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Mirapex (Pramipexole) Shows Promise as Initial Treatment for Parkinson's Disease: Presented at AAN

DENVER, CO -- April 17, 2002 -- Results of new data from an ongoing study add to the growing body of evidence demonstrating the effectiveness and potential benefits of the dopamine agonist Mirapex® (pramipexole dihydrochloride) as initial therapy in treating Parkinson's disease.

The various study results find that Mirapex reduces the risk of developing motor complications as compared to levodopa and may slow the loss of dopaminergic neuronal function in Parkinson's patients.

These results will be presented at the annual American Academy of Neurology (AAN) meeting in Denver, Colorado, April 13-20, 2002.

Among the findings presented are four-year results to the clinical trial known as CALM-PD (Comparison of the Agonist Pramipexole versus Levodopa on Motor Complications in Parkinson's Disease), conducted by the Parkinson Study Group (PSG). The two-year results of this research were originally reported in the Journal of the American Medical Association (JAMA) in October, 2000, and showed that patients initially treated with Mirapex developed fewer motor complications than patients initially treated with levodopa.

The four-year results are now complete, and continue to confirm this finding, showing initial treatment with Mirapex reduced the risk of developing motor complications by 30 percent compared to levodopa after 48 months.

The study, which evaluated 301 patients, defined the primary outcome as the time to the first occurrence of any of three motor complications: "wearing off" (medication efficacy time lessens), "on-off" (rapid fluctuation between symptom control) or dyskinesia. Mirapex significantly delayed the occurrence of all motor complications. In particular, Mirapex reduced the occurrence of "wearing off" and dyskinesia, which are the most frequent motor complications.

The results of this four-year research, just published in the April 3, 2002 issue of JAMA and presented yesterday at the AAN, showed that patients diagnosed with early Parkinson's disease who received initial treatment with Mirapex demonstrated a slower decline of dopaminergic neuronal functioning compared with patients who received initial treatment with levodopa. Earlier studies have established that patients with early Parkinson's disease have already lost an estimated 40 to 60 percent of dopamine neurons before symptoms are diagnosed.

Parkinson's disease affects approximately one percent of people over age 60, or 1.5 million people in the United States, causing tremor, muscle rigidity, slowed motion, shuffling gait and a loss of facial expression. Approximately 15 percent of patients develop Parkinson's disease before the age of 50. The nature and severity vary from patient to patient. All of these effects worsen over time. It is the second most chronic neurological disorder in older adults after Alzheimer's.

In the U.S., pramipexole - a compound from Boehringer Ingelheim research - is co-promoted by Pharmacia and Boehringer Ingelheim Pharmaceuticals Inc. as Mirapex. Pramipexole is approved for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy (without levodopa) or in combination with levodopa. Approval applies for treatment over the course of the disease through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur.

The most frequent side effects reported in clinical studies for early Parkinson's disease patients treated with pramipexole were nausea, dizziness, drowsiness and insomnia. In addition, 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.

Patients taking pramipexole have reported falling asleep while engaged in activities of daily living, including the operation of a motor vehicle, which sometimes resulted in accidents. Not all patients had perceived warning signs, such as excessive drowsiness, prior to falling asleep.

SOURCE: Pharmacia and Boehringer Ingelheim

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