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悪が得するアク〇ス?

pioglitazone(商品名はタケダの「アクトス」)について。
糖尿病ガイドラインではけっこう大切に書かれています。
参考:
 http://www.mnc.toho-u.ac.jp/mmc/guideline/list1-2.htm#tonyo
 http://minds.jcqhc.or.jp/G0000107_0046.html
でも最近、心不全の副作用で新聞をにぎわせたりしていたみたいです。浮世離れ
した生活にいる研修医な自分は知らなかったのですが(汗)、このあたり、読み
やすいです。
 http://www.yakugai.gr.jp/attention/attention.php?id=163


●The Lancet 2005; 366:1279-1289

"Secondary prevention of macrovascular events in patients with type 2
diabetes in the PROactive Study (PROspective pioglitAzone Clinical
Trial In macroVascular Events): a randomised controlled trial"

という論文があって、
(Pubmedで検索して読んでみましょう☆
 http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed )

"Pioglitazone reduces the composite of all-cause mortality, non-fatal
myocardial infarction, and stroke in patients with type 2 diabetes who
have a high risk of macrovascular events."

と結論づけているています。
タケダのMRはこれをもって、「アクトスはEvidenceがあります!」と売り込みま
す。400億円の売り上げのある薬らしいですから、たいせつです。

のだけれど。

ACP Journal club http://www.acpjc.org/
(American College of Physiciansの出している雑誌)
では、そのデータを使ってこう論じています。

●ACP J Club. 2006 Mar-Apr;144(2):34.
"Pioglitazone did not reduce a composite endpoint of macrovascular
complications and increased risk for heart failure in type 2 diabetes
with macrovascular disease"

とまったく逆の結論なのです。

ACPのほうでは1ページの中で上手に種明かしをしてくれています。
Lancetは、5238人でのその試験ではじめに設定した6項目(Primary composite
endpoint)ではひとつも有意な差のある結果は出なかったため、おそらくは期間
を延長してデータを3項目についてのみさらに集めて(“Main secondary”
composite endpoint)何とか有意差のあるデータを導いた、ということみたいで
す。
すでに「Randomized placebo-controlled trial」なのかどうかは疑わしい状態
で、でも、有意な差といってもNNTは49 (27 to 407)。つまり、のみつづけただ
いたい49人のうちのひとりが、pioglitazoneで得をするかもしれない、という状
態。

ACPはそのデータでさらに続けます。
pioglitazoneでは心不全の副作用がでる。そのNNHは23(16 to 38)、とのこと。
つまり、もしかするとpioglitazoneをのんだ16人にひとりは心不全おこすよ、と
いうこと。

ACPはそうやってまとめたうえで、
" Pioglitazone did not reduce a composite endpoint of macrovascular
complications and increased risk for heart failure in type 2 diabetes
with macrovascular disease"
と結論しているわけです。

有名な雑誌も眉につばつけて読まねばならない、という例ですねぇ。
常識的な治療方法、もやっぱり不安なところはある、という認識もたいせつなの
でしょうね。
そして最も重要なのは、こういった情報を「楽して!」みつけるという手法なわ
けです。
「楽して探す」「楽して読む」けれど「批判的に読む」「目の前の患者の利益に
あてはめる」EBMはやっぱりたいせつです。がんばらねばっ!


ついでに。
このあたりの新聞記事も一緒に読むと面白いかもしれません。

http://health.yahoo.co.jp/news/detail?idx0=w02070801
http://health.yahoo.co.jp/news/detail?idx0=w02070601

ともあれ。
世界経済の中でなんとかがんばり日本経済に貢献してくれているタケダの400億
の売り上げが、どうなることやら。今後に注目です。

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