News November 2004 Issue

In the News: 11/04

Methotrexate: In Low Doses, No Harm To Bone Health
Despite in vitro studies showing that methotrexate can bring on negative changes in bone mass, in low doses—from 7.5 to 20 milligrams a week—the popular arthritis drug poses no risk of osteoporosis. So concludes a recent Italian study that tested 731 female patients with rheumatoid arthritis who were divided on the basis of methotrexate use (non-users vs. patients who had taken the drug for at least six months). The study found that although methotrexate was not a significant predictor of osteoporosis, other factors—age, bone mass, menopause, and steroid use—were. At the time of the study, no data were available on the use of folinic acid supplements, which are often prescribed to prevent methotrexate toxicity and are thought to prevent osteoporosis.

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Successful Ankle Transplant A First
An Italian surgeon, Sandro Giannini, recently performed Europe’s first successful ankle transplant when he replaced the ankle of a rally-car driver with that of a 17-year-old boy who had recently died. The transplant, using procedures currently in practice in the United States, involved the implant of the entire ankle joint, including ankle bone and cartilage. Based on the success of the transplant (the patient, who had lost the mobility of his ankle in a car accident in 1991, is reported to be in good condition), European surgeons are now attempting to determine how the technique can be used in knee transplants.

Physicians have historically been hesitant to adopt the transplant procedure because of its risk of failure due to infection, preferring instead to either fuse the ankle (which restricts ankle motion) or replace it with an implant using polyethylene and metal components. Although the failure rate of ankle replacements has dropped dramatically—to 11 percent—in recent years, it still exceeds those of total knee and hip replacements.

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High Doses of Rofecoxib Triple Heart Attack Risk
A recent presentation by the Food & Drug Administration’s (FDA) Office of Drug Safety revealed that high doses (more than 25mg a day) of the arthritis drug rofecoxib (Vioxx) triples the risk of heart attack. The FDA-funded study, which analyzed the medical records of 1.4 million patients over a three-year period, also found that people who take rofecoxib at doses of less than 25mg a day had a 50 percent greater risk of heart attack than those who took any dose of celecoxib (Celebrex). The study population consisted of 40,405 patients who used celecoxib and 26,748 who were being treated with rofecoxib. Other patients in the study used the pain-relievers ibuprofen, naproxen, indomethacin, nabumetone, and sulindac.

A spokesperson for Merck & Co., manufacturer of Vioxx, said that the company disagrees with the study’s conclusions and claims that other trials have shown no significant differences in the rate of heart attack among Vioxx vs. placebo users. Although rofecoxib is currently approved for doses up to 50mg for pain treatment up to five days, FDA researchers found that many patients continued to take the drug beyond that period.

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Naproxen Beats Ibuprofen For Knee-Pain Relief
In a recent study involving 461 patients with osteoarthritis knee pain, it was found that naproxen sodium (440-660 mg/day) was more effective than ibuprofen (1200mg/day) at treating knee pain. Although both over-the-counter drugs were found to be effective at relieving passive-motion pain, pain on weight bearing, stiffness after rest, and day pain, only naproxen worked for pain at rest and night pain. For study patients over the age of 65, naproxen was found to be superior for all symptoms except pain on weight bearing, and significantly superior to ibuprofen for night-time pain relief.