Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD.
Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD.
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DOI：
10.1017/s1461145711001131
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发表时间：
2012-02
期刊：
影响因子：
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通讯作者：
Schäuble B
中科院分区：
文献类型：
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作者：
Buitelaar JK;Trott GE;Hofecker M;Waechter S;Berwaerts J;Dejonkheere J;Schäuble B
哌醋甲酯（MPH）被广泛用于注意缺陷多动障碍（ADHD）成人，但缺乏长期治疗和维持效果的数据。在一项为期52周的开放标签研究中，对渗透释放口服系统-哌甲酯（OROS-MPH）进行了评价，该研究的受试者之前已完成了短期安慰剂对照试验和短期开放标签扩展。使用研究者和受试者评定的Conners成人ADHD评定量表（CAARS：O-SV和CAARS：S-S）、临床总体印象-严重程度（CGI-S）、Sheehan残疾量表（SDS）和生活质量享受和满意度问卷（Q-LES-Q）评估疗效。完成≥52周治疗的受试者有资格进入4周随机化、安慰剂对照停药期，在此期间使用CAARS：O-SV和CGI-S评估治疗效果丧失。在开放期（n=156），平均CAARS：O-SV评分较基线降低1.9±7.8（p<0.01），观察到CAARS：S-S、CGI-S和SDS较基线的小幅统计学显著性改善。在双盲期（OROS-MPH，n=23;安慰剂，n=22），CAARS：OROS-MPH和安慰剂组的O-SV较双盲基线增加（4.0±7.6 vs. 6.5±7.8，无统计学显著性）。长期OROS-MPH治疗耐受性良好，停药后无撤药或反弹迹象。总之，OROS-MPH的短期获益在长期开放标签治疗期间持续存在。安慰剂对照停药设计的疗效维持仍有待在更大的患者人群中证实。
Methylphenidate (MPH) is widely prescribed for adults with attention deficit hyperactivity disorder (ADHD), but data on long-term treatment and maintenance of effect are lacking. Osmotic release oral system-methylphenidate (OROS–MPH) was evaluated in a 52-wk open-label study in subjects who had previously completed a short-term placebo-controlled trial and short-term open-label extension. Efficacy was assessed using the investigator- and subject-rated Conners’ Adult ADHD Rating Scales (CAARS:O-SV and CAARS:S-S), and the Clinical Global Impression – Severity (CGI-S), Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Subjects completing ≥52 wk of treatment were eligible for a 4-wk randomized, placebo-controlled withdrawal phase in which loss of treatment effect was assessed using CAARS:O-SV and CGI-S. In the open-label phase (n=156), mean CAARS:O-SV score decreased from baseline by 1.9±7.8 (p<0.01), and small, statistically significant improvements from baseline were observed for CAARS:S-S, CGI-S and SDS. In the double-blind phase (OROS-MPH, n=23; placebo, n=22), CAARS:O-SV increased from double-blind baseline in the OROS-MPH and placebo arms (4.0±7.6 vs. 6.5±7.8, not statistically significant). Long-term OROS-MPH treatment was well tolerated, and there was no evidence of withdrawal or rebound after discontinuation. In conclusion, the short-term benefits of OROS-MPH continue during long-term open-label treatment. Maintenance of efficacy in a placebo-controlled withdrawal design remains to be confirmed in larger patient populations.