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Objective: The aim of this study was to evaluate the safety and effectiveness of rotigotine under daily clinical practice in Parkinson's disease patients., Methods: The study was a prospective, non-interventional, observational study targeting patients who were treated with rotigotine for the first time, with a 1-year follow-up period from September 2013 to August 2016., Results: There were 603 patients in the safety population and 599 patients in the effectiveness population. The mean age was 71.6 years, and the age group of ≥65 and ≥80 years accounted for 80% and 18.6% of all patients, respectively. The frequency of adverse drug reaction (ADR) was 34.3%, and common ADRs were application site reaction (20.2%), typical for transdermal patches. However, the majority of patients recovered or was recovering from these ADRs and were non-serious. Although ADRs related to non-motor symptoms of Parkinson's disease were observed, most of them were non-serious. Total scores of the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) (ON-time) significantly decreased from baseline in the effectiveness population. In the analysis of overall improvement in 12 months of post-treatment, ≥70% of patients achieved mild or greater improvement. The safety profiles and improvements in the UPDRS-III score were similar in both the ≥80 years of age group and younger age group., Conclusion: There were no new or notable safety concerns observed, and the effectiveness of rotigotine was suggested in daily clinical practice.

A post hoc analysis was performed using data obtained over eight weeks from 200 Japanese patients with schizophrenia who were switched to brexpiprazole monotherapy in a long-term treatment study. The 8-week period comprised of a 4-week switching phase and a 4-week post-switch phase. For the antipsychotic switching schedule, brexpiprazole was first administered at 1 mg/day and increased to 2 mg/day by the end of week 4. Concurrently, the previous antipsychotic(s) was/were tapered gradually from the start of week 3 and discontinued by the end of week 4. Brexpiprazole could then be increased up to 4 mg/day according to the CGI-I criteria. At week 8, 1.8%, 23.2%, 25.0%, and 50% of patients were administered daily brexpiprazole doses of 1, 2, 3, and 4 mg, respectively. The discontinuation rate at week 8 was 17.0%. The major reasons for discontinuation were consent withdrawal (9.5%), occurrence of adverse events (5.5%), and physician's decision (2.0%). Commonly reported adverse events were nasopharyngitis (13.5%), schizophrenia (9.0%), insomnia (6.5%), headache (5.5%), and akathisia (5.5%). The discontinuation rate was 4.9% for patients who were switched from aripiprazole as the primary antipsychotic and 25.4% for those who were switched from other antipsychotics. Owing to the serious adverse events that led to treatment discontinuation, careful switching to brexpiprazole is necessary in patients who previously used olanzapine as their primary antipsychotic., (© 2020. Otsuka Pharmaceutical Co Ltd. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Neuropsychopharmacology.)

Objective: The ergot-derived dopamine agonists, cabergoline and pergolide, are associated with valvulopathy risk. In Japan, product labels were revised in April 2007 to recommend periodic echocardiography for patients taking these dopamine agonists, however, the compliance of physicians to follow through with this recommendation is unknown. This study assessed changes in echocardiography evaluation of patients with Parkinson's disease (PD) taking cabergoline or pergolide before and after the label revision and examined the factors related with echocardiography performance., Methods and Patients: Medical claim data from January 2005 to December 2008 were used. Patients were divided into a C-P group (prescribed either cabergoline or pergolide) or reference group (prescribed other anti-PD drugs), and further classified based on whether they were prescribed these drugs "pre-revision" or "post-revision." The Cochran-Armitage trend test was used to compare the proportion of echocardiograms obtained amongst these groups before and after the revision. The frequencies of echocardiograms performed among the treatment groups for each period were compared by Fisher's exact test., Results: A total of 222 subjects (C-P, 73; reference, 149) were assessed. The proportion of C-P patients undergoing echocardiography increased from 4.8% to 27.9% after revision of product labels (p=0.001), which was higher than those in the reference group following label revisions (11.0%) (p=0.014). Prescription duration of C-P after the revision was longer in the patients with echocardiography than without echocardiography (p=0.026)., Conclusion: Although echocardiography evaluations increased, more than 70% of PD patients prescribed cabergoline or pergolide did not undergo such assessment despite the product label recommendation. Adherence to drug safety recommendations should be facilitated with more feasible and effective measures.

The aim of this study was to evaluate the safety and tolerability of overnight switching from ergot-derived dopamine agonists such as cabergoline to equivalent doses of pramipexole in patients with Parkinson's disease. The safety of overnight switching to pramipexole from cabergoline, which has a long plasma half-life and may cause dopaminergic excess after switchover, has not been established. Twenty-two consecutive patients with Parkinson's disease were included, 18 of them on cabergoline treatment. Patients were assessed with the Unified Parkinson's Disease Rating Scale (UPDRS) given just prior to switching as well as after 2, 4, 8, and 12 weeks of treatment. Eight patients (36.4%) experienced adverse events, of whom two were withdrawn from the study. Generally, however, significant improvement in the UPDRS was obtained after 2 weeks and improvement was maintained up to 12 weeks of treatment. Therefore, our study showed that overnight switching from ergot-derived dopamine agonists including cabergoline to dose-equivalent pramipexole was safe when associated with good patient compliance.

Many Parkinson's disease (PD) patients treated with levodopa develop motor fluctuations and/or dyskinesia. This large, retrospective study was conducted to compare the prevalence and treatment of dyskinesia in PD patients in seven countries. A total of 380 physicians were interviewed and completed patient record forms retrospectively for their last 5 patients with dyskinesia (total 1,900). The overall prevalence of dyskinesia in PD patients was 34%, but the rate varied from 24 to 51% according to geographical location. This study showed that 51.0% of Japanese physicians and 50.6% of UK physicians were dissatisfied with current treatment strategies for dyskinesia. Regardless of geographical location, physicians were dissatisfied with the current treatment strategies for dyskinesia., ((c) 2007 S. Karger AG, Basel.)