勃林格殷格翰能倍乐安全性如何

Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine at the University of Manchester, pointed out: "Since COPD cannot be cured, improving patients' quality of life has become the main goal of treatment. Many patients have rapidly worsened when their disease is first diagnosed. Giving patients as much intervention as possible at an early stage can maximize the patient's ability to maintain a good quality of life for a longer period of time. Subgroup analysis shows that Respimat® can achieve this. "

This study is a large randomized double-blind controlled clinical trial involving a total of 17,135 COPD patients. It aims to compare the efficacy and safety of inhaling 2.5μg or 5μg tiotropium bromide using the Respimat device with that of 18μg tiotropium bromide using the HandiHaler device.

The primary endpoints of the study were the risk of death (non-inferiority study: Respimat group inhaled tiotropium bromide 2.5 or 5 μg, once daily vs. HandiHaler group inhaled tiotropium bromide 18 μg once daily), and the risk of the first COPD exacerbation after enrollment (superiority study: Respimat group inhaled tiotropium bromide 5 μg vs. HandiHaler group inhaled tiotropium bromide) 18μg). The study also evaluated the cardiovascular safety of the subjects, including the safety of the two inhalation devices in patients with stable heart disease.

Over an average follow-up period of 2.3 years, there were no significant differences in the primary study endpoint between the Respimat and HandiHaler groups. In terms of subject death risk, the relative risk ratios of the Respimat 5μg group and the 2.5μg group and the HandiHaler group were 0.96 and 1.0, respectively. In terms of the risk of a first COPD exacerbation, the relative risk ratio between the Respimat 5 μg group and the HandiHaler group was 0.98. In addition, there were no significant differences in the cause of death and the incidence of serious adverse cardiovascular events among the three groups.

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