Liebowitz Michael, Croft Harry A, Kajdasz Daniel K, Whalen Heidi, Gallipoli Susan, Athanasiou Maria, Reed Carol R
Dr. Liebowitz, MD, Affiliated with The Medical Research Network, LLC, New York, NY. Dr. Croft, MD, Affiliated with San Antonio Psychiatric Research Center, San Antonio, TX. Dr. Kajdasz, PhD and Ms. Whalen, MHS, Affiliated with Dogwood Pharmaceuticals, A Subsidiary of Forest Laboratories, Inc., New Haven, CT. Ms. Gallipoli, MSN, Former Full-Time Employee of Dogwood Pharmaceuticals, A Subsidiary of Forest Laboratories, Inc., New Haven, CT. Dr. Athanasiou, PhD, Affiliated with Athanasiou Consulting, LLC, Fond du Lac, WI. Dr. Reed, MD, Consultant to Forest Laboratories, Inc., New York, NY.
Psychopharmacol Bull. 2011 Sep 15;44(3):15-33.
Vilazodone is a selective serotonin reuptake inhibitor and 5-HT receptor partial agonist approved for the treatment of major depressive disorder (MDD). This report summarizes the safety and tolerability of vilazodone 40 mg/day during short- and long-term treatment of adult MDD.
Pooled data from two 8-week, double-blind studies of vilazodone (n = 436) vs placebo (n = 433) and data from one 52-week, open-label study (n = 616, vilazodone only) were analyzed. Patients aged 18-70 with DSM-IV-TR-defined MDD received vilazodone or placebo (8-week studies only) once daily, with food, titrated to 40 mg/day over 2 weeks. Safety and tolerability assessments included adverse events (AEs), laboratory tests, vital signs, electrocardiograms, and weight.
The most common AEs in all studies were diarrhea, nausea, and headache. Vilazodone-associated AEs in the two 8-week studies, defined as an incidence rate of ≥5% in the vilazodone group and at least twice that for placebo, were diarrhea (28.0% vs 9.2%), nausea (23.4% vs 5.1%), and insomnia (6.0% vs 2.1%), with the majority reported as mild to moderate and <5% of those patients requiring concomitant (directed) treatment for these conditions. Discontinuation rates due to AEs were 7.1% (vilazodone) and 3.2% (placebo) in the 8-week studies and 20.7% in the 52-week study. Vilazodone had no clinically significant effects on vital signs, laboratory tests, or electrocardiograms.
Vilazodone 40 mg/day was well tolerated during short- and long-term MDD treatment in these trials. Safety profiles associated with 8- and 52-week exposure were consistent.
维拉唑酮是一种选择性5-羟色胺再摄取抑制剂和5-羟色胺受体部分激动剂，已被批准用于治疗重度抑郁症（MDD）。本报告总结了维拉唑酮40毫克/天在成年MDD患者短期和长期治疗中的安全性和耐受性。
分析了两项为期8周的维拉唑酮（n = 436）与安慰剂（n = 433）双盲研究的汇总数据以及一项为期52周的开放标签研究（n = 616，仅维拉唑酮）的数据。年龄在18至70岁、符合DSM-IV-TR定义的MDD患者每天一次服用维拉唑酮或安慰剂（仅8周研究），与食物同服，在2周内滴定至40毫克/天。安全性和耐受性评估包括不良事件（AE）、实验室检查、生命体征、心电图和体重。
在所有研究中，最常见的AE是腹泻、恶心和头痛。在两项8周研究中，与维拉唑酮相关的AE（定义为维拉唑酮组发生率≥5%且至少是安慰剂组的两倍）为腹泻（28.0%对9.2%）、恶心（23.4%对5.1%）和失眠（6.0%对2.1%），大多数报告为轻度至中度，<5%的患者需要针对这些情况进行联合（定向）治疗。在8周研究中，因AE导致的停药率为7.1%（维拉唑酮）和3.2%（安慰剂），在52周研究中为20.7%。维拉唑酮对生命体征、实验室检查或心电图无临床显著影响。
在这些试验中，维拉唑酮40毫克/天在MDD短期和长期治疗期间耐受性良好。与8周和52周暴露相关的安全性概况是一致的。
