{"id":3467,"date":"2018-06-25T01:00:00","date_gmt":"2018-07-27T06:45:08","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e7%be%8e%e5%9b%bdfda%e8%a2%ab%e8%a6%81%e6%b1%82%e6%8a%8a%e9%9d%9e%e5%b8%83%e5%8f%b8%e4%bb%96%ef%bc%88uloric%ef%bc%89%e4%bb%8e%e7%be%8e%e5%9b%bd%e6%92%a4%e5%b8%82\/"},"modified":"2018-07-27T14:45:09","modified_gmt":"2018-07-27T06:45:09","slug":"%e7%be%8e%e5%9b%bdfda%e8%a2%ab%e8%a6%81%e6%b1%82%e6%8a%8a%e9%9d%9e%e5%b8%83%e5%8f%b8%e4%bb%96%ef%bc%88uloric%ef%bc%89%e4%bb%8e%e7%be%8e%e5%9b%bd%e6%92%a4%e5%b8%82","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/3467\/","title":{"rendered":"\u7f8e\u56fdFDA\u88ab\u8981\u6c42\u628a\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u4ece\u7f8e\u56fd\u64a4\u5e02"},"content":{"rendered":"
\n
<\/section>\n

\"\u7f8e\u56fdFDA\u88ab\u8981\u6c42\u628a\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u4ece\u7f8e\u56fd\u64a4\u5e02\"<\/p>\n


<\/p>\n

FiercePharma 2018-6-21\u6587\u7ae0\uff08\u5168\u6587\u7ffb\u8bd1\uff09<\/h1>\n

\u7ffb\u8bd1\uff1a\u5f20\u664b\u6770 <\/span>
<\/p>\n


<\/span><\/p>\n

When Takeda\u2019s gout drug Uloric (febuxostat) was approved by the FDA, it was with a requirement for postmarketing studies to further assess its safety. Now a nonprofit consumer advocacy group says the FDA should remove the drug from the U.S. market after findings released this March show significant deadly heart risks.<\/p>\n


<\/p>\n

\u5f53\u65e5\u672c\u6b66\u7530\u516c\u53f8\u7684\u6cbb\u7597\u75db\u98ce\u836f\u7269\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u88abFDA\u6279\u51c6\u4e0a\u5e02\u65f6\uff0c\u88ab\u8981\u6c42\u8fdb\u884c\u4e0a\u5e02\u540e\u7814\u7a76\u4ee5\u8fdb\u4e00\u6b65\u8bc4\u4f30\u5176\u5b89\u5168\u6027\u3002\u73b0\u5728\uff0c\u4e00\u4e2a\u975e\u8425\u5229\u6027\u6d88\u8d39\u8005\u6e38\u8bf4\u7ec4\u7ec7\u8868\u793a\uff0c\u9274\u4e8e\u4eca\u5e743\u6708\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u53d1\u5e03\u7814\u7a76\u62a5\u544a\u663e\u793a\u975e\u5e03\u53f8\u4ed6\u5177\u6709\u660e\u663e\u7684\u81f4\u6b7b\u6027\u5fc3\u810f\u98ce\u9669\u540e\uff0cFDA\u5e94\u8be5\u628a\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u4ece\u7f8e\u56fd\u64a4\u5e02\u3002<\/p>\n


<\/p>\n

In a petition (PDF) sent to the FDA on Thursday, Public Citizen stated there is \u201coverwhelming evidence that the serious cardiovascular harms of [Uloric] outweigh any purported clinical benefit,\u201d and that leaving it on the market would only cause \u201cfurther preventable harm\u201d to patients.<\/p>\n


<\/p>\n

\u5728\u8be5\u7ec4\u7ec7\u5411FDA\u53d1\u51fa\u7684\u516c\u6c11\u8bf7\u613f\u4e66\u4e2d\u6307\u51fa\uff0c\u5927\u91cf\u7684\u8bc1\u636e\u8868\u660e\u975e\u5e03\u53f8\u4ed6\uff08Uloric)\u7684\u4e25\u91cd\u5fc3\u8840\u7ba1\u635f\u5bb3\u5df2\u7ecf\u8d85\u8fc7\u4e86\u5df2\u6709\u7684\u4e34\u5e8a\u83b7\u76ca\uff0c\u800c\u5c06\u8be5\u836f\u7559\u5728\u5e02\u573a\u53ea\u4f1a\u5bfc\u81f4\u60a3\u8005\u4ea7\u751f\u66f4\u591a\u672c\u6765\u53ef\u9884\u9632\u7684\u4f24\u5bb3\uff01
<\/p>\n


<\/p>\n

The Japanese pharma submitted results from a postmarketing cardiovascular safety study previously required by the FDA in January, and it is \u201cworking with the agency to conduct a comprehensive review of this data,\u201d a Takeda spokeswoman told FiercePharma.<\/p>\n


