Weiden Peter J, Citrome Leslie, Alva Gus, Brams Matthew, Glick Ira D, Jackson Richard, Mattingly Greg, Kianifard Farid, Meng Xiangyi, Pestreich Linda, Hochfeld Marla, Winseck Adam
University of Illinois at Chicago, UIC Medical Center, 912 South Wood Street, MC 913, Chicago, IL 60612, USA.
New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY 10595, USA.
Schizophr Res. 2014 Mar;153(1-3):160-8. doi: 10.1016/j.schres.2013.11.042. Epub 2014 Feb 12.
In a 12-week randomized open-label trial, adults diagnosed with schizophrenia experiencing inadequate efficacy and/or poor tolerability on risperidone, olanzapine, or aripiprazole were randomized to switch to iloperidone either gradually (ie, down-titration of current therapy over the first 2weeks [to 50% on Day 1, 25% by Week 1, 0% by Week 2]) or immediately. All patients were titrated on iloperidone to 6mg BID by Day 4, then flexibly dosing between 6 and 12mg BID, as needed. The primary variable was the Integrated Clinical Global Impression of Change (I-CGI-C) and the primary analysis time point was Week 12. A total of 500 patients were randomized and received iloperidone (gradual switch, 240; immediate switch, 260), with 175, 155, and 170 patients switched from risperidone, olanzapine, and aripiprazole, respectively. I-CGI-C Results confirmed improved outcomes at Week 12, with scores that were similar between the gradual- and immediate-switch groups, respectively, for risperidone, 2.82 and 2.67 (95% CI: -0.229, 0.511); olanzapine, 2.87 and 3.03 (95% CI: -0.548, 0.235); and aripiprazole, 2.79 and 2.81 (95% CI: -0.405, 0.368). Incidence of adverse events (AEs) was similar in both switch groups, with the most frequently reported (≥10%) being dizziness, dry mouth, somnolence, and weight increase. In conclusion, switching to iloperidone by either a gradual or an immediate method did not reveal any clinically significant differences in ratings of overall efficacy and safety/tolerability outcomes, based on the I-CGI-C at 12weeks. Similar overall safety/AE profiles were observed regardless of the specific agent from which patients were switched.
在一项为期12周的随机开放标签试验中，被诊断为精神分裂症且对利培酮、奥氮平或阿立哌唑疗效不佳和/或耐受性差的成年人被随机分为两组，一组逐渐换用伊潘立酮（即在最初2周内逐渐减少当前治疗剂量[第1天降至50%，第1周降至25%，第2周降至0%]），另一组立即换用。所有患者在第4天将伊潘立酮滴定至每日两次、每次6mg，然后根据需要在每日两次、每次6至12mg之间灵活调整剂量。主要变量是综合临床总体印象变化（I-CGI-C），主要分析时间点为第12周。共有500名患者被随机分组并接受伊潘立酮治疗（逐渐换药组240例，立即换药组260例），分别有175例、155例和170例患者从利培酮、奥氮平和阿立哌唑换用。I-CGI-C结果证实第12周时疗效有所改善，逐渐换药组和立即换药组的评分相似，利培酮分别为2.82和2.67（95%CI：-0.229，0.511）；奥氮平分别为2.87和3.03（95%CI：-0.548，0.235）；阿立哌唑分别为2.79和2.81（95%CI：-0.405，0.368）。两组换药患者的不良事件（AE）发生率相似，最常报告的（≥10%）为头晕、口干、嗜睡和体重增加。总之，根据12周时的I-CGI-C，逐渐或立即换用伊潘立酮在总体疗效及安全性/耐受性结果评分方面未显示出任何临床显著差异。无论患者从哪种特定药物换用，总体安全性/AE概况相似。
