News September 2006 Issue

In the News: 09/06

Kyphoplasty: Pain Improvement Questioned

Few medical experts dispute the fact that kyphoplasty—a procedure in which bone cement is injected into a balloon that is wedged between fractured vertebrae in the spine—is effective in repairing a collapsed backbone and restoring vertebral height (January  2006 Arthritis Advisor). But a recent review questions whether the procedure actually improves patient pain and function. The ECRI Health Technology Assessment Information Service—a nonprofit  agency that produces reports on drugs, devices, and emerging medical technologies—analyzed 16 studies, most involving patients with osteoporotic vertebral fractures. Although there was “strong to moderate” evidence that kyphoplasty improved vertebral anatomy, the agency said there was no evidence that showed kyphoplasty, designed to prevent further fracture or collapse of the spine, to be more effective than anti-inflammatory medications, physical therapy, or simple bed rest in improving a patient’s pain and ability to function. Leaking bone cement was the most common side effect of the procedure, occurring in 34 percent of the vertebrae studied. The agency admitted that although leakage is common, it rarely causes problems for the patient.

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Anakinra Only Marginally Effective For Long-Term Use

Anakinra (Kineret) is of lasting use in only a small minority of patients with rheumatoid arthritis, according to a recent Dutch study. Anakinra is an injectable biologic response modifier that blocks the activity of interleukin-1, a protein in the body that causes joint damage. While moderately effective in placebo-controlled trials, its long-term effectiveness in clinical practice was only marginal. After three months, 43 percent of 146 patients showed a moderate response (12 percent had an effective response). After six months, 46 patients had switched to other drugs, and after two years only 20 patients had continued with anakinra.

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Celecoxib Poses Fewer Gastrointestinal Risks Than NSAIDs

Celecoxib (Celebrex) treats osteoarthritis as effectively as nonsteroidal anti-inflammatory drugs (NSAIDs) but with less risk of stomach problems, according to a recent study in the American Journal of Medicine. The study, which included more than 13,000 patients in 39 countries, examined the overall safety and effectiveness of celecoxib compared with the NSAIDs diclofenac (Voltaren) and naproxen (Naprosyn). Patients received varying doses of celecoxib, diclofenac, or naproxen twice a day. After 12 weeks, celecoxib was shown to be as effective as the NSAIDs for treating osteoarthritis pain. Patients in the celecoxib group, however, experienced fewer gastrointestinal problems than those who took NSAIDs. The study found no significant difference in cardiovascular events between the two types of medication.  Celecoxib is the only remaining COX-2 inhibitor on the market—both rofecoxib (Vioxx) and valdecoxib (Bextra) were previously pulled due to reports that they increased the risk of heart attack.

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Protein Boost Builds New Bone

Researchers at Stanford University have found a way to increase bone mass by altering the shape of a regulatory protein. Experimenting with mice, they found that by slightly increasing the activity of a protein called NFATc1, bone mass can be substantially increased. Bone continually forms and is broken down throughout life. Cells called osteoclasts continuously erode bone, while cells called osteoblasts replenish it. If the balance is upset, and more bone is destroyed than formed, osteoporosis results. Researchers modified the NFATc1 protein in mice so that it could move more easily to the nucleus of the osteoblast cell and become more active. They found that while increasing NFATc1 in osteoblasts also increased the number of bone-destroying osteoclasts, the osteoclasts never caught up, tipping the balance in favor of the bone-forming osteoblasts. This imbalance between bone formation and degradation, say researchers, could potentially be re-created by drug treatments for osteoarthritis. Researchers are now investigating chemical libraries for molecules that could increase NFATc1 enough to promote bone formation in people with osteoporosis, without causing undesirable side effects.