Marth Katharina, Schuller Elisabeth, Pohl Wolfgang
Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Wolkersbergenstraße 1, 1130 Vienna, Austria.
Almirall GmbH, Breitenfurter Straße 113, 1120 Vienna, Austria.
Respir Med. 2015 May;109(5):616-24. doi: 10.1016/j.rmed.2015.02.004. Epub 2015 Feb 18.
The inhaled long-acting muscarinic antagonist aclidinium bromide has been shown to significantly improve lung function parameters and symptom severity in patients with COPD in randomised placebo- and active-controlled clinical studies. To obtain a comprehensive view of the treatment effects, patient-reported outcomes were investigated in a real-life COPD population in routine clinical practice in Austria.
Multicentre, prospective, non-interventional study in patients with COPD who were newly initiated on treatment with Eklira® Genuair® (aclidinium bromide; recommended dose 400 μg twice daily) as first-line or add-on therapy. Patients were either treatment naïve or switched from other COPD medications. Health-related quality of life by means of the COPD Assessment Test™ (CAT) and symptom-related variables were evaluated at the first visit (baseline) and after approximately 12 weeks of treatment. Features of the inhaler were assessed by patients and physicians at the follow-up visit.
A total of 795 COPD patients (56% male; median age: 64 years) were enrolled and treated. During the observational period, the proportion of patients with at least moderate nighttime symptoms, early-morning symptoms, and limitations in morning activities decreased from 45.0% to 21.4%, from 57.7% to 26.0%, and from 49.9% to 25.3%, respectively. All improvements from baseline in symptom severity and activity limitation were statistically significant (p < 0.0001, all tests). The mean (±SD) frequency of nocturnal awakenings decreased from 1.2 (±1.4) to 0.7 (±1.2) times per night (p < 0.0001). Quality of life improved significantly in patients treated with aclidinium bromide over 3 months compared to baseline (p < 0.0001; mean CAT total score: 18.5 ± 7.5 vs. 13.8 ± 7.3). Up to 90% of the patients and up to 91% of the physicians assessed individual features of the inhaler as 'very good' or 'good'. Aclidinium bromide was well tolerated; 6.9% of the patients reported adverse drug reactions, none of which were serious.
This non-interventional study indicated beneficial effects of Eklira® Genuair® in the treatment of COPD with regard to nighttime and early-morning symptoms, limitation of morning activities, and quality of life under routine conditions. The acceptance of the inhaler device was high, which is a prerequisite to ensure adherence in long-term therapy.
在随机安慰剂对照和活性药物对照临床研究中，吸入性长效毒蕈碱拮抗剂阿地溴铵已被证明可显著改善慢性阻塞性肺疾病（COPD）患者的肺功能参数和症状严重程度。为全面了解治疗效果，在奥地利的常规临床实践中，对真实生活中的COPD患者群体进行了患者报告结局的调查。
对新开始使用Eklira® Genuair®（阿地溴铵；推荐剂量为每日两次，每次400μg）作为一线治疗或附加治疗的COPD患者进行多中心、前瞻性、非干预性研究。患者既往未接受过治疗或从其他COPD药物转换而来。在首次就诊（基线）时和治疗约12周后，通过慢性阻塞性肺疾病评估测试™（CAT）评估与健康相关的生活质量，并评估与症状相关的变量。在随访就诊时，由患者和医生评估吸入器的特性。
共纳入795例COPD患者（男性占56%；中位年龄：64岁）并进行治疗。在观察期内，至少有中度夜间症状、清晨症状和早晨活动受限的患者比例分别从45.0%降至21.4%、从57.7%降至26.0%、从49.9%降至25.3%。症状严重程度和活动受限从基线水平的所有改善均具有统计学意义（p < 0.0001，所有检验）。夜间觉醒的平均（±标准差）频率从每晚1.2（±1.4）次降至0.7（±1.2）次（p < 0.0001）。与基线相比，接受阿地溴铵治疗3个月的患者生活质量显著改善（p < 0.0001；平均CAT总分：18.5±7.5 vs. 13.8±7.3）。高达90%的患者和高达91%的医生将吸入器的各项特性评为“非常好”或“好”。阿地溴铵耐受性良好；6.9%的患者报告了药物不良反应，均不严重。
这项非干预性研究表明，在常规条件下，Eklira® Genuair®在治疗COPD方面对夜间和清晨症状、早晨活动受限及生活质量具有有益作用。吸入器装置的接受度很高，这是确保长期治疗依从性的一个前提条件。
