愛妥糖恐致膀胱癌 法德禁用

[joelin]

http://tw.news.yahoo.com/article/url/d/ ... 2tgnt.html

美國聯邦食品藥物管理局（ＦＤＡ）十五日指出，第二型糖尿病患者服用降血糖錠劑愛妥糖（Actos）超過一年，可能會升高罹患膀胱癌的風險。法國與德國已因服用愛妥糖恐引發膀胱癌，上周宣布禁用。


http://tw.news.yahoo.com/article/url/d/ ... 2t2kg.html

（路透巴黎/倫敦9日電）法國健康用品安全管理檢驗局（AFSSAPS）基於罹癌風險，今天要求暫停開立愛妥糖（Actos）處方。愛妥糖為日本武田製藥公司（Takeda Pharmaceutical Co）最暢銷的糖尿病用藥。


AFSSAPS表示，基於官方研究發現這類藥物會稍微增加罹患膀胱癌風險..

AFSSAPS要求醫師停止開立這2種藥物處方，但表示服用這類藥物的民眾在向醫師諮詢以前，應持續用藥。


AFSSAPS指出，法國公共衛生保險辦公室所做的研究顯示，愛妥糖所含的活性成分pioglitazone有致癌之虞，因此決定暫停使用。

[poki]

http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm


雖美國FDA說還沒定論, 建議照常使用,
這個藥大概真有問題,

膀胱癌少, 即使多1-2成機會, 也是很少,
我沒看過吃actos且得膀胱癌的

[MK]

期刊...

是下面這一篇...

Title：
Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone

http://care.diabetesjournals.org/conten ... 6.abstract

[李誠民]

Poki 醫師前輩您好!
這是最近Stockk醫師前輩提出個"口服降糖藥(一併感謝),衛生署下市..".我就提了聳動標題(?--Avandia下架,政府偷偷摸摸做事又一樁-)看看各前輩們的看法,似乎只有您對我指正較多,個人受益良多,再次謝謝!

李誠民 寫:
台灣中化與日本藥廠生產 picoglitazone(Actos),在未專利權消失前,開始作post-marketing trial,被LillyCo.告侵權行為,網站可查,台灣法院三(二?)審都敗訴,可是個人在去年一次研討會中就教中化經理說:三審勝訴,...不關我事,也就沒討論了!
"北風北 安全下莊"......但是如果又無奈,輪道搬風怎麼辦???????......


這件事我很清楚

actos是武田的, 所以是武田告中化, 不是Lilly
中化是被武田告仿單相同(台灣規定仿單有些部分必須跟原廠相同), 侵犯智慧財產權,
武田幾乎無勝訴可能, 但可利用假扣押阻礙中化出貨, 企業競爭常見的手法
我完全不怪衛生署,
判斷藥物對患者好或是不好, 不必全靠衛生署, 這就是醫生的價值

這類藥以前也有一個下市的藥叫Troglitazone, 因有肝毒性而下市,
結果有人DM 吃Troglitazone 血糖控制得很好, 也沒有發生肝毒性, 卻不能繼續用, 對這些人不就不公平嗎?
(當時, 糖尿病口服藥種類可沒今天那麼多, 胰島素種類也沒那麼多)

以下是推論, 未經證實 , 自己判斷:
2005年(或更早)就發現avandia 會增加LDL 30%, 而增加1 mg/dl的LDL 會增加 1% MI的機會,
大約可以解釋吃avandia增加30%MI的機會,
而actos不增加LDL, 會增加HDL, 所以actos不會像avandia 有MI的問題,
如果這個推斷成立, 有的患者 LDL 不高, 或是對降血脂藥效果很好的, 要服用avandia也不是不行,
我認為衛生署禁東禁西的反而綁手綁腳

我在2006年就幾乎完全不用avandia, 改用actos, 當醫生原本就要能判斷, 不必等衛生署禁用
ps1.:您的論點我是部分同意(因為隔行如隔山,但醫師基本信仰應一致的),但對於不怪衛生署一事,我是相當感冒的,我不同意
2.我所以在討論會問中化經理,無他,我只感覺台灣人被外國公司欺負了!
3. 我當時挫責感很重,幸虧有您 施大等前被打氣,否則我身為國民,舉證請TFDA(什麼咚咚)慢點,好向錯了,Actos後續,我就沒興趣了,在台灣當個好國民,那麼難嗎?看看許多同儕的許多發言,我又情緒化起來,,又上癮東拉西扯起來
4.醫師這行業,雖是科學範疇(西方醫學)但拖離不了人性的關懷,在科技發展下,逐漸走向商業化,與醫師基本價值與信仰,又是相左的,甚至東方醫學也學起西方的科技那套,在科技發展下,東 西皆然,醫師的價值與基本信仰對醫師反而是一種無形的束幅,當然挫則感愈來愈加重,難道無解?難到科技就必須吹毀醫師的人文關懷???....那科寄發展部是災難???...政府當然要負責,否則要政府幹嘛 ?!我憂心的是 醫師對社會的冷漠,但在這似乎可以找到溫暖?
5. Avandia,Actos請參閱Page4?5?,感謝施大 Poki的打氣!!!
6. 政府做事為什麼偷偷摸摸,而不是光明磊落,,更令人生厭的是還不讓國民做個好國民,這是違反憲法的哪一條?一併就教 施大,該怎麼處罰,還只是道歉了事?!..........

[tsaivgh]

請問各位醫生前輩，請問如果您的父親在吃ACTOS，您要讓他繼續吃嗎。前面有人說：也有人吃TROGLITAZONE 沒事。問題是你沒得膀胱癌前，你怎麼知道繼續吃會不會有事?? 不知到法國禁用ACTOS 証據有多強 ？

[SIMON]

得膀胱癌 和 發生了其他大血管病變
應該是兩難!
不用ACTOS的病人
有多少人願意改打INSULIN?

