This study evaluated the effects of ropinirole prolonged-release (RPR) in comparison with ropinirole immediate-release (RIR) on sleep-related disorders in Parkinson disease (PD).Thirty-three PD patients (aged 62.5 [SD, 8] years; PD duration, 9 [SD, 4] years) were evaluated on a stable dose of RIR and 5 to 13 weeks after switch to the closest possible dose of RPR. The following questionnaires were administered: Epworth Sleepiness Scale, PD Sleep Scale, Pittsburgh Sleep Quality Index, REM Sleep Behavior Disorder Screening Questionnaire, and PD Questionnaire 39. We further monitored the occurrence of restless legs syndrome and sleep attacks (SAs). Motor disability was evaluated by PD diary and by Unified Parkinson Disease Rating Scale part 3 on medication (ON) and after medication withdrawal (OFF). In 8 patients with marked subjective sleep disturbance, polysomnography, and multiple sleep latency test were performed.After switching to RPR, there was an improvement in PD Sleep Scale (94.9 [SD, 23] vs 102.2 [SD, 27]; P < 0.05 corrected), Pittsburgh Sleep Quality Index (7.2 [SD, 3] vs 5.8 [SD, 3]; P < 0.05 corrected), Epworth Sleepiness Scale (14.1 [SD, 5] vs 12.0 [SD, 6]; P < 0.05 corrected) and Unified Parkinson Disease Rating Scale part 3 in the ON state (20.9 [SD, 10] 10 vs 17.6 [SD, 10]; P < 0.05 corrected). Thirteen patients reported disappearance of SAs on RPR. Polysomnography and multiple sleep latency test showed no changes in a subgroup of 8 patients after the switch to RPR.Ropinirole prolonged-release compared with RIR improved subjective quality of sleep, reduced daytime sleepiness, and led to disappearance of SAs in some patients possibly due to a more stable plasma level of ropinirole.
- MeSH
- agonisté dopaminu aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- antiparkinsonika aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- dospělí MeSH
- indoly aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kvalita života MeSH
- léky s prodlouženým účinkem aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- Parkinsonova nemoc komplikace farmakoterapie patofyziologie MeSH
- poruchy spánku a bdění etiologie MeSH
- psychiatrické posuzovací škály MeSH
- senioři MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
OBJECTIVE: To assess the impact of the new botulinum neurotoxin type A preparation NT 201 (Xeomin; Merz Pharmaceuticals GmbH, Frankfurt, Germany) on muscle tone, functional disability, and caregiver burden in patients with poststroke upper limb spasticity in a randomized, placebo-controlled, double-blind study. METHODS: One hundred forty-eight patients with an Ashworth Scale score of 2 or higher for wrist and finger flexors and at least moderate disability in their principal therapeutic target of the Disability Assessment Scale were treated either with NT 201 (median, 320 U) or placebo and followed up for up to 20 weeks. Treatment of the wrist and finger muscles was mandatory. RESULTS: A significantly higher proportion of patients treated with NT 201 were responders (improvement of > or =1 point in the Ashworth Scale score), as observed in comparison to placebo 4 weeks after treatment in wrist flexors (odds ratio, 3.97; 95% confidence interval, 1.9-8.3; P < 0.001, intent to treat). For all treated flexor muscle groups, statistically significant odds ratios in favor of NT 201 were observed at week 4 (P < or = 0.009). Statistically significant results in favor of NT 201 were observed at all postinjection visits until week 12 in the principal therapeutic target (P < or = 0.005), in the global assessment of efficacy (P < 0.001), and in some tasks of the Carer Burden Scale (P < 0.05). Similar numbers of patients in each group experienced at least 1 adverse event (NT 201, n = 21; placebo, n = 20). Importantly, none of the patients developed neutralizing antibodies. CONCLUSIONS: NT 201 led to statistically significant improvements in muscle tone and disability and was well tolerated in patients with poststroke upper limb spasticity.
- MeSH
- bolest chemicky indukované patofyziologie MeSH
- bolesti hlavy chemicky indukované patofyziologie MeSH
- botulotoxiny typ A škodlivé účinky terapeutické užití MeSH
- cévní mozková příhoda komplikace farmakoterapie patofyziologie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- lidé středního věku MeSH
- lidé MeSH
- paže patofyziologie MeSH
- senioři MeSH
- svalová spasticita farmakoterapie etiologie patofyziologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
OBJECTIVE: The objective of the study was to determine the maximal achievable dose of rotigotine by assessing the tolerability of escalating doses of rotigotine transdermal patch in patients with advanced-stage Parkinson disease. METHODS: Thirty-four patients aged 30 years or older on a stable dose of l-dopa with an off time of at least 2.5 h/d were randomized to 2-titration schemes. The patients started on a dosage of 4 mg/24 h and received an incremental dosage of 4 mg/24 h per week in the fast-titration group and 2 mg/24 h per week in the slow-titration group to the maximal target dosage of 24 mg/24 h (patch size of 120 cm(2)). Thereafter, both groups entered a maintenance period of 42 days or longer for the rapid-titration group and 7 days or longer for the slow titration group followed by a 2-week safety follow-up period with stepwise dosage de-escalation of 4 mg/24 h for 4 days. RESULTS: Twenty-seven patients completed the trial, of whom 24 completed without dose reduction. Twenty-six patients (76%) were titrated to the maximum target dose and thus had a maximal achievable dosage of at least 24 mg/24 h. Adverse events, generally mild or moderate, included application site reaction (12%), nausea, dyskinesia, and visual hallucinations (9% each). The mean time spent off decreased by 2 to 3 h/d. Duration of on without dyskinesia periods increased (2 h/d). The mean total (SD) Unified Parkinson's Disease Rating Score decreased by 18.9 (14.2) in the fast-titration group and 17.8 (14.0) in the slow titration group. A shift from off to on without dyskinesias in status after waking up was observed. CONCLUSIONS: Rotigotine transdermal patch, up to 24 mg/24 h, was effective and well tolerated by patients with advanced-stage Parkinson disease.
- MeSH
- agonisté dopaminu aplikace a dávkování MeSH
- aplikace kožní MeSH
- dospělí MeSH
- hypokineze farmakoterapie patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- Parkinsonova nemoc farmakoterapie patofyziologie MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- tetrahydronaftaleny aplikace a dávkování MeSH
- thiofeny aplikace a dávkování MeSH
- ukončení terapie pacientem MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: To evaluate the effects of ropinirole on selected nonmotor symptoms of Parkinson's disease (PD), including anxiety, depressive symptoms, sleep disturbances/excessive daytime sleepiness, and sexual functions.
- MeSH
- behaviorální symptomy farmakoterapie patofyziologie psychologie MeSH
- deprese farmakoterapie patofyziologie psychologie MeSH
- financování organizované MeSH
- indoly terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- Parkinsonova nemoc farmakoterapie patofyziologie psychologie MeSH
- poruchy spánku a bdění farmakoterapie patofyziologie psychologie MeSH
- prospektivní studie MeSH
- senioři MeSH
- tremor farmakoterapie patofyziologie psychologie MeSH
- úzkost farmakoterapie patofyziologie psychologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH