Background: Parkinson’s disease (PD) is a progressive neurodegenerative disease that occurs as a result of loss of dopaminergic neurons from the substantia nigra. Rotigotine is a non-ergolinic dopamine agonist availa...Background: Parkinson’s disease (PD) is a progressive neurodegenerative disease that occurs as a result of loss of dopaminergic neurons from the substantia nigra. Rotigotine is a non-ergolinic dopamine agonist available as a silicone-based transdermal patch for the treatment of PD. In the European Union, rotigotine transdermal patch is indicated for use as monotherapy in early idiopathic PD, or in combination with levodopa through the disease course to the late stages where motor complications with levodopa become an issue. Objective: To investigate the safety and tolerability of transdermal rotigotine, in patients with PD being treated during routine clinical practice for 2 years. Results: 114 patients were enrolled, and evaluated for adverse events over a 24-month period. Adverse events occurred in 39 patients (34.21%). 23 patients (20.17%) reported application site reactions (dermatitis, erythema, itching), and 16 (14.03%) had systemic adverse events. Sleep disorders were the most common problem;the others were hallucinations, depression, dizziness, and syncope. No patient experienced dyskinesia. Adverse events necessitated the discontinuation of rotigotine for application site reactions in fourteen patients (12.28%) and 11 patients (9.64%);reasons for discontinuation were systemic adverse events. Conclusion: Rotigotine is safe and well tolerated when used to treat PD in routine clinical practice.展开更多
Objective: Levodopa is the gold-standard of therapy in Parkinson’s disease (PD), but it is associated with motor complications that affect 50% of patients after five years of treatment. Development of delirium and ps...Objective: Levodopa is the gold-standard of therapy in Parkinson’s disease (PD), but it is associated with motor complications that affect 50% of patients after five years of treatment. Development of delirium and psychosis is the main limitation of dopaminergic treatment in older persons. These adverse effects may result from pulsatile stimulation of the dopamine receptors. Dopamine agonists with transdermal delivery that continuously stimulate the dopamine receptors may reduce these complications. The objective of this study was to evaluate the frequencies of acute delirium and psychosis in elderly patients treated with rotigotine vs. levodopa in a newly diagnosed drugnaive Parkinson’s disease (PD). Methods: Patients admitted to the Geriatric-Rehabilitation Department of the University-Hospital of Parma were screened for the presence of Parkinsonism. All subjects admitted with diagnosis of PD according to the UK Brain Bank Criteria were randomly treated with Rotigotine or levodopa. All subjects were assessed by Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. Acute delirium was asessed by CAM Diagnostic Algorithm during the first week after admission. After six months, diagnosis of psychosis was performed according to pro posed diagnostic criteria by NINDS and NIMH. Patients with cognitive impairment (MMSE dementia with Lewy bodies (DLB), were excluded. Results: 60 consecutive newly diagnosed drugnaive PD patients were evaluated. No statistical significant difference between the two groups were observed in term of age, gender, MMSE score, severity of disease expressed by H&Y staging. 30 patients were treated with rotigotine (6 mg/daily) and 30 patients were treated with L-Dopa (250 mg/daily). All participants completed the study. UPDRS Part III was statistical significant lower in both groups after treatment from 26.4 to 18.3 (rotigotine group) and from 26.3 to 17.3 (levodopa group), but comparable within groups (p = 0.83). After 6-month follow-up, acute deliriu展开更多
Aim: To evaluate safety and efficacy of a transdermal rotigotine for the treatment of fatigue and quality of life (QOL) in patients with Parkinson’s disease (PD). This was a multi-sites open-label study of 58 PD pati...Aim: To evaluate safety and efficacy of a transdermal rotigotine for the treatment of fatigue and quality of life (QOL) in patients with Parkinson’s disease (PD). This was a multi-sites open-label study of 58 PD patients (male 26, female 32) who met a Japanese PD diagnosis criterion. They received a transdermal rotigotine 4.5 mg/day for 8 weeks. We added a rotigotine on the previous anti-Parkinson’s drugs. Clinical signs were evaluated by Hoehn-Yahr (H-Y) stage, unified Parkinson’s disease rating scale (UPDRS), fatigue severity scale (FSS), and Euro quality of life (QOL). The scores of UPDRS improved from 35.2 ± 8.0 (mean ± SD) to 31.8 ± 8.3 (P = 0.14). There was no significant improvement or worsening of the H-Y stages. The scores of FSS improved from 57.3 ± 12.7 (mean ± SD) to 50.1 ± 11.8 (P = 0.061). The scores of QOL improved from 38.1 ± 11.1 to 48.3 ± 10.0 (P = 0.068). Our data demonstrate that, in a small sample size, administration of a transdermal rotigotine was associated with few side effects and was modestly effective for the treatment of fatigue and QOL in patients with PD.展开更多
目的制备罗替戈汀经皮吸收贴剂,考察不同处方因素对药物渗透行为的影响,并进行初步的质量评价。方法采用有机溶媒挥散法制备罗替戈汀压敏胶分散型贴剂;采用单因素考察法,通过体外透皮实验,对贴剂的处方因素压敏胶、背衬、促透剂种类和...目的制备罗替戈汀经皮吸收贴剂,考察不同处方因素对药物渗透行为的影响,并进行初步的质量评价。方法采用有机溶媒挥散法制备罗替戈汀压敏胶分散型贴剂;采用单因素考察法,通过体外透皮实验,对贴剂的处方因素压敏胶、背衬、促透剂种类和浓度进行筛选;对自制罗替戈汀贴剂的质量进行初步的考察。结果确定优选处方为以罗替戈汀为主药,低玻璃化转变温度型压敏胶为基质,CoTranTM9726为背衬,以及质量分数5%的Plurol■Oleique CC 497为经皮吸收促透剂。结论处方优化后的罗替戈汀贴剂体外24 h经皮累积渗透量显著增加,为罗替戈汀经皮吸收贴剂的后续研究提供了一定的实验依据。展开更多
文摘Background: Parkinson’s disease (PD) is a progressive neurodegenerative disease that occurs as a result of loss of dopaminergic neurons from the substantia nigra. Rotigotine is a non-ergolinic dopamine agonist available as a silicone-based transdermal patch for the treatment of PD. In the European Union, rotigotine transdermal patch is indicated for use as monotherapy in early idiopathic PD, or in combination with levodopa through the disease course to the late stages where motor complications with levodopa become an issue. Objective: To investigate the safety and tolerability of transdermal rotigotine, in patients with PD being treated during routine clinical practice for 2 years. Results: 114 patients were enrolled, and evaluated for adverse events over a 24-month period. Adverse events occurred in 39 patients (34.21%). 23 patients (20.17%) reported application site reactions (dermatitis, erythema, itching), and 16 (14.03%) had systemic adverse events. Sleep disorders were the most common problem;the others were hallucinations, depression, dizziness, and syncope. No patient experienced dyskinesia. Adverse events necessitated the discontinuation of rotigotine for application site reactions in fourteen patients (12.28%) and 11 patients (9.64%);reasons for discontinuation were systemic adverse events. Conclusion: Rotigotine is safe and well tolerated when used to treat PD in routine clinical practice.
文摘Objective: Levodopa is the gold-standard of therapy in Parkinson’s disease (PD), but it is associated with motor complications that affect 50% of patients after five years of treatment. Development of delirium and psychosis is the main limitation of dopaminergic treatment in older persons. These adverse effects may result from pulsatile stimulation of the dopamine receptors. Dopamine agonists with transdermal delivery that continuously stimulate the dopamine receptors may reduce these complications. The objective of this study was to evaluate the frequencies of acute delirium and psychosis in elderly patients treated with rotigotine vs. levodopa in a newly diagnosed drugnaive Parkinson’s disease (PD). Methods: Patients admitted to the Geriatric-Rehabilitation Department of the University-Hospital of Parma were screened for the presence of Parkinsonism. All subjects admitted with diagnosis of PD according to the UK Brain Bank Criteria were randomly treated with Rotigotine or levodopa. All subjects were assessed by Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. Acute delirium was asessed by CAM Diagnostic Algorithm during the first week after admission. After six months, diagnosis of psychosis was performed according to pro posed diagnostic criteria by NINDS and NIMH. Patients with cognitive impairment (MMSE dementia with Lewy bodies (DLB), were excluded. Results: 60 consecutive newly diagnosed drugnaive PD patients were evaluated. No statistical significant difference between the two groups were observed in term of age, gender, MMSE score, severity of disease expressed by H&Y staging. 30 patients were treated with rotigotine (6 mg/daily) and 30 patients were treated with L-Dopa (250 mg/daily). All participants completed the study. UPDRS Part III was statistical significant lower in both groups after treatment from 26.4 to 18.3 (rotigotine group) and from 26.3 to 17.3 (levodopa group), but comparable within groups (p = 0.83). After 6-month follow-up, acute deliriu
文摘Aim: To evaluate safety and efficacy of a transdermal rotigotine for the treatment of fatigue and quality of life (QOL) in patients with Parkinson’s disease (PD). This was a multi-sites open-label study of 58 PD patients (male 26, female 32) who met a Japanese PD diagnosis criterion. They received a transdermal rotigotine 4.5 mg/day for 8 weeks. We added a rotigotine on the previous anti-Parkinson’s drugs. Clinical signs were evaluated by Hoehn-Yahr (H-Y) stage, unified Parkinson’s disease rating scale (UPDRS), fatigue severity scale (FSS), and Euro quality of life (QOL). The scores of UPDRS improved from 35.2 ± 8.0 (mean ± SD) to 31.8 ± 8.3 (P = 0.14). There was no significant improvement or worsening of the H-Y stages. The scores of FSS improved from 57.3 ± 12.7 (mean ± SD) to 50.1 ± 11.8 (P = 0.061). The scores of QOL improved from 38.1 ± 11.1 to 48.3 ± 10.0 (P = 0.068). Our data demonstrate that, in a small sample size, administration of a transdermal rotigotine was associated with few side effects and was modestly effective for the treatment of fatigue and QOL in patients with PD.
文摘目的制备罗替戈汀经皮吸收贴剂,考察不同处方因素对药物渗透行为的影响,并进行初步的质量评价。方法采用有机溶媒挥散法制备罗替戈汀压敏胶分散型贴剂;采用单因素考察法,通过体外透皮实验,对贴剂的处方因素压敏胶、背衬、促透剂种类和浓度进行筛选;对自制罗替戈汀贴剂的质量进行初步的考察。结果确定优选处方为以罗替戈汀为主药,低玻璃化转变温度型压敏胶为基质,CoTranTM9726为背衬,以及质量分数5%的Plurol■Oleique CC 497为经皮吸收促透剂。结论处方优化后的罗替戈汀贴剂体外24 h经皮累积渗透量显著增加,为罗替戈汀经皮吸收贴剂的后续研究提供了一定的实验依据。