也許先試著減量或改其他藥物試試

[amin30]

得膀胱癌 和 發生了其他大血管病變
應該是兩難!
不用ACTOS的病人
有多少人願意改打INSULIN?

也許先試著減量或改其他藥物試試

[MK]

得膀胱癌 和 發生了其他大血管病變
應該是兩難!
不用ACTOS的病人
有多少人願意改打INSULIN?
也許先試著減量或改其他藥物試試

禁了就換成Januvia~~~

健保承受得住嗎？！

那一篇期刊裡有一個表格如下，讓大家看一下...(僅供學術討論)

viewtopic.php?f=17&t=620&p=861962#p861962

[李誠民]

其實在開發所謂胰島素增敏藥物時--梵蒂雅前,就知道胰島素會有刺激Catecholamin的作用--血管收縮與體液滯留問題
蒂帆雅就在1999年上市了,主要藥廠(Glaxo 美國公司)所作研究追蹤根據糖化血色素(HgbA1c)降低1%,當然也隱匿了雖然血糖控治好了,但心血管疾病發生風險上昇了(即可能美國FDA有幫助隱匿之嫌),2008年底對於到底嚴格控制血糖能否降低心血管疾病(?)有了大型研究計畫結果出爐(美國衛生研究院五年計畫,作了三年就停止了,因為結果已顯示致死性新肌梗塞增加了),當然糖化血色素(HgbA1c)是否是好的糖尿病控制指標的文章也在這些年紛紛出現,至少糖尿病控制指標--HgbA1c從6-6.5%放寬到7甚至7.5%
今年八月新英格蘭雜誌(NEJM:Revisiting Rosiglitazone Story--Lessons learned 2010:363.803-6)作者(Dr. Rosen C.J.)就是當初2007年七月美國FDA 專家會議主持人,文中提到自2007年專家會議後,到今年七月專家會議有十篇新的實驗計畫都顯示梵蒂雅會增加心肌梗塞風險(30-80%),文章作者結論為退出市場吧!
有關新藥上市後才來做藥物副作用的研究是否適當,成為討論的焦點,因為這是醫學倫理極嚴重與嚴肅的課題,梵蒂雅 諾美婷 與降血脂藥,藥廠當然不樂於見到,影響新藥上市至少十年;我們在SARS與H1N1流行期間,克流感(美國藥廠)都是相同問題,隱匿或刮大其效用衛生署請小心,醫生是當醫生前需認同醫師誓言,與受道赫爾辛基與伊斯坦堡宣言所制約的,公衛專家或藥廠並沒這約束--當然如果是醫師還是要小心的

台灣健保許多制度的改變都可能違反了醫師誓言規範,尤其是不尊重(侵犯)醫師專業
P.S.:1.Rosiglitazone:a cautionary tale;Godlee F.:BMJ 2010341:c4896
2.Licensing drugs for diabetes;Lehman R.:BMJ2010;341:c4805
3. 我的前輩告訴我說:現代醫師不可沒有政治關與經濟關4.有用過梵蒂雅的前輩們,還是先看一下病歷記載,台灣病人是習慣告醫師的--容易,美國是告藥廠與國家--賠償金額極大;;前輩們!同意嗎?ˋ
avandia對心血管的影響和血糖的的控制到底好還壞?如果不好，我相信actos也應該一樣，不可能兩個一樣的藥對心血管的影響不一樣，而且Nissan先生的研究贊助者與ACTOS藥廠有關，讓人有不同的聯想

摘錄自BMJ 2010:341:c4848 文 不知能否解答您的指正:
.....
Where next for diabetes drugs?
While the focus has been firmly on rosiglitazone, what about pioglitazone? Its manufacturer Takeda had benefited from the controversy of rosiglitazone. But like rosiglitazone, pioglitazone is associated with an increased risk of oedema, heart failure, and bone fracture.23
As Professor Van Belle said, he doesn’t want to be sitting at an FDA advisory meeting in three years’ time discussing pioglitazone. Professor Gale is also concerned. In a letter to the UK regulator in 2008 seen by the BMJ, he wrote that...... “there is an urgent need to determine the safety of pioglitazone”....

...“Pioglitazone may or may not prove to be safer than rosiglitazone. There is an urgent need for more and better data addressing this issue. On present evidence, its safety cannot and should not be assumed,” he wrote. Takeda say that they continuously monitor the safety and efficacy of their compounds. ....

Meanwhile other anti-diabetic drugs using a similar pathway are in development: the chequered history of the glitazones not having deterred manufacturers. According to reports, Dr Reddy’s Laboratories and Nordic Bioscience’s partial PPAR-gamma agonist balaglitazone met its primary endpoint in its first phase III trial in patients with type 2 diabetes (reduction in glycated haemoglobin). It was claimed to be “non-inferior” to pioglitazone. The companies are currently in discussions with regulators and hope to eventually file the drug in the European Union and the United States.24 And both Roche and Metabolex have drugs in phase two trials.25

Will regulators, industry, and the clinical community do a better job for patients next time?
....1997
Troglitazone withdrawn from UK market after six weeks because of hepatotoxicity.....

1999
April: American Diabetes Association declares that the drug’s properties are not shared by any others, offering new options to healthcare professionals

May: Rosiglitazone approved as monotherapy by FDA with label precautions for use in patients with heart failure
September: European Association for the study of Diabetes heard that rosiglitazone would be useful as a first line therapy

October: Rosiglitazone turned down by EMA by 14 of 25 votes
....2000
March: Troglitazone withdrawn in United States....

