Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial.
ABSTRACT: Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped.A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.Eight clinics were randomized to provide usual care to patients (n?=?222) and 8 clinics were randomized to provide a telemonitoring intervention (n?=?228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped).At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P?=?.001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P?=?.003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P?=?.004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P?=?.07).Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up.clinicaltrials.gov Identifier: NCT00781365.
Project description:Importance:Hypertension is a leading cause of cardiovascular disease. The results were previously reported of a trial of home blood pressure (BP) telemonitoring and pharmacist management intervention in which the interventions stopped after 12 months. There were significantly greater reductions in systolic BP (SBP) in the intervention group than in the usual care group at 6, 12, and 18 months (-10.7, -9.7, and -6.6 mm Hg, respectively). Objectives:To examine the durability of the intervention effect on BP through 54 months of follow-up and to compare BP measurements performed in the research clinic and in routine clinical care. Design, Setting, and Participants:Follow-up of a cluster randomized clinical trial among 16 primary care clinics and 450 patients with uncontrolled hypertension in a large health system from March 2009 to November 2015. Interventions:A home BP telemonitoring intervention with pharmacist management or usual care. Main Outcomes and Measures:Change from baseline to 54 months in SBP and diastolic BP (DBP) measured as the mean of 3 measurements obtained at each research clinic visit. Results:Among 450 patients, 228 (mean [SD] age, 62.0 [11.7] years; 54.8% male) were randomized to the telemonitoring intervention and 222 (mean [SD] age, 60.2 [12.2] years; 55.9% male) to usual care. Research clinic BP measurements were obtained from 326 of 450 (72.4%) study patients at the 54-month follow-up visit, including 162 (mean [SD] age, 62.0 [11.1] years; 54.9% male) randomized to the telemonitoring intervention and 164 (mean [SD] age, 60.0 [11.2] years; 57.3% male) to usual care. Routine clinical care BP measurements were obtained from 439 of 450 (97.6%) study patients at 6248 visits during the follow-up period. Based on research clinic measurements, baseline mean SBP was 148 mm Hg in both groups. In the intervention group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 126.7, 125.7, 126.9, and 130.6 mm Hg, respectively. In the usual care group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 136.9, 134.8, 133.0, and 132.6 mm Hg, respectively. The differential reduction by study group in SBP from baseline to 54 months was -2.5 mm Hg (95% CI, -6.3 to 1.2 mm Hg; P?=?.18). The DBP followed a similar pattern, with a differential reduction by study group from baseline to 54 months of -1.0 mm Hg (95% CI, -3.2 to 1.2 mm Hg; P?=?.37). The SBP and DBP results from routine clinical measurements suggested significantly lower BP in the intervention group for up to 24 months. Conclusions and Relevance:This intensive intervention had sustained effects for up to 24 months (12 months after the intervention ended). Long-term maintenance of BP control is likely to require continued monitoring and resumption of the intervention if BP increases. Trial Registration:ClinicalTrials.gov Identifier: NCT00781365.
Project description:<h4>Objectives</h4>To compare the costs and cost-effectiveness of managing patients with uncontrolled blood pressure (BP) using telemonitoring versus usual care from the perspective of the National Health Service (NHS).<h4>Design</h4>Within trial post hoc economic evaluation of data from a pragmatic randomised controlled trial using an intention-to-treat approach.<h4>Setting</h4>20 socioeconomically diverse general practices in Lothian, Scotland.<h4>Participants</h4>401 primary care patients aged 29-95 with uncontrolled daytime ambulatory blood pressure (ABP) (?135/85, but <210/135 mm Hg).<h4>Intervention</h4>Participants were centrally randomised to 6 months of a telemonitoring service comprising of self-monitoring of BP transmitted to a secure website for review by the attending nurse/doctor and patient, with optional automated patient decision-support by text/email (n=200) or usual care (n-201). Randomisation was undertaken with minimisation for age, sex, family practice, use of three or more hypertension drugs and self-monitoring history.<h4>Main outcome measures</h4>Mean difference in total NHS costs between trial arms and blinded assessment of mean cost per 1 mm Hg systolic BP point reduced.<h4>Results</h4>Home telemonitoring of BP costs significantly more than usual care (mean difference per patient £115.32 (95% CI £83.49 to £146.63; p<0.001)). Increased costs were due to telemonitoring service costs, patient training and additional general practitioner and nurse consultations. The mean cost of systolic BP reduction was £25.56/mm Hg (95% CI £16.06 to £46.89) per patient.<h4>Conclusions</h4>Over the 6-month trial period, supported telemonitoring was more effective at reducing BP than usual care but also more expensive. If clinical gains are maintained, these additional costs would be very likely to be compensated for by reductions in the cost of future cardiovascular events. Longer-term modelling of costs and outcomes is required to fully examine the cost-effectiveness implications.<h4>Trial registration</h4>International Standard Randomised Controlled Trials, number ISRCTN72614272.
