FDA關於控制膽固醇的新警語,看一看吧....

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FDA關於控制膽固醇的新警語,看一看吧....

文章 熊哥 »

The FDA is making several changes to the labels of statins following a comprehensive review, the agency announced on Tuesday: http://www.fda.gov/Safety/MedWatch/Safe ... 293670.htm

•Incident diabetes and increased blood glucose are possible with statin use. Several meta-analyses found an increased risk for diabetes (9%–13%) in patients taking statins.
Reversible memory loss and confusion are possible, though rare. The FDA said there is no evidence that these side effects lead to significant cognitive decline later.
Routine monitoring of the liver enzyme alanine aminotransferase is no longer required, although testing before statin initiation and as clinically indicated is still recommended. The agency has concluded that serious liver injury among patients taking statins is rare and cannot be prevented with routine monitoring.
•Use of lovastatin is now contraindicated with strong CYP3A4 inhibitors — including itraconazole and erythromycin — to reduce the risk for rhabdomyolysis. Lovastatin's new label also lists dose limitations and several other drugs to avoid.
Last edited by 熊哥 on 週四 3月 01, 2012 11:46 pm, edited 2 time in total.
傳說中的杜老爺是也 ! http://mypaper.pchome.com.tw/bear1002
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Re: 喜歡降血脂(膽固醇)的看一看吧....

文章 PAPA »

所以結論是 血酯沒很高 不要吃嗎? (omg) (omg)
有CV man可以指引一下嗎?


難怪覺得記性越來越差 (倒地) (倒地)
chenyuehchung.
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Re: 喜歡降血脂(膽固醇)的看一看吧....

文章 chenyuehchung. »

1.FDA new warning,esp at high dose statin.
可能增加new onset DM or worsen DM control,提醒各位小心,其實在
使用上statin benefit還是遠遠大於DM risk,不需改變用藥習慣....
2.再之前許多trial已發現此現象,可能與glucuronidation有關.
3.不建議 f/u liver enz.
4.lovastatin易與其他藥有cross-reation.
5.花園內其實我之前已po,坦白說我不喜歡這個標題,語義中有:對喜歡用此類藥品的醫師消遣之嫌,不知作者原意如何,若有誤解我道歉,我認為這是公開版面,如果涉及專業問題請先詳閱原文內容,了解其前因後果再行po文已示負責,對一般民眾也少一些誤導....
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 熊哥 »

我一直相信 J curve現象啦 !
對於有人偏執地強調要降到多麼低的程度不以為然................


http://tw.nextmedia.com/applenews/artic ... D/20120301
這兩天門診會很難過,會被神經質的病人問到抓狂...
傳說中的杜老爺是也 ! http://mypaper.pchome.com.tw/bear1002
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 amaranth »

要說明一下是增加odds ratio 9%不是發生率,255個病人經過四年會多一個DM CASE

CYP3A4抑制劑種類還不少,不過紅黴素應該是被歸類於中等強度而非STRONG(跟葡萄柚汁同級),INTRACONAZOLE是STRONG

STATIN中lovastatin/simvastatin主要走CYP3A4代謝,
LIPITOR也是不過影響比較少
所以藥典上會寫lovastatin/simvastatin不該跟CYP3A4抑制劑併用,
LIPITOR則是要調整劑量
FDA特別挑出藥典有記載的內容不知道是什麼原因,可能是要再強調吧

Pravastatin,fluvastatin跟rosuvastatin不太走CYP3A4
如果相關藥物非用不可,請改用底下那三種
Last edited by amaranth on 週四 3月 01, 2012 7:52 am, edited 2 time in total.
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Re: 喜歡降血脂(膽固醇)的看一看吧....

文章 amaranth »

chenyuehchung. 寫:1.FDA new warning,esp at high dose statin.
可能增加new onset DM or worsen DM control,提醒各位小心,其實在
使用上statin benefit還是遠遠大於DM risk,不需改變用藥習慣....
2.再之前許多trial已發現此現象,可能與glucuronidation有關.
3.不建議 f/u liver enz.
4.lovastatin易與其他藥有cross-reation.
5.花園內其實我之前已po,坦白說我不喜歡這個標題,語義中有:對喜歡用此類藥品的醫師消遣之嫌,不知作者原意如何,若有誤解我道歉,我認為這是公開版面,如果涉及專業問題請先詳閱原文內容,了解其前因後果再行po文已示負責,對一般民眾也少一些誤導....
http://www.ncbi.nlm.nih.gov/pubmed?term=20167359
2010年meta-analysis,ODDS RATIO 1.09
結論:Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change.

