Hypertension
Conditions
Interventions
benidipine
amlodipine
Sponsors
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study participants, aged over 30 years, were recruited by physicians from Kobe University Graduate School of Medicine. The entry period was from December 2011 to December 2013. We enrolled consecutive hypertensive outpatients whose BP had been uncontrolled without any anti-hypertensive drugs or with usual-dose of ARBs alone at least 4 weeks. This study is a prospective, randomized, open-label, comparative multicenter study. Eligibile patients were randomly assigned to switch to a therapy with benidipine 8mg/day or with 5mg amlodipine. The primary outcome was the change in office BP from baseline value at 12 and 24 weeks. Therapeutic target levels of office BPs were 130/85 mmHg for patients aged less than 64 years, 140/90 mmHg for patients aged 65 years or more, and 130/80 mmHg for patients with diabetes mellitus and/or chronic kidney disease as defined by the 2009 JSH guidelines. Clinic BPs were measured by the auscultation method using a mercury sphygmomanometer during rest in a seated position. BPs at home were measured using an automatic digital sphygmomanometer. The self-monitoring of morning BP was made within 1-hour after waking, before taking antihypertensive drugs. The mean pressure was calculated as diastolic blood pressure plus one-third of pulse pressure. Patients whose diastolic BP reached under 90 mmHg or decreased from the baseline value by 10 mmHg at 12 weeks were defined as responders. Throughout the study, lipid-lowering, anti-diabetic, or uricosuric drug regimens were continued without changing their dose or usage.
Exclusion criteria
Exclusion criteria: Patients with severe uncontrolled hypertension (diastolic BP over 110 mmHg), secondary hypertension, hyperuricemia, a past history of gout attack, poorly controlled [glycated hemoglobin A1c (HbA1C over 8.0] or insulin-treated diabetes mellitus, cardiovascular events including myocardial infarction and stroke within the preceding 3 months, severe liver dysfunction, renal failure (serum creatinine over 2.0 mg/dL), active malignancy, pregnancy, severe bile dysfunction, or allergy to benidipine or amlogipin were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure, serum lipid profile, electrites, endocrinological profile | — |
Secondary
| Measure | Time frame |
|---|---|
| left ventricular mass, cardiovascular function | — |
Countries
Japan
Contacts
Public ContactTatsuro Ishida
Kobe University Hospital Division of Cardiovascular Medicine
Outcome results
None listed