Rationale, study design, baseline characteristics and blood pressure at 16 weeks in the HONEST Study

Abstract

On the basis of the studies that investigated the relationship between baseline clinic blood pressure (CBP) or home blood pressure (HBP) values and cardiovascular (CV) events, HBP has been reported to have a stronger prognostic ability. However, few studies have compared the prognostic ability of on-treatment CBP and HBP. The relationship between on-treatment HBP, measured twice in the morning and twice at bedtime, and CV events was investigated in over 20 000 patients in the HONEST (Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure) Study, a prospective, 2-year observational study of treatment with an angiotensin receptor blocker, olmesartan (OLM), in OLM-naive hypertensive patients. This report summarizes the study protocol, the baseline characteristics of the patients and CBP and HBP at 16 weeks. A total of 22 373 patients were registered across Japan; baseline data from 22 162 patients were collected. Baseline HBP (mean±s.d.) in the morning (the first measurement) was 151.6±16.4/87.1±11.8 mm Hg and at bedtime was 144.3±16.8/82.8±11.9 mm Hg, whereas CBP was 153.6±19.0/87.1±13.4 mm Hg. At 16 weeks, morning HBP was 135.0±13.7/78.8±9.9 mm Hg and bedtime HBP was 129.7±13.8/74.7±10.1 mm Hg, whereas CBP was 135.6±15.4/77.6±10.9 mm Hg. The follow-up period for each patient ends on 30 September 2012. The HONEST Study is expected to provide evidence showing the relationship between baseline and on-treatment CBP and HBP levels (both first and second measurements) and CV events.

Clinical Practice of Two Measurements of Home Blood Pressure on Each Occasion in Patients with Chronic Kidney Disease

“…Although the 2nd SBP was 2-3 mm Hg lower than the 1st SBP in the population as a whole, about 30% of the patients had 2nd - 1st SBP >0 mm Hg. The results of our study agree with those of the previous studies, in which the mean values of 2nd measurements were 2-3/1-2 mm Hg lower than the mean values of 1st measurements on each occasion [10,11,12,13,14,15,16]. However, the details regarding the differences between the two measurements were not clarified in these previous studies.…”

“…The European guideline proposes three measurements on each occasion [9]. Many previous studies have shown that the BP of the second measurement was lower than that of the first measurement [10,11,12,13,14,15,16]. However, it is not clear whether this tendency is a consistent finding for each subject over a long period.…”

“…One of these studies showed that 30-40% of healthy individuals had higher 2nd measurement than 1st measurement values [11]. In the Home Blood Pressure Measurement with Olmesartan Naive Patients to Establish Standard Target Blood Pressure (HONEST) study, the greatest proportion of 2nd - 1st morning SBP differences lay within the range of 0 to -4.9 mm Hg (43.1%) in 22,162 patients with essential hypertension [16]. The proportion of patients whose 2nd - 1st morning SBP differences were >0 mm Hg was 26.3%.…”

Home Blood Pressure and Cardiovascular Outcomes in Patients During Antihypertensive Therapy

“…11 HONEST is a large-scale prospective observational study with a 2-year follow-up period and is registered at the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm) with the unique trial number UMIN000002567.…”

“…11 In the present analysis, we used HBP and CBP data from patients receiving antihypertensive treatment to determine their relationship with the incidence of cardiovascular events, which was a primary objective of the HONEST study.…”