http://www.ncbi.nlm.nih.gov/pubmed?term=21693744
2011年比較中等跟高量治療的meta-analysis
高量治療的糖尿病Odds ratios 1.12
高量治療的CV EVENT Odds ratios0.84(包含掛掉,MI跟冠狀動脈成形術)

利弊都有,感覺上好處比風險高,不過還是要自己評估一下
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 熊哥 »

amaranth 寫:要說明一下是增加odds ratio 9%不是發生率,255個病人經過四年會多一個DM CASE

CYP3A4抑制劑種類還不少,不過紅黴素應該是被歸類於中等強度而非STRONG(跟葡萄柚汁同級),INTRACONAZOLE是STRONG

STATIN中lovastatin/simvastatin會走CYP3A4代謝,LIPITOR也有不過比較少
所以藥典上會寫lovastatin/simvastatin不該跟CYP3A4抑制劑併用,
LIPITOR則是要調整劑量
FDA特別挑出藥典有記載的內容不知道是什麼原因,可以是要再強調吧

Pravastatin,fluvastatin跟rosuvastatin不走CYP3A4
如果相關藥物非用不可,請改用底下那三種
那rosuvastatin是不是就不需避諱葡萄柚汁了呢 ?
傳說中的杜老爺是也 ! http://mypaper.pchome.com.tw/bear1002
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jesuischinoise
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 jesuischinoise »

閒話
中醫說膽固醇是命門之火
反對降膽固醇
常常喜樂 不住禱告 凡事謝恩

用認養取代買賣,可愛狗貓待認養(品種狗貓也有):
全國動物收容系統

http://www.meetpets.org.tw/pets/dog
http://www.meetpets.org.tw/pets/cat

敬畏耶和華心存謙卑,就得富有,尊榮,生命為賞賜
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amaranth
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 amaranth »

熊哥 寫:
amaranth 寫:要說明一下是增加odds ratio 9%不是發生率,255個病人經過四年會多一個DM CASE

CYP3A4抑制劑種類還不少,不過紅黴素應該是被歸類於中等強度而非STRONG(跟葡萄柚汁同級),INTRACONAZOLE是STRONG

STATIN中lovastatin/simvastatin會走CYP3A4代謝,LIPITOR也有不過比較少
所以藥典上會寫lovastatin/simvastatin不該跟CYP3A4抑制劑併用,
LIPITOR則是要調整劑量
FDA特別挑出藥典有記載的內容不知道是什麼原因,可以是要再強調吧

Pravastatin,fluvastatin跟rosuvastatin不走CYP3A4
如果相關藥物非用不可,請改用底下那三種
那rosuvastatin是不是就不需避諱葡萄柚汁了呢 ?
藥典上rosuvastatin底下是沒列啦,還有上一篇我抄錯了 (不要啊)
是"不太"走不是不走,等一下會去偷改 (賊)
因為主要不走CYP3A4代謝,所以那三種受到的影響小很多,
不過叫病人吃藥別配葡萄柚汁也不會怎樣嘛... (爽) 能避則避以防萬一

Lovastatin,simvastatin跟LIPITOR的藥物交互作用欄都有葡萄柚汁這條

Grapefruit Juice: May increase the serum concentration of HMG-CoA Reductase Inhibitors. Management: Consider avoiding concurrent use of GFJ (especially larger amounts) with lovastatin, simvastatin, or atorvastatin. Consider using a lower statin dose or a statin that is less likely to interact when possible. Risk D: Consider therapy modification

UPTODATE作者是評估一天不要超過8oz葡萄柚汁(226.796cc,免洗紙杯一杯多一點)或者半顆葡萄柚就不至於造成影響
不過國人體格跟體質能不能適用就不知道了

相對上Pravastatin,fluvastatin跟rosuvastatin的交互作用條目下就沒有葡萄柚汁這條
Last edited by amaranth on 週四 3月 01, 2012 2:45 pm, edited 2 time in total.
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 cyc »

•Reversible memory loss and confusion are possible, though rare.
難怪老是忘記吃藥了沒 (眼汪汪)
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Re: 喜歡降血脂(膽固醇)的看一看吧....

