Abstract | BACKGROUND: Studies 016 and SETTLE showed that safinamide was safe and effective as adjunct therapy in patients with advanced Parkinson's disease (PD) and motor fluctuations. The addition of safinamide to a stable dose of levodopa alone or with other antiparkinsonian medications significantly increased ON time with no/non-troublesome dyskinesia, decreased OFF time and improved Parkinson's symptoms. OBJECTIVE: To evaluate the clinical effects of safinamide 100 mg/day on motor fluctuations and cardinal Parkinson's symptoms in specific patient subgroups using pooled data from Studies 016 and SETTLE. METHODS: Both studies were double blind, placebo-controlled, randomized, phase 3 trials which enrolled patients with mid- to late-stage PD experiencing motor fluctuations while receiving optimized and stable doses of levodopa, alone or with other dopaminergic treatments. The present post-hoc analyses assessed the change from baseline in ON time (with no or non-troublesome dyskinesia) and OFF time in subgroups of patients who were receiving only levodopa at baseline, who were classified as "mild fluctuators" (daily OFF time ≤4 h), and who were receiving concomitant dopaminergic therapy, with or without amantadine, and the effects of safinamide versus placebo on individual cardinal PD symptoms during ON time. RESULTS: CONCLUSIONS:
Safinamide was a safe and effective first adjunct therapy in levodopa-treated patients and improved 4/5 cardinal symptoms of PD while providing benefits to mild and non-mild fluctuators and patients receiving other concomitant dopaminergic therapies.
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Authors | Carlo Cattaneo, Marco Sardina, Ermino Bonizzoni |
Journal | Journal of Parkinson's disease
(J Parkinsons Dis)
Vol. 6
Issue 1
Pg. 165-73
( 2016)
ISSN: 1877-718X [Electronic] Netherlands |
PMID | 26889632
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antiparkinson Agents
- Benzylamines
- Levodopa
- safinamide
- Alanine
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Topics |
- Aged
- Alanine
(administration & dosage, analogs & derivatives)
- Antiparkinson Agents
(administration & dosage)
- Benzylamines
(administration & dosage)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Levodopa
(administration & dosage)
- Male
- Middle Aged
- Parkinson Disease
(drug therapy)
- Treatment Outcome
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