PROactive 10 ・・・エンドポイントをねじ曲げ後出しじゃんけん

政治ではトヨタ・キヤノンに逆らうもの無しだが、医療界でも武田に逆らうもの無し？


これって竅ってみれば、わざわざエンドポイントを変更して都合良く解釈しているように思えるのだが・・・

　　↓

"Because there was some controversy about our secondary end point, we decided to apply the PROactive data to other definitions of MACE often used in major clinical trials to see whether the results still held irrespective of which components of the MACE end point were included. We found a consistent reduction in events with all definitions with pioglitazone. This shows that we haven't been scrabbling around for one end point that was positive and that whichever MACE end point we used, we would have gotten a similar result."(heartwire)

Major adverse cardiovascular events をMACEと略すんだと感心・・・他のことは別に関心もないが、武田がうるさく宣伝するだろうから・・・予習


Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: Results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10)
American Heart Journal Vol.155(4):712-717 April 2008

PROspective pioglitAzone Clinical Trial In macro Vascular Events(PROactive)はpioglitazoneの心血管死亡、非致死的心筋梗塞、非致死的卒中（MACE1)と６つのpost hoc MACE成分（全原因、心血管、心臓死亡率；＋非致死的心筋梗塞；＋非致死的卒中；and/or 急性冠症候群）を評価

最終受診時、MACE1に寄与する第一イベントは、pioglitazone群で257(9.9%）、プラセボ群で313(11.9%)(hazard ratio 0.82, 95% CI 0.70-0.97, P = .0201)

他のMACEエンドポイントのうち５つでpioglitazoneにて有意な優越性がみられた(P<.05)で６つの項目で傾向があった(P=.052 ハザード比 0.79-0.83)

関連：アクトスのPROactive試験速報・・・・異議ありとの話　2005-10-07 14:26