本帖最後由 lsc0019 於 2009-8-22 02:04 編輯
作者：Yael Waknine
出處：WebMD醫學新聞
August 4, 2009 — 美國食品藥物管理局(FDA)核准treprostinil吸入溶液 (Tyvaso，United Therapeutics Corp公司)用於增加紐約心臟協會第3類(New York Heart Association class 3)症狀之病患、以及世界衛生組織第1類肺動脈高血壓(pulmonary arterial hypertension，PAH)病患之行走距離。
此產品每天給藥4次，含有和核准用於治療PAH之treprostinil sodium注射劑(Remodulin，United Therapeutics公司)一樣的活性成分。
核准treprostinil吸入溶液是根據「TReprostinil Sodium Inhalation Used in the Management of PAH (TRIUMPH-1)」試驗之資料，顯示該產品獲得顯著優於安慰劑的運動能力助益，6分鐘行走距離獲得20公尺的改善(P< .0005)。研究中最常報告(發生率≧10%)的副作用包括咳嗽、頭痛、噁心、頭昏眼花、熱潮紅、喉嚨發炎、咽喉痛與腹瀉。
Treprostinil吸入溶液未曾於有明顯潛在肺病(例如氣喘或慢性阻塞性肺病)的病患進行研究，那些有急性肺部感染者應慎用。
此外，以treprostinil治療可能會增加體動脈壓低(low systemic arterial pressure)之病患、使用利尿劑、抗高血壓藥物或其他血管擴張治療患者之低血壓風險。
根據新聞稿，該公司將進行上市後研究，以促進該產品之吸入系統的可用性，且確認改版之裝置可以有預期的劑量。另外，將有研究評估對於使用Treprostinil吸入溶液之病患咽喉的長期風險以及肺毒性。
FDA Approves Treprostinil Inhalation Solution for Improving Exercise Ability in Patients With PAH
By Yael Waknine
Medscape Medical News
August 4, 2009 — The US Food and Drug Administration (FDA) has approved treprostinil inhalation solution (Tyvaso, United Therapeutics Corp) for increasing walk distance in patients with New York Heart Association class 3 symptoms associated with World Health Organization group 1 pulmonary arterial hypertension (PAH).
The product, which is administered 4 times daily, contains the same active ingredient as treprostinil sodium injection (Remodulin, United Therapeutics), which is also approved for the treatment of PAH.
Approval of treprostinil inhalation solution was based on data from the TReprostinil Sodium Inhalation Used in the Management of PAH (TRIUMPH-1) trial, showing that the product yielded significant benefits in exercise ability relative to placebo, as demonstrated by a 20-m improvement in 6-minute walk distance (P < .0005). Adverse events most commonly reported in the study (incidence ? 10%) included cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain, and diarrhea.
Treprostinil inhalation solution has not been studied in patients with significant underlying lung disease (eg, asthma or chronic obstructive pulmonary disease) and should be used with caution in those with acute pulmonary infections.
Also, treatment with treprostinil may increase the risk for hypotension in patients with low systemic arterial pressure and those receiving diuretics, antihypertensives, or other vasodilator therapies.
According to a news release, the company will be conducting postmarketing studies to enhance usability of the product's inhalation system and verify expected dosing with the modified device. An additional study will evaluate the long-term risk for oropharyngeal and pulmonary toxicities in patients using treprostinil inhalation solution. |
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