<\/p>\n

\u65e5\u672c\u5236\u836f\u516c\u53f81\u6708\u4efd\u6309\u7167FDA\u8981\u6c42\u63d0\u4ea4\u4e86\u975e\u5e03\u53f8\u4ed6\u4e0a\u5e02\u540e\u5fc3\u8840\u7ba1\u5b89\u5168\u7814\u7a76\u7684\u7ed3\u679c\uff0c\u8be5\u516c\u53f8\u6b63\u5728\u201c\u4e0eFDA\u5408\u4f5c\u5bf9\u8be5\u6570\u636e\u8fdb\u884c\u5168\u9762\u5ba1\u67e5\u201d\uff0c\u6b66\u7530\u5236\u836f\u53d1\u8a00\u4eba\u544a\u8bc9FiercePharma\u3002<\/p>\n


<\/p>\n

A spokesman for the FDA told FiercePharma the agency will review Public Citizen\u2019s letter and will respond directly to the organization.<\/p>\n


<\/p>\n

FDA\u53d1\u8a00\u4eba\u544a\u8bc9FiercePharma\uff0cFDA\u5c06\u5ba1\u67e5\u516c\u6c11\u516c\u6c11\u4fe1\u51fd\uff0c\u5e76\u5c06\u76f4\u63a5\u56de\u590d\u6b66\u7530\u516c\u53f8\u3002<\/p>\n


<\/p>\n

The 2009 approval allowed Uloric to be used as a treatment of hyperuricemia\u2014instead of for the direct reduction in gout flares\u2014in gout patients. But it followed two failed attempts in 2005 and 2006 under TAP Pharmaceutical.<\/p>\n


<\/p>\n

\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u4e8e2009\u5e74\u88abFDA\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u75db\u98ce\u60a3\u8005\u7684\u9ad8\u5c3f\u9178\u8840\u75c7\uff0c\u800c\u4e0d\u662f\u76f4\u63a5\u51cf\u5c11\u75db\u98ce\u53d1\u4f5c\u3002\u4f46\u662f\u4e4b\u524d\u6b66\u7530\u5236\u836f\u516c\u53f8\u4e8e2005\u548c2006\u5e74\u4e24\u6b21\u5c1d\u8bd5\u5747\u544a\u5931\u8d25\u3002<\/p>\n


<\/p>\n

The FDA had rejected the medication out of concerns for increased cardiovascular risks observed in clinical trials. At the time of the second NDA submission, FDA reviewers noted 9 of the total 12 deaths among subjects on Uloric were attributable to CV causes, whereas no serious adverse CV events were linked to comparator allopurinol or placebo.<\/p>\n


<\/p>\n

\u7531\u4e8e\u62c5\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230\u7684\u5fc3\u8840\u7ba1\u98ce\u9669\u589e\u52a0\uff0cFDA\u62d2\u7edd\u4e86\u975e\u5e03\u53f8\u4ed6\u7684\u4e0a\u5e02\u3002\u5728\u7b2c\u4e8c\u6b21NDA\u63d0\u4ea4\u65f6\uff0cFDA\u5ba1\u67e5\u5458\u6ce8\u610f\u5230\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u6cbb\u7597\u65f612\u540d\u53d7\u8bd5\u8005\u4e2d\u67099\u4eba\u6b7b\u4e8e\u5fc3\u8840\u7ba1\u539f\u56e0\uff0c\u800c\u53d1\u73b0\u6ca1\u6709\u4e25\u91cd\u7684\u5fc3\u8840\u7ba1\u4e0d\u826f\u4e8b\u4ef6\u4e0e\u5bf9\u7167\u836f\u522b\u560c\u5464\u9187\u6216\u5b89\u6170\u5242\u6709\u5173\u3002<\/p>\n


<\/p>\n

In response to the FDA\u2019s concern, Takeda conducted another trial that ultimately didn\u2019t find the same CV safety signal. But after putting data from all three phase 3 studies and two long-term extension studies together, the FDA reviewers couldn\u2019t determine \u201cwith much confidence\u201d whether Uloric poses greater risk. So, when they did approve the drug, they slapped a warning on the drug\u2019s label and asked Takeda to run a large, postmakreting study to further examine Uloric\u2019s CV safety profile.<\/p>\n


