A n a l y s i s o fR e c e n t P a p e r s i n H y p e r t e n s i o nJ a n N . B a s i l e , M D , S e n i o r E d i t o r

Michael J. Bloch, MD;1 Jan N. Basile, MD2

PATIENT SELF-MANAGEMENT IMPROVESBLOOD PRESSURE CONTROLHypertension affects more than 73 million peoplein the United States—approximately 1 in 3 of theadult population. It is a leading cause of morbidityand mortality worldwide. Numerous clinical trialshave shown that controlling blood pressure (BP) inpatients with hypertension significantly reduces therisk of cardiovascular (CV) events such as stroke,myocardial infarction, and heart failure. Despitethe availability of effective and newer antihyperten-sive therapies, BP continues to be inadequately con-trolled in clinical practice. In fact, recent data fromthe National Health and Nutrition ExaminationSurvey (NHANES) found that BP control wasachieved in only 50.1% of patients with hyperten-sion. Therefore, a potentially important role fornew approaches to improve BP control exists, espe-cially in primary care, where most of the manage-ment of hypertension occurs. One such approach isto involve patients in their own care, engagingpatients in the self-monitoring and self-managementof their own BP. This is similar to models currentlyused in the management of diabetes, asthma, andanticoagulation control but has only been tested intwo studies that have assessed self-monitoring ofBP in combination with self-titration of antihyper-tensive drugs as a strategy to improve BP control inthose with hypertension.

The Telemonitoring and Self-Management ofHypertension Trial (TASMINH2) was a prospec-tive, randomized, open trial in the United Kingdominvolving 24 general practices (8–56 patients perpractice) between March 2007 and May 2008. Tobe enrolled, patients had to be aged 35 to 85, treat-ed with 1 or 2 antihypertensive drugs, have a BP>140 ⁄90 mm Hg, and be willing to self-monitortheir BP using a telemonitoring system, where homeBP readings were transmitted to a health care pro-fessional to make sure that very high or low read-ings were not being ignored by the patient. Inaddition, patients were to self-titrate their ownmedication based on a predefined and agreed uponschedule. Exclusion criteria included a BP>200 ⁄100 mm Hg, a postural drop in systolic BP>20 mm Hg, terminal disease, dementia, or aspouse already in the study. Assigned to the inter-vention or control group in a 1:1 ratio based on acomputer-generated allocation sequence, open ran-domization was stratified by the individual generalpractice with minimization for sex, baseline systolicBP (�150 mm Hg vs >150 mm Hg), and the pres-ence or absence of diabetes or chronic kidney dis-ease (CKD). Outcome measurement was notblinded but used the automatic mode of the sphyg-momanometer to measure BP without the need forintervention by the investigator other than to acti-vate the cuff device. All participants received infor-mation from the British Hypertension Society onlifestyle interventions to reduce BP. All participatingfamily physicians were given a copy of the currentNational Institute for Health and Clinical Excel-lence (NICE) guidelines. Patients allocated to thecontrol group received usual care for hypertensionand were asked to attend one review session withtheir family physician who remained responsiblefor all of their care. Patients assigned to theintervention group were invited to 2 trainingsessions conducted by the research team wherethey were trained to take their own BP with anOMRON 705IT automated sphygmomanometer

1From the Department of Internal Medicine, Universityof Nevada School of Medicine, Medical Director, RiskReduction Center, Saint Mary’s Regional MedicalCenter; and 2the Seinsheimer Cardiovascular HealthProgram, Division of General Internal Medicine ⁄Geriatrics, Medical University of South Carolina,Ralph H. Johnson VA Medical Center, Charleston, SCAddress for correspondence:Michael J. Bloch, MD, Risk Reduction Center, SaintMary’s Regional Medical Center, 645 North ArlingtonStreet, Suite 460, Reno, NV 89503E-mail: mbloch@aol.com

doi: 10.1111/j.1751-7176.2010.00400.x

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(Omron Healthcare Europe, Hoofddorp, TheNetherlands) and to transmit their BP readings tothe research team by means of an automatedmodem device (i-modem; Netmedical, DeMeern,The Netherlands).

