INDIANAPOLIS, Nov. 9, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced new data showing that treatment
with FORTEO® for 24 months was associated with
significantly fewer vertebral and clinical fractures (a composite
of painful vertebral and non-vertebral fractures) compared with
risedronate, a widely used oral bisphosphonate, in postmenopausal
women with severe osteoporosis in the VERO clinical trial. Study
results are published in the November
9 issue of The Lancet.1
Results from the study's primary endpoint showed that at 24
months, fewer patients taking FORTEO® had new vertebral
fractures as compared to patients taking risedronate (5.4% vs.
12.0%, p <0.0001).
The two year randomized, double-blind, double-dummy clinical
trial compared subcutaneous daily teriparatide (20 μg) with oral
weekly risedronate (35 mg) in 1,360 women with at least two
moderate or one severe vertebral fracture and low bone mass.
"The VERO study data reinforces the efficacy of
FORTEO® in reducing fractures and can help physicians
make informed prescribing decisions," said David L. Kendler, Professor of Endocrinology in
the University of British Columbia,
Vancouver and first author of the
article.
This is the first trial in osteoporosis research that has shown
a significant fracture reduction outcome as a primary endpoint
in a head-to-head, active-drug comparative study.
After 24 months of treatment:
- New vertebral fractures occurred in 5.4% of patients in the
teriparatide group, as compared with 12.0% in the risedronate group
after 24 months (a relative risk reduction of 56%;
p<0.001).
- The reduction in new vertebral fractures with teriparatide was
observed as early as 12 months of treatment, with 3.1% of patients
in the teriparatide group compared with 6.0% in the risedronate
group having had at least one new vertebral fracture (a relative
risk reduction of 48%; p<0.05).
- New and worsening vertebral fractures occurred in 6.0% of the
patients in the teriparatide group, as compared with 12.9% of the
patients in the risedronate group (a relative risk reduction of
54%; p<0.001).
- Clinical fractures (a composite endpoint of non-vertebral plus
painful vertebral fractures) occurred in 4.8% of patients in the
teriparatide group, compared with 9.8% in the risedronate group (a
relative risk reduction of 52%; p<0.001).
- No statistically significant difference between groups in the
incidence of non-vertebral fractures was observed: non-vertebral
fragility fractures occurred in 4.0% of patients in the
teriparatide group and 6.1% in the risedronate group (p=0.10).
- There were no statistically significant differences between
treatment groups in the change from baseline in back pain and
quality of life, although both groups showed an improvement
compared to baseline.
- Adverse events and safety laboratory findings were consistent
with the known safety profile of each drug. More patients treated
with teriparatide had at least one high value of serum calcium or
uric acid, and lower levels of serum magnesium and vitamin D.
FORTEO® is a prescription medication used in both men
and postmenopausal women with osteoporosis who are at high risk for
having broken bones, or fractures.2 FORTEO®
is used in both men and women with osteoporosis due to use of
glucocorticoid medicines, such as prednisone, for several months,
who are at high risk for having broken bones, or fractures.
FORTEO® can be used by people who have had a fracture
related to osteoporosis, or who have several risk factors for
fracture, or who cannot use other osteoporosis treatments.
During the drug testing process, the medicine in
FORTEO® caused some rats to develop osteosarcoma, which,
in humans, is a serious but rare bone cancer. Osteosarcoma has been
reported rarely in people who took FORTEO®, and it is
unknown if people who take FORTEO® have a higher chance
of getting the disease. Before patients take FORTEO®,
patients should tell their healthcare provider if they have Paget's
disease of bone, are a child or young adult whose bones are still
growing or have had radiation therapy. For more information about
FORTEO®, please see the important safety information,
including Boxed Warning regarding osteosarcoma, below.
About the Study
"Effects of 24 months treatment of
teriparatide compared with risedronate on new fractures in
postmenopausal women with severe osteoporosis: a randomized,
double-dummy, clinical trial" (Study B3D-EW-GHDW [VERO Study]) was
a Phase 4, multinational, multicenter, prospective, randomized,
parallel, active comparator, clinical trial.
The primary endpoint was the incidence of new vertebral
fractures after two years assessed by quantitative morphometry.
Secondary outcomes were clinical fractures, non-vertebral
fractures, other spine fractures endpoints, height loss, back pain,
quality of life (EQ-5D) and safety. Adverse events and safety
laboratory findings were consistent with the known safety profile
of each drug.
1,360 patients were randomized to receive either teriparatide 20
μg/day injection (FORTEO®) plus weekly oral placebo or
oral risedronate 35 mg/week plus daily placebo injection for a
24-month, double-blind, double dummy treatment phase in study sites
from 14 participant countries in Europe, North
America (USA and
Canada) and South America (Argentina and Brazil). Patients were postmenopausal women
over 45 years of age with a BMD T-score <-1.5 standard
deviations at the femoral neck, total hip or lumbar spine, and at
least two moderate or one severe prevalent vertebral fragility
fractures.
