Lilly Announces Review of Data on Long-Term Raloxifene Treatment for Postmenopausal Osteoporosis Published in Current Medical Research & Opinion
INDIANAPOLIS, Aug. 9, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data on EVISTA® (raloxifene HCl tablets) therapy for more than three years was published online in Current Medical Research & Opinion. The review includes summaries of previously published information; new, previously unpublished observations; and new data on EVISTA use. EVISTA is indicated for the treatment of osteoporosis in postmenopausal women and reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
The majority of available data came from the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Continued Outcomes of Raloxifene Evaluation (CORE) trial. In these trials, patients were evaluated for up to eight years. While available information is supportive of EVISTA use for more than three years, the optimum duration of EVISTA therapy is not known.
"Because of the chronic nature of postmenopausal osteoporosis and the risk of invasive breast cancer associated with the disease in postmenopausal women with osteoporosis, it is critical to evaluate medications that treat these conditions that require therapy over a prolonged period of time," said lead author Robert Recker, M.D., professor of medicine, chief, division of endocrinology, director, Osteoporosis Research Center, Creighton University School of Medicine.
Use of EVISTA was evaluated by changes in vertebral fracture risk reduction, bone mineral density (BMD), markers of bone turnover, iliac crest bone biopsies, and invasive breast cancer risk reduction:
•Vertebral fracture risk reduction: In the MORE trial, the
relative risk reduction during the fourth year of the study was
similar to the relative risk reduction during years zero to
three.
•BMD: Patients who stopped EVISTA therapy in the one-year
period between the end of the MORE trial and the beginning of the
CORE trial experienced a significant decrease in BMD. Once
treatment resumed in the CORE trial, lumbar spine and femoral neck
BMD increased in the EVISTA group.
•Bone turnover: In a previously unpublished analysis of data
from the MORE study, patients who received EVISTA for three
continuous years had lower bone resorption as measured by
c-terminal telopeptide (CTX) values, with the average being similar
to that found in premenopausal women. EVISTA is not for use in
premenopausal women.
•Iliac crest bone biopsies: Newly reported data from a subset
of patients in the CORE trial included results of iliac crest
biopsies in three patients treated with EVISTA for eight years.
These iliac crest biopsies showed normal bone and bone cells and
double label in all specimens.
•Invasive breast cancer risk reduction: In a subset of
postmenopausal women followed for up to eight years from
randomization of the MORE trial to the end CORE, a reduction in the
incidence of invasive breast cancer was observed in the EVISTA
versus placebo group. The long term effects and the recommended
length of therapy are not known.
Study safety findings included:
•In clinical trials, patients in the EVISTA versus placebo
group had higher incidence of venous thromboembolic events (blood
clots in the legs, lungs or eyes), including deep vein thrombosis
and pulmonary embolism, compared with patients who received
placebo. EVISTA is contraindicated in women with active or past
history of venous thromboembolism (VTE), including deep vein
thrombosis, pulmonary embolism and retinal vein thrombosis.
•The safety profile of EVISTA after four years of treatment
was similar to that of EVISTA following three years of
therapy.
•Additional adverse events (>2% and more common with EVISTA
than with placebo) included hot flashes, leg cramps, swelling,
flu-like symptoms, joint pain and sweating.
"Lilly is committed to providing information regarding our
therapies to help healthcare professionals and their patients
engage in more informed discussions about available treatment
options for postmenopausal osteoporosis," said co-author John
Krege, M.D., medical fellow, Eli Lilly and Company.
About the Review
"Long-term Raloxifene for Postmenopausal Osteoporosis" is a literature review of available information concerning EVISTA use for greater than three years for the treatment of postmenopausal osteoporosis and invasive breast cancer risk reduction in postmenopausal women with osteoporosis. Two reviewed studies were the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Continued Outcomes of Raloxifene Evaluation (CORE) trial. The review includes summaries of previously published information, as well as a number of previously unpublished observations from analyses of the clinical study databases. In addition, new data from three patients who underwent iliac crest bone biopsies after eight years of EVISTA therapy were reported.
