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(Hypertension. 2008;51:393.)
© 2008 American Heart Association, Inc.

Original Articles

Effects of Candesartan Compared With Amlodipine in Hypertensive Patients With High Cardiovascular Risks

Candesartan Antihypertensive Survival Evaluation in Japan Trial

Toshio Ogihara; Kazuwa Nakao; Tsuguya Fukui; Kohshiro Fukiyama; Kenji Ueshima; Koji Oba; Tosiya Sato; Takao Saruta for the Candesartan Antihypertensive Survival Evaluation in Japan Trial Group

From the Osaka University Graduate School of Medicine (T.O.), Osaka, Japan; EBM Research Center (K.N., K.U., K.O.) and Department of Medicine and Clinical Science (K.N.), Kyoto University Graduate School of Medicine, Kyoto, Japan; St Luke’s International Hospital (T.F.), Tokyo, Japan; Japan Seaman’s Relief Association Moji Hospital (K.F.), Fukuoka, Japan; Department of Biostatistics (T.Sato), Kyoto University School of Public Health, Graduate School of Medicine, Kyoto, Japan; and Keio University Graduate School of Medicine (T.Saruta), Tokyo, Japan.

Correspondence to Kazuwa Nakao, Department of Medicine and Clinical Science and EBM Research Center, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawaracho, Sakyo-ku, Kyoto 606-8507, Japan. E-mail nakao{at}kuhp.kyoto-u.ac.jp

The Candesartan Antihypertensive Survival Evaluation in Japan Trial was designed to compare the long-term effects of the angiotensin II receptor blocker candesartan and the calcium channel blocker amlodipine on the incidence of cardiovascular events, represented as a composite of sudden death and cerebrovascular, cardiac, renal, and vascular events in high-risk Japanese hypertensive patients. We conducted a prospective, randomized, open-label study with blinded assessment of the end point in 4728 Japanese hypertensive patients (mean age: 63.8 years; mean body mass index: 24.6 kg/m²). Patients were followed for an average of 3.2 years. Blood pressure was well controlled with both treatment-based regimens (systolic blood pressure/diastolic blood pressure: 136.1/77.3 mm Hg for candesartan-based regimens and 134.4/76.7 mm Hg for amlodipine-based regimens after 3 years). Primary cardiovascular events occurred in 134 patients with both the candesartan- and amlodipine-based regimens. The 2 treatment-based regimens produced no significant differences in cardiovascular morbidity or mortality in the high-risk Japanese hypertensive patients (hazard ratio: 1.01; 95% CI: 0.79 to 1.28; P=0.969). In each primary end point category, there was no significant difference between the 2 treatment-based regimens. New-onset diabetes occurred in fewer patients taking candesartan (8.7/1000 person-years) than in those taking amlodipine (13.6/1000 person-years), which resulted in a 36% relative risk reduction (hazard ratio: 0.64; 95% CI: 0.43 to 0.97; P=0.033). We disclosed that candesartan-based and amlodipine-based regimens produced no statistical differences in terms of the primary cardiovascular end point, whereas candesartan prevented new-onset diabetes more effectively than amlodipine.

Key Words: antihypertensive therapy • hypertension • cardiovascular diseases • angiotensin II • calcium channel blockers • clinical trials