Durgam Suresh, Chen Changzheng, Gommoll Carl P, Edwards John, Citrome Leslie
Allergan, Jersey City, NJ, USA.
Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA.
Neuropsychiatr Dis Treat. 2016 Dec 2;12:3073-3081. doi: 10.2147/NDT.S117581. eCollection 2016.
In three 8-week studies of vilazodone 40 mg/d (NCT00285376, NCT00683592, and NCT01473394) and a 10-week study of vilazodone 20 or 40 mg/d (NCT01473381), adults with major depressive disorder (MDD) showed significantly greater improvement with vilazodone versus placebo in global disease severity as measured by mean change from baseline in Clinical Global Impression of Severity (CGI-S) score. To assess the proportion of patients achieving clinically meaningful improvement, a post hoc pooled analysis was conducted using categorical shifts in disease severity based on CGI-S scores at baseline and end of treatment (EOT).
Analyses were conducted in the pooled intent-to-treat population (N=2,218). Definitions of categorical shifts included CGI-S ≥4 (moderately ill or worse) at baseline to CGI-S ≤2 (normal or borderline ill) at EOT; CGI-S ≥5 (markedly ill or worse) at baseline to CGI-S ≤2 at EOT; and CGI-S ≥6 (severely ill or worse) at baseline to CGI-S ≤3 (mildly ill or better) at EOT.
At baseline, 2,217 patients were moderately ill or worse. The percentage who improved to normal or borderline ill was significantly higher with vilazodone than with placebo (40.0% versus 27.8%; odds ratio [OR] =1.7, <0.001; number needed to treat [NNT] =9). In the 979 patients who were markedly ill or worse at baseline, the percentage who improved to normal or borderline ill was significantly higher with vilazodone than with placebo (36.8% versus 25.5%; OR =1.7, <0.001; NNT =9). The small number of severely ill patients at baseline (n =43) provided inadequate power to detect statistically significant between-group differences, but an NNT =5 was found for improvement to mildly ill or better.
Categorical shift analyses, defined using baseline and EOT CGI-S scores, showed that significantly higher proportions of patients had clinically meaningful improvements in global disease severity with vilazodone 20-40 mg/d versus placebo. This type of analysis may be useful for evaluating the effects of antidepressant treatment in adults with MDD.
在三项为期8周的研究（NCT00285376、NCT00683592和NCT01473394）中，使用每日40毫克的维拉唑酮，以及一项为期10周的研究（NCT01473381）中，使用每日20或40毫克的维拉唑酮，患有重度抑郁症（MDD）的成年人在全球疾病严重程度方面，与安慰剂相比，维拉唑酮显示出显著更大的改善，这通过临床总体印象严重程度（CGI-S）评分从基线的平均变化来衡量。为了评估达到具有临床意义改善的患者比例，使用基于基线和治疗结束时（EOT）的CGI-S评分的疾病严重程度分类变化进行了一项事后汇总分析。
在汇总的意向性治疗人群（N = 2218）中进行分析。分类变化的定义包括基线时CGI-S≥4（中度患病或更严重）至EOT时CGI-S≤2（正常或临界患病）；基线时CGI-S≥5（明显患病或更严重）至EOT时CGI-S≤2；以及基线时CGI-S≥6（严重患病或更严重）至EOT时CGI-S≤3（轻度患病或更好）。
在基线时，2217名患者为中度患病或更严重。维拉唑酮组改善至正常或临界患病的百分比显著高于安慰剂组（40.0%对27.8%；优势比[OR]=1.7，P<0.001；治疗所需人数[NNT]=9）。在基线时明显患病或更严重的979名患者中，维拉唑酮组改善至正常或临界患病的百分比显著高于安慰剂组（36.8%对25.5%；OR = 1.7，P<0.001；NNT = 9）。基线时严重患病患者数量较少（n = 43），不足以检测出组间统计学上的显著差异，但发现改善至轻度患病或更好的NNT = 5。
使用基线和EOT时的CGI-S评分定义的分类变化分析表明，与安慰剂相比，每日20 - 40毫克维拉唑酮组中，有显著更高比例的患者在全球疾病严重程度方面有具有临床意义的改善。这种分析类型可能有助于评估抗抑郁治疗对患有MDD的成年人的效果。