<\/p>\n

\u4e3a\u4e86\u56de\u5e94FDA\u7684\u62c5\u5fe7\uff0c\u6b66\u7530\u8fdb\u884c\u4e86\u53e6\u4e00\u9879\u8bd5\u9a8c\u5e76\u6700\u7ec8\u6ca1\u6709\u627e\u5230\u76f8\u540c\u7684\u5fc3\u8840\u7ba1\u5b89\u5168\u6027\u8bc1\u636e\u3002\u4f46\u662f\uff0c\u5c06\u6240\u6709\u4e09\u9879\u4e09\u671f\u7814\u7a76\u548c\u4e24\u9879\u957f\u671f\u6027\u5ef6\u671f\u7814\u7a76\u7684\u6570\u636e\u653e\u5728\u4e00\u8d77\u5206\u6790\u540e\uff0cFDA\u5ba1\u67e5\u4eba\u5458\u65e0\u6cd5\u786e\u5b9a\u6027\u5f97\u51fa\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u662f\u5426\u4f1a\u5e26\u6765\u66f4\u5927\u7684\u98ce\u9669\u3002\u6240\u4ee5\uff0c\u5f53FDA\u6279\u51c6\u8be5\u836f\u7269\u4e0a\u5e02\u65f6\uff0c\u8981\u6c42\u5728\u836f\u7269\u7684\u6807\u7b7e\u4e0a\u6253\u4e86\u4e00\u4e2a\u8b66\u544a\uff0c\u5e76\u8981\u6c42\u6b66\u7530\u516c\u53f8\u505a\u4e00\u9879\u5927\u578b\u7684\u4e0a\u5e02\u540e\u7814\u7a76\uff0c\u4ee5\u8fdb\u4e00\u6b65\u68c0\u6d4b\u975e\u5e03\u53f8\u4ed6\uff08Uloric\uff09\u7684\u5fc3\u8840\u7ba1\u5b89\u5168\u6027\u3002<\/p>\n


<\/p>\n

Concerns flared up on Nov. 15, 2017, when the FDA issued a drug safety communication alerting the public of increased cardiovascular events with Uloric, compared to allopurinol. The agency at that time said it will \u201cconduct a comprehensive review and will update the public with any new information,\u201d once it has the full final result<\/p>\n


<\/p>\n

2017\u5e7411\u670815\u65e5\uff0cFDA\u53d1\u5e03\u4e86\u4e00\u9879\u836f\u7269\u5b89\u5168\u6027\u901a\u8baf\uff0c\u63d0\u9192\u516c\u4f17\u6ce8\u610f\u975e\u5e03\u53f8\u4ed6\u589e\u52a0\u5fc3\u8840\u7ba1\u4e8b\u4ef6\uff08\u4e0e\u522b\u560c\u9187\u6bd4\u8f83\uff09\u3002\u5f53\u65f6FDA\u8868\u793a\u5c06\u201c\u8fdb\u4e00\u6b65\u8fdb\u884c\u5168\u9762\u5ba1\u67e5\uff0c\u4e00\u65e6\u6709\u4efb\u4f55\u65b0\u4fe1\u606f\u5c06\u53ca\u65f6\u516c\u5e03\u4e8e\u4f17\u201d\u3002<\/p>\n


<\/p>\n

Findings from the 6,190-subject study were then published this March in The New England Journal of Medicine. In that study, researchers noted that after 32 months, overall adverse CV events were similar in both arms, but \u201c[a]ll-cause mortality and cardiovascular mortality were higher with [Uloric] than with allopurinol.\u201d<\/p>\n


<\/p>\n

\u4eca\u5e743\u6708\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u53d1\u8868\u8be5\u98796,190\u4f8b\u75db\u98ce\u60a3\u8005\u7684\u7814\u7a76\u7ed3\u679c\u3002\u6307\u51fa\u5728\u8be5\u7814\u7a76\u4e2d\uff0c\u7814\u7a76\u4eba\u5458\u53d1\u73b0\u5e73\u5747\u6cbb\u759732\u4e2a\u6708\u540e\uff0c\u975e\u5e03\u53f8\u4ed6\u548c\u522b\u560c\u9187\u6cbb\u7597\u7ec4\u603b\u4f53\u7684\u4e0d\u826f\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u76f8\u4f3c\uff0c\u4f46\u662f\u975e\u5e03\u53f8\u4ed6\u7ec4\u7684\u5168\u56e0\u6b7b\u4ea1\u7387\u548c\u5fc3\u8840\u7ba1\u6b7b\u4ea1\u7387\u9ad8\u4e8e\u522b\u560c\u5464\u9187\u7ec4\uff08\u6ce8\uff1a\u975e\u5e03\u53f8\u4ed6\u7ec4\u60a3\u8005\u5fc3\u8840\u7ba1\u6b7b\u4ea1\u98ce\u9669\u589e\u52a034%\uff08HR 1.34\uff0c95% CI\uff0c1.03-1.73\uff09\uff0c\u5168\u56e0\u6b7b\u4ea1\u7387\u589e\u52a022%\uff08HR 1.22\uff0c95% CI\uff0c1.01-1.47\uff09\u3002\u5176\u4e2d\uff0c\u5fc3\u810f\u6027\u731d\u6b7b\u6700\u5e38\u89c1-\u975e\u5e03\u53f8\u4ed6\u7ec483\u4f8b\uff082.7%\uff09\uff0c\u522b\u560c\u9187\u7ec456\u4f8b\uff081.8%\uff09\uff09\u3002<\/p>\n


