scholarly journals A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice

2020 ◽  
Vol 10 (3) ◽  
pp. 176 ◽  
Author(s):  
Javier Pagonabarraga ◽  
José Matías Arbelo ◽  
Francisco Grandas ◽  
Maria-Rosario Luquin ◽  
Pablo Martínez Martín ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Practice ◽  
Motor Fluctuations ◽  
Adjunctive Treatment ◽  
Good Tolerability ◽  
Time Control ◽  
Clinical Scenarios ◽  
Off Time

Safinamide is an approved drug for the treatment of motor fluctuations in Parkinson’s disease (PD). Scarce data are available on its use in clinical practice. A group of Spanish movement disorders specialists was convened to review the use of safinamide across different clinical scenarios that may guide neurologists in clinical practice. Eight specialists with recognized expertise in PD management elaborated the statements based on available evidence in the literature and on their clinical experience. The RAND/UCLA method was carried, with final conclusions accepted after a 2-round modified Delphi process. Higher level of agreement between panellists was reached for the following statements. Safinamide significantly improves mean daily OFF time without troublesome dyskinesias. Adjunctive treatment with safinamide is associated with motor improvements in patients with mid-to-late PD. The efficacy of safinamide on motor fluctuations is maintained at long-term, with no increase over time in dyskinesias severity. The clinical benefits of safinamide on pain and depression remain unclear. Safinamide presents a similar incidence of adverse events compared with placebo. The efficacy and safety of safinamide shown in the pivotal clinical trials are reproduced in clinical practice, with improvement of parkinsonian symptoms, decrease of daily OFF time, control of dyskinesias at the long term, and good tolerability and safety.

scholarly journals Long-term safety and efficacy of opicapone in Japanese Parkinson’s patients with motor fluctuations

2021 ◽  
Author(s):  
Atsushi Takeda ◽  
Ryosuke Takahashi ◽  
Yoshio Tsuboi ◽  
Masahiro Nomoto ◽  
Tetsuya Maeda ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Adverse Events ◽  
Motor Fluctuations ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Open Label Extension ◽  
Off Time

AbstractThe double-blind part of the COMFORT-PD (COMt-inhibitor Findings from Opicapone Repeated Treatment for Parkinson’s Disease) study in Japanese levodopa-treated patients with Parkinson’s disease and motor fluctuations found that both opicapone 25 and 50 mg were significantly more effective than placebo. This 52-week open-label extension study evaluated the long-term safety and efficacy of opicapone 50 mg tablets in patients who completed the double-blind part of the COMFORT-PD study. Safety was monitored via adverse events, laboratory testing, and physical, cardiovascular and neurological examinations. Efficacy was primarily assessed by change in OFF-time. Secondary efficacy measures included: ON-time, percentage of OFF/ON-time responders, other outcomes from the double-blind part. 391/437 patients were transferred to the open-label extension period and included in the safety analysis set (full analysis set, n = 387; open-label completers, n = 316). Adverse events were frequently reported (n = 338, 86.4%), but < 50% were considered drug-related (39.9%) and few were considered serious (2.6%) or led to discontinuation (2.8%). Decreased OFF-time was consistently observed over the open-label period regardless of initial randomization. Change [LSM (SE)] in OFF-time from the open-label baseline to the last visit showed a persistent effect in patients initially randomized to opicapone 25 mg [− 0.37 (0.20) h, P = 0.0689] and opicapone 50 mg [− 0.07 (0.21) h, P = 0.6913] whereas opicapone 50 mg led to a statistically significant reduction in the previous placebo group [− 1.26 (0.19) h, P < 0.05]. Once-daily opicapone 50 mg was generally well tolerated and consistently reduced OFF-time over 52 weeks in Japanese levodopa-treated patients with motor fluctuations.Trial registration JapicCTI-153112; date of registration: December 25, 2015.

scholarly journals Long-term effect of apomorphine infusion in advanced Parkinson’s disease: a real-life study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Bruna Meira ◽  
Bertrand Degos ◽  
Elise Corsetti ◽  
Mohamed Doulazmi ◽  
Emeline Berthelot ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Real Life ◽  
Routine Care ◽  
Motor Fluctuations ◽  
Psychological Status ◽  
Long Term Effects ◽  
Good Tolerability ◽  
Advanced Parkinson’S Disease

