在一项为期12周的随机开放标签试验中,诊断为精神分裂症的成年人对利培酮的疗效不足和/或耐受性差,奥氮平,或阿立哌唑被随机分配以逐渐改用伊潘立酮(即,在前2周内将当前疗法的滴定降低[在第1天降至50%,在第1周时为25%,在第2周时为0%])或立即。所有患者在第4天时服用伊潘立酮至6mgBID,然后灵活地给药6至12mgBID,根据需要。主要变量是综合临床总体变化印象(I-CGI-C),主要分析时间点是第12周。共有500名患者被随机分组并接受了伊潘立酮(逐步转换,240;立即切换,260),有175、155和170名患者从利培酮改用,奥氮平,和阿立哌唑,分别。I-CGI-C结果证实在第12周时改善了结局,逐渐转换组和立即转换组之间的得分相似,分别,对于利培酮,2.82和2.67(95%CI:-0.229,0.511);奥氮平,2.87和3.03(95%CI:-0.548,0.235);阿立哌唑,2.79和2.81(95%CI:-0.405,0.368)。两个转换组的不良事件(AE)发生率相似,最常报告(≥10%)的是头晕,口干,嗜睡,和体重增加。总之,通过逐渐或立即的方法转换为伊潘立酮,在总体疗效和安全性/耐受性结果的评分方面没有任何临床上的显着差异,基于12周时的I-CGI-C。观察到类似的总体安全性/AE概况,而不管患者从其转换的具体药剂。
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.