WHIPPANY, N.J., May 13, 2016 /PRNewswire/ -- Bayer will present
six abstracts investigating the treatment of pulmonary arterial
hypertension (PAH) and chronic thromboembolic pulmonary
hypertension (CTEPH) with riociguat in scientific sessions at the
2016 American Thoracic Society (ATS) International Conference, to
be held May 13-18th in
San Francisco, California.
"We are pleased to share data from several recent and ongoing
studies examining the treatment of pulmonary arterial hypertension
and chronic thromboembolic pulmonary hypertension with riociguat,"
said Dario Mirski, MD, Bayer's
senior vice president and head of medical affairs for the
Americas. "Bayer is committed to continued exploration of
this treatment option for patients with life-threatening diseases,
and we look forward to the valuable scientific exchange at ATS this
year."
The studies Bayer will present are:
- Baseline Characteristics of Patients Enrolled in a Prospective
Study of Riociguat for Pulmonary Hypertension Associated with
Idiopathic Interstitial Pneumonia (RISE-IIP Study) *Note: this
study has been discontinued.
- Presentation: Monday, May 16, 2016; 11:00 –
12:45 p.m.; Moscone Center; Area H,
Hall D
- Riociguat Treatment for Porto-Pulmonary Hypertension: A
Subgroup Analysis from the PATENT-1 Study
- Poster # 990
- Presentation: Wednesday, May 18,
2016; 11:00 a.m. –
12:45 p.m.; Moscone Center; Area H,
Hall D
- Riociguat for the Treatment of Pulmonary Arterial Hypertension
and Chronic Thromboembolic Pulmonary Hypertension: Real-Life Data
From the EXPERT Registry
- Poster # 1028
- Presentation: Wednesday, May 18,
2016; 11:00 a.m. –
12:45 p.m.; Moscone Center; Area H,
Hall D
- The RESPITE Study: Riociguat in Patients with PAH and an
Inadequate Response to Phosphodiesterase 5 Inhibitors
- Poster # 1012
- Presentation: Tuesday, May 17,
2016; 2:15 p.m. – 3:00 p.m.; Moscone Center; Room 3024
- Application of the Criteria for Satisfactory Clinical Response
to Riociguat Treatment of Patients with Pulmonary Arterial
Hypertension (PATENT-1 and PATENT-2)
- Poster # 962
- Presentation: Wednesday, May 18,
2016; 11:00 a.m. –
12:45 p.m.; Moscone Center; Area H,
Hall D
- Baseline Demographics of the Prospective, Multicenter,
Single-Arm, Open-Label, Phase IV MOTION Study of Riociguat in
Pulmonary Arterial Hypertension
- Poster # 1024
- Presentation: Wednesday, May 18,
2016; 11:00 a.m. –
12:45 p.m.; Moscone Center; Area H,
Hall D
About Pulmonary Arterial Hypertension (PAH)
PAH (WHO
Group 1), a form of PH, is characterized by elevated blood pressure
in the pulmonary arteries. It is a chronic disease which produces
symptoms such as shortness of breath, dizziness and fatigue, and
the severity of symptoms usually correlates with the progression of
the disease.1
About Chronic Thromboembolic Pulmonary Hypertension
(CTEPH)
CTEPH (WHO Group 4) is a progressive type of
pulmonary hypertension, in which it is believed that thromboembolic
occlusion (organized blood clots) of pulmonary vessels gradually
lead to an increased blood pressure in the pulmonary arteries,
resulting in an overload of the right heart. CTEPH may evolve after
prior episodes of acute pulmonary embolism, but the pathogenesis is
not yet completely understood. The standard and potentially
curative treatment for CTEPH is pulmonary thromboendarterectomy
(PTE), a surgical procedure in which the blood vessels of the lungs
are cleared of clot and scar material. However, a considerable
number of patients with CTEPH (20%-40%) are not operable and in up
to 35 percent of patients, the disease persists or reoccurs after
PTE.
About Riociguat
Riociguat, licensed in the U.S. as
Adempas (riociguat), is a stimulator of soluable guanylate cyclase
(sGC) and is the only treatment approved in the U.S. for use in two
types of pulmonary hypertension (WHO Groups 1 and 4).
