圣路易斯(MD Consult)——2012年7月26日，Amarin公司宣布，美国食品药品管理局(FDA)已经批准Vascepa(icosapent ethyl)胶囊作为成人重度高甘油三酯血症(TG水平≥500 mg/dl)患者饮食疗法的辅助治疗药物，用于降低甘油三酯(TG)水平。Vascepa是一种超纯的Ω-3脂肪酸产品。

该公司通过一项随机、安慰剂对照、双盲、设平行组的研究对Vascepa的有效性和安全性进行了评估，受试者为空腹TG水平非常高(500~2000 mg/dl)的成人患者。基线时，25%的患者接受Vascepa与他汀配伍治疗，28%患有糖尿病，39%的患者TG水平>750 mg/dl。4 g剂量的Vascepa治疗组患者在接受12周治疗后甘油三酯中位水平降低了33%，与安慰剂对照组相比具有统计学意义(P<0.001)，其低密度脂蛋白胆固醇水平相对于安慰剂对照组未升高。

Vascepa治疗组患者中最常报告的不良反应为关节痛。

Vascepa对重度高甘油三脂血症患者胰腺炎风险的影响及其对重度高甘油三脂血症患者心血管死亡率和发病率的影响均尚未确定。

Vascepa的日剂量为4 g，通过口服用药。患者在接受Vascepa治疗前及治疗期间，应适当控制营养摄入量和体力活动。

Amarin预计Vascepa在2013年第一季度初上市。

ST LOUIS (MD Consult) - On July 26, 2012, Amarin announced that the US Food and Drug Administration has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG levels ≥ 500 mg/dL). Vascepa is an ultra-pure omega-3 fatty acid product.

The efficacy and safety of Vascepa were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting TG levels (between 500 mg/dL and 2000 mg/dL). At baseline, 25% of patients were receiving concomitant statin therapy, 28% had diabetes, and 39% had TG levels > 750 mg/dL. Patients treated for 12 weeks with the 4-g dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (P < .001), and did not show an increase in low density lipoprotein cholesterol levels relative to placebo.

The most commonly reported adverse reaction in Vascepa-treated patients was arthralgia.

The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Furthermore, the effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia levels has not been determined.

The daily dose of Vascepa is 4 grams administered orally. Patients should engage in appropriate nutritional intake and physical activity before receiving Vascepa, which should continue during treatment.

Amarin anticipates commercial launch of Vascepa early in the first quarter of 2013.

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