文章 smallant »

chenyuehchung. 寫:1.FDA new warning,esp at high dose statin.
可能增加new onset DM or worsen DM control,提醒各位小心,其實在
使用上statin benefit還是遠遠大於DM risk,不需改變用藥習慣....
2.再之前許多trial已發現此現象,可能與glucuronidation有關.
3.不建議 f/u liver enz.
4.lovastatin易與其他藥有cross-reation.
5.花園內其實我之前已po,坦白說我不喜歡這個標題,語義中有:對喜歡用此類藥品的醫師消遣之嫌,不知作者原意如何,若有誤解我道歉,我認為這是公開版面,如果涉及專業問題請先詳閱原文內容,了解其前因後果再行po文已示負責,對一般民眾也少一些誤導....
(GOODJOB) (GOODJOB) (GOODJOB)
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Re: 喜歡降血脂(膽固醇)的看一看吧....

文章 kwojohn »

smallant 寫:
chenyuehchung. 寫:1.FDA new warning,esp at high dose statin.
可能增加new onset DM or worsen DM control,提醒各位小心,其實在
使用上statin benefit還是遠遠大於DM risk,不需改變用藥習慣....
2.再之前許多trial已發現此現象,可能與glucuronidation有關.
3.不建議 f/u liver enz.
4.lovastatin易與其他藥有cross-reation.
5.花園內其實我之前已po,坦白說我不喜歡這個標題,語義中有:對喜歡用此類藥品的醫師消遣之嫌,不知作者原意如何,若有誤解我道歉,我認為這是公開版面,如果涉及專業問題請先詳閱原文內容,了解其前因後果再行po文已示負責,對一般民眾也少一些誤導....
(GOODJOB) (GOODJOB) (GOODJOB)
(cheer) (cheer) (cheer)
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 chenyuehchung. »

1.ESC 2011 guideline about statin in DM and Mets:
Low-density lipoprotein-cholesterol: Trials specifically performed in subjects with type 2 diabetes as well as subsets of individuals with diabetes in major statin trials have consistently demonstrated significant benefits of statin therapy on CVD events in people with type 2 diabetes. Statin therapy reduces the 5 year incidence of major CVD events by 20% per mmol/L reduction in LDL-C regardless of initial LDL-C or other baseline characteristics based on meta-analysis. The CTT meta-analysis further indicates that subjects with type 2 diabetes will benefit from cholesterol-lowering therapy in RRR to a similar degree as non-diabetic patients, but being at higher absolute risk the absolute benefit will be greater resulting in a lower NNT. Recent studies have suggested an increased incidence of diabetes in patients treated with statins. This effect must not lessen our attention to the treatment of patients as the overall benefit in CV events reduction still remains.
螢幕快照 2012-03-01 下午11.07.14.png
螢幕快照 2012-03-01 下午11.05.45.png
2.encourge LDL<70 in very high risk gr.(statin+fibrate)
螢幕快照 2012-03-01 下午11.06.39.png
螢幕快照 2012-03-01 下午11.06.24.png
3.drug-drug interaction:
fluva and rosuva 經2C9 pathway,較少interaction,但非無,i.e.:viagra,coumadin
螢幕快照 2012-03-01 下午11.16.39.png
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Re: 喜歡嚴格控制膽固醇的看一看吧....

文章 chenyuehchung. »

螢幕快照 2012-03-01 下午11.16.47.png
4.反過來說:lipid control in CKD:
stage 2-3:evidence more strong.
stage 4-5: less effect on hard end point except SHARP trial.
2011ESC:
Therapeutic targets for patients with chronic kidney disease: CKD is acknowledged as a CAD risk equivalent. This has set the LDL-C reductions as the primary target of therapy. Non-HDL-C should be the second objective in the management of mixed dyslipidaemia. The treatment algorithm should be based on GFR. Drugs eliminated mainly by the hepatic route should be preferred (fluvastatin, atorvastatin, pitavastatin, and ezetimibe). Statins metabolized via CYP3A4 may result in adverse effects due to drug– drug interactions, and special caution is required. Fenofibrate is also nondialysable and should not be used in patients with GFR <50 mL/min/1.73 m.
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Re: FDA關於控制膽固醇的新警語,看一看吧....

文章 haowu15 »

(跪拜禮new) (GOODJOB)
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Re: FDA關於控制膽固醇的新警語,看一看吧....

文章 flaming »

最近門診常有病人問這則新聞
不知各位大大都怎麼回答??
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Re: FDA關於控制膽固醇的新警語,看一看吧....

文章 Thanatos »

謝分享

人生哪有辦得完
知是夢幻哪來坎
理上辦事存善念
忽然夢了記得返