在患有慢性阻塞性肺病的患者中使用罗夫卢米拉斯特的长期安全性,这是一个跨国观察数据库队列研究
Edeltraut Garbe1, Fabian Hoti2, Tania Schink1
1Department Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
International journal of chronic obstructive pulmonary disease
|August 26, 2024
概括
在瑞典和挪威,在COPD患者中使用Roflumilast并没有增加死亡风险. 德国和美国略有增加,可能是由于混因素.
科学领域:
- 肺部医学 肺部医学
- 药物监督 药物监督 药物监督
- 流行病学 流行病学
背景情况:
- 慢性阻塞性肺病 (COPD) 和慢性支气管炎需要长期治疗策略.
- 罗夫米拉斯特是一种固-4抑制剂,用于治疗COPD.
- 了解罗米拉斯的长期安全性,特别是死亡率,对于临床实践至关重要.
研究的目的:
- 评估ROFLUMILAST在患有COPD或慢性支气管炎的患者的长期安全性.
- 评估不同国家的罗夫米拉斯特使用与5年全因死亡率之间的关联.
主要方法:
- 使用来自德国,挪威,瑞典和美国的电子医疗保健数据库进行回顾性队列研究.
- 包括年龄≥40岁的患者,以及与罗米拉斯暴露和未暴露个体的匹配队列.
- 倾向性得分匹配考虑了人口统计,COPD严重程度和并发症. 考克斯回归模型分析了5年全因死亡率.
主要成果:
- 分析了112,541名未暴露和23,239名暴露的患者.
- 在德国和美国",一直使用"罗夫卢米拉斯特与5年死亡风险的小幅增加有关 (HRs > 1).
- 相反,德国,挪威和瑞典的"当前使用"罗米拉斯特显示了5年死亡风险的降低 (HRs < 1).
结论:
- 在瑞典和挪威使用罗米拉斯特时没有观察到增加5年死亡风险.
- 德国和美国"常用"的死亡风险略有增加,可能归因于依指示的残留混.
- 目前使用罗米拉斯特与德国,挪威和瑞典的死亡率降低有关,需要进一步调查.
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