July: Rosiglitazone given market authorisation in Europe with restrictions and with warnings on heart failure. GlaxoSmithKline (GSK, then SmithKline Beecham) is asked to conduct two post-marketing trials: one study to look at effect on cardiovascular structure; the other to assess cardiovascular safety—the RECORD trial.
October: Pioglitazone approved in Europe
2001
February: FDA approve new warnings on potential for heart failure

2004
With an increasing number of people taking rosiglitazone, World Health Organization picks up safety signals and alerts GSK
June: GSK ordered to publish summaries of results of all its clinical trials on its website once a product has been launched in a settlement in New York

....2005
September: Internal GSK meta-analysis finds 29% non-significant increased risk of ischaemic cardiovascular events.....
2006
February: FDA approves Avandaryl (rosiglitazone maleate and glimepiride)

April: FDA approves new warnings on risks of cardiovascular events....May: Internal GSK meta-analysis finds 31% increase in ischaemic events.....

June: EMA approves Avaglim (rosiglitazone maleate and glimepiride)

....2007
May: New England Journal of Medicine publishes meta-analysis reporting 43% increased risk of myocardial infarction ...----(美國醫學雜誌)

June: NEJM publishes interim analysis of the RECORD trial

....July: FDA advisory committee finds increased cardiac ischaemic risk but votes to keep drug on market....

October: European Medicines Evaluation Agency asserts positive benefit-risk profile, recommends new warnings for patients with ischaemic heart disease

....November: FDA approves new boxed warnings that drug may increase myocardial ischaemic events, including myocardial infarction, though evidence “inconclusive”...

December: UK Medicine and Healthcare products Regulatory Agency warns drug might be associated with small increased risk of cardiac ischaemia

2008
Updated internal GSK analysis finds no risk of myocardial infarction or other major cardiovascular events2009
March: International Journal of Cardiology meta-analysis finds no risk of myocardial infarction

June: RECORD trial published in the Lancet. EMA add a statement to their scientific information document saying there was no difference in the number of adjudicated primary endpoints between the arms of the study.

....2010
February: US Senate finance committee releases report that includes internal FDA safety report calling for drug to be withdrawn...
February: GSK responds with 30 page document

June: David Graham’s study leaked to the Pharmalot blog. It is published in JAMA regardless. At the same time, another JAMA journal, Archives of Internal Medicine, publishes an updated meta-analysis by Steve Nissen

13-14 July: FDA advisory committee meeting held. FDA drug approver gives damning verdict on the RECORD trial. Majority of committee vote either to withdraw the drug or restrict it severely ....15 July MHRA meet.----這是我投書衛生署數次開始,為什麼不等FDA正式公告,卻在蘋果日報發佈,暫下架
Commission on Human Medicines vote to withdraw rosiglitazone.....---FDA是Co. Commission on Human Medicine是參院委員會的差別觀念,我才有
....TIDE trial suspended by the FDA...---Glaxo 垂死掙札-個人意見

19-22 July: EMA meet to discuss rosiglitazone

26 July: the MHRA send out “dear doctor” letter advising doctors to consider alternative treatments where appropriate
September: EMA will finalise its review

我已知其命運,就沒住意了!
開始關注Actos(pioglitazone)想命運應事一樣的,為什麼是膀胱癌出包,不是fatal CAD(還需較長時間?)
x:EMA:European Medicines Agency
x:MHRA:Medicines and Healthcare prodoct Regulatory Agency (UK)
Rosglitazone 是Glaxo第二大暢銷藥,每年約有三十億美元銷售額
BMJ2010;341:c5333:inciders criticise FDA's decision not to withdraw rosiglitazone:
......
David Graham, associate director for science and medicine at the FDA’s Office of Surveillance and Epidemiology, was critical of the FDA’s response. “The FDA decision was disappointing, was not in the best interests of patient safety and public health, was not evidence based, and was inherently self contradictory
很抱歉!Actos(pioglitazone)是Lilly co.與武田共同生產的PPARG(TZD)降血糖藥,;控制血糖目的就是減少血管損害,減少心血管疾病與腦中風發生,就如同1970年代控制血壓的 Framgminham study 一樣,所以開發了 ACEI Ca. blockade B1 inhibitor...;
所以Rosiglitazone會增加30-80%急性心肌梗塞風險,降血糖的目的就不知為何了?
況且ACCORD study顯示嚴格控制血糖,低血糖的機率增加了,致死性心血管疾病風險也增加了,HgbA1c指標值也放寬了--7-7.5%
p.s.:目前也有許多文章探討HgbA1c是否是血糖控制良好的指標?
請指正!

個人感想::1.還是有學者,主要醫師是有正義感的,藥廠 FDA 政府多是利益考量----菸害防制, 果糖--癌症篩檢與新藥(標靶),都是同樣道理,這也就是藥廠 (玉米)工會 菸草公會 等擁有強大力量,遊說法案制訂與保護龐大商業利益(包含政府)
2.反觀國內醫師團體逐漸沒落(?社會就缺乏正義愈來愈明顯,醫師還能再冷漠嘛 ?),健保龐大財務虧空,卻仍以為政治服務為主軸,只是極度浪費資源,淪為外國藥廠與利益團體中的肥羊而已',學術(?)---不於置評,公衛界就只想利益(?當然不可一竿子打翻一船人),有良知的 醫界與學界好好反省吧!!!

[李誠民]

Tsauvgh先生您好!
您也可以上pub med.查,當然您閱讀NEMJM BMJ JAMA or Lancet等主要醫學雜誌,看它是否連續討論或多個雜誌有不同意見(或同意見,代表事情大條了),實證醫學的研究就要小心了,因為您往往不知研究結果(甚至大型或相同結果),背後是否有藥廠支持或真正意義

為什麼Actos是因膀胱癌下市,而是不是當初預測的心血管疾病原因,?

