MIRAPEX has a well-established safety and tolerability profile
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MIRAPEX helps reserve
the use of levodopa
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FOR THE INITIAL AND LONG-TERM TREATMENT OF PARKINSON'S DISEASE (PD)

3-Fold improvement in
levodopa-resistant tremor

MIRAPEX plus levodopa delivered a more than 3-fold improvement in levodopa-resistant tremor compared with levodopa alone7

Mirapex plus levodopa improves levodopa-resistant tremor 3-fold compared to levodopa alone

Pogarell O. Journal of Neurology, Neurosurgery, and Psychiatry, 2002.
Multicenter, double-blind, placebo-controlled, randomized, 12-week trial in 84 patients with Parkinson's disease (Hoehn and Yahr stages I-IV) and marked, drug-resistant tremor. Objective: to compare the tremorlytic properties of MIRAPEX vs placebo as add-on medication in Parkinson's disease patients. Dosing: patients were titrated to a maximum dose of MIRAPEX 4.5 mg/day. Primary outcome variable was the absolute change in tremor score (calculated as the sum of UPDRS items 16, 20, and 21) during "on" periods from baseline to outcome. Secondary outcome variables included absolute and relative (%) changes in separate tremor score items and other UPDRS score items. Conclusion: MIRAPEX is an effective agent for patients with Parkinson's disease and levodopa-resistant tremor.

Significant improvements with MIRAPEX plus levodopa3,7

MIRAPEX plus levodopa delivered a nearly 5-fold improvement in resting tremor compared with levodopa alone3

Mirapex plus levodopa improves resting tremor nearly 5-fold compared to levodopa alone

Möller JC. Movement Disorders, 2005.
Multicenter, double-blind, placebo-controlled, parallel-group, 32-week study in 354 patients with Parkinson's disease on levodopa and experiencing motor fluctuations. 174 patients received MIRAPEX, and 180 received placebo. Objective: to assess the safety and efficacy of MIRAPEX in advanced Parkinson's disease. Dosing: MIRAPEX or matching placebo was administered tid as an add-on to levodopa in 7 dosages, upwardly titrated from a daily dose of 0.375 mg to 4.5 mg. Primary outcome variables were the high responder rate and improvement in total UPDRS (Unified Parkinson's Disease Rating Scale) scores of more than 30%, and a dose reduction of levodopa of considerable proportion. Secondary outcome variables included reduction in "off " time of 2.5 hours/day.
Conclusion: this study confirms that MIRAPEX has a well-established safety and tolerability profile during long-term administration.

  • Tremor affects the majority of Parkinson's disease patients and can have a significant impact, limiting everyday activities and social interactions11,12

MIRAPEX plus levodopa improved ADL scores by 28% and motor symptom scores by 44% in patients with levodopa-resistant tremor7

Mirapex vs placebo improves tremorlytic properties as add-on medication in Parkinson's disease patients

Pogarell O. Journal of Neurology, Neurosurgery, and Psychiatry, 2002.
Multicenter, double-blind, placebo-controlled, randomized, 12-week trial in 84 patients with Parkinson's disease (Hoehn and Yahr stages I-IV) and marked, drug-resistant tremor. Objective: to compare the tremorlytic properties of MIRAPEX vs placebo as add-on medication in Parkinson's disease patients. Dosing: patients were titrated to a maximum dose of MIRAPEX 4.5 mg/day. Primary outcome variable was the absolute change in tremor score (calculated as the sum of UPDRS items 16, 20, and 21) during "on" periods from baseline to outcome. Secondary outcome variables included absolute and relative (%) changes in separate tremor score items and other UPDRS score items. Conclusion: MIRAPEX is an effective agent for patients with Parkinson's disease and levodopa-resistant tremor.

 
 

Important Information about MIRAPEX: MIRAPEX is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD).

Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Hallucinations and postural (orthostatic) hypotension may occur. In clinical trials for early PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea (28% vs. 18%), dizziness (25% vs. 24%), somnolence (22% vs. 9%), insomnia (17% vs. 12%), asthenia (14% vs. 12%), and constipation (14% vs. 6%). In clinical trials for advanced PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are postural hypotension (53% vs. 48%), dyskinesia (47% vs. 31%), extrapyramidal syndrome (28% vs. 26%), insomnia (27% vs. 22%), dizziness (26% vs. 25%), accidental injury (17% vs. 15%), hallucinations (17% vs. 4%), and dream abnormalities (11% vs. 10%).

Patients and caregivers should be informed that impulse control disorders and compulsive behaviors have been reported in patients taking dopamine agonists, including MIRAPEX.

Please see full Prescribing Information.

This information is intended for U.S. residents only.