Study published in JAMA supports an alternative treatment approach in Parkinson's disease

October 17, 2000

Initiating therapy with MIRAPEX® provides better long-term strategy than frequently used approach

ROCHESTER, N.Y., October 18, 2000 - A study published in today's Journal of the American Medical Association found that statistically fewer patients who started treatment with the dopamine agonist MIRAPEX (pramipexole dihydrochloride tablets) developed motor complications vs. patients on initial treatment with levodopa (28% vs. 51% incidence). Starting treatment with MIRAPEX delayed the onset of motor complications, and reduced the incidence compared to patients who began therapy with levodopa. At two years, 72 percent of MIRAPEX treated patients were free from motor complications.

The clinical trial known as the CALM-PD (Comparison of the Agonist Pramipexole vs. Levodopa on Motor Complications in Parkinson's Disease) was conducted by the Parkinson Study Group (PSG), a non-profit group of research physicians and other health care providers from medical centers in the U.S. and Canada experienced in the care of Parkinson's patients.

"Two years after beginning treatment with MIRAPEX, patients were well controlled and had significantly less episodes of wearing off and dyskinesia - complications which typically accompany the progression of Parkinson's disease and the long-term use of levodopa," said Karl Kieburtz, MD, of the Parkinson Study Group (PSG) and Department of Neurology at the University of Rochester School of Medicine. "This treatment approach, provides symptom control and potentially, a longer treatment span during which they are able to maintain their motor function."

Parkinson's disease affects approximately one percent of people aged 60 and over, though it can strike younger people, for a total of approximately one million people in the United States. The nature and severity of symptoms, which include tremor, muscle rigidity, slowed motion, shuffling gait and loss of facial expression, vary from patient to patient. Levodopa has been available for the last 30 years and is typically the medication most often prescribed. Over time the effect of levodopa may become shorter and fluctuations in the motor symptoms appear during the day leading to dose increases or more frequent administrations. This is also accompanied by the occurrence of dyskinesias (involuntary movements resulting in fragmented or jerky motions). After five years of levodopa treatment, 50-75% of patients develop motor complications.

"The traditional approach has been to start patients on levodopa and as the disease progresses, to add additional therapies. Now we know there is a benefit in starting with a dopamine agonist such as MIRAPEX," said Ira Shoulson, MD, Chair of the Parkinson Study Group (PSG) and Director of Experimental Therapeutics at the University of Rochester School of Medicine. "This is important information for the health care providers and patients to consider."

The double-blind, randomized study was conducted at 22 movement disorder centers among 301 patients with early Parkinson's disease. Patients in the study received early treatment with either MIRAPEX or levodopa. During the first 10 weeks, each patient was titrated to the maximum tolerated dose of MIRAPEX or levodopa. From weeks 11 through month 23.5, the MIRAPEX dose remained fixed, however investigators could add open label levodopa to either group as needed to treat emerging or continuing symptoms. The primary endpoint was the time to the first occurrence of any of the three dopaminergic complications: 'wearing off' (medication efficacy time lessens), 'on-off' (rapid fluctuation between symptom control) or dyskinesias.

Results at two years showed a consistently lower proportion of patients who initiated therapy with MIRAPEX developing motor complications' than the patients who began therapy on levodopa. In particular, wearing-off was seen in 38 percent of the levodopa patients versus only 24 percent of the MIRAPEX patients. Dyskinesias developed in 31 percent of the levodopa patients versus only 10 percent of the MIRAPEX patients.

Pramipexole use was associated with a greater likelihood of somnolence, hallucinations and edema. The differences in somnolence and hallucinations almost exclusively occurred when subjects started experimental therapy during the escalation phase of the trial. Pramipexole was not as potent in its effects on treating Parkinson's symptoms, but the evidence indicates that despite these differences, both patients and physicians judged the symptoms to be adequately treated. Pramipexole was jointly developed by Boehringer Ingelheim and Pharmacia Corporation (formerly Pharmacia & Upjohn). Internationally, it is marketed by Boehringer Ingelheim and Pharmacia as MIRAPEX, MIRAPEXIN or SIFROL. In the United States, pramipexole is co-promoted by Pharmacia and Boehringer Ingelheim Pharmaceuticals Inc. as MIRAPEX.

The Parkinson Study Group (PSG) is a non-profit group of academic research physicians and other health care providers from medical centers in the United States and Canada, experienced in the care of Parkinson patients and dedicated to clinical research of Parkinson's disease. The PSG was formed in 1986, prompted by the recognition that clinical research in Parkinson's disease (PD) required the participation of large numbers of research patients (subjects) under the cooperative care of skilled and experienced research physicians.
-end-
For the full text of the study go to: http://jama.ama-assn.org/ or http://www.parkinson-study-group.org/

Ketchum UK

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