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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Parkinsons+Dis
2016 ; 6
(1
): 165-73
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Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson s
Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE
#MMPMID26889632
Cattaneo C
; Sardina M
; Bonizzoni E
J Parkinsons Dis
2016[]; 6
(1
): 165-73
PMID26889632
show ga
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: Safinamide significantly increased mean ON time (with no or
non-troublesome dyskinesia) and reduced mean OFF time when used as first adjunct
therapy in levodopa-treated patients and patients with mild motor fluctuations.
Mean daily ON time (with no or non-troublesome dyskinesia) and OFF time were
favorably changed, compared with placebo, to similar extents regardless of
whether patients were receiving concomitant dopamine agonists,
catechol-O-methyltransferase inhibitors and amantadine. Additionally, safinamide
improved bradykinesia, rigidity, tremor and gait. 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.