The Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients (JATOS): Protocol, Patient Characteristics, and Blood Pressure during the First 12 Months

Abstract

IntroductionThe rapid growth of the elderly population in industrialized countries has led to an increased incidence of hypertension and hypertension-related cardiovascular diseases (1, 2). The management of hypertension in the elderly has therefore assumed new importance. Systolic blood pressure (SBP) increases steadily with age, whereas diastolic blood pressure (DBP) increases until 55 years and then declines (3). In the National Health and Nutritional Examination Survey (NHANES) study, isolated systolic hypertension was present in 65% of all hypertensive patients older than 60 years (1). SBP is a more important predictor of target organ damage than DBP in the elderly (4).Recent guidelines for the management of hypertension rec-*The details of the JATOS study group are shown in the Appendix. Address for Reprints: Masao Ishii, M.D., the Yokohama Seamen's Insurance Hospital, 43−1, Kamadai-cho,

Optimal Combination of Effective ANtihypertensives (OCEAN) study: a prospective, randomized, open-label, blinded endpoint trial—rationale, design and results of a pilot study in Japan

“…Patients receiving efonidipine with DBP o120 mm Hg were included in the JATOS Study. 19 Patients already on antihypertensive treatment with SBP o210 mm Hg and DBP o115 mm Hg were included in the VALUE Study. 20 Therefore, by including patients with slightly higher BPs on monotherapy with amlodipine, the randomization rate will be increased without endangering patients or decreasing the number of patients enrolled, and the feasibility of the study would increase.…”

Impact of renal function on cardiovascular events in elderly hypertensive patients treated with efonidipine

“…12,13 The present renal subanalysis attempted to elucidate the roles of BP level, age, and the presence of proteinuria or DM in renal function and to evaluate whether baseline renal function or change in eGFR affects the incidence of cardiovascular events. The results showed that the incidence of renal events (that is, doubling of serum creatinine levels or end-stage renal disease) did not differ between the strict-treatment group and the mild-treatment group (Figure 2).…”

“…The study design and protocols have been detailed in a previous publication, 12 and the study was registered at the UMIN Clinical Trial Registry (http:// www.umin.ac.jp/ctr/index.htm; trial #UMIN000001021). The random assignment, data collection and analyses were performed by the JATOS Central Registration Office.…”

“…Upon obtaining informed consent, physicians were allowed to give information on patient profiles to the JATOS Central Registration Office, which subsequently assigned the subjects to two systolic BP target arms (strict-treatment group; o140 mm Hg, and mild-treatment group; 140 to o160 mm Hg) by computer-assisted random allocation. 12 Antihypertensive therapy with efonidipine (20-60 mg per day), a long-acting Ca channel blocker with renal afferent and efferent arteriolar dilator action, [16][17][18][19][20] was given to all patients, and if the target systolic BP was not achieved, additional antihypertensive agents, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics and b-blockers, were administered.…”

“…12 The rationale, design and patient characteristics have already been published, 12 and the principal results have been announced. 13 This article reports further subanalysis of the JATOS data to clarify the role of antihypertensive therapy in the progression of CKD.…”