To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Significant Clinical Benefit Seen With Mirapex In Parkinson's Patients URL: http://www.pslgroup.com/dg/138DC6.htm Doctor's Guide October 13, 1999
SEATTLE, WA -- October 13, 1999 -- The first study conducted exclusively in minority patients of a Parkinson's disease drug shows that Mirapex® (pramipexole dihydrochloride tablets) plus levodopa significantly improves symptoms in patients with advanced Parkinson's disease. The PRIME (Pramipexole in Ethnic Minorities with Parkinson's Disease) study was created in response to the low number of minorities enrolled in previous Parkinson's disease clinical trials.
"Approximately one-fifth of all Parkinson's disease is diagnosed in minorities, yet only about five percent of the patients in clinical trials are minority group members-including patients of African-American, Asian and Hispanic descent," noted principal investigator Caroline Tanner, MD, PhD, of The Parkinson's Institute in Sunnyvale, CA and member of the Parkinson's Study Group. "This study looked at non-Caucasian Parkinson's patients and found Mirapex to be effective in these individuals." The results were presented at Symposia on Etiology, Pathogenesis and Treatment of Parkinson's Disease and Other Movement Disorders meeting, in concurrence with the annual meeting of the American Neurological Association.
The study, conducted at 18 centers across the country by the Parkinson's Study Group (PSG), included 144 patients (51 women, 93 men) with advanced Parkinson's disease who were already on levodopa therapy. Participants randomized into the eleven week study were all of African-American (48 patients), Asian-American (42 patients) or Hispanic-American (54 patients) heritage. Patients continued on levodopa and were titrated to a maximum of 4.5mg/day of pramipexole or matching placebo tablets.
A significant improvement in Parkinson's disease signs and symptoms as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) -- including activities of daily living and motor symptoms-was seen in the patients receiving the combination of levodopa plus pramipexole versus the patients receiving levodopa plus placebo.
Patients receiving the combination of products reported improvements in their ability to do basic tasks, including eating, bathing and dressing. Physicians also noted improvements in motor skills for patients treated with pramipexole and levodopa compared with placebo. In addition, 40 percent of the patients in the treatment group registered improvements in the severity of their disease (Modified Hoehn and Yahr scale) compared to 23 percent in the placebo group.
"By commissioning this study, Pharmacia & Upjohn and Boehringer Ingelheim have made an important contribution to our knowledge of how this disease affects minority patients and thereby broadened our understanding of the patients for whom pramipexole may be appropriate therapy," asserted Dr. Tanner. "It is important that we encourage the participation of patients from all backgrounds as new treatments are developed for Parkinson's disease and other conditions."
Approximately one million people in the U.S. have Parkinson's disease, with one percent of people over age 60 affected by the condition. The disease causes tremors, muscle rigidity, slowed motion, shuffling gait and a loss of facial expression. All of these effects worsen over time.
The U.S. Food and Drug Administration (FDA) approved Mirapex as treatment for the signs and symptoms of idiopathic Parkinson's disease in 1997. Based on prescription audit data, Mirapex is the number-one prescribed dopamine agonist in the U.S. In studies conducted prior to approval, the most frequently reported side effects reported by patients in advanced stages of PD who were treated with pramipexole and levodopa were postural hypotension, dyskinesias, extrapyramidal syndrome, insomnia, dizziness and hallucinations.
All PD patients should be informed that postural hypotension may occur more frequently during initial treatment and hallucinations can occur at any time during the course of treatment. There have been reports of patients treated with Mirapex falling asleep during activities of daily living, including operation of a motor vehicle.
Pramipexole was jointly developed by Boehringer Ingelheim and Pharmacia & Upjohn. Internationally, it is marketed by Boehringer Ingelheim and Pharmacia & Upjohn as Mirapex, MirapexIN® or SIFROL®. In the United States, pramipexole is co-promoted by Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceuticals Inc. as Mirapex.
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