About EVISTA® (raloxifene HCl tablets)
EVISTA is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM), which appears to act like estrogen in bone and to block the effects of estrogen in some tissues. It is an osteoporosis therapy for postmenopausal women that also reduces the risk of invasive breast cancer in postmenopausal women with osteoporosis.
EVISTA is approved by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of osteoporosis in postmenopausal women. EVISTA is also indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. There are Important Limitations of Use for breast cancer risk reduction:
•There are no data available regarding the effect of EVISTA
on invasive breast cancer incidence in women with inherited
mutations (BRCA1, BRCA2) to be able to make specific
recommendations on the effectiveness of EVISTA.
•EVISTA is not indicated for the treatment of invasive breast
cancer or reduction of the risk of recurrence.
•EVISTA is not indicated for the reduction in the risk of
noninvasive breast cancer.
EVISTA 60 mg tablets are taken once daily and can be taken with
calcium and vitamin D supplements, with or without food.
Important Safety Information about EVISTA® (raloxifene HCl tablets)
What is the most important information patients should know about EVISTA?
Patients should not take EVISTA if they have had or are at risk for
getting blood clots in the legs, lungs or eyes, as it may increase
the risk of blood clots. Patients should stop taking EVISTA and
call their doctor if they have leg pain or warmth, swelling of the
legs, hands or feet, chest pain, shortness of breath or a sudden
vision change, as these may be signs of a blood clot. Being unable
to move around for long periods may increase this risk. If patients
will need to be still for a long time, they should talk to their
doctor about ways to reduce the risk of blood clots.
EVISTA does not increase the risk of a heart attack or stroke in
women who have had or are at risk for a heart attack; however,
EVISTA increases the likelihood of dying from stroke in these
women, should one occur. Before taking EVISTA patients should tell
their doctor if they have had a stroke, a mini-stroke, irregular
heartbeat, high blood pressure, heart attack, history of smoking,
or believe they have other risk factors for stroke or a heart
attack.
EVISTA is not right for everyone. Patients should not take EVISTA
if they:
•have had blood clots in their legs, lungs or eyes.
•are pregnant, nursing or may become pregnant, as EVISTA may
cause fetal harm.
What should patients tell their doctor before taking
EVISTA?
Patients should talk to their doctor about all their medical conditions including:
•If they have had blood clots in their legs, lungs or
eyes.
•If they have had a stroke, mini-stroke, irregular heartbeat,
high blood pressure, heart attack, history of smoking, or think
they have other risk factors for stroke or heart attack.
•EVISTA should not be used for prevention of heart
disease.
•If they are premenopausal. Patients should only take
prescription EVISTA if they are past menopause.
•If they have liver or kidney disease. Women with liver or
kidney disease should use EVISTA with caution.
•EVISTA should not be taken with estrogens in the form of
pills, patches or injections.
•If they have taken estrogen in the past and had a high
increase of triglycerides (a kind of fat in the blood).
What are the possible side effects of EVISTA?
•Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
What are the possible drug interactions with EVISTA?
•If patients take warfarin (Coumadin®, Jantoven®)
or other coumarin blood thinners, they may need to do a blood test
(prothrombin time, pro-time or INR) when they first start or if
they need to stop taking EVISTA. Their doctor may need to adjust
the dose of their warfarin or other coumarin blood thinners.
•EVISTA should not be taken with cholestyramine or
estrogens.
For more information about EVISTA, please see the Full Prescribing
Information (http://pi.lilly.com/us/evista-pi.pdf)
including Boxed Warning, and Medication Guide (http://pi.lilly.com/us/evista-ppi.pdf).
RA Media ISI 01AUG2011
About Eli Lilly and Company
Eli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Information about Lilly is available at www.lilly.com. P-LLY
EVISTA® is a registered trademark of Eli Lilly and Company.
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
Posted: August 2011
