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【medical-news】4名因Byetta治疗死亡病例
Company Reports Four Additional Deaths with Byetta
公司报告，增加4名因Byetta治疗死亡病例
BOSTON (Reuters) - Amylin Pharmaceuticals Inc said there have been four deaths among patients with pancreatitis who took its diabetes drug, Byetta, in addition to two deaths reported last week by U.S. regulators.
波斯顿路透新闻Amylin Pharmaceuticals Inc亚莫林药业集团称 ，除上星期美国整顿办报道的因使用Byetta死亡的两个病例外，又有四例胰腺炎患者因用该药死亡。
The company said the four cases had not been captured in the report last week by the Food and Drug Administration, which said it had received six reports of patients who developed hemorrhagic or necrotizing pancreatitis that required hospitalization. Two of those patients died.
公司称，上星期， 食品药品管理局未报道这4名患者，该局报道的是需要住院治疗6个患者，发生出血性坏死性胰腺，两例死亡。，
Amylin shares, after closing 2 percent lower at $27.24 on Nasdaq, fell 13 percent in extended trading after the four additional deaths were announced, but they later pared those losses to about 8 percent down.
4例死亡患者经报道后，亚莫林Amylin的股票，Nasdaq收盘时降低两个百分点27.24美元，成交额回落13%，随后他们又减少到8%
The additional four cases did not involve patients with the necrotizing form of the disease, which affects 15 percent to 20 percent of patients with inflammation of the pancreas, said Amylin, which makes Byetta with partner Eli Lilly & Co.
Byett制造商，礼来公司的合作伙伴，亚莫林Amylin称，后加的4个病例未见出血，有15 %到 20%胰腺炎患者发生出血，
Orville Kolterman, Amylin's senior vice president of research and development, said in an interview the four deaths were not considered related to the pancreatitis.
亚莫林Amylin公司研发部主任Orville Kolterman 在一次接受采访时说，他认为这4个死亡病例与胰腺炎无关。
"It appears the FDA focused on necrotizing and hemorrhagic pancreatitis, whereas these other four cases only had pancreatitis in their history," Kolterman Orville Kolterman说“看来，食品药品管理局，着重在出血性坏死性胰腺炎，而这4例只有胰腺炎的病史“
In the necrotizing form of pancreatitis, enzymes digest the pancreas, which can lead to a hemorrhage.
坏死性胰腺炎，酶消化胰腺，导致出血。
Even so, he said the company was reporting them "in the interests of transparency."
他说，即使如此，公司正在“以明确的关注态度“进行报道。
Canaccord Adams analyst Adam Cutler said the company was trying to make a case for why pancreatitis is unlikely to be caused by Byetta, "yet the FDA is concerned."
Canaccord Adams analyst Adam Cutler提出，公司曾设法研究，Byetta为甚么不可能引起胰腺炎，“食品药品管理局也很关心此事“
Byetta, known chemically as exenatide, was launched in mid-2005. Amylin and Lilly hope to file for U.S. approval of a longer-acting version of the drug that needs to be taken just once a week by mid-2009.
Byetta，被认为是exenatide的一种化学药品，2005年中期投放。亚莫林和礼来公司期待美国批准，作为一种，每周用一次的长效药品，2009年使用。
Given the FDA's concerns, Cutler said: "I'm wondering whether they will have to do longer, larger, safety trials" of the version that is designed to stay in the body for a full week. Such a decision could significantly delay the drug reaching the market.
Cutler称，出于食品药品管理局的关心“我认为公司是否要对该药品进行更长，更大，更安全的试验“设计的原意，是该药品要在体内保持作用达一个星期之久。这一决定显著延缓了药品上市的时间。
The prescribing information for Byetta was updated to include the risk of pancreatitis last October. The FDA cited 30 reports of pancreatitis in Byetta patients and said the drug was suspected in some cases. Amylin alerted doctors.
亚莫林公司提醒医生，去年10月校正了Byetta处方资料，包括胰腺炎的危险。食品药品管理局引用了30例胰腺炎患者用过Byetta治疗，提出有些病例怀疑是药物引起。
One of the four deaths reported on Tuesday was known at that time, Kolterman said.
Kolterman说已经知道，4例死亡病例中有1例是周二报道的
Amylin CEO Daniel Bradbury told analysts on a conference call that the company has since received positive feedback from doctors.
亚莫林公司首席执行官Daniel Bradbury在一个会议上告诉分析家们，号召公司今后要接受医生的确实的反馈意见
"Once physicians understand the context of the data they are comfortable continuing to prescribe Byetta," he said. "We haven't seen a major impact on Byetta prescribing."
他说“一旦医声了解这些资料，他们也可以安安心心地使用Byetta“‘我们还没有见到一份有重要影响的Byetta处方”
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作者:admin@医学,生命科学 2010-11-19 05:11
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