TY - JOUR
T1 - Antihypertensive drug effects according to the pretreatment self-measured home blood pressure
T2 - The HOMED-BP study
AU - Sano, Hikari
AU - Hara, Azusa
AU - Asayama, Kei
AU - Miyazaki, Seiko
AU - Kikuya, Masahiro
AU - Imai, Yutaka
AU - Ohkubo, Takayoshi
N1 - Funding Information:
Funding This study was funded by grants from the Japan Cardiovascular Research Foundation, the Japan Arteriosclerosis Prevention Fund and Tohoku University. Fujitsu Systems East Limited (Tokyo, Japan) and Omron Healthcare Co, Ltd. (Kyoto, Japan) developed and maintained the internet-based infrastructure for the measurement of the blood pressure at home and the management of patients. This study was also supported by Grants-in-Aid for Scientific Research (23390171, 25253059, 26860093, 16K15359, 17H04126 and 18K06759) from the Ministry of Education, Culture, Sports, Science and Technology, Japan, and Grants-in-Aid for the Japanese Society for the Promotion of Science (JSPS) fellows (25.7756 and 25.9328). No funding agencies had any role in the design or conduct of the study; in the collection, analysis or interpretation of the data; or in the preparation, review or approval of the manuscript.
Publisher Copyright:
©
PY - 2020/12/12
Y1 - 2020/12/12
N2 - Objectives To clarify whether or not the antihypertensive drug effect is proportional to the baseline pretreatment self-measured home blood pressure (HBP) in accordance with the law of initial value (Wilder's law). Design A post-hoc analysis of a multicentre clinical trial. Setting Outpatients across Japan with mild-to-moderate essential hypertension. Participants Among 3518 randomised participants, 2423 who self-measured HBP during the pretreatment drug-free period (10-28 days after starting fixed-dose antihypertensive monotherapy) with a mean 7.0 years follow-up were eligible. Main outcome measures We analysed individual HBP readings during pretreatment and monotherapy. Results The day-to-day HBP during both the pretreatment period and monotherapy period remains almost the same throughout each period; the results were consistent, regardless of the pretreatment HBP. Following monotherapy, the reduction in the HBP increased by 2.2 mm Hg (95% CI: 1.8 to 2.5 mm Hg) per 10 mm Hg pretreatment HBP increase, up to 11.0 mm Hg (95% CI: 9.9 to 12.0 mm Hg) among patients with an HBP ≥165 mm Hg during pretreatment. Among the 1005 patients receiving low-dose monotherapy (defined daily dose: 0.5 units), the reduction peaked at 8.9-9.1 mm Hg in those with pretreatment HBP 155-164 mm Hg and ≥165 mm Hg (p=0.88). Conclusions According to Wilder's law, the HBP reduction due to fixed-dose monotherapy was proportional to the pretreatment HBP without any regression to the mean phenomenon. With low-dose antihypertensive drugs, however, the HBP reduction peaked in patients with a high pretreatment HBP, indicating the need for such patients to receive a sufficient amount of antihypertensive drug medication at the initial treatment. Trial registration UMIN Clinical Trial Registry (http://www.umin.ac.jp/ctr), Unique identifier: C000000137.
AB - Objectives To clarify whether or not the antihypertensive drug effect is proportional to the baseline pretreatment self-measured home blood pressure (HBP) in accordance with the law of initial value (Wilder's law). Design A post-hoc analysis of a multicentre clinical trial. Setting Outpatients across Japan with mild-to-moderate essential hypertension. Participants Among 3518 randomised participants, 2423 who self-measured HBP during the pretreatment drug-free period (10-28 days after starting fixed-dose antihypertensive monotherapy) with a mean 7.0 years follow-up were eligible. Main outcome measures We analysed individual HBP readings during pretreatment and monotherapy. Results The day-to-day HBP during both the pretreatment period and monotherapy period remains almost the same throughout each period; the results were consistent, regardless of the pretreatment HBP. Following monotherapy, the reduction in the HBP increased by 2.2 mm Hg (95% CI: 1.8 to 2.5 mm Hg) per 10 mm Hg pretreatment HBP increase, up to 11.0 mm Hg (95% CI: 9.9 to 12.0 mm Hg) among patients with an HBP ≥165 mm Hg during pretreatment. Among the 1005 patients receiving low-dose monotherapy (defined daily dose: 0.5 units), the reduction peaked at 8.9-9.1 mm Hg in those with pretreatment HBP 155-164 mm Hg and ≥165 mm Hg (p=0.88). Conclusions According to Wilder's law, the HBP reduction due to fixed-dose monotherapy was proportional to the pretreatment HBP without any regression to the mean phenomenon. With low-dose antihypertensive drugs, however, the HBP reduction peaked in patients with a high pretreatment HBP, indicating the need for such patients to receive a sufficient amount of antihypertensive drug medication at the initial treatment. Trial registration UMIN Clinical Trial Registry (http://www.umin.ac.jp/ctr), Unique identifier: C000000137.
KW - cardiology
KW - epidemiology
KW - hypertension
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U2 - 10.1136/bmjopen-2020-040524
DO - 10.1136/bmjopen-2020-040524
M3 - Article
C2 - 33310801
AN - SCOPUS:85097902806
VL - 10
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 12
M1 - 40524
ER -