1Department of Psychiatry and Behavioral Sciences,New York Medical College,Valhalla,New York.
2ACADIA Pharmaceuticals Inc.,San Diego,California.
CNS Spectr. 2018 Jun;23(3):228-238. doi: 10.1017/S1092852917000736. Epub 2017 Nov 3.
Our aim was to describe the efficacy and tolerability of pimavanserin, a highly selective serotonin 5-HT2A receptor inverse agonist/antagonist indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis (PDP), using the metrics of number needed to treat (NNT) and number needed to harm (NNH).
Categorical efficacy and tolerability data were extracted from the clinical trial databases of the double-blind placebo-controlled studies of pimavanserin in persons with PDP. NNT and NNH values were calculated with their respective 95% confidence intervals. The likelihood to be helped or harmed (LHH) was then calculated contrasting therapeutic response versus discontinuation because of an adverse event.
NNT values for pimavanserin 34 mg/d versus placebo for several definitions of clinical response are 10, and/or are not statistically significant, and/or show an advantage for pimavanserin over placebo (such as for postural hypotension). In terms of LHH, pimavanserin 34 mg/d is about five times more likely to result in clinical response (as measured by a ≥3 point decrease from baseline on the Scale for the Assessment of Positive Symptoms adapted for Parkinson's disease) versus discontinuation due to an adverse event.
Using the metrics of NNT, NNH, and LHH, pimavanserin 34 mg/d for the treatment of PDP appears to have a compelling benefit/risk profile.
我们旨在描述 pimavanserin 的疗效和耐受性，pimavanserin 是一种高度选择性的 5-羟色胺 5-HT2A 受体反向激动剂/拮抗剂，用于治疗帕金森病精神病（PDP）相关的幻觉和妄想。使用需要治疗的人数（NNT）和需要伤害的人数（NNH）来衡量。
从 pimavanserin 治疗 PDP 患者的双盲安慰剂对照研究的临床试验数据库中提取分类疗效和耐受性数据。计算 NNT 和 NNH 值及其相应的 95%置信区间。然后通过对比治疗反应与因不良事件而停药的情况，计算获益或受损的可能性（LHH）。
pimavanserin 34mg/d 与安慰剂相比，几种临床反应定义的 NNT 值为 10，且/或无统计学意义，且/或显示 pimavanserin 优于安慰剂（例如体位性低血压）。就 LHH 而言，pimavanserin 34mg/d 更有可能导致临床反应（如帕金森病适应的阳性症状评定量表基线下降≥3 分），而不是因不良事件停药。
使用 NNT、NNH 和 LHH 等指标，pimavanserin 34mg/d 治疗 PDP 似乎具有引人注目的获益/风险比。
