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The anti-Parkinson's drug pramipexole (Mirapex) was approved by the Food and Drug Administration two years ago for treating patients with Parkinson's disease, and many studies of its effectiveness were completed before and after its approval. Most of the patients in these studies, however, were white. Researchers now report that the first U.S. study of the disease in minority patients shows that pramipexole is also effective in these groups.
According to Dr. Caroline Tanner, leader of the study, "approximately one-fifth of all Parkinson's disease is diagnosed in minorities, yet only about five percent of patients in clinical trials are minority group members." Tanner is from the Parkinson's Institute in Sunnyvale, California.
The new study was conducted at 18 centers around the country and included 144 patients (51 female, 93 male) with advanced Parkinson's who were already taking levodopa. There were 48 African-Americans, 42 Asian-Americans, and 54 Hispanic Americans in the study.
Patients continued taking levodopa and added either pramipexole or a placebo for 11 weeks, with a maximum dose of 4.5 mg/day of pramipexole. Both the patients and their doctors rated signs and symptoms of the disease, including motor symptoms (tremors, rigidity, slowness, shuffling gait, etc.) and activities of daily living.
At the end of 11 weeks, patients taking pramipexole reported significant improvements in their ability to complete basic tasks, such as eating, bathing, and dressing. Physicians reported improvement in motor skills for this group, and 40 percent of these patients showed improvements on a measure of disease severity. Only 23 percent of the placebo group showed these improvements.
The researchers, who reported their results at a meeting of the American Neurological Association in October 1999, concluded that pramipexole is effective in treating minority patients with advanced Parkinson's, but noted that more of these patients need to be included in future clinical studies.
Pramipexole can cause postural hypotension-dizziness when rising from a seated or lying-down position--and, occasionally, hallucinations. In addition, warnings were issued recently that a few patients taking pramipexole have experienced sleep attacks-fall asleep suddenly while carrying out activities of daily life, including driving a car.