Patients to Track Incremental Successes
ST. LOUIS, Nov 22, 2010 (BUSINESS WIRE) —
The Arthritis Foundation and Covidien (NYSE: COV) have joined
forces to help advance awareness and support for millions of people
suffering from osteoarthritis in the United States. Covidien will
serve as a sponsor of the Foundation’s Let’s Move Together
Movement Tracker, an educational and physical activity resource for
those suffering from arthritis. The tracker provides patients with
personalized, step-by-step support to reach their exercise goals
and stay physically active–an important component of effective
arthritis treatment.1,2
The Let’s Move Together Movement Tracker is an online
tool members can use to set personal goals, benchmark their
physical activity and keep motivated to stay active. Social media
applications for the tracker include a widget, enabling users to
display progress updates on their Arthritis Foundation community
page, Facebook or MySpace pages.
“The Foundation is committed to identifying ways to cure and
treat arthritis, but prevention is also central to our mission.
Regular physical activity, which is encouraged by the Movement
Tracker, can play a great role in prevention of the most common
form of arthritis,” said Rick Bell, Managing Director of Cause
Development with the Arthritis Foundation. “We are excited about
working with Covidien on this important initiative.”
Launched in January 2009, the Let’s Move Together
campaign is a nationwide movement designed to inspire people to
move every day to prevent or treat arthritis. The campaign
encourages daily physical activity for better health and
participation in the Arthritis Foundation’s local Arthritis
Walks–an annual event that promotes fun and fitness.
“Knee osteoarthritis affects more than 10 million
Americans–many of whom live with significant pain that affects
their daily function,” said Herbert Neuman, M.D., Vice President of
Medical Affairs and Chief Medical Officer, Pharmaceuticals,
Covidien. “Our goal, in conjunction with the Arthritis Foundation,
is to provide educational and useful tools, like the Movement
Tracker, to patients seeking treatment-plan support and long-term
success.”
Knee OA is among the five leading causes of disability in
adults.3,4 According to the Arthritis Foundation, it is
a chronic condition in which joint cartilage, the smooth tissue
that cushions the bone and allows easy joint movement, breaks down,
leading to pain, stiffness and loss of movement in the
joint.5
Mallinckrodt, a Covidien company, has introduced
PENNSAID(R) (diclofenac sodium topical solution) 1.5%
w/w, a topical non-steroidal anti-inflammatory drug (NSAID).
PENNSAID is indicatedfor treatment of the signs and symptoms of
osteoarthritis of the knee(s).For more information on PENNSAID,
including Important Risk Information and boxed warning, see
below.
About the Arthritis Foundation
The Arthritis Foundation (
www.arthritis.org) is the leading health organization
addressing the needs of the 50 million adults and 300,000 children
living with arthritis, the nation’s most common cause of
disability. The Foundation helps individuals take control of
arthritis by providing public health education; pursuing public
policy and legislation; supporting research and conducting
evidence-based programs to improve the quality of life for those
living with arthritis.
About Covidien
Covidien is a leading global healthcare products company that
creates innovative medical solutions for better patient outcomes
and delivers value through clinical leadership and excellence.
Covidien manufactures, distributes and services a diverse range of
industry-leading product lines in three segments: Medical Devices,
Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4
billion, Covidien has approximately 42,000 employees worldwide in
more than 60 countries, and its products are sold in over 140
countries. Please visit
www.covidien.com to learn more about our business.
About PENNSAID
PENNSAID (diclofenac sodium topical solution) 1.5% w/w is a
NSAID in a vehicle solution containing the penetrating agent
DMSO.1,2 PENNSAID was developed to help increase the
effective, local delivery of pain relief to patients suffering from
knee osteoarthritis, a disorder impacting an estimated 10 million
patients in the United States.6 PENNSAID is the only
FDA-approved topical NSAID for the treatment of the signs and
symptoms of knee osteoarthritis which demonstrated statistically
significant differences in all three primary efficacy endpoints:
pain and physical function (WOMAC), patient overall health
assessment (POHA) and patient global assessment (PGA) of knee
osteoarthritis.1,2,3,7
IMPORTANT RISK INFORMATION ABOUT
PENNSAID
Cardiovascular Risk
–Nonsteroidal anti-inflammatory drugs (NSAIDs) may
cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. This
risk may increase with duration of use. Patients with
cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk.
