gtreiow 2010-1-5 11:49
FDA核准Tiotropium用於減少COPD惡化
作者：Yael Waknine
出處：WebMD醫學新聞
December 18, 2009 — 美國食品藥物管理局(FDA)核准吸入型長效抗膽鹼製劑tiotropium bromide (商品名Spiriva HandiHaler，Boehringer Ingelheim Pharmaceuticals藥廠)擴展一項適應症，用於減少慢性阻塞性肺病(chronic obstructive pulmonary disease，COPD)患者之惡化。
該項核准是根據「Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT)」研究與針對退伍軍人進行之6個月研究的資料，藥廠表示，兩個研究共包括約8,000名COPD病患。
惡化可能是由感染和環境刺激引起，定義是新發生症狀或症狀增加(包括咳嗽、有痰、哮喘或呼吸困難)且持續至少3天，因而需要改變治療或住院。
雖然UPLIFT研究並未達到其主要終點(延緩肺功能衰退率)，臨床資料顯示，在現有的呼吸道藥物中增加 tiotropium，在4年時明顯改善肺功能且減少COPD惡化。
Boehringer Ingelheim Pharmaceuticals藥廠藥物管理事務副總裁Christopher Corsico醫師表示，藉由此次核准，Spiriva HandiHaler成為第一個不含類固醇、可以減少COPD惡化的維持治療方式，我們也很高興，此產品的標籤現在將納入指標性之UPLIFT研究資料，提供醫師在進行治療決策時的重要資訊。
Tiotropium之前獲核准用於長期、每日一次維持治療COPD有關的支氣管痙攣，包括慢性支氣管炎和肺氣腫。
FDA Approves Tiotropium for Reducing COPD Exacerbations
By Yael Waknine
Medscape Medical News
December 18, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for the inhaled, long-acting anticholinergic agent tiotropium bromide (Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc) for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The approval was based on data from the Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT) study and a 6-month study conducted in the Veterans Affairs setting. Together the studies involved nearly 8000 patients with COPD, the manufacturer said.
Exacerbations, which can be caused by infection and environmental irritants, were defined as new-onset or increase in symptoms (including cough, sputum, wheezing, or difficulty breathing) that lasted for at least 3 days and required a change in treatment that could include hospitalization.
Although the UPLIFT study did not achieve its primary endpoint of showing a slowed rate of lung function decline relative to placebo, clinical data demonstrated that the addition of tiotropium to preexisting respiratory medications sustained improved lung function during 4 years and reduced COPD exacerbations.
"With today's approval, Spiriva HandiHaler is now the first steroid-free maintenance treatment that has been shown to reduce COPD exacerbations," said Christopher Corsico, MD, vice president, drug regulatory affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We also are pleased that the product label will now include data from the landmark UPLIFT trial, which provides important information for physicians to consider when making treatment decisions."
Tiotropium previously was approved for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.