Project description:Despite extensive knowledge of hypertension treatment, the prevalence of uncontrolled hypertension is high and increasing in low- and middle-income countries.To test whether a community health worker-led multicomponent intervention would improve blood pressure (BP) control among low-income patients with hypertension.A cluster randomized trial was conducted in 18 centers for primary health care within a national public system providing free medications and health care to uninsured patients in Argentina. A total of 1432 low-income adult patients with uncontrolled hypertension were recruited between June 2013 and April 2015 and followed up to October 2016.Nine centers (743 patients) were randomized to the multicomponent intervention, which included a community health worker-led home intervention (health coaching, home BP monitoring, and BP audit and feedback), a physician intervention, and a text-messaging intervention over 18 months. Nine centers (689 patients) were randomized to usual care.The coprimary outcomes were the differences in systolic and diastolic BP changes from baseline to the end of follow-up of patients with hypertension. Secondary outcomes included the proportion of patients with controlled hypertension (BP <140/90 mm Hg). Three BP measurements were obtained at each of 2 baseline and 2 termination visits using a standard protocol, the means of which were used for analyses.Of 1432 participants (mean age, 55.8 years [SD, 13.3]; 772 women [53.0%]), 1357 (94.8%) completed the trial. Baseline mean systolic BP was 151.7 mm Hg for the intervention group and 149.8 mm Hg for the usual care group; the mean diastolic BP was 92.2 mm Hg for the intervention group and 90.1 mm Hg for the usual care group. Systolic BP reduction from baseline to month 18 was 19.3 mm Hg (95% CI, 17.9-20.8 mm Hg) for the intervention group and 12.7 mm Hg (95% CI, 11.3-14.2 mm Hg) for the usual care group; the difference in the reduction was 6.6 mm Hg (95% CI, 4.6-8.6; P?<?.001). Diastolic BP decreased by 12.2 mm Hg (95% CI, 11.2-13.2 mm Hg) in the intervention group and 6.9 mm Hg (95% CI, 5.9-7.8 mm Hg) in the control group; the difference in the reduction was 5.4 mm Hg (95% CI, 4.0-6.8 mm Hg; P?<?.001). The proportion of patients with controlled hypertension increased from 17.0% at baseline to 72.9% at 18 months in the intervention group and from 17.6% to 52.2% in the usual care group; the difference in the increase was 20.6% (95% CI, 15.4%-25.9%; P?<?.001). No adverse events were reported.Low-income patients in Argentina with uncontrolled hypertension who participated in a community health worker-led multicomponent intervention experienced a greater decrease in systolic and diastolic BP than did patients who received usual care over 18 months. Further research is needed to assess generalizability and cost-effectiveness of this intervention and to understand which components may have contributed most to the outcome.clinicaltrials.gov Identifier: NCT01834131.
Project description:<h4>Background</h4>Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care.<h4>Methods</h4>This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366.<h4>Findings</h4>1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups.<h4>Interpretation</h4>Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care.<h4>Funding</h4>National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.
Project description:There is a paucity of data describing the sustained benefits of lifestyle interventions on health behaviors and blood pressure (BP).We examined the persistence of changes in health habits and BP in the ENCORE study, a trial in which 144 overweight individuals with above-normal BP were randomized to one of the following 16-week interventions: Dietary Approaches to Stop Hypertension (DASH) diet alone (DASH-A), DASH diet plus a behavioral weight management intervention (DASH-WM), or Usual Care. Follow-up assessments were conducted 8 months after the end of treatment.At 16 weeks, systolic BP was reduced by 16.1 (95% confidence interval (CI) = 13.0-19.2) mm Hg in the DASH-WM group, 11.2 (95% CI = 8.1-14.3) mm Hg in the DASH-A group, and 3.4 (95% CI = 0.4-6.4) mm Hg in the Usual Care group. A decrease in BP persisted for 8 months, with systolic BP lower than baseline by 11.7 (95% CI = 8.1-15.3) mm Hg in the DASH-WM group, 9.5 (95% CI = 6.7-12.1) mm Hg in the DASH-A group, and 3.9 (95% CI = 0.5-7.3) mm Hg in the Usual Care group (P < 0.001 for active treatments vs. Usual Care). DASH-WM subjects lost 8.7 kg during the intervention and remained 6.3 kg lighter on follow-up examination. Changes in diet content were sustained in both DASH intervention groups. Among those who participated in DASH-WM, however, caloric intake was no longer lower, and only 21% reported still exercising regularly 8 months after completing the intervention.Changes in dietary habits, weight, and BP persisted for 8 months after completion of the 16-week ENCORE program, with some attenuation of the benefits. Additional research is needed to identify effective methods to promote long-term maintenance of the benefits of lifestyle modification programs.Clinicaltrials.gov identifier: NCT00571844.
