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オオヤマ ゲンコウ
OYAMA Genko
大山 彦光 所属 埼玉医科大学 医学部 脳神経内科 職種 教授 |
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| 論文種別 | 学術雑誌(原著) |
| 言語種別 | 英語 |
| 査読の有無 | 査読あり |
| 表題 | Efficacy and safety of a once-daily extended-release formulation of pramipexole switched from an immediate-release formulation in patients with advanced Parkinson's disease: Results from an open-label study |
| 掲載誌名 | 正式名：Drug Research ISSNコード：2194-9379 |
| 巻・号・頁 | 63(12),639-643頁 |
| 著者・共著者 | M. Takanashi,Y. Shimo,T. Hatano,G. Oyama,N. Hattori |
| 発行年月 | 2013/12 |
| 概要 | This study aimed to evaluate the efficacy and safety of an extended-release tablet formulation of pramipexole (PPX-ER) given once daily when switched from an immediate-release tablet formulation (PPX-IR) given 3 times daily. This open-label study included 29 patients with idiopathic Parkinson's disease (PD) who were followed for 8 weeks. Primary endpoints were Unified Parkinson's Disease Rating Scale (UPDRS) part III score, a physician evaluation of motor symptoms nocturnal and early morning symptoms (NEMS) score, based on the results for 4 items in the Parkinson's Disease Sleep Scale and the Movement Disorder Society - sponsored revision of the UPDRS and patients' formulation preference, determined through questionnaires. Secondary endpoints were nocturnal sleep disturbance, evaluated using the revised version of the Parkinson's Disease Sleep Scale (PDSS-2) quality of life, evaluated using the 39-item Parkinson's Disease Questionnaire (PDQ-39) Clinical Global Impression-Improvement (CGI-I) score Patient Global Impression-Improvement (PGI-I) score and caregiver formulation preference. UPDRS part III score (mean±SD) was significantly decreased after 4 weeks (13.9±7.3 P=0.030) and 8 weeks (12.2±7.3 P< 0.001) from baseline (15.3±7.0). However, no significant change was found in NEMS scale, PDSS-2 or PDQ-39 scores. After 8 weeks, the responder rates based on CGI-I and PGI-I scores were 27.6% and 20.7%, respectively. As a result of the questionnaire, 63.0% of patients and 58.8% of their caregivers preferred PPX-ER. A non-serious drug-related adverse event (diarrhea) was observed in one patient. In conclusion, PPX-ER can be considered as a useful treatment option when PPX-IR needs to be switched to other dopamine agonists. This study is registered with UMIN-CTR (UMIN000006521). © Georg Thieme Verlag KG Stuttgart. New York. |
| DOI | 10.1055/s-0033-1351257 |