FDA核准Duloxetine用於廣泛性焦慮症的維持治療

作者：Yael Waknine  
出處：WebMD醫學新聞

　　November 30, 2009 — 美國食品藥物管理局(FDA)核准duloxetine HCl(商品名Cymbalta緩釋膠囊，Eli Lilly製藥公司)擴增一項適應症，用於廣泛性焦慮症(generalized anxiety disorder，GAD)的維持治療。之前，僅限急性治療使用選擇性血清素-正腎上腺素再吸收抑制劑。
　　
　　廣泛性焦慮症特徵是經常且隨時有焦慮、誇大憂慮和緊張，在美國影響約700萬人。若不治療，症狀會逐漸惡化，對病患的工作能力、家庭、與社會狀態會有負面影響。
　　
　　美國Cymbalta藥物主任James M. Martinez醫師在該藥廠的新聞稿中表示，因為廣泛性焦慮症可能是慢性疾病，醫師和病患的重點在於找到對急性期和維持期都有效的治療選項。
　　
　　【藉由此次新增之核准，Cymbalta對此往往令人衰弱之狀況的維持治療提供了新選擇】
　　FDA的核准是根據429名病患使用duloxetine進行初步治療26週，劑量範圍為每天60-120mg的雙盲研究資料，結果顯示，相較於換成安慰劑組，繼續使用duloxetine 26週的病患，廣泛性焦慮症復發比率顯著下降(15%相較於46.4%)。
　　
　　研究中最常報告之治療中突現的副作用，包括噁心、頭痛、口乾、腹瀉、頭昏眼花、便秘、疲勞與排汗增加。
　　
　　Duloxetine緩釋膠囊原本獲核准用於重鬱症的急性和維持治療，以及糖尿病週邊神經疼痛和纖維肌痛的處置。


FDA Approves Duloxetine for Maintenance Treatment of Generalized Anxiety Disorder

By Yael Waknine
Medscape Medical News

November 30, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for duloxetine HCl (Cymbalta delayed-release capsules, Eli Lilly Company, Inc) for the maintenance treatment of generalized anxiety disorder (GAD). Previously, use of the selective serotonin-norepinephrine reuptake inhibitor was limited to acute therapy.

GAD is a pattern of frequent and constant anxiety, exaggerated worry, and tension that affects approximately 7 million people in the United States. Left untreated, symptoms may progressively worsen with a corresponding negative effect on the patient's ability to function well in work, family, and social situations.

"Since generalized anxiety disorder can be a chronic illness, it is important that doctors and their patients find a treatment option that is effective in both the acute and maintenance phase of treatment," said James M. Martinez, MD, US medical director for Cymbalta, in a company news release. "With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition."

The FDA's action was based on data from a double-blind study of 429 patients who had responded to 26 weeks of initial treatment with duloxetine at doses ranging from 60 to 120 mg/day. Results showed that patients who continued to receive duloxetine for 26 weeks had a significantly decreased rate of GAD relapse compared with those switched to placebo (15% vs 46.4%).

Treatment-emergent adverse events most commonly reported in the study included nausea, headache, dry mouth, diarrhea, dizziness, constipation, fatigue, and increased sweating.

Duloxetine extended-release capsules previously were approved for the acute and maintenance treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain and fibromyalgia.