CQCQ001 2010-5-20 12:28
FDA核准Naproxen/Esomeprazole複方錠用於關節炎
作者：Yael Waknine
出處：WebMD醫學新聞
May 5, 2010 — 美國食品藥物管理局(FDA)核准一種含固定劑量的延長釋放腸衣naproxen與立即釋放的esomeprazole magnesium複方藥物(商品名Vimovo；AstraZeneca及Pozen公司)。
非類固醇抗發炎藥物(NSAID)/質子幫浦抑制劑結合可以緩解骨關節炎、類風濕性關節炎與僵直性脊椎炎的徵兆和症狀，且可減少某些病患的NSAID相關胃潰瘍風險。
骨關節炎影響約2700萬名美國人，一般使用NSAIDs如naproxen治療，根據藥廠的新聞稿，多達50%的長期NSAID使用者有胃腸道潰瘍風險。
AstraZeneca藥廠醫療辦公室主任Howard Hutchinson醫師在藥廠的新聞稿中表示，單一個Vimovo藥丸就可以提供止痛效果，且含有質子幫浦抑制劑可對有NSAID相關胃潰瘍風險的關節炎病患有幫助。
FDA之核准是根據PN400-301和PN400-302這兩篇研究的資料，研究顯示，相較於每天兩次500 mg腸衣型naproxen，每天使用兩次naproxen/esomeprazole緩釋錠，則內視鏡檢查發現胃潰瘍的比率可以降低(分別是4.1% vs 23.1%以及7.1% vs 24.3%；兩篇研究的P值均 < .001)。
使用naproxen/esomeprazole最常見(>5%)的副作用包括糜爛性胃炎、消化不良、胃炎、腹瀉、胃潰瘍、上腹痛以及噁心。
Naproxen/esomeprazole治療應避免用於冠狀動脈繞道手術的手術時期疼痛，其他使用禁忌包括已知對這些成分或benzimidazoles過敏的病患；氣喘、蕁麻疹或對阿斯匹靈或其他NSAIDs有過敏型反應者；嚴重肝功能不佳的病患；懷孕後期婦女等。
液體滯留、心衰竭、高血壓、腎臟或肝功能、心血管疾病和年長者要謹慎使用。
歐盟醫藥協會正在評估Naproxen/esomeprazole緩釋錠劑。
FDA Approves Naproxen/Esomeprazole Combo for Arthritis
By Yael Waknine
Medscape Medical News
May 5, 2010 — The US Food and Drug Administration (FDA) has approved a fixed-dose tablet combination of delayed-release enteric-coated naproxen and immediate-release esomeprazole magnesium (Vimovo; AstraZeneca and Pozen, Inc).
The nonsteroidal anti-inflammatory drug (NSAID)/proton pump inhibitor combo is indicated to relieve signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis while decreasing the risk for NSAID-related gastric ulcers in susceptible patients.
Osteoarthritis, which affects approximately 27 million Americans, is commonly treated with NSAIDs such as naproxen. According to a company news release, as many as 50% of chronic NSAID users are at risk for gastrointestinal ulcers.
"In a single pill, Vimovo provides a proven pain reliever with a built-in [proton pump inhibitor] for arthritis patients at risk for NSAID-associated gastric ulcers," said Howard Hutchinson, MD, chief medical officer, AstraZeneca, in a company news release.
FDA approval was based on data from the pivotal PN400-301 and PN400-302 six-month studies, showing that twice-daily use of naproxen/esomeprazole delayed-release tablets yielded a decreased rate of endoscopic gastric ulcers compared with 500 mg enteric-coated naproxen given twice daily (4.1% vs 23.1% and 7.1% vs 24.3%, respectively; P < .001 for both studies).
Adverse events most commonly (>5%) reported with use of naproxen/esomeprazole included erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea.
Naproxen/esomeprazole therapy should not be used to treat perioperative pain in the setting of coronary artery bypass graft surgery. Use is likewise contraindicated in patients with known hypersensitivity to either component or substituted benzimidazoles; those with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs; patients with severe hepatic insufficiency; and women in the late stages of pregnancy.
Caution is advised when treating patients with fluid retention, heart failure, hypertension, renal or hepatic insufficiency, cardiovascular disease, and the elderly.
Naproxen/esomeprazole delayed-release tablets are currently under review by the European Medicines Association.