疾病阶段和运动波动持续时间可预测药物耐受性:一项关于帕金森病患者使用奥匹卡朋的真实、前瞻性意大利多中心研究。

IF 1.9 Q3 PHARMACOLOGY & PHARMACY Drugs - Real World Outcomes Pub Date : 2024-09-01 Epub Date: 2024-07-02 DOI:10.1007/s40801-024-00442-1
Ruggero Bacchin, Marco Liccari, Mauro Catalan, Lucia Antonutti, Paolo Manganotti, Maria Chiara Malaguti, Bruno Giometto
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引用次数: 0

摘要

背景:奥匹卡朋是第三代儿茶酚-O-甲基转移酶抑制剂,目前用于治疗帕金森病的运动性波动。其疗效和安全性已在临床试验中得到证实,但在现实生活中,特别是在意大利帕金森病患者群体中使用该药的数据却缺失:我们旨在收集有关阿哌卡朋用于治疗帕金森病相关运动波动时的实际耐受性/安全性的数据:我们连续招募了 152 名帕金森病患者,并在使用阿哌卡彭后对他们进行了为期 2 年的随访。我们获得了基线临床和人口统计学信息,包括病程、分期、表型以及轴性和非运动症状。我们还收集了中断治疗的原因以及使用阿哌卡彭后出现的不良反应:结果:89名患者(58%)报告了不良事件,46名患者(30%)中断了治疗。根据病程和左旋多巴治疗路径,"早期 "患者发生不良反应的频率较低;运动波动持续时间≥12个月以及Hoehn和Yahr量表评分≥2.5分是预测停药的主要因素:本研究证实了奥匹卡朋在实际生活中的良好耐受性/安全性,并为意大利帕金森病患者提供了针对具体国家的数据。
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Disease Stage and Motor Fluctuation Duration Predict Drug Tolerability: A Real-Life, Prospective Italian Multicenter Study on the Use of Opicapone in Parkinson's Disease.

Background: Opicapone is a third-generation catechol-O-methyl-transferase inhibitor currently used for the treatment of motor fluctuations in Parkinson's disease. Its benefit and safety have been established by clinical trials; however, data about its use in a real-life context, and particularly in an Italian population of patients with Parkinson's disease, are missing.

Objectives: We aimed to gather data about the real-life tolerability/safety of opicapone when used for the treatment of Parkinson's disease-related motor fluctuations.

Methods: We enrolled 152 consecutive patients with Parkinson's disease and followed them for 2 years after opicapone introduction. We obtained baseline clinical and demographical information, including disease duration, stage, phenotype, as well as axial and non-motor symptoms. We collected the reasons for any treatment interruption and adverse events emerging after opicapone introduction.

Results: Eighty-nine (58%) patients reported adverse events and 46 (30%) patients discontinued the treatment. Adverse events occurred less frequently in "earlier" patients accordingly to the disease course and L-Dopa treatment pathway; a motor fluctuation duration ≥12 months and Hoehn and Yahr scale score ≥2.5 were the main predictors of therapy withdrawal.

Conclusions: This study confirms the good tolerability/safety profile of opicapone in a real-life setting and provides country-specific data for Italian patients with Parkinson's disease.

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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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