個人解讀是美國FDA的信用(Credit,不只是Avandia Actos,而是十多年來長期隱瞞事實的結果),面臨參院強大壓力要求重組(當然也牽涉美國Health Care reform一環,另一issue),如果Actos結果出來,不如先說會引發癌症發生機率 增高,否則FDA 跨國大藥廠死的(?)都更難看!這就是政治的藝術,醫師能不具備嗎?!
ps:就教於各醫師前輩

[李誠民]

MK醫師前輩您好!

您提Junovia 因有專利權還未消失,當然貴,健保局(或TFDA,我不喜歡的字)通過,就要公平訂定使用規範,不可因醫師(包過基層醫師--最重要,各級醫院)按規範使用,就不可刪減,嚴肅說,健保局與TFDA都沒資格,干涉醫師專業判斷與用藥(用藥事醫師的一門藝術),更遑論我強烈反對台灣健保的點值設計(政府不成強盜 土匪的行為?請深思)

至於是否要使用Insulin?
我個人看法::糖尿病治療因分類為NIDDM&IDDM(非胰島素依賴與胰島素依賴)所以Insulin就是第二線用藥,至於口服降糖藥藥分為第一 第二 第三... 線,....

Metaformin不是好選項?(價廉 老藥 新作用發現,這是開放園地,個人不想討論,避免醫師困擾 與外界錯誤解讀),但前提是不論專家會議 TFDA 健保局的決定,應符合公平 正義原則,醫界受批評是結果,因為不符合公平 正義原則,就成為公共議題,各界都可批評,當然公衛 社會專家...具其他專業更要發聲,但絕對會模糊焦點, ,是好還是錯,我個人認為錯的機率大,因為醫師養成教育就是有價值觀與基本信仰的行業,雖然科技發展是帶來商業化
ps:醫師不應再對社會冷麼了,否則科技 發展不會帶給人類更好的生活?(個人意見)

[poki]

請問各位醫生前輩，請問如果您的父親在吃ACTOS，您要讓他繼續吃嗎。前面有人說：也有人吃TROGLITAZONE 沒事。問題是你沒得膀胱癌前，你怎麼知道繼續吃會不會有事?? 不知到法國禁用ACTOS 証據有多強 ？

糖尿病患不管有沒有吃pioglitazone, 得膀胱癌機會多幾成, 吃pioglitazone也多幾成, 但機會還是很低,
例如: 抽菸得膀胱癌機會多6倍, 你會覺得抽菸得膀胱癌機會很高嗎?

這種case control study, 有相關未必是因果相關, 但我看因果相關的機會很高,
我是建議可繼續用, 改胰島素效果更好, 或用2年再改依島素, 或改 januvia, 選擇在個人,

januvia, 也被懷疑與某些癌症相關, 或許時間未到還沒爆而已, 未必更好

[MK]

糖尿病患不管有沒有吃pioglitazone, 得膀胱癌機會多幾成

Title：
Diabetes and risk of incident cancer: a large population-based cohort study in Israel

http://www.ncbi.nlm.nih.gov/pubmed/20148361

Abstract
Type 2 diabetes mellitus has been associated with an increased risk of a variety of cancers in observational studies, but few have reported the relationship between diabetes and cancer risk in men and women separately.

The main goal of this retrospective cohort study was to evaluate the sex-specific risk of incident overall and site-specific cancer among people with DM compared with those without, who had no reported history of cancer at the start of the follow-up in January 2000.

During an average of 8 years of follow-up (SD = 2.5), we documented 1,639 and 7,945 incident cases of cancer among 16,721 people with DM and 83,874 free of DM, respectively.

In women, DM was associated with an adjusted hazard ratio of 1.96 (95% CI: 1.53-2.50) and 1.41 (95% CI: 1.20-1.66) for cancers of genital organs and digestive organs, respectively. A significantly reduced HR was observed for skin cancer (0.38; 95% CI: 0.22-0.66).

In men with DM, there was no significant increase in overall risk of cancer. DM was related with a 47% reduction in the risk of prostate cancer.

These findings suggest that the nature of the association between DM and cancer depends on sex and specific cancer site.

[MK]

請問各位醫生前輩，請問如果您的父親在吃ACTOS，您要讓他繼續吃嗎。前面有人說：也有人吃TROGLITAZONE 沒事。問題是你沒得膀胱癌前，你怎麼知道繼續吃會不會有事?? 不知到法國禁用ACTOS 証據有多強 ？

糖尿病患不管有沒有吃pioglitazone, 得膀胱癌機會多幾成, 吃pioglitazone也多幾成, 但機會還是很低,
例如: 抽菸得膀胱癌機會多6倍, 你會覺得抽菸得膀胱癌機會很高嗎?

這種case control study, 有相關未必是因果相關, 但我看因果相關的機會很高,
我是建議可繼續用, 改胰島素效果更好, 或用2年再改依島素, 或改 januvia, 選擇在個人,

januvia, 也被懷疑與某些癌症相關, 或許時間未到還沒爆而已, 未必更好

嗚嗚嗚嗚...

光用Insulin也會造成Cancer...

嗚嗚嗚嗚...

那到底是DM引起的...

