Jones Roy W, Soininen Hilkka, Hager Klaus, Aarsland Dag, Passmore Peter, Murthy Anita, Zhang Richard, Bahra Ranbir
Research Institute for the Care of the Elderly, St Martin's Hospital, Bath, UK.
Int J Geriatr Psychiatry. 2004 Jan;19(1):58-67. doi: 10.1002/gps.1038.
To compare directly, in the same patient cohort, the ease of use and tolerability of donepezil and galantamine in the treatment of Alzheimer's disease (AD), and investigate the effects of both treatments on cognition and activities of daily living (ADL).
Patients with mild to moderate AD from 14 European centres were randomised to receive open-label donepezil (up to 10 mg once daily) or galantamine (up to 12 mg twice daily) for 12 weeks, according to the approved product labelling. Physicians and caregivers completed questionnaires rating satisfaction with treatment/ease of use in daily practice. Secondary assessments were the ADAS-cog, the MMSE, and the DAD scale to assess ADL. Tolerability was evaluated by reporting adverse events (AEs).
Both physicians and caregivers reported significantly greater overall satisfaction/ease of use for donepezil (n = 64) compared with galantamine (n = 56) at weeks 4, 12, and endpoint (week 12 LOCF; all p-values <0.05). Significantly greater improvements in cognition were also observed for donepezil versus galantamine on the ADAS-cog at Week 12 and endpoint (p-values <0.05). ADL improved significantly in the donepezil group compared with the galantamine group at weeks 4, 12, and endpoint (p-values <0.05). Most AEs were mild to moderate, however, 46% galantamine-treated patients reported gastrointestinal AEs vs 25% donepezil patients.
Physician and caregiver ease of use/satisfaction scores, and assessments of cognition and ADL, showed significant benefits for donepezil compared with galantamine in this direct comparative trial. Both treatments were well tolerated, with more gastrointestinal AEs reported for galantamine vs donepezil.
在同一患者队列中直接比较多奈哌齐和加兰他敏治疗阿尔茨海默病（AD）的易用性和耐受性，并研究两种治疗方法对认知和日常生活活动（ADL）的影响。
来自14个欧洲中心的轻至中度AD患者根据批准的产品标签随机接受开放标签的多奈哌齐（每日一次，剂量高达10毫克）或加兰他敏（每日两次，剂量高达12毫克）治疗12周。医生和护理人员完成问卷调查，对日常实践中的治疗满意度/易用性进行评分。二级评估包括ADAS-cog、MMSE和DAD量表，以评估ADL。通过报告不良事件（AE）来评估耐受性。
在第4周、第12周和终点（第12周LOCF；所有p值<0.05），与加兰他敏组（n = 56）相比，医生和护理人员均报告多奈哌齐组（n = 64）的总体满意度/易用性显著更高。在第12周和终点时，多奈哌齐在ADAS-cog上的认知改善也显著优于加兰他敏（p值<0.05）。在第4周、第12周和终点时，与加兰他敏组相比，多奈哌齐组的ADL有显著改善（p值<0.05）。大多数AE为轻至中度，然而，46%接受加兰他敏治疗的患者报告有胃肠道AE，而接受多奈哌齐治疗的患者为25%。
在这项直接比较试验中，与加兰他敏相比，医生和护理人员的易用性/满意度评分以及认知和ADL评估显示多奈哌齐具有显著优势。两种治疗方法耐受性良好，加兰他敏报告的胃肠道AE比多奈哌齐更多。