Two self-measurements of BP were made eachmorning within a 5-minute interval with the secondreading acted upon during the first week of eachmonth. A month of readings was deemed to be‘‘above target’’ if the readings on 4 or more daysduring the week were above target. If patients had2 consecutive months of BP readings above target,they would contact their physician for a prescrip-tion allowing them to adjust their medicines basedon the self-titration schedule. Self-titration scheduleswere agreed upon between participants and theirfamily doctor and included the option to monitorrenal function when using an angiotensin-convert-ing enzyme inhibitor. Monthly summaries of eachpatient’s BP readings were sent to their family doc-tor. The targeted BP from home readings was basedon the NICE guidelines, which were adjusted downby 10 ⁄5 mm Hg (130 ⁄85 mm Hg for patients withdiabetes or CKD) in accordance with the recom-mendations from the British Hypertension Society.A telemonitored BP >200 ⁄100 mm Hg or systolicBP <100 mm Hg triggered a BP check by the prac-tice, which made sure that the patient had followedtheir safety advice.

The primary outcome for the study was thechange in mean systolic BP from the day of entryto each follow-up visit at 6 and 12 months andwas adjusted for the following covariates: baselineBP >150 mm Hg, sex, and diabetes or CKD. Ofthe 1650 patients eligible for enrollment, 91%(480 of the 527 patients randomly assigned)attended follow-up visits at 6 and 12 months, forwhich complete data were available for the pri-mary outcome. Mean office BP at baseline was152 ⁄85 mm Hg in both groups. After 6 months,mean office BP in the usual care and interventiongroups was 143 ⁄80 mm Hg and 139 ⁄80 mm Hg,respectively. Mean systolic BP decreased by12.9 mm Hg (95% confidence interval [CI], 10.4–15.5) from baseline to 6 months in the self-man-agement group and by 9.2 mm Hg (95% CI, 6.7–11.8) in the control group (difference betweengroups, 3.7 mm Hg; 95% CI, 0.8–6.6; P=.013).Mean office BP after 12 months was 140 ⁄80 mmHg and 135 ⁄77 mm Hg in the usual care andintervention groups, respectively. From baseline to12 months, systolic BP decreased by 17.6 mm Hg(95% CI, 14.9–20.3) in the self-management groupand by 12.2 mm Hg (95% CI, 9.5–14.9) in the

control group (difference between groups, 5.4 mmHg; 95% CI, 2.4–8.5; P=.004. There was no sig-nificant difference between the intervention andcontrol groups in diastolic BP at 6 months(1.3 mm Hg; P=.108), but it was significant at12 months (2.7 mm Hg; P=.001). Of the 210patients (80%) who self-managed their hyperten-sion for the full 12 months of the study, 148(70%) made at least one medication change.Patients in the intervention group were prescribed0.32 (0.21–0.43) additional antihypertensive drugscompared with the control group at 6 months(P=.001) and 0.46 (0.34–0.58) additional antihy-pertensive drugs at 12 months (P=.001). More par-ticipants in the intervention group required �3antihypertensive agents to control their BP, includ-ing more thiazide diuretic and calcium channelblocker use, and fewer required a single agent. Sideeffects were measured by use of standard question-naires. Leg swelling was more frequent in the self-management group (74 patients [32%]; controlgroup, 55 patients [22%]; P=.022) with no otherdifferences noted between groups for any of theother side effects monitored. While the quality oflife improved in the self-management group overtime, the difference between groups was not signifi-cant. After 12 months in the trial, patients wereasked to rank their preferred method of BP moni-toring by choosing between measurement by adoctor, nurse, self-monitoring in the practice, orself-monitoring at home. A total of 71% of theintervention group ranked self-monitoring at homeas their preferred method for BP monitoring com-pared with 43% of the control group (P<.001).

Self-management of hypertension using a sim-ple drug titration plan in combination with telem-onitoring of BP resulted in significant reductionsin systolic BP at 6 and 12 months compared withusual care. The self-addition of medications whenpatients were not at goal may have overcomeany therapeutic inertia sometimes associated withphysician management. Self-management repre-sents an important addition to the control ofhypertension in primary care.—McManus RJ,Mant J, Bray EP, et al. Telemonitoring and self-management in the control of hypertension(TASMINH2): a randomized controlled trial.Lancet. 2010;376:163. (http://dx.doi.org/10.1016/S0140-6736(10)60964-6)

COMMENTA number of potential reasons for suboptimal con-trol of BP have been identified in the literature.These include, but are not limited to, nonadherence

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to antihypertensive therapy, which has been impli-cated in up to 50% of treatment failures, financialconstraints, and lack of access to health care.In addition to these patient-related factors, thera-peutic inertia has been a concern. Defined as a fail-ure of the practitioner to begin new medication orincrease the dose of existing medications whentreatment goals are not met, physicians often fail toact to improve BP control despite recognition ofthe problem.