Adempas is indicated for the treatment of adults with
persistent/recurrent chronic thromboembolic pulmonary hypertension
(CTEPH), (WHO Group 4) after surgical treatment, or inoperable
CTEPH, to improve exercise capacity and WHO functional class.
Adempas is also indicated for the treatment of adults with
pulmonary arterial hypertension (PAH), (WHO Group 1), to improve
exercise capacity, WHO functional class and to delay clinical
worsening*.
Efficacy was shown in patients on Adempas monotherapy or in
combination with endothelin receptor antagonists or prostanoids.
Studies establishing effectiveness of riociguat included
predominately patients with WHO functional class II–III and
etiologies of idiopathic or heritable PAH (61%) or PAH associated
with connective tissue diseases (25%).
*Time to clinical worsening was a combined endpoint defined as
death (all-cause mortality), heart/lung transplantation, atrial
septostomy, hospitalization due to persistent worsening of
pulmonary hypertension, start of new PAH-specific treatment,
persistent decrease in 6MWD and persistent worsening of WHO
functional class.
The development and commercialization of riociguat is part of
the worldwide strategic collaboration between Merck & Co., Inc
(through a subsidiary) and Bayer AG in the field of soluble
guanylate cyclase (sGC) modulators.
INDICATIONS
- Adempas (riociguat) tablets are indicated for the treatment of
adults with persistent/recurrent chronic thromboembolic pulmonary
hypertension (CTEPH), (WHO Group 4) after surgical treatment, or
inoperable CTEPH, to improve exercise capacity and WHO functional
class.
- Adempas is indicated for the treatment of adults with pulmonary
arterial hypertension (PAH), (WHO Group 1), to improve exercise
capacity, WHO functional class and to delay clinical
worsening.*
Efficacy was shown in patients on Adempas monotherapy or in
combination with endothelin receptor antagonists or prostanoids.
Studies establishing effectiveness included predominantly patients
with WHO functional class II–III and etiologies of idiopathic or
heritable PAH (61%) or PAH associated with connective tissue
diseases (25%).
*Time to clinical worsening was a combined endpoint defined as
death (all-cause mortality), heart/lung transplantation, atrial
septostomy, hospitalization due to persistent worsening of
pulmonary hypertension, start of new PAH-specific treatment,
persistent decrease in 6MWD and persistent worsening of WHO
functional class.
IMPORTANT SAFETY INFORMATION
|
WARNING:
EMBRYO-FETAL TOXICITY
|
Do not administer
Adempas (riociguat) tablets to a pregnant female because it may
cause fetal harm.
|
Females of
reproductive potential: Exclude pregnancy before the start of
treatment, monthly during treatment, and 1 month after stopping
treatment. Prevent pregnancy during treatment and for one
month after stopping treatment by using acceptable methods of
contraception.
|
For all female
patients, Adempas is available only through a restricted program
called the Adempas Risk Evaluation and Mitigation Strategy (REMS)
Program.
|
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.
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 and contraception requirements.
- Pharmacies must be certified with the program and must only
dispense to patients who are authorized to receive Adempas.
Further information, including a list of certified pharmacies,
is available at www.AdempasREMS.com or
1-855-4ADEMPAS.
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.
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 full
Prescribing Information, including Boxed Warning, at
www.adempas-us.com.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer is a
global enterprise with core competencies in the Life Science fields
of health care and agriculture. Its products and services are
designed to benefit people and improve their lives. At the same
time, the Group aims to create value through innovation, growth and
high earning power. Bayer is committed to the principles of
sustainable development and to its social and ethical
responsibilities as a corporate citizen. In fiscal 2015, the Group
employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted
to EUR 2.6 billion, R&D expenses
to EUR 4.3 billion. These figures
include those for the high-tech polymers business, which was
floated on the stock market as an independent company named
Covestro on October 6, 2015. For more
information, go to www.bayer.us.
Bayer® and the Bayer Cross® are registered trademarks of
Bayer
Forward Looking Statement
This news release may
contain forward-looking statements based on current assumptions and
forecasts made by Bayer Group or subgroup management. Various known
and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial
situation, development or performance of the company and the
estimates given here. These factors include those discussed in
Bayer's public reports which are available on the Bayer Web site at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
1 Pulmonary Hypertension Association. About Pulmonary
Hypertension. Available at: http://www.phassociation.org/AboutPH.
Accessed April 20, 2016.
Intended for U.S. Media Only
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