FDA批准Linzess治疗腹泻型肠易激综合征和慢性特发性便秘

圣路易斯(MD Consult)——2012年8月30 ，Ironwood 制药公司和美国食品药品管理局(FDA)宣布批准Linzess(利那洛肽)用于治疗成人便秘型肠易激综合征(IBS-C)或慢性特发性便秘(CIC)。Linzess活性成分利那洛肽属于新型鸟苷酸环化酶C激动剂，在肠道发挥局部作用，全身暴露程度最小。

Linzess治疗IBS-C的安全性和有效性得到了2项双盲研究的证实。共计1,604例患者随机接受至少12周的290 μg Linzess或安慰剂治疗，结果显示，Linzess在减少腹部疼痛和增加完全自主性排便次数方面优于安慰剂。

Linzess治疗CIC的安全性和有效性也是通过2项双盲研究得到证实。共计1,272例患者随机接受12周的145 μg 、 290 μg Linzess或安慰剂治疗，研究结果显示，Linzess组患者完全自主性排便次数多于安慰剂组。290 μg剂量的Linzess未获批准，因为研究显示该剂量组效果并不优于145 μg剂量组。

在各项研究中，Linzess治疗1周内达到最大疗效，并且改善效果贯穿于整个治疗期。

应用Linzess 290 μg还可显著减少腹部疼痛。该作用在治疗1周内显现，并持续整个治疗期。

两项研究中最常见的不良反应为腹泻、腹痛、胃肠胀气和腹胀。

Linzess的获准附带一项黑框警告，提醒患者和医务工作者该药不能用于年龄≤17岁的患者。

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ST LOUIS (MD Consult) - On August 30, 2012, Ironwood Pharmaceuticals and the US Food and Drug Administration announced the approval of Linzess (linaclotide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide, the active ingredient in Linzess, is a first-in-class guanylate cyclase-C agonist and acts locally in the intestine with minimal systemic exposure.

The safety and effectiveness of Linzess for the management of IBS-C were established in 2 double-blind studies. A total of 1604 patients were randomly assigned to receive 290 μg of Linzess or placebo for at least 12 weeks. Results showed Linzess was more effective in reducing the amount of abdominal pain and increasing the number of complete spontaneous bowel movements compared with placebo.

The safety and effectiveness of Linzess for the management of CIC were established in 2 double-blind studies. A total of 1272 patients were randomly assigned to receive Linzess at doses of 145 μg or 290 μg or placebo for 12 weeks. Results from these studies showed that patients who received Linzess experienced more complete spontaneous bowel movements than patients who received placebo. The 290 μg dose is not approved for chronic constipation because studies indicated it was no more effective than the 145 μg dose.

In each trial, the drug reached maximum effectiveness within the first week of treatment, and improvements were maintained throughout the treatment period.

The use of Linzess 290 μg was also shown to significantly reduce abdominal pain. These effects were seen within the first week of treatment and improvements were maintained throughout the treatment period.

The most common adverse reactions in both studies were diarrhea, abdominal pain, flatulence, and abdominal distension.

Linzess is approved with a Boxed Warning to alert patients and health care professionals that the drug should not be used in patients aged 17 years or younger.