Overall, 72·1% of patients had received at least one prior
osteoporosis medication, most commonly a bisphosphonate.
Important Safety Information about FORTEO
Read this Medication Guide before you start taking FORTEO and
each time you get a refill. There may be new information. Also,
read the User Manual that comes with the FORTEO delivery device
(pen) for information on how to use the device to inject your
medicine the right way. This Medication Guide does not take the
place of talking with your healthcare provider about your medical
condition or your treatment.
What is the most important information I should know about
FORTEO?
- Possible bone cancer. During drug testing, the medicine
in FORTEO caused some rats to develop a bone cancer called
osteosarcoma. In people, osteosarcoma is a serious but rare cancer.
Osteosarcoma has rarely been reported in people who took FORTEO. It
is not known if people who take FORTEO have a higher chance of
getting osteosarcoma.
- You should not take FORTEO for more than 2 years over your
lifetime.
- There is a voluntary Patient Registry for people who take
FORTEO. The purpose of the registry is to collect information
about the possible risk of osteosarcoma in people who take FORTEO.
For information about how to sign up for this patient registry,
call 1-866-382-6813 or go to www.forteoregistry.rti.org.
What is FORTEO?
- FORTEO is a prescription medicine that is like a hormone made
by the body called parathyroid hormone or PTH. FORTEO may help to
form new bone, increase bone mineral density and bone
strength.
- FORTEO can lessen the number of fractures of the spine and
other bones in postmenopausal women with osteoporosis.
- The effect on fractures has not been studied in men.
- FORTEO is used in both men and postmenopausal women with
osteoporosis who are at high risk for having fractures. FORTEO can
be used by people who have had a fracture related to osteoporosis,
or who have several risk factors for fracture, or who can not use
other osteoporosis treatments.
- FORTEO is used in both men and women with osteoporosis due to
use of glucocorticoid medicines, such as prednisone, for several
months, who are at high risk for having broken bones (fractures).
These include men and women with either a history of broken bones,
who have several risk factors for fracture, or who can not use
other osteoporosis treatments.
It is not known if FORTEO is safe and effective in children.
FORTEO should not be used in children and young adults whose bones
are still growing.
Who should not use FORTEO?
Do not use FORTEO if you:
- are allergic to any of the ingredients in FORTEO. See the end
of this Medication Guide for a complete list of the ingredients in
FORTEO.
What should I tell my healthcare provider before taking
FORTEO?
Before you take FORTEO, tell your healthcare
provider if you:
- have the condition listed in the section "Who should not use
FORTEO?"
- have Paget's disease or other bone disease
- have cancer in your bones
- have trouble injecting yourself and do not have someone who can
help you
- are a child or young adult whose bones are still growing
- have or have had kidney stones
- have had radiation therapy
- have or had too much calcium in your blood
- have any other medical conditions
- are pregnant or thinking about becoming pregnant. It is not
known if FORTEO will harm your unborn baby.
- are breast-feeding or plan to breast-feed. It is not known if
FORTEO passes into your breast milk. You and your doctor should
decide if you will take FORTEO or breast feed. You should not do
both.
Tell your healthcare provider about all the medicines you
take including prescription and non-prescription medicines,
vitamins, and herbal supplements. Your healthcare provider needs
this information to help keep you from taking FORTEO with other
medicines that may harm you.
- Especially tell your doctor if you take medicines that contain
digoxin (Digoxin*, Lanoxicaps*, Lanoxin*).
How should I use FORTEO?
- Inject FORTEO one time each day in your thigh or abdomen (lower
stomach area). Talk to a healthcare provider about how to rotate
injection sites.
- Before you try to inject FORTEO yourself, a healthcare provider
should teach you how to use the FORTEO delivery device to give your
injection the right way.
- Read the detailed User Manual at the end of this Medication
Guide.
- You can take FORTEO with or without food or drink.
- The FORTEO delivery device has enough medicine for 28 days. It
is set to give a 20 microgram dose of medicine each day. Do not
inject all the medicine in the FORTEO delivery device at any one
time.
- Do not transfer the medicine from the FORTEO delivery device to
a syringe. This can result in taking the wrong dose of FORTEO. If
you do not have pen needles to use with your FORTEO delivery
device, talk with your healthcare provider.
- FORTEO should look clear and colorless. Do not use FORTEO if it
has particles in it, or if it is cloudy or colored.
- Inject FORTEO right away after you take the delivery device out
of the refrigerator.
- After each use, safely remove the needle, recap the delivery
device, and put it back in the refrigerator right away.
- You can take FORTEO at any time of the day. To help you
remember to take FORTEO, take it at about the same time each
day.
- If you forget or cannot take FORTEO at your usual time, take it
as soon as you can on that day. Do not take more than one injection
in the same day.