還是藥物引起的？！

1.Long-term effects of insulin glargine on the risk of breast cancer
http://www.ncbi.nlm.nih.gov/pubmed/21614572

2.Insulin: a novel agent in the pathogenesis of prostate cancer
http://www.ncbi.nlm.nih.gov/pubmed/18665451

3.Diabetes Mellitus and Increased Risk of Cancer: Focus on Metformin and the Insulin Analogs
http://pharmacotherapyjournal.org/doi/a ... ookieSet=1

[poki]

DM 本身就跟很多 Cancer 有關,
所以研究方法不好時, 會得到任何DM的藥, 都會得Cancer 的結論



有關DM & Bladder cancer的

Abstract
Aims/hypothesis Epidemiological evidence indicates that
individuals with diabetes mellitus have an increased risk
of several cancers. We performed a systematic review with
meta-analysis to evaluate the association between diabetes
and risk of bladder cancer.
Methods Pertinent studies were identified by searching
MEDLINE (from January 1966 to July 2006) and by
reviewing the reference lists of retrieved articles. We
included case–control and cohort studies reporting relative
risk (RR) estimates with 95% CIs (or data to calculate
them) of bladder cancer associated with diabetes. Studies of
type 1 diabetes were not included. Summary RRs were
calculated using a random-effects model.
Results A total of 16 studies (seven case–control studies,
three cohort studies and six cohort studies of diabetic
patients) fulfilled the inclusion criteria. Analysis of all
studies showed that diabetes was associated with an
increased risk of bladder cancer, compared with no diabetes
(RR=1.24, 95% CI 1.08–1.42). There was strong evidence
of heterogeneity among these studies (p<0.0001). Stratification
by study design found that diabetes was associated with
an increased risk of bladder cancer in case–control studies
(RR=1.37, 95% CI 1.04–1.80, pheterogeneity=0.005) and cohort
studies (RR=1.43, 95% CI 1.18–1.74, pheterogeneity=0.17),
but not in cohort studies of diabetic patients (RR=1.01, 95%
CI 0.91–1.12, pheterogeneity=0.35).
Conclusions/interpretation Findings from this meta-analysis
suggest that individuals with diabetes may have a modestly
increased risk of bladder cancer.

http://www.springerlink.com/content/420u2vpw14415ru4/fulltext.pdf

[施肇榮]

~~~~

您提Junovia 因有專利權還未消失,當然貴,健保局(或TFDA,我不喜歡的字)通過,就要公平訂定使用規範,不可因醫師(包過基層醫師--最重要,各級醫院)按規範使用,就不可刪減,嚴肅說,健保局與TFDA都沒資格,干涉醫師專業判斷與用藥(用藥事醫師的一門藝術),更遑論我強烈反對台灣健保的點值設計(政府不成強盜 土匪的行為?請深思)

~~~~

不管喜不喜歡
醫師或醫師 TO BE不去了解健保的設計
就注定失敗

因為健保法是立法院制定的
立法院是最大的民意機關
健保法，換句話說，就是全民的意旨
健保局只是執行健保法的機關而已

健保設計總額每年以固定的錢買醫療服務
你要多提供無料的服務，THAT'S FINE
只是拿不到錢，就不要ㄞ

[李誠民]

不管喜不喜歡
醫師或醫師 TO BE不去了解健保的設計
就注定失敗

因為健保法是立法院制定的
立法院是最大的民意機關
健保法，換句話說，就是全民的意旨
健保局只是執行健保法的機關而已

健保設計總額每年以固定的錢買醫療服務
你要多提供無料的服務，THAT'S FINE
只是拿不到錢，就不要ㄞ


台灣有多少立委諸公有醫學常識 知識,不一定需要,它的思維邏輯也可判斷,美國參院 眾院不是如此?

但台灣立法諸公對醫療法案,多來自政府資訊或媒體,部會偏跛? 修出的法案當然四不像,健保局當然是太上皇,基本的保險觀念---保險人 被保險人與醫療題供者,需維持等邊三角關係都沒(?視而不見)

醫師按健保規定申請,卻無理被刪,就有理?

健保局為政治服務,虧空了還亂不知節制,他沒能力就不要做腦殘的事,醫師或診所 醫院拿不到錢,只是多提供吳料的服務?
PS:1.總額買固定醫療服務(???),卻欺騙民眾(被保險人)有最好的服務,對醫療提供者卻是隨意扣款,透析治 療 不是最單純 最少爭議的醫療行為?卻是假藉總額之名,行最不尊重生命與維護基本人權的事?!哪個民主先進國家是如此胡搞的?!....
2.沒了基本人權維護,沒了尊重生命,那要健保幹嘛! 要政府幹嘛?!好好公平分配醫療資源,有效管理有限醫療資源,國人就阿彌陀彿了!

[cchic]

得膀胱癌 和 發生了其他大血管病變
應該是兩難!
不用ACTOS的病人
有多少人願意改打INSULIN?
也許先試著減量或改其他藥物試試

禁了就換成Januvia~~~

健保承受得住嗎？！

那一篇期刊裡有一個表格如下，讓大家看一下...(僅供學術討論)

viewtopic.php?f=17&t=620&p=861962#p861962

januvia比ACTOS便宜吧，可是效果並不好，我個人覺得AVANDIA與ACTOS是互鬥倒的，希望還有更新的TZD出來

[李誠民]

Lancet. 1998 Sep 12;352(9131):854-65.
Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group.[No authors listed]
Erratum in
Lancet 1998 Nov 7;352(9139):1558.

Abstract
BACKGROUND: In patients with type 2 diabetes, intensive blood-glucose control with insulin or sulphonylurea therapy decreases progression of microvascular disease and may also reduce the risk of heart attacks. This study investigated whether intensive glucose control with metformin has any specific advantage or disadvantage.