–PENNSAID is contraindicated in the perioperative
setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
–NSAIDs cause an increased risk of serious
gastrointestinal adverse events including bleeding, ulceration, and
perforation of the stomach or intestines, which can be fatal. These
events can occur at any time during use and without warning
symptoms. Elderly patients are at greater risk for serious
gastrointestinal events.
PENNSAID is contraindicated in patients:
- with a known hypersensitivity to
diclofenac sodium or any other component of PENNSAID - who have experienced asthma, urticaria,
or allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal anaphylactic-like reactions to NSAIDs have
been reported in such patients.
Elevation of one or more liver tests may occur during therapy
with NSAIDs. PENNSAID should be discontinued immediately if
abnormal liver tests persist or worsen.
Use with caution in patients with fluid retention or heart
failure. Hypertension can occur with NSAID treatment. Monitor blood
pressure closely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renal papillary
necrosis and other renal injury. Use PENNSAID with caution in
patients at greatest risk of this reaction, including the elderly,
those with impaired renal function, heart failure, liver
dysfunction, and those taking diuretics and ACE-inhibitors.
Should not be used in pregnant or lactating women and is not
approved for use in pediatric patients.
Anaphylactoid reactions may occur in patients without prior
exposure to PENNSAID. NSAIDs can cause serious skin adverse events
such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and
toxic epidermal necrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patients
receiving PENNSAID were application site skin reactions including
dry skin (32%), contact dermatitis characterized by skin erythema
and induration (9%), contact dermatitis with vesicles (2%) and
pruritus (4%). In a long term safety study, contact dermatitis
occurred in 13% and contact dermatitis with vesicles in 10% of
patients, generally within the first 6 months of exposure, leading
to a withdrawal rate for an application site event of 14%. Other
common adverse events greater than placebo include: dyspepsia (9%),
abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea
(4%).
Do not apply to open wounds. Protect treated knee(s) from
natural or artificial sunlight. Topicals such as sunscreen and bug
repellant may be applied after PENNSAID treated knee(s) are
completely dry. Avoid contact of PENNSAID with eyes and mucous
membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be avoided unless benefit
outweighs risk and periodic laboratory evaluations are
conducted.
See
Full Prescribing Informationfor additional Important
Risk Information.
PENNSAID is a registered trademark of Nuvo Research Inc.
1 Minor MA. Exercise in the treatment of
osteoarthritis. Rheum Dis Clin North Am 25(2):397-415,
1999.
2 Ytterberg SR, Mahowald ML, Krug HE. Exercise for
arthritis. Baillieres Clin Rheumatol 8:161-189, 1994.
3 Osteoarthritis. Centers for Disease Control and
Prevention Web site.
http://www.cdc.gov/arthritis/basics/osteoarthritis.htm. Updated
February 4, 2010. Accessed April 12, 2010.
4 Guccione AA, Felson DT, Anderson JJ, et al. The
effects of specific medical conditions on the functional
limitations of elders in the Framingham Study. Am J Public
Health. 1994;84:351-358.
5 Arthritis Foundation. Osteoarthritis Fact Sheet.
http://www.arthritis.org/media/newsroom/media-kits/Osteoarthritis_fact_sheet.pdf
[ Last Accessed April 2010]
6 Parmet S, Lynm C, Glass RM (2003). Osteoarthritis
of the knee. JAMA, 289(8), 1068.
7 Tugwell PS, Wells GA, Shainhouse J. Equivalence
study of a topical diclofenac solution (PENNSAID) compared with
oral diclofenac in symptomatic treatment of osteoarthritis of the
knee: a randomized controlled trial. Journal of
Rheumatology, 2004;31(10), 2002-12.
SOURCE