Department of Psychiatry, Faculty of Medicine, University of Alberta, 9942-108 Street, Edmonton, Alberta T5K 2J5, Canada.
Curr Med Res Opin. 2013 Mar;29(3):227-39. doi: 10.1185/03007995.2012.762903. Epub 2013 Jan 22.
To evaluate the long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release (XR) from an oral antipsychotic in patients with schizophrenia. Reasons for switching included insufficient efficacy, tolerability, and/or non-acceptability. The primary endpoint was the percentage of patients achieving an improvement in Clinical Global Impression - Clinical Benefit (CGI-CB) scale scores.
A 24-week, international, multicentre, open-label, prospective study ( www.clinicaltrials.gov : NCT00640601). After a 7-14 day enrolment period (depending whether prior antipsychotic mono- or combination therapy), all patients received quetiapine XR 300 mg once daily (day 1), 600 mg/day (day 2), 600-800 mg/day (day 3) and 400-800 mg/day thereafter, with down-titration and discontinuation of prior antipsychotic by day 4.
A total of 62% of patients completed the study and 56.9% (LOCF, ITT) achieved a significant improvement in CGI-CB (95% CI [0.51, 0.63]; p = 0.02). Switches due to insufficient efficacy showed a significant improvement (60%, 95% CI [0.51, 0.68]; p = 0.02), compared to 54.4% ([0.44, 0.64]; p = 0.38) and 52.4% ([0.36, 0.68]; p = 0.76) of switches due to insufficient tolerability and non-acceptability respectively (both p = ns). Patients previously on olanzapine and quetiapine IR showed a significant improvement in CGI-CB (62.6% [p = 0.02] and 61.2% [p = 0.04], respectively). Somnolence (18.0%) and dizziness (14.6%) were the main adverse events. Anticholinergic use decreased from 7.1 to 2.7%. Overall mean weight gain was 0.4 kg; 12.9% of patients experienced a weight gain of ≥7% and 15% experienced a clinically relevant shift in triglycerides from baseline.
A majority of patients switched from other antipsychotics to quetiapine XR experienced clinical benefit. This was supported by all other efficacy outcomes regardless of the reason for switching. Safety data confirmed quetiapine XR was safe and well tolerated. The open-label design and lack of a placebo group represent limitations.
评估将精神分裂症患者从口服抗精神病药物转换为每日一次喹硫平延长释放剂（XR）的长期临床获益和疗效。转换的原因包括疗效不足、耐受性和/或不可接受性。主要终点是达到临床总体印象-临床疗效（CGI-CB）量表评分改善的患者比例。
这是一项为期 24 周的国际、多中心、开放性、前瞻性研究（www.clinicaltrials.gov：NCT00640601）。在 7-14 天的入组期（取决于先前是否使用单一或联合抗精神病药物）后，所有患者接受喹硫平 XR 300mg 每日一次（第 1 天）、600mg/天（第 2 天）、600-800mg/天（第 3 天），然后 400-800mg/天，在第 4 天开始减少和停用先前的抗精神病药物。
共有 62%的患者完成了研究，56.9%（LOCF，ITT）的患者 CGI-CB 显著改善（95%CI[0.51，0.63]；p=0.02）。由于疗效不足而转换的患者显著改善（60%，95%CI[0.51，0.68]；p=0.02），而由于耐受性不足和不可接受性而转换的患者分别为 54.4%（95%CI[0.44，0.64]；p=0.38）和 52.4%（95%CI[0.36，0.68]；p=0.76）（均为 p=ns）。先前使用奥氮平和喹硫平 IR 的患者 CGI-CB 显著改善（62.6%[p=0.02]和 61.2%[p=0.04]）。主要不良反应为嗜睡（18.0%）和头晕（14.6%）。抗胆碱能药物的使用从 7.1%降至 2.7%。总体平均体重增加 0.4kg；12.9%的患者体重增加≥7%，15%的患者甘油三酯从基线有临床相关变化。
大多数从其他抗精神病药物转换为喹硫平 XR 的患者都获得了临床获益。这得到了所有其他疗效结果的支持，无论转换的原因是什么。安全性数据证实喹硫平 XR 是安全且耐受良好的。开放性设计和缺乏安慰剂组是其局限性。
