FDA clears Cymbalta to treat chronic musculoskeletal pain

The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004.

“Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This approval means that many of those people now have another treatment option.”

Since its initial approval, about 30 million patients in the United States have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.

More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing data from the previously approved patient populations.

The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.

While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective.

The recommended dose for Cymbalta is a 60 milligram capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.

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Vertebroplasty for Patients With Osteoporosis Provides Effective Pain Relief

/PRNewswire/ -- Patient selection is key for vertebroplasty--a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy--to be effective and successful, according to a study of more than 1,500 persons who were followed over seven years. Additionally, collaboration between an interventional radiologist and other medical experts in treating a patient is imperative, say researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

"Vertebroplasty puts lives and vertebrae back together," said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy. Before treatment, many osteoporotic patients are in constant pain and cannot manage everyday activities. Vertebroplasty, a minimally invasive treatment performed by interventional radiologists under imaging guidance, stabilizes collapsed vertebrae with the injection of medical-grade bone cement into the spine. The treatment provides pain relief and improves one's quality of life--if given to appropriately selected candidates in whom conventional medical treatment has failed (such as analgesics or narcotic drugs that provide minimal or no pain release or doses that are intolerable), he further explained. "Our long-term follow-up confirmed this: pain relief and quality of life significantly improved with vertebroplasty," said Anselmetti.

Osteoporosis, the most common type of bone disease, is characterized by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. Osteoporosis affects 10 million Americans and is responsible for 700,000 vertebral fractures each year. Multiple vertebral fractures can result in chronic pain and disability, loss of independence, stooped posture and compression of the lungs and stomach.

"Vertebroplasty dramatically improves back pain within hours of the procedure, provides long-term pain relief and has a low complication rate, as demonstrated in multiple studies," said Anselmetti. Vertebroplasty provides pain relief from the complications of osteoporosis (vertebral fractures) but not the disease that caused it (osteoporosis), said Anselmetti. "For the best results, collaboration between physicians is mandatory. All osteoporotic patients need to be followed by an interventional radiologist, who determines which patients are appropriate candidates to receive vertebroplasty treatment, and an experienced medical expert (in this study, a rheumatologist) to ensure continued treatment for osteoporosis," he said.

Anselmetti illustrated a typical case: an 80-year-old Italian woman, who was diagnosed last year with two painful osteoporotic vertebral collapses, underwent medical treatment for osteoporosis (with the drug teriparatide) and was still in pain when she was prescribed an external brace. After there was evidence of two new fractures (verified by MR imaging), she received vertebroplasty, experiencing "complete pain regression, no need for the brace and a dramatic Lazarus-like ability to perform daily activities," he noted.

Researchers studied 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from back-pain for vertebral collapses (MRI confirmed) who underwent a clinical interview; their medical treatment, pain grade, quality of life and extent of vertebral fracture were reviewed. Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist. Because interventional radiologists use high-quality, image-guiding systems (such as digital flat-panel fluoroscopy with built-in rotational image acquisition), treatment time is decreased, making for a safer procedure, added Anselmetti.

In 1,494 patients (96.9 percent), the average pretreatment pain score on the 11-point visual analog scale was 8.2+/-1.8, and it dropped "significantly" to an average of 1.1+/-1.6 after vertebroplasty treatment, said Anselmetti. A patient's ability to manage everyday life--such as washing, dressing or standing--was measured by the commonly used Oswestry Disability Questionnaire, which was completed by patients before and after vertebroplasty. The ODQ scores changed from an average of 68.7+/-7.6 percent to 18.5+/-8.2 percent. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the VAS significantly dropping from 7.9+/-1.5 to 1.3+/-1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Anselmetti said that additional studies need to be performed, such as a large randomized trial comparing conventional medical treatment to medical treatment plus vertebroplasty. In Europe, this is difficult, as patients with chronic back pain for vertebral osteoporotic fractures prefer to be treated by vertebroplasty--and not randomized into a medical treatment-only group. "Patients who are in so much pain ask if they can be considered for vertebroplasty treatment," said the co-author of "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience."

More information about the Society of Interventional Radiology, interventional radiologists and vertebroplasty can be found online at www.SIRweb.org.

Abstract 16: "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience," G.C. Anselmetti, A. Manca, G. Chiara, G. Iussich and D. Regge, all at the Institute for Cancer Research and Treatment, Candiolo, Italy; and G. Isaia, University of Turin, Turin, Italy, SIR 35th Annual Scientific Meeting March 13-18, 2010, Tampa, Fla. This abstract can be found at www.SIRmeeting.org.

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