Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease

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• 作者：Roland Buhl^a ; ^{r.buhl@3-med.klinik.uni-mainz.de} ; Sheldon Magder^b ; Ulrich Bothner^c ; Kay Tetzlaff^c ; ^d ; Florian Voß ; ^c ; Lazaro Loaiza^c ; Claus F. Vogelmeier^e ; Lorcan McGarvey^f
• 关键词：COPD ; Long-acting muscarinic antagonist ; Long-acting β-agonist ; Safety ; Maintenance bronchodilator
• 刊名：Respiratory Medicine
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：122
• 期：Complete
• 页码：58-66
• 全文大小：446 K
• 卷排序：122

文摘

Two placebo-controlled 1-year studies of tiotropium/olodaterol, combined (5/5 µg and 2.5/5 µg) vs monotherapies, in COPD. 3100 patients with moderate to very severe COPD, including 784 patients with cardiovascular co-morbidities, were included. AEs were balanced across treatments in the total population and in patient subgroups with cardiovascular co-morbidities. Independent, adjudicated SAEs analysis in 494/3100 patients: 260 (respiratory), 53 (cardiovascular), 16 (cerebrovascular). SAE incidences were comparable between treatments: there was no evidence of increased risk for combination vs monotherapy.