AbstractLong-term effects of continuous subcutaneous apomorphine infusion (CSAI) on health-related quality of life (HRQoL) and predictors of CSAI discontinuation are poorly known. Data from consecutive advanced Parkinson’s disease patients treated in routine care were retrospectively collected over 24 months after CSAI initiation, with a focus on the 39-item Parkinson’s disease questionnaire (PDQ-39). We determined predictors of CSAI discontinuation and HRQoL improvement using multiple regression analysis. Of the 110 subjects evaluated over a 2-year period, 35% discontinued CSAI. Of those who continued treatment, HRQoL remained stable with a sustained reduction in motor fluctuations. The observed effect on dyskinesias was mild and transient. Of note, patients with preexisting impulse control disorders showed an overall good tolerability. PDQ-39 was the only baseline predictor of HRQoL improvement after 2 years of treatment. The presence of dyskinesias, poorer psychological status, shorter disease duration, male sex, and worse OFF state were predictors of discontinuation. Best candidates for CSAI are patients with: (i) poor baseline HRQoL and (ii) marked motor fluctuations.

Long-term detection of motor fluctuations by wrist-worn sensors in Parkinson's disease

Basal Ganglia ◽  
2017 ◽  
Vol 8 ◽  
pp. 22
Author(s):  
Daniel Pichler ◽  
Urban Fietzek ◽  
Franz Pfister ◽  
Ahmad Ahmadi ◽  
Felix Achilles ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Motor Fluctuations

Opicapone in clinical practice in Parkinson's disease German patients with motor fluctuations: Findings from the OPTIPARK study

2021 ◽  
Vol 429 ◽  
pp. 119429
Author(s):  
Heinz Reichmann ◽  
Andrew Lees ◽  
Diogo Magalhães ◽  
José Rocha ◽  
Patrício Soares-Da-Silva
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Practice ◽  
Motor Fluctuations

Opicapone in clinical practice in Parkinson's disease UK patients with motor fluctuations: Findings from the OPTIPARK study

2021 ◽  
Vol 429 ◽  
pp. 119428
Author(s):  
Andrew Lees ◽  
Heinz Reichmann ◽  
Diogo Magalhães ◽  
José Rocha ◽  
Patrício Soares-Da-Silva
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Practice ◽  
Motor Fluctuations

scholarly journals The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II

2021 ◽  
Vol 12 ◽  
Author(s):  
José-Francisco Rocha ◽  
Georg Ebersbach ◽  
Andrew Lees ◽  
Eduardo Tolosa ◽  
Joaquim J. Ferreira ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Wide Spectrum ◽  
Motor Fluctuation ◽  
Motor Fluctuations ◽  
Disease Course ◽  
Treatment Pathway ◽  
Levodopa Treatment ◽  
Post Hoc ◽  
Off Time

Introduction: Opicapone (OPC) was efficacious in reducing OFF-time in two pivotal trials in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (BIPARK-I and -II). Post-hoc analyses of these trials evaluated the efficacy of OPC following pre-defined segmentation of the wide spectrum of motor fluctuations in PD.Methods: Data from matching treatment arms in BIPARK-I and -II were combined for the placebo (PLC) and OPC 50-mg groups, and exploratory post-hoc analyses were performed to investigate the efficacy of OPC 50 mg vs. PLC in subgroups of patients who were in “earlier” vs. “later” stages of both their disease course (e.g., duration of PD &lt;6 years vs. ≥6 years) and levodopa treatment pathway (e.g., number of daily levodopa intakes &lt;4 vs. ≥4). Efficacy variables included changes from baseline in absolute OFF-time and total ON-time.Results: The Full Analysis Set included 517 patients (PLC, n = 255; OPC 50 mg, n = 262). OPC 50 mg was significantly more effective than PLC in reducing OFF-time and increasing ON-time in the majority of subgroup analyses (p &lt; 0.05). Moreover, patients in “earlier” stages of both their disease course and levodopa treatment pathway experienced numerically greater efficacy when using OPC 50 mg, in comparison with those in “later” stages.Conclusion: OPC 50 mg was efficacious over the whole trajectory of motor fluctuation evolution in PD patients. There was also a signal for enhanced efficacy in patients who were earlier vs. later in their disease course and levodopa treatment pathway.

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