Sabbagh Marwan, Han SeolHeui, Kim SangYun, Na Hae-Ri, Lee Jae-Hong, Kandiah Nagaendran, Phanthumchinda Kammant, Suthisisang Chuthamanee, Senanarong Vorapun, Pai Ming-Chyi, Narilastri Diatri, Sowani Ajit M, Ampil Encarnita, Dash Amitabh
Alzheimer's and Memory Disorders Division, Barrow Neurological Institute, Phoenix, Ariz., USA.
Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of Korea.
Dement Geriatr Cogn Dis Extra. 2016 Sep 9;6(3):382-395. doi: 10.1159/000448214. eCollection 2016 Sep-Dec.
The 'Asia-Pacific Expert Panel (APEX) for donepezil 23 mg' met in November 2015 to review evidence for the recently approved high dose of donepezil and to provide recommendations to help physicians in Asia make informed clinical decisions about using donepezil 23 mg in patients with moderate-to-severe Alzheimer's disease (AD).
In a global phase III study (study 326) in patients with moderate-to-severe AD, donepezil 23 mg/day demonstrated significantly greater cognitive benefits versus donepezil 10 mg/day, with a between-treatment difference in mean change in the Severe Impairment Battery score of 2.2 points (p < 0.001) in the overall population and 3.1 points (p < 0.001) in patients with advanced AD. A subanalysis of study 326 demonstrated that the benefits and risks associated with donepezil 23 mg/day versus donepezil 10 mg/day in Asian patients with moderate-to-severe AD were comparable to those in the global study population.
Donepezil 23 mg is a valuable treatment for patients with AD, particularly those with advanced disease. The APEX emphasized the importance of patient selection (AD severity, tolerability of lower doses of donepezil, and absence of contraindications), a stepwise titration strategy for dose escalation, and appropriate monitoring and counseling of patients and caregivers in the management of patients with AD.
“多奈哌齐23毫克亚太专家小组（APEX）”于2015年11月召开会议，审查近期获批的高剂量多奈哌齐的证据，并提供建议，以帮助亚洲医生就是否在中重度阿尔茨海默病（AD）患者中使用23毫克多奈哌齐做出明智的临床决策。
在一项针对中重度AD患者的全球III期研究（研究326）中，与每日10毫克多奈哌齐相比，每日23毫克多奈哌齐显示出显著更大的认知益处，总体人群中严重损害量表评分的治疗组间平均变化差异为2.2分（p<0.001），晚期AD患者中为3.1分（p<0.001）。对研究326的亚组分析表明，在亚洲中重度AD患者中，每日23毫克多奈哌齐与每日10毫克多奈哌齐相比的获益和风险与全球研究人群中的情况相当。
23毫克多奈哌齐是AD患者，尤其是晚期患者的一种有价值的治疗方法。APEX强调了患者选择（AD严重程度、较低剂量多奈哌齐的耐受性以及无禁忌症）、剂量递增的逐步滴定策略以及在AD患者管理中对患者和护理人员进行适当监测和咨询的重要性。
