FDA approves Tirzepatide as the first and only
prescription medicine for
moderate-to-severe
obstructive sleep apnea in
adults with obesity
(UAE) - The U.S. Food and Drug Administration (FDA) approved
lately Tirzepatide, produced
by
Eli Lilly and Company
(NYSE: LLY), as the first
and only prescription
medicine for adults with
moderate-to-severe
obstructive sleep apnea
(OSA) and obesity.
Tirzepatide may help adults
with moderate-to-severe
obstructive sleep apnea and
obesity improve their sleep
disorder. It should be used
with a reduced-calorie diet
and increased physical
activity.
"Too often,
OSA is brushed off as 'just
snoring' — but it's far more
than that”, said Julie
Flygare, J.D., president and
CEO of Project Sleep. “It's
important to understand OSA
symptoms and know that
treatments are available,
including new options like
Tirzepatide. We hope this
will spark more meaningful
conversations between
patients and healthcare
providers and ultimately
lead to better health
outcomes”.
OSA is
asleep-related breathing
disorder characterized by
complete or partial
collapses of the upper
airway during sleep, which
can lead to pauses in
breathing (apnea) or shallow
breathing (hypopnea) and a
potential decrease in oxygen
saturation and/or waking
from sleep. One of the
hallmarks of OSA is snoring,
but fatigue, excessive
daytime sleepiness and
disrupted sleep are also key
symptoms, making this
serious condition easily
overlooked.
"Today,
many cases of OSA go
undiagnosed and untreated,
leaving millions at risk for
serious health
consequences," said Patrik
Jonsson, executive vice
president, and president of
Lilly Cardiometabolic Health
and Lilly USA. “Tirzepatide
is the first medication that
significantly improves
moderate-to-severe OSA and
aids in long-term weight
loss in adults with obesity.
Nearly half of clinical
trial patients saw such
improvements that they no
longer had symptoms
associated with OSA, marking
a critical step forward in
reducing the burden of this
disease and its
interconnected health
challenges.”
This
approval was based on
results from the
SURMOUNT-OSA phase 3
clinical trials, which
evaluated Tirzepatide (10 mg
or 15 mg) for the treatment
of moderate-to-severe OSA in
adults with obesity, with
and without positive airway
pressure (PAP) therapy over
the course of a year.
Tirzepatide was about five
times more effective than
placebo in reducing
breathing disruptions in
adults not on PAP therapy,
leading to 25 fewer
breathing disruptions per
hour with Tirzepatide and
five with placebo. In adults
on PAP therapy, Tirzepatide
led to 29 fewer breathing
disruptions per hour
compared to six with
placebo. After one year, 42%
of adults on Tirzepatide and
50% of adults on Tirzepatide
with PAP therapy experienced
remission or mild,
non-symptomatic OSA,
compared to 16% and 14% on
placebo, respectively.
In addition to improved
OSA symptoms, adults on
Tirzepatide lost an average
of 45 lbs (18%) of their
body weight, while adults on
Tirzepatide with PAP therapy
lost an average of 50 lbs
(20%) of their body weight,
compared to 4 lbs (2%) and 6
lbs (2%) on placebo,
respectively.
About SURMOUNT-OSA
SURMOUNT-OSA (NCT05412004)
was a multi-center,
randomized, double-blind,
parallel, placebo-master
protocol comparing the
efficacy and safety of
Tirzepatide® (tirzepatide)
to placebo in adults living
with moderate-to-severe
obstructive sleep apnea
(OSA) and obesity who were
unable or unwilling to use
positive airway pressure
(PAP) therapy (Study 1) and
those who were and planned
to stay on PAP therapy
during the duration of the
trial (Study 2). Under a
master protocol, the trials
randomized 469 participants
across the U.S., Australia,
Brazil, China, Czechia,
Germany, Japan, Mexico and
Taiwan in a 1:1 ratio to
receive Tirzepatide maximum
tolerated dose (MTD) of 10
mg or 15 mg or placebo. The
primary objective of both
studies was to demonstrate
that Tirzepatide is superior
in change in apnea-hypopnea
index (AHI) from baseline at
52 weeks as compared to
placebo.
SURMOUNT-OSA
utilized an MTD of 10 mg or
15 mg once-weekly. The
starting dose of 2.5 mg
Tirzepatide was increased by
2.5 mg every four weeks
until maximum tolerated dose
was achieved. Participants
who tolerated 15 mg
continued on 15 mg as their
MTD. Participants who
tolerated 10 mg but did not
tolerate 15 mg continued on
10 mg as their MTD.
About Tirzepatide
Tirzepatide injection is
FDA-approved to treat adults
with moderate-to-severe
obstructive sleep apnea and
obesity. It is also approved
in combination with a
reduced-calorie diet and
increased physical activity
to reduce excess body weight
and maintain weight
reduction long term in
adults with obesity or
adults with overweight in
the presence of at least one
weight-related comorbid
condition.
Tirzepatide is the first and
only dual-activating GIP
(glucose-dependent
insulinotropic polypeptide)
and GLP-1 (glucagon-like
peptide-1) obesity
medication. Tirzepatide
tackles an underlying cause
of excess weight. It reduces
appetite and how much you
eat.
Note: The above
information is intended for
healthcare professionals and
education purposes and is
not meant to influence
prescribing practices or
promote one product over
another nor is it a
substitute for professional
medical advice. Consult with
a healthcare professional
for personalized treatment
options.