WEDNESDAY, June 21 (HealthDay News) -- Treatment with cyclophosphamide can produce significant but modest clinical gains in lung function for scleroderma patients, according to a study published in the June 22 issue of the New England Journal of Medicine.
Donald P. Tashkin, M.D., of the University of California Los Angeles, and colleagues conducted a double-blind, randomized, placebo-controlled study of 158 scleroderma patients at 13 centers across the United States. The subjects had restrictive lung physiology, dyspnea and evidence of inflammatory interstitial lung disease. The subjects were divided into two groups and received up to 2 mg per kilogram of body weight of oral cyclophosphamide or placebo for one year. Those who had completed at least six months of treatment were included in the analysis of results, a total of 145 patients, and forced vital capacity (FVC) was measured every three months.
The cyclophosphamide group had a mean absolute 2.53 percent improvement in FVC versus the placebo group, and although there were more adverse events in the cyclophosphamide group, there was no significant difference between the two groups in terms of serious adverse events.
"The beneficial effect of cyclophosphamide on pulmonary function was paralleled by a significant improvement in dyspnea, functional ability, the health-related quality of life and skin thickness," the authors write. However, they caution that the study did not examine the long-term consequences of using the drug.
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