アンジオテンシンII受容体拮抗薬とアンジオテンシン変換酵素阻害薬（HIJ-CREATE）

HIJ-CREATEトライアルの結果、カンデサルタンは短期の心血管イベントのリスクを軽減するがアンジオテンシン変換酵素阻害薬はリスクを変化させない可能性のあることが示唆された

HIJ-CREATE trial suggests candesartan may decrease short-term risk for cardiovascular events whereas angiotensin-converting enzyme inhibitors do not alter risk

高血圧および冠動脈疾患を有する患者に対し、アンジオテンシンII受容体拮抗薬は少なくとも短期の主要な心血管系有害事象を減少させるが、アンジオテンシン変換酵素阻害薬はリスクに影響しないようである、とAmerican Heart AssociationのLate-Breaking Clinical Trialセッションで発表された。HIJ-CREATEトライアルにおいては、2,049人の患者をカンデサルタンを基本とした治療またはアンジオテンシン受容体拮抗薬以外の薬剤を基本とした標準的な治療を行う群に無作為に割り付けた。約35%の患者が急性冠症候群の既往を、38%が心筋梗塞の既往を有していた。平均追跡期間4.2年のイベント発症率は、カンデサルタン群で264例（25.8%）、アンジオテンシン受容体拮抗薬以外の群で288例（28.1%）であった（有意差なし）。しかし、カンデサルタンは無作為化後3～6ヵ月の一次エンドポイント発現率を有意に低下させた。

Angiotensin II receptor blockers may decrease risk for major adverse cardiovascular events in patients with hypertension and coronary artery disease, at least in the short term, but angiotensin-converting enzyme inhibitors do not appear to affect risk, according to a late-breaking clinical trial presentation at the annual meeting of the American Heart Association.

The HIJ-CREATE trial was intended to clarify whether candesartan-based regimens (as the example of an angiotensin II receptor blocker) were more effective in preventing major adverse cardiovascular events than an angiotensin-converting enzyme inhibitor?based regimen, according to Hiroshi Kasanuki, MD, the study’s senior author and chief professor of internal medicine in the department of cardiology at Tokyo Women’s Medical University.

Using a multi-center approach, the randomized, open-label, blinded-endpoint trial included follow-up visits at 6, 12, 24, 36, 48 and 60-month intervals. A total of 2,049 patients were randomized to candesartan-based therapy without any angiotensin-converting enzyme inhibitors or non-receptor-blocker-based standard treatment at 14 sites in Japan between June 2001 and April 2004.

About 35 percent of patients had experienced a prior acute coronary syndrome event and 38 percent had a history of myocardial infarction.

The primary endpoint of the study was to determine the amount of time that would pass until the first major adverse cardiovascular event. Major secondary endpoints included incidence of coronary revascularization and new-onset diabetes.

There were 552 primary events during a mean follow-up of 4.2 years: 264 (25.8 percent) in the candesartan group and 288 (28.1 percent) in the non-receptor-blocker group (not a significant difference). However, candesartan significantly reduced incidence of primary end points at 3 to 6 months after randomization.