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

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.


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