Panel defends low-dose steroids.
Systemic corticosteroids can be likened to fine wine, Dr. Johannes W.J. Bijlsma said in summarizing the panel's findings at the annual European Congress of Rheumatology.
"We think that a little bit of glucocorticoids, like a glass of wine, may be beneficial for many people, whereas a lot of glucocorticoids, like a bottle of wine, is helpful to no one," said Dr. Bijlsma, professor of rheumatology and clinical immunology at Utrecht (the Netherlands) University Medical Center.
He was one of a dozen prominent European and American rheumatologists and endocrinologists who reviewed the literature on the side-effect profile of systemic corticosteroids at 7.5 mg/day or less when used for years by patients with rheumatic diseases. All panelists had participated in randomized controlled trials or epidemiologic studies that addressed the safety issues. It seemed an appropriate time to assess side effects in light of recent evidence that low-dose steroids have a disease-modifying effect in rheumatoid arthritis, Dr. Bijlsma explained.
The panelists' first key finding was that although doses of 7.5 mg/day or less are what are most commonly used in the everyday treatment of rheumatologic diseases, few studies have looked at associated side effects. The panel focused on five trials totaling more than 750 patients with early rheumatoid arthritis randomized to low-dose steroids or placebo for at least 1 year. Two of the studies--the West of Scotland Early Rheumatoid Arthritis Corticosteroid Trial (WOSERACT) and a German trial--are not yet published.
The incidence of side effects associated with long-term low-dose steroids was much lower than what many clinicians expect based upon rates quoted in many review articles and textbooks--sources that typically extrapolate from studies involving far higher doses.
It is often stated that long-term glucocorticoid therapy is associated with up to a 20% increased rate of new-onset hypertension. But in the three randomized trials of long-term low-dose therapy that addressed this issue, new hypertension wasn't significantly more frequent than with placebo: 19 cases in 281 steroid-treated patients, and 12 cases in 276 on placebo. Similarly, new-onset diabetes occurred in just 2 of 185 patients on long-term glucocorticoid therapy at 7.5 mg/day or less, compared with 3 of 186 on placebo, Dr. Bijlsma said.
In the five randomized trials collectively, bone mineral density after 1-4 years of low-dose steroid therapy did not differ from placebo. Fractures were not increased with steroid therapy in four of the five studies. In the outlier, the Utrecht study, fractures increased after 3 years of steroid therapy. But this trial began in 1990, well before physicians began routinely using preventive measures including calcium and vitamin D supplements and bisphosphonates in steroid-treated patients, as became standard practice in more recent trials.
"Today osteoporosis remains a danger, but it has become a manageable danger," he observed.
Treatment-related weight gain is a major concern for patients. The data documented a modest weight gain during 2 years of low-dose steroid therapy--an average of 1.4 kg more than with placebo. "But we should also recognize there's a catabolic process in early rheumatoid arthritis--and weight gain can be one of the signs patients are improving." Dr. Bijlsma said.
Low-dose corticosteroid monotherapy was not associated with increased gastrointestinal side effects. But when used in combination with NSAIDs, the resultant increase in peptic ulcer disease was greater than with NSAIDs alone.
Rates of wide-angle glaucoma, cataracts, and infections did not differ between the steroid and placebo arms.
The panel's full report will appear in the Annals of Rheumatic Diseases.
BY BRUCE JANCIN
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|Publication:||Internal Medicine News|
|Date:||Sep 1, 2004|
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