Olmesartan clinical trial in Okinawan patients under OKIDS (OCTOPUS) study: design and methods.
BACKGROUND
Guidelines for treatment of hypertension are not available for chronic hemodialysis (HD) population, despite the high mortality rate due to cardiovascular disease (CVD). Survival is much better among hypertensive patients than normal to hypotensive patients. Target levels of blood pressure and the class of antihypertensive drugs have not been examined in prospective studies.


METHODS
We designed a prospective randomized controlled study among hypertensive HD patients in Okinawa (Okinawa Dialysis Study, OKIDS). The outcomes will be compared between two treatment regimens, such as (1) renin-angiotensin system (RAS) inhibitor Olmesartan and others, and (2) antihypertensive drugs without RAS inhibitors, in a parallel fashion. The title of the study is Olmesartan Clinical Trial in Okinawan Patients under OKIDS (OCTOPUS). Outcomes are any cause of death and CVD in 3 years in a total of 462 patients. Subjects are age 20-79 years and ambulatory on thrice weekly HD treatment. Eligible patients have resistant hypertension: pre-HD session blood pressure 140/90 mmHg and over for more than 1 month regardless with the use of antihypertensive drugs. Patients treated with RAS drugs are eligible if they continue to be hypertensive for more than 1 month after switching to non-RAS antihypertensive drugs.


CONCLUSIONS
This study provides evidence for the target levels of blood pressure at a pre-HD session and the impact of RAS inhibitors. We also evaluate the usefulness of home blood pressure monitoring in HD patients.
Iseki
Kunitoshi
K
Dialysis Unit, University Hospital of The Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan. chihokun@med.u-ryukyu.ac.jp.
Tokuyama
Kiyoyuki
K
Tokuyama Clinic, Urasoe, Okinawa, Japan.
Shiohira
Yoshiki
Y
Tomishiro-Chuo Hospital, Tomigusuku, Okinawa, Japan.
Higa
Akira
A
Shuri Jokamachi Clinic, Naha, Okinawa, Japan.
Hirano
Hiroshi
H
Churaumi Clinic, Nago, Okinawa, Japan.
Toma
Shigeki
S
Toma Naika Clinic, Nishihara, Okinawa, Japan.
Kohagura
Kentaro
K
Department of Cardiovascular Medicine, Nephrology and Neurology, University of The Ryukyus, Okinawa, Japan.
Ueda
Shinichiro
S
Clinical Pharmacology and Therapeutics, University of The Ryukyus, Okinawa, Japan.
D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D018660:Blood Pressure Monitoring, Ambulatory; D006801:Humans; D006977:Hypertension, Renal / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D007093:Imidazoles / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D007676:Kidney Failure, Chronic / Q000401:mortality; D006435:Renal Dialysis / Q000401:mortality; D013777:Tetrazoles / Q000627:therapeutic use*
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; C437965:olmesartan