METHODS: Of 4075 patients recruited to UKPDS in 15 centres, 1704 overweight (>120% ideal bodyweight) patients with newly diagnosed type 2 diabetes, mean age 53 years, had raised fasting plasma glucose (FPG; 6.1-15.0 mmol/L) without hyperglycaemic symptoms after 3 months' initial diet. 753 were included in a randomised controlled trial, median duration 10.7 years, of conventional policy, primarily with diet alone (n=411) versus intensive blood-glucose control policy with metformin, aiming for FPG below 6 mmol/L (n=342). A secondary analysis compared the 342 patients allocated metformin with 951 overweight patients allocated intensive blood-glucose control with chlorpropamide (n=265), glibenclamide (n=277), or insulin (n=409). The primary outcome measures were aggregates of any diabetes-related clinical endpoint, diabetes-related death, and all-cause mortality. In a supplementary randomised controlled trial, 537 non-overweight and overweight patients, mean age 59 years, who were already on maximum sulphonylurea therapy but had raised FPG (6.1-15.0 mmol/L) were allocated continuing sulphonylurea therapy alone (n=269) or addition of metformin (n=268).

FINDINGS: Median glycated haemoglobin (HbA1c) was 7.4% in the metformin group compared with 8.0% in the conventional group. Patients allocated metformin, compared with the conventional group, had risk reductions of 32% (95% CI 13-47, p=0.002) for any diabetes-related endpoint, 42% for diabetes-related death (9-63, p=0.017), and 36% for all-cause mortality (9-55, p=0.011). Among patients allocated intensive blood-glucose control, metformin showed a greater effect than chlorpropamide, glibenclamide, or insulin for any diabetes-related endpoint (p=0.0034), all-cause mortality (p=0.021), and stroke (p=0.032). Early addition of metformin in sulphonylurea-treated patients was associated with an increased risk of diabetes-related death (96% increased risk [95% CI 2-275], p=0.039) compared with continued sulphonylurea alone. A combined analysis of the main and supplementary studies showed fewer metformin-allocated patients having diabetes-related endpoints (risk reduction 19% [2-33], p=0.033). Epidemiological assessment of the possible association of death from diabetes-related causes with the concurrent therapy of diabetes in 4416 patients did not show an increased risk in diabetes-related death in patients treated with a combination of sulphonylurea and metformin (risk reduction 5% [-33 to 32], p=0.78).

INTERPRETATION: Since intensive glucose control with metformin appears to decrease the risk of diabetes-related endpoints in overweight diabetic patients, and is associated with less weight gain and fewer hypoglycaemic attacks than are insulin and sulphonylureas, it may be the first-line pharmacological therapy of choice in these patients.

[superdog]

januvia比ACTOS便宜吧，可是效果並不好，我個人覺得AVANDIA與ACTOS是互鬥倒的，希望還有更新的TZD出來

+1

[superdog]

http://www.fda.gov.tw/news.aspx?newssn=7770&classifysn=4

偶們 FDA 官腔官調　是這麼唱的：
＂..同時亦應提醒病人如服藥後出現血尿、尿急、小便疼痛、背或腹部疼痛等症狀時，應立即回診告知醫師，並鼓勵病人閱讀相關之用藥說明，倘病人有疑慮或疑問，切勿自行停藥，應立即諮詢藥師或處方醫師。 ..＂

尿急？背痛？腹痛？
１００個不吃actos 的患者會背痛，另外１００個吃 ACTOS 的也會背痛
今天如果吃 ACTOS 的患者來診間：＂先生，偶腰痠背痛，就是粗你的　ACTOS 害的....＂？

[MK]

januvia比ACTOS便宜吧，可是效果並不好，我個人覺得AVANDIA與ACTOS是互鬥倒的，希望還有更新的TZD出來

1.個人感覺...
　Pioglitazone 15mg/day的效果跟Januvia 100mg的效果差不多...
　（當然還是看患者的subtype比較準）

2.其實TZD是有其他藥物的...
　不過台灣沒有哩...(我猜是原廠嫌台灣健保市場太小,不想進到台灣來弄爛全球市場)
http://en.wikipedia.org/wiki/Thiazolidi ... _the_class

[李誠民]

我想知道是Avandia or Actos台灣食品藥物管理局是否下架(停止販售)?,原因為何?

ps:證明自己是個好國民?證明自己還有讀書?無聊透頂!

[虎克]

我想知道是Avandia or Actos台灣食品藥物管理局是否下架(停止販售)?,原因為何?

ps:證明自己是個好國民?證明自己還有讀書?無聊透頂!

好像還沒有下架，不過我老闆直接讓使用actos者，更改為DDP-4抑制劑
以你的觀點，這樣的反應夠快吧？有何comment?

[李誠民]

食品藥物管理管理局說明含pioglitazone成分藥品之藥品安全資訊 (發布日期2011-06-17)


美國 FDA 近期發布 pioglitazone 成分藥品之用藥安全資訊，依據研究發現病人長期服用該藥品可能會增加罹患膀胱癌之風險，美國 FDA 要求含 pioglitazone 成分藥品應於仿單加刊相關警語及注意事項，加刊內容為「服用此藥品超過 1 年以上，可能增加膀胱癌風險」。 另查， 我國藥物不良反應通報資料，尚無疑似使用含該成分藥品導致膀胱癌相關不良反應之通報案件。我國食品藥物管理局已儘速蒐集彙整國內外所有資料，將於近期內召開藥物安全評估委員會，評估該成分藥品之臨床效益與風險。
轉載自TFDA官方網站:: (有說跟沒說一樣?官式警語?後加的)

Pioglitazone 屬於 thiazolidinedione 類 (TZDs) 之第二型糖尿病治療藥物 ，衛生署於 90 年核准含 pioglitazone 成分藥品，迄目前為止含該成分藥品許可證 共 25 張， 用於治療第 2 型糖尿病患者（非胰島素依賴型糖尿病，ＮＩＤＤＭ） 。

