Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: The TASMIN-SR randomized clinical trial
McManus RJ., Mant J., Haque MS., Bray EP., Bryan S., Greenfield SM., Jones MI., Jowett S., Little P., Penaloza C., Schwartz C., Shackleford H., Shovelton C., Varghese J., Williams B., Hobbs FDR.
IMPORTANCE: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups. OBJECTIVE: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80mmHg and the home measurement target was 120/75mmHg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES: The primary outcomewas the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS: Primary outcome datawere available from 450 patients (81%). The mean baseline blood pressurewas 143.1/80.5mmHg in the intervention group and 143.6/79.5mmHg in the control group.After 12 months, the mean blood pressure had decreased to 128.2/73.8mmHg in the intervention group and to 137.8/76.3mmHg in the control group, a difference of 9.2mmHg (95%CI, 5.7-12.7) in systolic and 3.4mmHg (95%CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baselinewas 143.5/80.2mmHg in the intervention group vs 144.2/79.9mmHg in the control group, and at 12 months, the meanwas 128.6/73.6mmHg in the intervention group vs 138.2/76.4mmHg in the control group, with a difference of 8.8mmHg (95%CI, 4.9-12.7) for systolic and 3.1mmHg (95%CI,0.7-5.5) for diastolic blood pressure between groups. These resultswere comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN87171227 Copyright 2014 American Medical Association. All rights reserved.