<\/p>\n

Following the release of the study, Takeda said in a statement that the reason for the imbalance in cardiovascular deaths has not been identified.<\/p>\n


<\/p>\n

\u5728\u4e0a\u8ff0\u7814\u7a76\u53d1\u5e03\u540e\uff0c\u6b66\u7530\u516c\u53f8\u5728\u4e00\u4efd\u58f0\u660e\u4e2d\u8868\u793a\uff0c\u8be5\u7814\u7a76\u4e2d\u5fc3\u8840\u7ba1\u6b7b\u4ea1\u5931\u8861\u7684\u539f\u56e0\u5c1a\u672a\u786e\u5b9a\u3002<\/p>\n


<\/p>\n

\u201cThe agency should have demanded that an appropriately designed clinical trial to assess febuxostat\u2019s cardiovascular risks be conducted before, not after approval,\u201d said Michael Carome, M.D., director of Public Citizen\u2019s Health Research Group, in a statement. \u201cThe FDA almost certainly would have denied approval of febuxostat if data from this post-market trial had been available at the time of the initial submission.\u201d<\/p>\n


<\/p>\n

\u516c\u5171\u516c\u6c11\u5065\u5eb7\u7814\u7a76\u673a\u6784\u8d1f\u8d23\u4eba\u533b\u5b66\u535a\u58ebMichael Carome\u6307\u51fa\uff0cFDA\u5e94\u8be5\u8981\u6c42\u5728\u6279\u51c6\u975e\u5e03\u53f8\u4ed6\u4e0a\u5e02\u524d\u800c\u4e0d\u662f\u4e0a\u5e02\u540e\u8bbe\u8ba1\u9002\u5f53\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4ee5\u8bc4\u4f30\u975e\u5e03\u53f8\u4ed6\u7684\u5fc3\u8840\u7ba1\u98ce\u9669\u3002\u5728\u8be5\u673a\u6784\u4e00\u9879\u7533\u660e\u4e2d\u63d0\u51fa\uff0c\u5982\u679c\u8fd9\u4e2a\u4e0a\u5e02\u540e\u4e34\u5e8a\u7814\u7a76\u6570\u636e\u5728\u6700\u521d\u63d0\u4ea4\u76f8\u5173\u8d44\u6599\u65f6\u5c31\u63d0\u4f9b\uff0c\u51e0\u4e4e\u53ef\u4ee5\u80af\u5b9aFDA\u4f1a\u62d2\u7edd\u6279\u51c6\u975e\u5e03\u53f8\u4ed6\u4e0a\u5e02!<\/p>\n


<\/p>\n

Besides higher risks of cardiovascular risks, the organization also argued there\u2019s not enough data showing Uloric is more effective in the actual prevention of gout flares, other than that it\u2019s able to lower serum uric acid levels, which can cause acute painful gout episodes.<\/p>\n


<\/p>\n

\u9664\u4e86\u975e\u5e03\u53f8\u4ed6\u4f1a\u589e\u52a0\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u98ce\u9669\uff0cFDA\u540c\u65f6\u6307\u51fa\u975e\u5e03\u53f8\u4ed6\u6ca1\u6709\u8db3\u591f\u7684\u8bc1\u636e\u663e\u793a\u5bf9\u4e8e\u75db\u98ce\u53d1\u4f5c\u7684\u9884\u9632\u4f5c\u7528\u6bd4\u522b\u560c\u9187\u66f4\u6709\u6548\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u975e\u5e03\u53f8\u4ed6\u8fd8\u53ef\u4ee5\u5728\u964d\u5c3f\u9178\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u8bf1\u53d1\u6025\u6027\u75db\u98ce\u53d1\u4f5c\u3002<\/p>\n


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\u8f6c\u81eaHUA\u533b\u835f\u8403<\/span><\/p>\n


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\u5f80\u671f\u7cbe\u5f69<\/span><\/strong><\/p>\n

\u4e00\u81f4\u6027\u8bc4\u4ef7\u76843\u5bb6\u4e0e3\u5e74<\/a><\/span><\/p>\n

\u6c47\u805a\u5357\u836f\u7275\u7ebf\u642d\u6865  \u6821\u4f01\u643a\u624b\u5171\u540c\u63a2\u7d22\u4eba\u624d\u57f9\u517b\u65b0\u6a21\u5f0f\u4e00\u4e00\u9996\u5c4aCRA\u4eba\u624d\u57f9\u8bad\u73ed\u7eaa\u5b9e<\/a><\/p>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u6c47\u805a\u5357\u836f <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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