In an effort to overcome therapeutic inertia, andhave patients more involved in their own care, TAS-MINH2 advances our knowledge on the importanceof self-titration and self-management in the treat-ment and control of hypertension. It found that self-management of hypertension, consisting of regularself-measurements of BP, and a simple plan thatallowed self-titration of BP medications, was moreeffective in lowering systolic BP at the end of6 months and 1 year compared with usual care; theabsolute reduction in BP being 3.7 mm Hg at6 months and 5.4 mm Hg at 1 year. Taking only 2self-measurements of BP every morning for 1 weekeach month, those with average readings on �4 daysof the week above the target BP of 130 ⁄85 mm Hgand 130 ⁄75 mm Hg in those with diabetes or CKDfor 2 consecutive months were required to adjusttheir antihypertensive medications according to aprespecified titration schedule. Of note, they con-tacted their family physician or research team onlywhen the telemonitored values were above the safetylimits of >200 ⁄100 mm Hg or <100 mm Hg.

The improvement in BP control most likelyoccurred because of the increased adjustment andincreased use of antihypertensive medications, par-ticularly thiazide diuretic and calcium channelblocker therapy, seen in the group self-managingtheir hypertension. It is difficult, however, to sepa-rate the contribution of self-management from therole that a lower BP goal or the role that telemon-itoring played. Telemonitoring was used to checkthat participants had adhered to safety advice, butthe main thrust of this study was self-manage-ment, with patients adjusting their medication reg-imen based on their home BP results, unlike inother trials that prompted physicians or nurses tomake the medication changes. When the prespeci-fied BP thresholds for additional antihypertensivetherapy were reached in the self-managementgroup, a prescription would be called in for thepatient by the research team. Of note, the benefi-cial effects on BP at 12 months were not associ-ated with any increase in anxiety or differences inquality of life even though the self-management

group required more antihypertensive therapy.Except for lower extremity edema, probably theresult of the increased calcium channel blocker usein the self-management group, side effects were simi-lar between groups. By the end of the trial, patientswho self-managed their hypertension rated self-mon-itoring of BP more preferable to measurement by adoctor or nurse or self-monitoring in the practice.

The study has several limitations, however. First,while follow-up was achieved in >90% of thepatients in both groups, it is possible that those lostto follow-up had worse BP control than those whoattended study visits. In fact, patients in the inter-vention group were less likely to attend follow-up,possibly reflecting the additional burden imposedby self-management. Second, the study took placein England. No blacks, Latinos, or other minoritygroups were studied and socially challengedpatients were under-represented, questioning howgeneralizable the study findings would be in theUnited States. In addition, the study did not allowpatients who required �3 antihypertensive agentsto be enrolled, excluding all those with resistanthypertension.

While understanding the cost-effectiveness of theintervention is important and will be separatelyreported, the present study could affect how wetreat patients with uncomplicated hypertension inthe future. Before doing so, however, several ques-tions need to be asked. Who is the best group ofpatients with hypertension to be treated with self-management: those with newly diagnosed disease,those requiring �2 antihypertensive medications?What is the optimum self-titration schedule, andafter how many self-measurements should a patientbe considered uncontrolled and self-manage theirantihypertensive medications? Will physicians bepaid for overseeing home BP management that doesnot require face-to-face interaction, the model thatpresently dictates reimbursement?

The present study suggests that out-of-office self-monitoring and self-management of BP in patientswith hypertension can be accomplished in a pri-mary care setting if there is a defined patient treat-ment algorithm, a telemonitoring BP feedbacksystem, and patients and physicians involved in acoordinated health care management system. Cur-rent studies in the United States are ongoing andwill determine whether the present findings fromEngland can be exported to patients we are morelikely to see in the United States, those from low-income or low-literacy communities who may beless able to participate and replicate the findingsfrom the present study.

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