The second progress report on the Hypertension Objective treatment based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study.
BACKGROUND
The Hypertension Objective treatment based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study is a large-scale intervention trial to determine both optimal target blood pressure (BP) on the basis of self-measured BP at home, and optimal initial antihypertensive medication.


OBJECTIVE
To investigate the quality of randomization at the end of March 2003, and BP-controlled conditions during initial 6 months.


METHODS
We evaluated the number of patients randomized by the end of March 2003, and BP changes during the initial 6 months based on intention-to-treat analysis.


RESULTS
By the end of March 2003, a total of 1086 patients (12% of a planned randomization of 9000 patients) had been randomized. Among 653 patients who had been followed for > or =6 months after randomization, mean systolic/diastolic BPs at randomization in the calcium antagonist, angiotensin-converting enzyme and angiotensin II receptor blocker groups were 149/89, 150/89 and 149/88 mmHg, respectively. Blood pressures were reduced after 3 months (137/83, 139/82 and 136/82 mmHg, respectively), and further reduced after 6 months (134/81, 135/80 and 133/80 mmHg, respectively), with no significant differences identified between groups. In more- and less-intensive BP-lowering groups, mean systolic/diastolic BPs at randomization were 149/88 and 150/89 mmHg, respectively. Although BPs were reduced after treatment for 3 months (137/83 and 137/82 mmHg, respectively) and 6 months (134/80 and 135/80 mmHg, respectively) in each target group, significant differences were still not observed between groups.


CONCLUSIONS
Good quality of randomization was observed at the end of March 2003, but rate of achievement for target BPs was insufficient.
Saito
Shin
S
Departments of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Science and Medicine, 1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
Asayama
Kei
K
Ohkubo
Takayoshi
T
Kikuya
Masahiro
M
Metoki
Hirohito
H
Obara
Taku
T
Hashimoto
Junichiro
J
Totsune
Kazuhito
K
Miura
Yukio
Y
Imai
Yutaka
Y
D047228:Angiotensin II Type 1 Receptor Blockers / Q000494:pharmacology / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D001795:Blood Pressure Determination / Q000379:methods*; D002121:Calcium Channel Blockers / Q000494:pharmacology / Q000627:therapeutic use; D002985:Clinical Protocols; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*
D047228:Angiotensin II Type 1 Receptor Blockers; D000806:Angiotensin-Converting Enzyme Inhibitors; D002121:Calcium Channel Blockers