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KYOTO HEART: Valsartan associated with fewer stroke events in high-risk patients

Lower incidence of stroke/transient ischemic attack and angina pectoris were among the observed benefits.

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European Society of Cardiology Congress 2009

The addition of valsartan to conventional antihypertensive therapy was associated with improved CV outcomes in a population of Japanese patients at high risk for CV events.

Researchers for the KYOTO HEART study enrolled 3,031 Japanese patients with uncontrolled hypertension and assigned them to either valsartan (Diovan, Novartis) plus antihypertensive medication (n=1,517) or conventional antihypertensive treatment without valsartan (n=1,514). The primary study endpoint was a composite of fatal and nonfatal CV or cerebrovascular events, including stroke/transient ischemic attack, MI, hospitalization for HF, hospitalization for angina pectoris, aortic dissection, lower limb arterial obstruction, emergency thrombosis, transition to dialysis or a doubling in serum creatinine levels.

The study was terminated prematurely for ethical reasons after a median of 3.27 years, according to a press release, due to the observed unequivocal benefit in the valsartan treatment group. Fewer patients in the valsartan group experienced a primary endpoint vs. those in the conventional group (83 vs. 155; HR=0.55; 95% CI, 0.42-0.72). The researchers reported that the difference was due primarily to a reduction in angina pectoris (HR=0.51; 95% CI, 0.31-0.86) and stroke/TIA (HR=0.55; 95% CI, 0.34-0.89).

There were no significant differences in all-cause mortality or CV morality between the treatment groups, and there were no significant differences in incidences of acute MI, HF, arteriosclerosis obliterance or aortic dissection. There was also no difference in mean BP between the groups at the end of the study (mean 133 mm Hg/76 mm Hg for both groups), but mean BP was lower after treatment for both groups compared with the mean baseline BP of 157 mm Hg/88 mm Hg.

“The KYOTO HEART study confirms that the angiotensin receptor blocker valsartan exerts an overall CV protective effect in high-risk Japanese hypertensive patients and in particular exerts anti-stroke and anti-angina actions,” Hiroaki Matsubara, MD, PhD, a professor of medicine at Kyoto Prefectural University of Medicine in Kyoto, Japan, concluded in his presentation at the European Society of Cardiology Congress in Barcelona, Spain.

Matsubara H. #3582-3583. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2009; Barcelona, Spain.