ST LOUIS (MD Consult) - On November 11, 2010, EMD Serono and Theratechnologies announced that the US Food and Drug Administration has approved Egrifta (tesamorelin), a once-daily injectable medication for the reduction of excess abdominal fat (abdominal lipohypertrophy) in patients infected with human immunodeficiency virus (HIV). Abdominal lipodystrophy is a condition that has been associated with the use of many antiretroviral drugs used to treat HIV. Egrifta acts by inducing the release of endogenous growth hormone (GH).

The safety and efficacy of Egrifta were evaluated in 2 clinical trials involving 816 adult men and women infected with HIV with lipodystrophy and excess abdominal fat. Of these patients, 543 received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat (as measured using computed tomography [CT]) compared with patients receiving placebo. Some patients reported improvements in their self image.

The most commonly reported adverse effects associated with the use of Egrifta in clinical studies included arthralgia, erythema and pruritis at the injection site, abdominal pain, swelling, and myalgia. Worsening blood-glucose control occurred more often in patients treated with Egrifta than with placebo.

The use of Egrifta is contraindicated in women who are pregnant, in patients with disruption of the hypothalamic-pituitary axis as a result of hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma, as well as patients with known hypersensitivity to tesamorelin and/or mannitol, and in patients with active malignancies (either newly diagnosed or recurrent).

Treatment with Egrifta stimulates GH production and increases serum insulin-like growth factor I (IGF-I). Levels of IGF-I should be monitored closely during Egrifta therapy. Careful consideration should be given to discontinuing Egrifta in patients with persistent elevations of IGF-I levels, particularly if the efficacy response is not robust (eg, determined on the basis of visceral adipose tissue changes measured by waist circumference or by using CT).

Glucose status should be carefully evaluated before initiating Egrifta treatment. In addition, all patients treated with Egrifta should be monitored periodically for changes in glucose metabolism. Careful consideration should be given to discontinuing Egrifta in patients who experience impaired glucose tolerance and who do not demonstrate a clear efficacy response.

Increased mortality in patients with acute critical illness as a result of complications after open heart surgery, abdominal surgery, or multiple accidental trauma, or in patients with acute respiratory failure has been reported after treatment with pharmacologic amounts of growth hormone. The use of Egrifta in critically ill patients has not been studied.

圣路易斯(MD Consult)——2010年11月11日，EMD Serono公司和Theratechnologies公司宣布，美国食品药品管理局已经批准Egrifta (替莫瑞林)、一天一次注射药用于减少人类免疫缺陷病毒(HIV)感染者腹部过多的脂肪(腹部脂肪过量)。腹部脂肪代谢障碍是一种与使用治疗HIV感染的多种抗病毒药物有关的疾病。Egrifta通过诱导内源性生长激素(GH)的释放来发挥作用。

有2项临床试验评估了Egrifta的安全性与疗效，研究对象为816例伴有脂肪代谢障碍和腹部脂肪过量的成人HIV感染者(男女均有)。在这些患者中，有543例患者在历时26周、以安慰剂作对照的试验期内接受了Egrifta治疗。这两项研究均表明，与安慰剂对照组相比，Egrifta治疗组患者的腹部脂肪减少量(采用CT测量)较大。某些患者报告称自我形象得到了改善。

 

在临床研究中，与使用Egrifta有关的最常见的不良反应包括关节痛、注射部位出现红斑和瘙痒、腹痛、水肿以及肌痛。与安慰剂组相比，血糖控制不佳在Egrifta治疗组的患者中更常见。
Egrifta禁用于孕妇、因垂体切除术、垂体机能减退、垂体瘤/垂体手术、头部辐射或头部创伤而引起下丘脑垂体轴破坏的患者及已知对替莫瑞林和(或)甘露醇过敏的患者以及恶性肿瘤活动期患者(新发或复发)。

采用Egrifta治疗可刺激GH分泌和增加血清胰岛素样生长因子I(IGF-I)的水平。在Egrifta治疗期间应密切监测IGF-I的水平。对于IGF-I水平持续升高的患者，应慎重考虑是否停用Egrifta，尤其是在疗效反应不强的情况下(如根据腰围或采用CT测量的内脏脂肪组织的变化来确定)。

在开始使用Egrifta治疗前应仔细评估患者的血糖状况。此外，应对所有接受Egrifta治疗的患者定期监测糖代谢的变化。对于糖耐量减低的患者以及未显示有明确疗效反应的患者，应慎重考虑是否停用Egrifta。

有报告称，由开放性心脏手术、腹部手术或多个意外创伤后的并发症所致的急性危重疾病患者或急性呼吸衰竭患者在采用生长激素治疗后的死亡率增加。目前尚未对病危患者进行Egrifta的研究。