Long-term efficacy and safety of celecoxib in Alzheimer's disease
Long-term efficacy and safety of celecoxib in Alzheimer's disease
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DOI：
10.1159/000096588
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发表时间：
2007-01-01
影响因子：
2.4
通讯作者：
Niculescu, Liviu
中科院分区：
文献类型：
--
作者：
Soininen, Hilkka;West, Christine;Niculescu, Liviu
背景与目的：环氧合酶-2（考克斯-2）可能在阿尔茨海默病（AD）的神经病理过程中发挥重要作用。塞来昔布（200 mg bid）是一种选择性考克斯-2抑制剂，在年龄≥ 50岁的轻中度AD患者中评估其疗效和安全性，以确定治疗是否能有效延缓认知功能恶化。方法：这是一项为期52周的多中心、随机、双盲、安慰剂对照、平行组研究。主要疗效终点为阿尔茨海默病评估量表-认知行为（ADAS-cog）综合评分和第52周基于临床医生访谈的印象变化+（CIBIC+）从基线至第52周的变化。结果：第52周时，安慰剂组和塞来昔布200 mg bid组ADAS-cog评分较基线的变化相似（分别为5.00和4.39）。CIBIC+评分也相似（4.83和4.92）。进行了两项扩展研究，但基于这些疗效结果提前终止。所有3项研究的安全性数据表明，塞来昔布通常耐受良好。结论：在本研究中，塞来昔布200 mg bid并未减缓AD的进展，不良事件的发生与患有复杂慢性疾病的老年人群的预期一致。版权所有（C）2007 S. Karger AG，巴塞尔。
Background/Aims: Cyclooxygenase-2 (COX-2) may play an important role in the neuropathology of Alzheimer's disease ( AD). The efficacy and safety of celecoxib ( 200 mg bid), a COX-2 selective inhibitor, were assessed in patients >= 50 years with established mild-to-moderate AD to determine whether treatment was effective in retarding deterioration of cognitive function. Methods: This was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The primary efficacy end points were the change from baseline to week 52 in the Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-cog) composite score and the week 52 Clinician's Interview-Based Impression of Change Plus (CIBIC+). Results: At 52 weeks, change in ADAS-cog scores from baseline was similar for placebo and celecoxib 200 mg bid groups (5.00 and 4.39, respectively). CIBIC+ scores were also similar (4.83 and 4.92). Two extension studies were conducted but were terminated early based on these efficacy results. Safety data from all 3 studies indicated that celecoxib was generally well-tolerated. Conclusion: Celecoxib 200 mg bid did not slow the progression of AD in this study, and the occurrence of adverse events was as expected for an elderly population with a complex chronic medical condition. Copyright (C) 2007 S. Karger AG, Basel.