Wingate University School of Pharmacy, Levine College of Health Sciences, Wingate, NC, USA.
Ann Pharmacother. 2013 Jul-Aug;47(7-8):1017-28. doi: 10.1345/aph.1S002. Epub 2013 Jun 4.
To evaluate the efficacy and safety of aclidinium bromide, a novel, long-acting inhaled muscarinic receptor antagonist approved by the Food and Drug Administration (FDA) in July 2012, as a treatment in the management of moderate to severe chronic obstructive pulmonary disease (COPD).
Literature was identified through PubMed/MEDLINE (2000-March 2013) and International Pharmaceutical Abstracts using the search terms aclidinium, COPD, chronic bronchitis, emphysema, anticholinergic, and muscarinic antagonist. In addition, US government websites, including fda.gov and clinicaltrials.gov, were reviewed for pertinent information. Forest Laboratories, Inc provided previously unpublished clinical trial data. All reference citations from identified publications were reviewed for possible inclusion.
All identified Phase 1, 2a, 2b, and 3 studies evaluating the safety and efficacy of aclidinium bromide were reviewed.
Once- and twice-daily aclidinium bromide was assessed for efficacy and safety in patients with moderate to severe COPD. In comparison to placebo, aclidinium significantly improves trough and peak forced expiratory volume in 1 second (FEV1). Significant increases in trough and peak FEV1 were sustainable for up to 64 weeks. In addition to improvement in trough and peak FEV1, twice-daily aclidinium 400 μg induced clinically meaningful improvements in the health status of patients with moderate to severe COPD. Aclidinium was generally well tolerated, with headache, cough, diarrhea, and nasopharyngitis the most common treatment-related adverse effects noted in clinical trials. Aclidinium did not demonstrate a difference in the incidence of systemic anticholinergic-associated adverse effects in comparison to placebo or active comparator.
Aclidinium bromide is a novel, inhaled, long-acting anticholinergic that, when administered at the FDA-approved dose, safely produces clinically and statistically significant bronchodilation and improves health status in patients with moderate to severe COPD. Long-term clinical trials assessing the efficacy and safety of aclidinium are warranted.
评估aclidinium 溴化物的疗效和安全性，aclidinium 溴化物是一种新型长效吸入型毒蕈碱受体拮抗剂，于 2012 年 7 月获美国食品药品监督管理局（FDA）批准用于治疗中重度慢性阻塞性肺疾病（COPD）。
通过 PubMed/MEDLINE（2000 年至 2013 年 3 月）和国际药学文摘使用以下检索词进行文献检索：aclidinium、COPD、慢性支气管炎、肺气肿、抗胆碱能药物和毒蕈碱拮抗剂。此外，还查阅了美国政府网站，包括 fda.gov 和 clinicaltrials.gov，以获取相关信息。Forest Laboratories，Inc. 提供了先前未发表的临床试验数据。对所有确定的出版物的参考文献进行了审查，以确定是否纳入。
对评估 aclidinium 溴化物安全性和疗效的所有已确定的 1 期、2a 期、2b 期和 3 期临床试验进行了回顾。
评价了每日一次和每日两次 aclidinium 溴化物治疗中重度 COPD 的疗效和安全性。与安慰剂相比，aclidinium 溴化物可显著改善谷值和峰值用力呼气量（FEV1）。谷值和峰值 FEV1 的改善可持续长达 64 周。除了改善谷值和峰值 FEV1 外，每日两次 aclidinium 溴化物 400μg 还可显著改善中重度 COPD 患者的健康状况。在临床试验中，最常见的与治疗相关的不良反应是头痛、咳嗽、腹泻和鼻咽炎。与安慰剂或阳性对照药物相比，aclidinium 溴化物并未显示出在全身抗胆碱能相关不良反应发生率上的差异。
aclidinium 溴化物是一种新型吸入长效抗胆碱能药物，在 FDA 批准的剂量下使用时，可安全地产生具有临床和统计学意义的支气管扩张作用，并改善中重度 COPD 患者的健康状况。需要进行长期临床试验以评估 aclidinium 的疗效和安全性。
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