News April 2005 Issue

In the News: 04/05

New Osteoporosis Drug On The Horizon
The good news: A potent antiresorptive drug called AMG162 (Amgen) has been shown to quickly increase bone-mineral density. The bad news: It’s not available yet—but it promises to be well worth waiting for. The product, which has shown positive results in animal studies, has now demonstrated conclusive evidence of its effectiveness in a clinical trial involving 441 postmenopausal women. The subjects, who were injected with the drug once every three to six months, showed remarkably rapid bone restoration when compared to those on such weekly oral treatments as alendronate and risedronate or the injectable drug teriparatide (Forteo). The most common side effect of all three treatments was dyspepsia, though it was substantially lower (5 percent of patients) for those on Amgen.

AMG162 is a human antibody that targets the activator of nuclear factor kappa B ligand (RANKL), sometimes a key villain in bone erosion. Though RANKL is critically involved in normal bone development, there is evidence that its overexpression is also involved in bone destruction.

Researchers laud AMG162’s ability to block bone resorption, calling it “the most potent inhibitor of bone damage that has been seen so far,” with the potential for ending the accelerated bone loss seen not only in osteoporosis, but in rheumatoid arthritis and other bone diseases.

AMG162 is currently being examined in additional clinical trials, which means it will be another two to three years before the product is available to physicians.

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Increasing Age May Mean Suffering Less
Getting older doesn’t have a lot of advantages, but here’s one it does have: less pain. According to a study reported in a recent issue of Pain Medicine, there appears to be an age gap in how people experience chronic pain. Researchers at the University of South Florida examined the records and questionnaire results of 525 black Americans and 5,298 white Americans, broken into age subgroups of under 50 and 50 and older.

Younger patients in both racial groups reported increased depression, more pain intensity, and more difficulties in coping with pain than their older counterparts. Researchers concluded that increasing age reflects both a broader life experience and different expectations regarding pain. Dr. Carmen Green, the study’s co-author, concluded that older people may feel that pain is just a normal part of getting older and is something you deal with, while younger people, often burdened by job and family stress, may experience more negative feelings that add to their pain.

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Cry Wolf? Naproxen Alert Called A Scare
A group of physicians has called into question the National Institutes of Health’s claim that naproxen (Aleve) poses a heart-attack risk.

As reported in our March issue, NIH’s large-scale Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) turned up evidence that naproxen, which had not been found to increase coronary risk in earlier studies, appeared to increase the danger of heart attack and stroke by 50 percent. The NIH did admit that the drug was being examined for uses far different from the pain-relieving use for which it is approved, and that there were conflicting results between its study and previous trials.

Now, a physician research team from VA Outcomes Group, an affiliate of Dartmouth Medical School which specializes in the interpretation of medical studies, has claimed that concerns over the safety of naproxen were exaggerated. Laying the blame squarely on the national media in the wake of the publicity surrounding the Vioxx scare, Steven Woloshin, M.D., lead author of the study, claimed in a report prepared for the Washington Post that the NIH failed to distinguish between naproxen users in the study (who were taking naproxen in hopes of preventing Alzheimer’s) and naproxen users in the general public (who take the drug to treat pain).

Said Dr. Woloshin, “For people choosing to take naproxen for pain relief, the balance between risk and benefit is very different. Here, the benefit is known, while the risk is less certain....The NIH  should have communicated the information needed to understand the nature and magnitude of the risk, if any, posed by naproxen. If it was too soon to release [the information], it was too soon to frighten the public.”