【最多关注】COPD新药罗氟司特薄膜片给慢性阻塞性肺病带来新治疗选择

It is an oral selective phosphodiesterase 4 (PDE4) inhibitor. In July 2010, the European Union approved it for severe chronic obstructive pulmonary disease (COPD). It was first launched in Germany and the United Kingdom. In February 2011, roflumilast was launched in the United States under the trade name Daliresp, in the form of film-coated tablets.

Roflumilast is the first oral anti-inflammatory treatment drug specially developed for patients with severe COPD. It is also the first new type of COPD treatment drug approved by the EU in more than ten years.

Roflumilast is approved for the maintenance treatment of severe COPD associated with chronic bronchitis (post-diastolic FEV1 less than 50% of predicted) in adult patients with a history of frequent exacerbations. But it must be combined with other bronchodilators.

New COPD drug roflumilast film tablets bring new treatment options for chronic obstructive pulmonary disease

In vitro experiments and animal model tests have shown that roflumilast has extensive anti-inflammatory effects. In vitro, roflumilast N-oxide can affect many cell types, including neutrophils, monocytes/macrophages, CD4+ and CD8+ T cells, endothelial cells, epithelial cells, smooth muscle cells, and fibroblasts. By affecting these cells, roflumilast acts on multiple aspects of the pathogenesis of COPD. In vivo, roflumilast has an effect on many aspects of the pathogenesis of chronic obstructive pulmonary disease, such as tobacco-induced pulmonary inflammatory response, respiratory ciliary dyskinesia, pulmonary fibrosis, emphysema, airway remodeling, oxidative stress response, pulmonary vascular remodeling, and pulmonary hypertension.

In addition, four phase III clinical studies laid the foundation for the approval of roflumilast. More than 3,000 COPD patients were included in two pivotal placebo-controlled clinical studies. Studies have shown that roflumilast can significantly improve patients with moderate to severe exacerbations and prediastolic FEV1, regardless of whether it is combined with a long-acting β2 agonist. The study also demonstrated that roflumilast significantly improved patients' lung function compared with placebo.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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