The occurrence rate of cerebrovascular and cardiac events in patients receiving antihypertensive therapy from the post-marketing surveillance data for valsartan in Japan (J-VALID)

Abstract

It is well known that blood pressure (BP) management reduces the incidence of cerebrovascular and cardiovascular events. However, it is unclear how many of these events occur in hypertensive patients who receive pharmacological treatment. The aim of this survey was to evaluate the occurrence rate of both types of events in patients receiving valsartan-based treatment. Of 30 366 patients treated with valsartan, 28 356 patients were observed for 2.93 years. Antihypertensive drugs other than valsartan were used in 56.8% of patients. After the administration of valsartan, the systolic and diastolic BP significantly decreased from 161.1±19.1/90.4±13.1 to 139.9±18.1/79.6±11.9 mm Hg. Cerebrovascular events were observed in 550 patients (1.94%, 9.29/1000 patient-years), and cardiac events were observed in 576 patients (2.03%, 9.73/1000 patient-years). A comparative analysis of the hazard ratios for cerebrovascular and cardiac events according to the BP level at the endpoint showed a BP-dependent reduction of risk for cerebrovascular events, and the change in risk exhibited a J-curve phenomenon in the relationship between cardiac events and systolic BP. The J-curve phenomenon was not observed in patients aged <75 years, but it was observed for the systolic BP in patients aged 75 years. Adverse drug reactions were observed in 1925 of 28 420 patients (6.77%). This post-marketing surveillance data for valsartan showed the outcomes for treated hypertensive patients in a large population in Japan who were followed for up to 3 years. These data will add important knowledge regarding the treatment of hypertension in Japan.

Protocol for Evaluating the Cardio-Ankle Vascular Index to Predict Cardiovascular Events in Japan: A Prospective Multicenter Cohort Study

“…The relative risk of cerebrovascular events in patients with a CAVI >10 has been estimated to be 1.73 compared with patients with a CAVI ≤ 10; thus, the study enrolled 2.5 times as many patients with a CAVI ≤ 10 as patients with a CAVI >10 [19] , in whom the risk of cerebrovascular events is anticipated to be 4.6% in 5 years [25] . From these data, the risks of cerebrovascular events in patients with a CAVI ≤ 10 and in those with a CAVI >10 were anticipated to be 0.038 and 0.066 in 5 years, respectively.…”

The implications of blood pressure targets from the 2018 European Society of Cardiology hypertension guidelines in Asian patients: a systematic review and meta-analysis

“…The comprehensive search identified 15 studies, out of which 4 studies were RCTs, 7 studies were observational, and the remaining 4 studies were post-hoc analyses of RCTs (Table 1). [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] The meta-analysis flow diagram is depicted in Figure 1. In one RCT with dual intervention, patients were randomized to follow strict or standard BP targets and to receive angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers.…”

“…Asayama et al 2012 25 Fan et al 2017 26 JATOS 2008 27 Kamishima et al 2019 28 Kario et al 2014 29 Lee et al 2017 30 Lee et al 2018 31 Ogihara et al 2009 32,33 Ogihara et al 2010 34 Teramoto 2012 35 Wan et al 2018 36 Wei et al 2013 37 Yamashita 2013 38 Yamazaki et al 2013 39 Zheng et al 2015 40 The table represents only the study characteristics for which data were available from the majority of reports.…”

Low Diastolic Blood Pressure as a Risk for All-Cause Mortality in VA Patients

“…Owing to the debatable nature of the clinical significance of the J-curve [15–17], major societal guidelines have not previously given due recognition to the phenomenon. While the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure has been the gold standard for nearly a decade [7], it fails to address the question as to the potential harms with lowering blood pressure beyond a certain threshold.…”