extension
studies. Without a control group, these data must be
interpreted cautiously.

PAH

93%
PROBABILITY OF SURVIVAL
AT 2 YEARS

CTEPH

94%
PROBABILITY OF SURVIVAL
AT 2 YEARS

WARNINGS AND PRECAUTIONS
Hypotension. Adempas reduces blood pressure. Consider
the potential for symptomatic hypotension or ischemia in
patients with hypovolemia, severe left ventricular outflow
obstruction, resting hypotension, autonomic dysfunction,
or concomitant treatment with antihypertensives or
strong CYP and P-gp/BCRP inhibitors. Consider a dose
reduction if patient develops signs or symptoms of
hypotension.
Bleeding. In the placebo-controlled clinical trials, serious
bleeding occurred in 2.4% of patients taking Adempas
compared to 0% of placebo patients. Serious hemoptysis
occurred in 5 (1%) patients taking Adempas compared
to 0 placebo patients, including one event with fatal
outcome. Serious hemorrhagic events also included 2
patients with vaginal hemorrhage, 2 with catheter site
hemorrhage, and 1 each with subdural hematoma,
hematemesis, and intra-abdominal hemorrhage.
Pulmonary Veno-Occlusive Disease. Pulmonary
vasodilators may significantly worsen the cardiovascular
status of patients with pulmonary veno-occlusive disease
(PVOD). Therefore, administration of Adempas to such
patients is not recommended. Should signs of pulmonary
edema occur, the possibility of associated PVOD should
be considered and if confirmed, discontinue treatment
with Adempas.

BAYER, the Bayer Cross, and Adempas are registered trademarks of Bayer.
Bayer HealthCare LLC
100 Bayer Boulevard, Whippany, NJ 07981 USA
©2014 Bayer HealthCare Inc.
400-10-0003-14b September 2014

At 1 year,
probability
of survival was
97% in both
open-label
extension
studies.

MOST COMMON ADVERSE REACTIONS
• The most common adverse reactions occurring
more frequently (≥3%) on Adempas than placebo
were headache (27% vs 18%), dyspepsia/gastritis
(21% vs. 8%), dizziness (20% vs 13%), nausea
(14% vs 11%), diarrhea (12% vs 8%), hypotension
(10% vs 4%), vomiting (10% vs 7%), anemia
(7% vs 2%), gastroesophageal reflux disease
(5% vs 2%), and constipation (5% vs 1%).
• Other events that were seen more frequently in
Adempas compared to placebo and potentially
related to treatment were: palpitations, nasal
congestion, epistaxis, dysphagia, abdominal
distension and peripheral edema.
For important risk and use information, please see the
Brief Summary of the full Prescribing Information,
including Boxed Warning, on the next page.
Stimulating

Visit

Adempas-US.com
Soluble Guanylate Cyclase

for more information