Revision as of 20:13, 25 July 2015 editJytdog (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers, Rollbackers187,951 edits Undid revision 673059581 by Petrarchan47 (talk) please back off and hold your horses. i'll be done in an hour or two← Previous edit |
Revision as of 20:16, 25 July 2015 edit undoJytdog (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers, Rollbackers187,951 edits add medical uses and side effectsNext edit → |
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'''Alirocumab''' (trade name '''Praluent''')<ref>, World Health Organization</ref> is a human ] ] inhibitor ] drug approved by the FDA in July 2015 as a second line treatment of ] for people whose cholesterol is not controlled by diet and ] treatment. It is also known as '''REGN727''' and '''SAR236553'''.<ref name=sheridan2013>{{cite pmid|24316621}}</ref> |
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'''Alirocumab''' (trade name '''Praluent''')<ref>, World Health Organization</ref> is a human ] ] inhibitor ] drug approved by the FDA in July 2015 as a second line treatment of ] for adults whose cholesterol is not controlled by diet and ] treatment. It is also known as '''REGN727''' and '''SAR236553'''.<ref name=sheridan2013>{{cite pmid|24316621}}</ref> |
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==Medical uses== |
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Alirocumab is used as a second line treatment to lower ] for people who have ] and people with ] who require additional lowering of LDL cholesterol when diet and ] treatment have not worked.<ref name=Label> Label revised, July 2015. Page accessed July 25, 2015</ref> It is administered by injection.<ref name=Label/> |
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==Side effects== |
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Side effects that occurred in more than 2% of people treated with in clinical trials and that occurred more frequently than with placebo, included nose and throat irritation, injection site reactions and bruising, flu, urinary tract infection, diarrhea, bronchitis and cough, and muscle pain, soreness, and spasms.<ref name=Label/> |
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==History== |
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==History== |
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It was discovered by ] and is being co-developed with ]. A main competitor in the race to worldwide health authority approval is ] in development by Amgen.{{cn}} |
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It was discovered by ] and is being co-developed with ]. A main competitor in the race to worldwide health authority approval is ] in development by Amgen.{{cn}} |
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In July 2015, the FDA approved alirocumab to lower ] for people who have ] and people with ] who require additional lowering of LDL cholesterol when diet and ] treatment have not worked.<ref name=FDA2014>FDA. July 24, 2015 </ref> This was the first approval of a ] inhibitor.<ref name=FDA2014/> |
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In July 2015, the FDA approved alirocumab as a second line treatment to lower ] for people who have ] and people with ] who require additional lowering of LDL cholesterol when diet and ] treatment have not worked.<ref name=FDA2014>FDA. July 24, 2015 </ref> This was the first approval of a ] inhibitor.<ref name=FDA2014/> |
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==Research== |
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==Research== |
Side effects that occurred in more than 2% of people treated with in clinical trials and that occurred more frequently than with placebo, included nose and throat irritation, injection site reactions and bruising, flu, urinary tract infection, diarrhea, bronchitis and cough, and muscle pain, soreness, and spasms.
A phase 3 trial of statin intolerant patients called ODYSSEY ran for 65 weeks. Results were presented at the 2014 European Society of Cardiology meeting.
A 78-week study of alirocumab in 2341 people taking statins who were at high risk for cardiovascular events and had high LDL cholesterol levels was published in April 2015.