食品藥物管理局提醒醫師，勿處方該藥品於活動性膀胱癌之病人，對於已有膀胱癌病史之病人，應謹慎 評估其血糖控制與復發 膀胱癌風險，審慎處方。同時亦應提醒病人如服藥後出現血尿、尿急、小便疼痛、背或腹部疼痛等症狀時，應立即回診告知醫師，並鼓勵病人閱讀相關之用藥說明，倘病人有疑慮或疑問，切勿自行停藥，應立即諮詢藥師或處方醫師。

此外，食品藥物管理局已建立藥物安全資訊主動監控機制，除有藥物不良反應通報系統之外，對於安全有關訊息，隨時進行瞭解，以保障民眾之用藥安全，提醒醫療人員或病患懷疑因為使用（服用）藥品導致不良反應發生時，請立即通報給衛生署所建置之全國藥物不良反應通報中心，藥物不良反應通報專線 02-2396-0100 ，網站： http://adr.doh.gov.tw 。

好像還沒有下架，不過我老闆直接讓使用actos者，更改為DDP-4抑制劑
以你的觀點，這樣的反應夠快吧？有何comment?----No comment!
ps:Avandia我查不到

[李誠民]

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Washington Post&New York TimesArticle::
FDA Study Said to Show Avandia Risk
By MARILYNN MARCHIONE
The Associated Press
Thursday, May 24, 2007; 11:26 PM


-- The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration "several months ago" recommended a "black box" on the drug's label _ the strongest possible warning.


Sen. Charles Grassley, R-Iowa, speaks in this 2006 file photo in Des Moines, Iowa. The government's own evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week, Grassley said. (AP Photo/Matthew Putney, File) (Matthew Putney - Associated Press)
It is the first confirmation that the FDA's own analysis of Avandia shows a similar magnitude of heart attack risks _ dangers that were first publicly raised in a medical journal report published earlier this week.

Grassley complained that FDA higher-ups have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision.
"That's a long time from now when you have millions of Americans taking this drug," said the statement by the Iowa Republican. "Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem."

The FDA has been under fire since Monday's report came out, attacked by consumer advocates for dropping the ball on drug safety and for taking no stronger action in light of the new warning signs.

Avandia, sold by the British company GlaxoSmithKline PLC, is a blockbuster medication used to treat Type 2 diabetes, the most common form of the disease. More than 6 million people worldwide have taken the drug, whose U.S. sales topped $2.2 billion last year.
On Monday, an analysis led by Cleveland Clinic cardiology chief Dr. Steven Nissen of 42 separate studies on Avandia concluded that it raised the risk of heart attacks by 43 percent, compared to the rates among people taking no or other diabetes drugs. The analysis also indicated that Avandia might increase the risk of heart-related deaths.

GlaxoSmithKline strongly disputes the conclusions. Company officials said that while their own similar analysis suggested a 31 percent greater risk _ information it shared with the FDA as early as 2005 _ more rigorous, albeit smaller, individual studies did not show that.

Critics have accused the FDA of being lax in monitoring drug safety, and some members of Congress scheduled hearings and have subpoenaed key people to appear.

Grassley's staff has been meeting with FDA staffers and others and gathering documents all week to investigate the issue, said Jill Kozeny, press officer for the Senate Finance Committee, of which Grassley is ranking member.

FDA spokeswoman Julie Zawisza confirmed Thursday the internal analysis that Grassley's statement revealed, but added, "we have conflicting data" from individual studies, and therefore "are continuing to review the results of GSK's ongoing trial to determine the actual risk."

She said she could not discuss "ongoing regulatory matters" like the black box warning that Grassley's statement says was urged months ago by the FDA's Division of Drug Risk Evaluation.

As for the number of heart attacks possibly linked to the drug _ as many as 20 a day, Grassley contends _ Zawisza said: "A relationship between the drug and these deaths has not been established. We don't have data to support such a conclusion."

Any increase in heart attack risk is especially worrisome for diabetics because two-thirds of them die of heart problems.

About 1 million Americans are currently taking Avandia, which costs from $90 to $170 for a one-month supply. The FDA and diabetes experts are advising users of the medication to talk to their doctors and not to immediately discontinue the drug, which helps keep blood-sugar levels under control.


-- The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration "several months ago" recommended a "black box" on the drug's label _ the strongest possible warning.


Sen. Charles Grassley, R-Iowa, speaks in this 2006 file photo in Des Moines, Iowa. The government's own evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week, Grassley said. (AP Photo/Matthew Putney, File) (Matthew Putney - Associated Press)
It is the first confirmation that the FDA's own analysis of Avandia shows a similar magnitude of heart attack risks _ dangers that were first publicly raised in a medical journal report published earlier this week.

Grassley complained that FDA higher-ups have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision.

"That's a long time from now when you have millions of Americans taking this drug," said the statement by the Iowa Republican. "Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem."

The FDA has been under fire since Monday's report came out, attacked by consumer advocates for dropping the ball on drug safety and for taking no stronger action in light of the new warning signs.

Avandia, sold by the British company GlaxoSmithKline PLC, is a blockbuster medication used to treat Type 2 diabetes, the most common form of the disease. More than 6 million people worldwide have taken the drug, whose U.S. sales topped $2.2 billion last year.

On Monday, an analysis led by Cleveland Clinic cardiology chief Dr. Steven Nissen of 42 separate studies on Avandia concluded that it raised the risk of heart attacks by 43 percent, compared to the rates among people taking no or other diabetes drugs. The analysis also indicated that Avandia might increase the risk of heart-related deaths.

GlaxoSmithKline strongly disputes the conclusions. Company officials said that while their own similar analysis suggested a 31 percent greater risk _ information it shared with the FDA as early as 2005 _ more rigorous, albeit smaller, individual studies did not show that.

