Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.
University of Exeter Medical School, Exeter, UK.
Parkinsonism Relat Disord. 2021 Jun;87:25-31. doi: 10.1016/j.parkreldis.2021.04.012. Epub 2021 Apr 28.
Pimavanserin, a selective 5-HT inverse agonist/antagonist, was approved for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). We present durability of response with pimavanserin in patients with PDP for an additional 4 weeks of treatment.
This was an open-label extension (OLE) study in patients previously completing one of three double-blind, placebo-controlled (Core) studies. All patients received pimavanserin 34 mg once daily. Efficacy assessments included the Scale for the Assessment of Positive Symptoms (SAPS) PD and H + D scales, Clinical Global Impression (CGI) Improvement and Severity scales and Caregiver Burden Scale (CBS), through 4 weeks in the OLE. Safety assessments were conducted at each visit.
Of 459 patients, 424 (92.4%) had a Week 4 efficacy assessment. At Week 4 (10 weeks total treatment), SAPS-PD mean (standard deviation) change from OLE baseline was -1.8 (5.5) and for SAPS-H + D was -2.1 (6.2) with pimavanserin 34 mg. Patients receiving placebo during the Core studies had greater improvements (SAPS-PD -2.9 [5.6]; SAPS-H + D -3.5 [6.3]) during the OLE. For participants treated with pimavanserin 8.5 or 17 mg during the Core studies, further improvement was observed during the OLE with pimavanserin 34 mg. The mean change from Core Study baseline for SAPS-PD score was similar among prior pimavanserin 34 mg and prior placebo-treated participants (-7.1 vs. -7.0). The CGI-I response rate (score of 1 or 2) at Week 4 was 51.4%. Adverse events were reported by 215 (46.8%) patients during the first 4 weeks of OLE. The most common AEs were fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%), insomnia (2.4%), and peripheral edema (2.2%) CONCLUSIONS: Patients previously on pimavanserin 34 mg during three blinded core studies had durability of efficacy during the subsequent 4 week OLE SAPS-PD assessment. Patients previously on blinded placebo improved after 4 weeks of OL pimavanserin treatment. These results in over 400 patients from 14 countries support the efficacy of pimavanserin for treating PDP.
匹莫范色林是一种选择性 5-HT 反向激动剂/拮抗剂，已被批准用于治疗帕金森病精神病（PDP）相关的幻觉和妄想。我们报告了匹莫范色林在 PDP 患者中额外 4 周治疗的反应持久性。
这是一项先前完成三项双盲、安慰剂对照（核心）研究之一的患者的开放标签扩展（OLE）研究。所有患者均接受匹莫范色林 34mg 每日一次。通过 OLE 的 4 周评估疗效，包括帕金森病阳性症状量表（SAPS）PD 和 H+D 量表、临床总体印象（CGI）改善和严重程度量表以及照顾者负担量表（CBS）。安全性评估在每次就诊时进行。
在 459 名患者中，有 424 名（92.4%）在 OLE 第 4 周进行了疗效评估。在第 4 周（总治疗 10 周）时，匹莫范色林 34mg 治疗后，SAPS-PD 的平均（标准差）变化为-1.8（5.5），SAPS-H+D 为-2.1（6.2）。在 OLE 期间，接受安慰剂治疗的患者（SAPS-PD-2.9[5.6]；SAPS-H+D-3.5[6.3]）改善更大。在核心研究期间接受匹莫范色林 8.5 或 17mg 治疗的参与者，在 OLE 期间接受匹莫范色林 34mg 治疗时，进一步改善。匹莫范色林 34mg 治疗的参与者，在核心研究基线时，SAPS-PD 评分的平均变化在先前接受匹莫范色林 34mg 治疗的参与者和先前接受安慰剂治疗的参与者之间相似（-7.1 vs.-7.0）。第 4 周时，CGI-I 反应率（评分 1 或 2）为 51.4%。在 OLE 的前 4 周内，有 215 名（46.8%）患者报告了不良事件。最常见的 AE 是跌倒（5.9%）、幻觉（3.7%）、尿路感染（2.8%）、失眠（2.4%）和外周水肿（2.2%）。
先前在三项双盲核心研究中接受匹莫范色林 34mg 治疗的患者，在随后的 4 周 OLE SAPS-PD 评估中具有持久的疗效。在接受 4 周 OLE 匹莫范色林治疗后，先前接受安慰剂治疗的患者病情有所改善。来自 14 个国家的 400 多名患者的这些结果支持匹莫范色林治疗 PDP 的疗效。
