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Orally Disintegrating Selegiline in Parkinson Patients With Dopamine Agonist-Related Adverse Effects

Journal

CLINICAL NEUROPHARMACOLOGY
Volume 33, Issue 1, Pages 5-10

Publisher

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/WNF.0b013e3181b7926f

Keywords

Parkinson disease; orally disintegrating selegiline; dopamine agonist adverse effects

Funding

  1. Valeant Pharmaceuticals

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Objective: To determine whether adding orally disintegrating selegiline (ODS) while decreasing dopamine agonist (DA) dosages would reduce DA-related adverse effects (AEs) of excessive daytime sleepiness (EDS). pedal edema, hallucinations, and impulse control disorders (ICDs) without compromising efficacy in Parkinson disease (PD) patients. Methods: This was a 12-week open-label study of 60 PD patients with motor fluctuations and DA-related AEs of FDS, pedal Edema. hallucinations, and ICDs. Orally disintegrating selegiline was initiated at 1.25 mg once daily, and down titration of the DA was started with a goal of a 50%) reduction by 1 week. At week 6, ODS was increased to 2.5 mg, and further reductions of the DA were allowed if the AEs were not resolved. Results: The addition of ODS allowed a reduction in the mean daily dose of pramipexole from 2.3 to 0.5 mg and immediate-release ropinirole from 11.2 to 2.9 mg. Most subjects reported a reduction or resolution of DA-related AEs 94% with EDS (n = 50), 73% with pedal edema (n = 26), 86% with hallucinations (n = 15), and 94% with ICDs (n = 25). Mean activities of daily living and motor scores front the Unified Parkinson's Disease Rating Scale as well as quality-of life scores were significantly improved without an increase in daily off time. The most common AEs, most of which resolved after titration, were worsening of PD, nausea/vomiting, dyskinesia, increased off time, body aches, insomnia, orthostatic hypotension, and increased anxiety and depression. Conclusions: In most subjects, the addition of ODS with decreasing dosages of DAs substantially reduced EDS. pedal edema, hallucinations, and ICDs without compromising efficacy.

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