Critics have accused the FDA of being lax in monitoring drug safety, and some members of Congress scheduled hearings and have subpoenaed key people to appear.

Grassley's staff has been meeting with FDA staffers and others and gathering documents all week to investigate the issue, said Jill Kozeny, press officer for the Senate Finance Committee, of which Grassley is ranking member.

FDA spokeswoman Julie Zawisza confirmed Thursday the internal analysis that Grassley's statement revealed, but added, "we have conflicting data" from individual studies, and therefore "are continuing to review the results of GSK's ongoing trial to determine the actual risk."

She said she could not discuss "ongoing regulatory matters" like the black box warning that Grassley's statement says was urged months ago by the FDA's Division of Drug Risk Evaluation.

As for the number of heart attacks possibly linked to the drug _ as many as 20 a day, Grassley contends _ Zawisza said: "A relationship between the drug and these deaths has not been established. We don't have data to support such a conclusion."

Any increase in heart attack risk is especially worrisome for diabetics because two-thirds of them die of heart problems.

About 1 million Americans are currently taking Avandia, which costs from $90 to $170 for a one-month supply. The FDA and diabetes experts are advising users of the medication to talk to their doctors and not to immediately discontinue the drug, which helps keep blood-sugar levels under control.

Original Article
Published at www.nejm.org May 21, 2007
(10.1056/NEJMoa072761)

Effect of Rosiglitazone on the Risk of Myocardial Infarction
and Death from Cardiovascular Causes
ABSTRACT
Background Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus, but its effect on cardiovascular morbidity and mortality has not been determined.

Methods We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. Of 116 potentially relevant studies, 42 trials met the inclusion criteria. We tabulated all occurrences of myocardial infarction and death from cardiovascular causes.

Results Data were combined by means of a fixed-effects model. In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06).

Conclusions Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.

FDA statement::
MedWatch - 2007
Safety Information Alerts
Avandia (rosiglitazone)
Audience: Endocrinologists, other healthcare professionals, consumers
[Posted 05/21/2007] FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus

ps:1.美國德州 加州...於1993-1995年(記不清了),就有專打Avandia訴訟官司的律師
2.這是摘錄自網站2007年(第一次FDA對Avandia 會議與媒體報導),兩年後...
3.我對台灣食品藥物管理局在美國FDAjo未正式報告出爐前(第二次專家會議結束),於蘋果日報A4版,刊登"暫不下架"文,引起好奇
4.扯上政治,就難善了!!!美國FDA面臨重組應是遲早的事,(與它十多年包庇 隱瞞藥廠醜聞不斷,有關;;歐巴馬健保改革也有關)
TFDA(我不喜歡的名詞)不應引以為戒???

[poki]

好像還沒有下架，不過我老闆直接讓使用actos者，更改為DDP-4抑制劑
以你的觀點，這樣的反應夠快吧？有何comment?

你沒發覺這個人有些跳tone嗎?

[李誠民]

Benlysta press kit Horizant press kit Navy Yard press kit Media contacts Home Media & News Press release archive
This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

GSK to purchase Shenzhen Neptunus stake in previously formed joint venture for influenza vaccines in China
Issued: Tuesday 14 June 2011, London, UK



GlaxoSmithKline (GSK) announced today that it has entered into an agreement to acquire the remaining 51% equity interest of Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Neptunus) in the joint venture (JV) company, Shenzhen GSK-Neptunus Biologicals Co. Ltd. (GSKNB), for a total cash consideration of£24 million (US$39 million). After approval of this agreement by the Peoples Republic of China’s authorities, GSK will become the sole owner of GSKNB.

Established in June 2009, the GSKNB alliance focuses on the development and manufacture of seasonal and pandemic influenza vaccines for China, Hong Kong and Macau. GSK increased its equity share from 40% to 49% in August 2010.

The decision to acquire the outstanding interest in the GSKNB JV reflects GSK’s intention to further expand its vaccines presence in China through the establishment of local vaccine manufacturing capability.

Commenting on the agreement, Jean Stephenne, Chairman and President GSK Biologicals, said, “The decision to acquire the remaining equity interest in GSKNB reflects the importance GSK places in expanding our product offering in China and making new vaccines available to improve public health in this fast growing emerging market. GSKNB employees have made good progress preparing the site for the production of influenza vaccines and we look forward to continuing this work.”

“GSK has licensed more vaccines in China than any other global manufacturer and has packaged more than 100 million vaccines at our Shanghai facility. Today’s announcement represents an expansion of GSK’s long-term commitment to vaccine supply, manufacturing and development in China.” said John Lepore, Vice President and General Manager, Biologicals and Corporate, GSK China.


GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

大藥廠幾乎都是跨國企業,一為擴展市場,一為分散風險,但藥廠還是藥廠,商業利益考量已成唯一目的;;尤其是在科技發展競爭下;;,醫師沒有經濟觀,行嗎?
Glaxo只是總部在英國

[Sawa]

今天寫了第二次的再申覆
病人糖尿病的用藥就兩種
一個是Actos
一個是Metformin
他砍了我Actos,上次砍的理由寫：有其他便宜的藥可以先用
我寫- 這是內分泌醫師調整物後長期服用.請不要亂砍
他這次在寫-無內分泌科醫師建議不宜開立
我給他回-
請看所附前數次看診病歷，全部都是內分泌科醫師開立
且健保無規定此藥只能內分泌科醫師才能開而內科醫師不能開

真是來找碴的∼ 我發現健保局這個好像是古代的
以夷治夷... 以醫師來治醫師
讓自己罵來罵去窩裡反.
全聯會是否考慮不要再提供或是建議醫師去審這個健保了.（似乎不太可能）. 我只是想到他用的是以夷治夷這招....心裡有點不悅.