SAN DIEGO, May 13, 2015 /PRNewswire/ -- ResMed (NYSE: RMD)
today announced that SERVE-HF, a multinational, multicenter,
randomized controlled Phase III trial did not meet its primary
endpoint. SERVE-HF was designed to assess whether the
treatment of moderate to severe predominant central sleep apnea
with Adaptive Servo-Ventilation (ASV) therapy could reduce
mortality and morbidity in patients with symptomatic chronic heart
failure in addition to optimized medical care.
The study did not show a statistically significant difference
between patients randomized to ASV therapy and those in the control
group in the primary endpoint of time to all-cause mortality or
unplanned hospitalization for worsening heart failure (based on a
hazard ratio [HR] = 1.136, 95 percent confidence interval [95% CI]
= (0.974, 1.325), p-value = 0.104). The results from SERVE-HF
are preliminary and will be submitted for future publication after
further analysis.
A preliminary analysis of the data identified a statistically
significant 2.5 percent absolute increased risk of cardiovascular
mortality for those patients in the trial who received ASV therapy
per year compared to those in the control group. In the
study, the cardiovascular mortality rate in the ASV group was 10
percent per year compared to 7.5 percent per year in the control
group. There were no issues associated with the performance
of the ASV therapy device in the trial.
"Patient safety is our first and foremost priority. We have
alerted and are working with appropriate global regulatory
authorities about the safety signal observed in this study," said
Glenn Richards, M.D., ResMed Chief
Medical Officer. "The safety signal in SERVE-HF was observed
only with the use of ASV therapy in people who have predominant
central sleep apnea and symptomatic chronic heart failure with
reduced ejection fraction. We are further analyzing the data
to understand why this unexpected result was observed in this
trial."
ResMed is working with global regulatory authorities to
proactively revise the labels and instructions for use for ResMed
ASV devices to include a contraindication for people with
symptomatic chronic heart failure (with left ventricular ejection
fraction, LVEF, less than or equal to 45 percent). The company is
also proactively informing healthcare providers, physicians, and
patients of the cardiovascular safety signal observed in
SERVE-HF.
The safety signal observed in SERVE-HF was observed only with
ASV therapy in patients with moderate to severe predominant central
sleep apnea and symptomatic chronic heart failure with reduced
ejection fraction. The study did not include people with
central sleep apnea in the absence of heart failure. It is
also important to note that SERVE-HF did not include any patients
with predominant obstructive sleep apnea, and did not include any
other treatment modality such as continuous positive airway
pressure (CPAP) or auto-adjusting positive airway pressure
(APAP).
"SERVE-HF did not meet its primary endpoint, however this study
provides valuable, practice-changing guidance on how to best care
for people with chronic heart failure," said Prof. Martin
Cowie, M.D., the co-principal investigator of the study and
Professor of Cardiology at Imperial College, London. "SERVE-HF was a well-designed
and executed study and because of it we now know that ASV therapy
should not be used to treat central sleep apnea in people with
symptomatic chronic heart failure with reduced ejection
fraction."
Healthcare providers and patients who have questions or would
like more information are encouraged to call 1-800-478-9010 and
visit www.SERVE-HFFAQs.com
About Sleep-Disordered Breathing
Sleep-disordered
breathing encompasses a spectrum of breathing problems during
sleep. The two most common types of sleep apnea, a condition
that results in repetitive pauses in breathing during sleep, are
obstructive sleep apnea and central sleep apnea.
Obstructive sleep apnea (OSA) is a sleep disorder in which the
throat muscles relax, block the airways and stop the flow of breath
during sleep.
Central sleep apnea is a sleep disorder in which the brain does
not transmit the "breathe" signal to the muscles that control
breathing during sleep. In some cases, people with central
sleep apnea also exhibit an abnormal breathing pattern known as
Cheyne-Stokes respiration. With Cheyne-Stokes respiration,
there is a period of shallow breathing followed by deep breathing,
with intermittent central apnea, in which the breath is stopped for
more than 10 seconds during each apnea.
In both obstructive and central sleep apnea, the lack of oxygen
causes the person to wake up and start breathing again,
interrupting continuous sleep. In central sleep apnea, this
occurs more than five times per hour of sleep.
Sleep-disordered breathing is found more commonly in patients
with heart failure than it is in the general population, and people
with heart failure often report poor sleep as a symptom.
About SERVE-HF
SERVE-HF is a multinational,
multicenter, randomized controlled Phase III study that was
designed to assess whether treatment of moderate to severe
predominant central sleep apnea with ASV therapy in addition to
optimized medical care could reduce mortality and morbidity in
patients with symptomatic chronic heart failure.
About ResMed
The global team at ResMed (NYSE:RMD) is
united in their commitment to changing lives with every
breath. With more than 4,000 employees and a presence in over
100 countries, the company has been pioneering new and innovative
devices and treatments for sleep-disordered breathing, chronic
obstructive pulmonary disease, and other key chronic diseases for
more than 25 years. ResMed's world-leading products and
innovative solutions improve the quality of life for millions of
patients worldwide, reduce the impact of chronic disease, and save
healthcare costs. For more information about ResMed and its
businesses, visit www.resmed.com or follow @resmed on Twitter.
Safe harbor statement
Statements contained in
this release that are not historical facts are "forward-looking"
statements as contemplated by the Private Securities Litigation
Reform Act of 1995. These forward-looking statements — including
statements regarding subsequent analyses of existing data and new
data received from past, ongoing and future studies, the nature and
scope of the impact that study results may have on the current or
future markets for ResMed ASV devices, and the nature and timing of
regulatory and other legal action — are subject to risks and
uncertainties, which could cause actual results to materially
differ from those projected or implied in the forward-looking
statements. Additional risks and uncertainties are discussed in
ResMed's periodic reports on file with the U.S. Securities &
Exchange Commission. ResMed does not undertake to update its
forward-looking statements.
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SOURCE ResMed