New
treatment guidelines published in the current issue of
Arthritis and Rheumatism by the American College of
rheumatology (ACR) recommend bisphosphonates as
first-line therapy in conjunction with
calcium and vitamin D
for preventing and treating glucocorticoid-induced
osteoporosis (GIO), or steroid-induced bone loss.
The guidelines state that for patients at risk for, or already
experiencing GIO, a bisphosphonate is the recommended
first-line treatment along with modification of lifestyle risk
factors for osteoporosis. Actonel® (risedronate
sodium
tablets) 5mg is the only drug in the U.S. approved by the
FDA for both prevention and treatment of GIO in men and
women.
According to the ACR, more than 30 million Americans may
be affected by
diseases that are treated with glucocorticoid
therapy (e.g. prednisone). Glucocorticoids are the primary
therapy for many inflammatory and
autoimmune diseases
-- including asthma and
rheumatoid arthritis – as well as
many allergic conditions. In as little as 3 months, chronic
steroids (>7.5 mg/d of prednisone or equivalent) can cause
significant bone loss.
It is estimated that up to 50 percent of patients on chronic
glucocorticoid therapy will experience osteoporotic fractures.
Unfortunately, the majority of these patients do not receive
treatment to prevent GIO.
Actonel® (risedronate sodium tablets) 5mg is the only
therapy proven to reduce vertebral fracture incidence in GIO
patients on chronic glucocorticoid treatment in just one year.
A combined analysis of 2 clinical studies demonstrated that
Actonel 5mg reduced the incidence of vertebral fracture by
70 percent in one year (19% of the 111 patients in the
placebo group fractured compared to only 5% of the 111
patients in the Actonel 5mg group).
According to the new ACR guidelines, treatment with a
bisphosphonate is recommended to prevent bone loss in all
men and postmenopausal women in whom long-term
glucocorticoid treatment at medium to high doses is being
initiated or continued. The guidelines also recommend
calcium and vitamin D supplementation in conjunction with
bisphosphonate therapy.
About Actonel
Actonel 5 mg is indicated for the treatment and prevention
of
Postmenopausal Osteoporosis in women and GIO in men
and women who are either initiating or continuing systemic
glucocorticoid treatment (>7.5 mg/d prednisone or
equivalent) for chronic diseases.
Actonel® (risedronate sodium tablets) should not be used
in patients with low blood calcium, known allergy to Actonel,
or an inability to stand or sit upright for at least 30 minutes.
Low blood calcium and other disturbances of bone and
mineral
metabolism should be effectively treated before
starting Actonel therapy. Actonel is not recommended for
use in patients with severe kidney disease.
Bisphosphonates may cause upper gastrointestinal
disorders such as dysphagia (difficulty swallowing),
esophagitis (irritation of the esophagus), and esophageal or
gastric ulcers. Patients should take Actonel with a full
glass
of plain
water (6-8 oz.) to facilitate delivery to the stomach,
and should not lie down for 30 minutes after taking the
drug.
In
clinical trials, Actonel was generally well tolerated. Most
side effects were mild to moderate and did not require
patients to stop taking Actonel. Overall, side effects
regardless of causality, were comparable to placebo and
included infection (primarily upper respiratory, placebo
patients, 29.7% vs. Actonel patients 29.9%), back
pain
(23.6% vs. 26.1%), and joint pain (21.1% vs. 23.7%).