- If you take more FORTEO than prescribed, call your healthcare
provider. If you take too much FORTEO, you may have nausea,
vomiting, weakness, or dizziness.
Follow your healthcare provider's instructions about other ways
you can help your osteoporosis, such as exercise, diet, and
reducing or stopping your use of tobacco and alcohol. If your
healthcare provider recommends calcium and vitamin D supplements,
you can take them at the same time you take FORTEO.
What are the possible side effects of
FORTEO?
FORTEO can cause serious side effects including:
- See "What is the most important information I should know about
FORTEO?"
- Decrease in blood pressure when you change positions.
Some people feel dizzy, get a fast heartbeat, or feel faint right
after the first few doses. This usually happens within 4 hours of
taking FORTEO and goes away within a few hours. For the first few
doses, take your injections of FORTEO in a place where you can sit
or lie down right away if you get these symptoms. If your symptoms
get worse or do not go away, stop taking FORTEO and call your
healthcare provider.
- Increased calcium in your blood. Tell your healthcare
provider if you have nausea, vomiting, constipation, low energy, or
muscle weakness. These may be signs there is too much calcium in
your blood.
Common side effects of FORTEO include:
Your healthcare provider may take samples of blood and urine
during treatment to check your response to FORTEO. Also, your
healthcare provider may ask you to have follow-up tests of bone
mineral density.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects of FORTEO. For more
information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
How should I store FORTEO?
- Keep your FORTEO delivery device in the refrigerator between
36° to 46°F (2° to 8°C).
- Do not freeze the FORTEO delivery device. Do not use FORTEO if
it has been frozen.
- Do not use FORTEO after the expiration date printed on the
delivery device and packaging.
- Throw away the FORTEO delivery device after 28 days even if it
has medicine in it (see the User Manual).
Keep FORTEO and all medicines out of the reach of
children.
General information about FORTEO
Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. Do not use FORTEO for a condition for
which it was not prescribed. Do not give FORTEO to other people,
even if they have the same condition you have.
This Medication Guide summarizes the most important information
about FORTEO. If you would like more information, talk with your
healthcare provider. You can ask your pharmacist or healthcare
provider for information about FORTEO that is written for
healthcare professionals. For more information, go to
www.FORTEO.com or call Lilly at 1-866-436-7836.
What are the ingredients in FORTEO?
Active ingredient: teriparatide
Inactive ingredients: glacial acetic acid, sodium acetate
(anhydrous), mannitol, metacresol, and water for injection. In
addition, hydrochloric acid solution 10% and/or sodium hydroxide
solution 10% may have been added to adjust the product to pH 4.
What is Osteoporosis?
Osteoporosis is a disease in which the bones become thin and
weak, increasing the chance of having a broken bone. Osteoporosis
usually causes no symptoms until a fracture happens. The most
common fractures are in the spine (backbone). They can shorten
height, even without causing pain. Over time, the spine can become
curved or deformed and the body bent over. Fractures from
osteoporosis can also happen in almost any bone in the body, for
example, the wrist, rib, or hip. Once you have had a fracture, the
chance for more fractures greatly increases.
The following risk factors increase your chance of getting
fractures from osteoporosis:
- past broken bones from osteoporosis
- very low bone mineral density (BMD)
- frequent falls
- limited movement, such as using a wheelchair
- medical conditions likely to cause bone loss, such as some
kinds of arthritis
- taking steroid medicines called glucocorticoids, such as
prednisone
- other medicines that may cause bone loss, for example: seizure
medicines (such as phenytoin), blood thinners (such as heparin),
and high doses of vitamin A
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
*The brands listed are trademarks of
their respective owners and are not trademarks of Eli Lilly and
Company.
For more safety information, please see Medication Guide
(http://pi.lilly.com/us/forteo-medguide.pdf) and Prescribing
Information (http://pi.lilly.com/us/forteo-pi.pdf) in the
USA or the Summary of Product
Characteristics EU
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000425/WC500027994.pdf),
including Boxed Warning regarding osteosarcoma. Please see full
user manual that accompanies the delivery device.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels.
P-LLY
FORTEO® is a registered trademark of Eli Lilly and
Company
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about FORTEO as a potential treatment for patients with
severe osteoporosis, and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of development and
commercialization. Among other things, there can be no guarantee
that future study results will be consistent with the results to
date or that FORTEO will continue to be commercially
successful. For further discussion of these and other risks
and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q
filings with the United States Securities and Exchange Commission.
Except as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
1 The Lancet, Effects of teriparatide and risedronate
on new fractures in post-menopausal women with severe osteoporosis
(VERO): a multicentre, double-blind, double-dummy, randomized
controlled trial.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32137-2/fulltext?elsca1=tlxpr.
Accessed November 9, 2017.
2 FORTEO PI. Available at
http://pi.lilly.com/us/forteo-pi.pdf
Refer to: Scott MacGregor; jsmacgregor@lilly.com;
(317) 440-4699 (Lilly)
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