Project description:Background Self-monitoring of blood pressure (SMBP) improves blood pressure (BP) outcomes at 12-months, but information is lacking on how SMBP affects hypertension care processes and longer-term BP outcomes. Methods and Results We pooled individual participant data from 4 randomized clinical trials of SMBP in the United Kingdom (combined n=2590) with varying intensities of support. Multivariable random effects regression was used to estimate the probability of antihypertensive intensification at 12 months for usual care versus SMBP. Using these data, we simulated 5-year BP control rates using a validated mathematical model. Trial participants were mostly older adults (mean age 66.6 years, SD 9.5), male (53.9%), and predominantly white (95.6%); mean baseline BP was 151.8/85.0 mm Hg. Compared with usual care, the likelihood of antihypertensive intensification increased with both SMBP with feedback to patient or provider alone (odds ratio 1.8, 95% CI 1.2-2.6) and with telemonitoring or self-management (3.3, 2.5-4.2). Over 5 years, we estimated 33.4% BP control (<140/90 mm Hg) with usual care (95% uncertainty interval 27.7%-39.4%). One year of SMBP with feedback to patient or provider alone achieved 33.9% (28.3%-40.3%) BP control and SMBP with telemonitoring or self-management 39.0% (33.1%-45.2%) over 5 years. If SMBP interventions and associated BP control processes were extended to 5 years, BP control increased to 52.4% (45.4%-59.8 %) and 72.1% (66.5%-77.6%), respectively. Conclusions One year of SMBP plus telemonitoring or self-management increases the likelihood of antihypertensive intensification and could improve BP control rates at 5 years; continuing SMBP for 5 years could further improve BP control.
Project description:<h4>Objective</h4>To determine whether an emergency department (ED) education and empowerment intervention coupled with early risk assessment can help improve blood pressure (BP) in a high-risk population.<h4>Methods</h4>A hypertension emergency department intervention aimed at decreasing disparities (AHEAD2) is a 3-arm, single-site randomized pilot trial for feasibility in an urban academic ED. A total of 150 predominantly ethnic minorities with no primary care provider and severely elevated blood pressure (BP) (?160/100 mm Hg) were enrolled over 10 months. Participants were randomized into 1 of 3 study arms: (1) enhanced usual care (EUC), (2) ED-initiated screening, brief intervention, and referral for treatment (ED-SBIRT), or (3) ED- SBIRT plus a 48-72 hours post-acute care hypertension transition clinic (ED-SBIRT+PACHT-c). Primary outcomes were change in systolic and diastolic BP (SBP and DBP) from baseline to 9 months. Secondary outcomes were BP control (BP <140/90 mm Hg), changes in hypertension knowledge, medication adherence, and limited bedside echocardiogram (LBE) findings.<h4>Results</h4>SBP reduction from baseline to month 9 was -26.8 (95% confidence interval [CI]: -32.8, -20.7) mm Hg for ED-SBIRT, -23.4 (95% CI: -29.5, -17.3) mm Hg for ED-SBIRT+PACHT-c, and -18.9 (95% CI: -24.9, -12.9) mm Hg for EUC. DBP decreased by -12.5 (95% CI: -16.1, -9.0) mm Hg for ED-SBIRT, -11.3 (95% CI: -14.8, -7.7) mm Hg for ED-SBIRT+PACHT-c, and -8.4 (95% CI: -11.9, -4.9) mm Hg for EUC. A multicomponent intervention compared with EUC resulted in SBP decrease of -7.9 mm Hg (95% CI: -16.4, 0.6). At 9 months, hypertension was controlled for 29.3% (95% CI: 20.3, 38.3) of intervention and 23.5% (95% CI: 11.9, 35.2) of EUC participants. All groups saw improvements in hypertension knowledge, medication adherence, and LBEs, with greater improvements in intervention groups.<h4>Conclusions</h4>The study findings suggest that a multicomponent intervention comprising of ED education and empowerment coupled with early risk assessment may help improve BP in a high-risk population.
Project description:<h4>Objective</h4>To determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure.<h4>Design</h4>Multicentre randomised controlled trial.<h4>Setting</h4>20 primary care practices in south east Scotland.<h4>Participants</h4>401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥ 135/85 mm Hg but ≤ 210/135 mm Hg).<h4>Intervention</h4>Self measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months.<h4>Main outcome measures</h4>Blinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation.<h4>Results</h4>200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study.<h4>Conclusions</h4>Supported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective.<h4>Trial registration</h4>Current Controlled Trials ISRCTN72614272.
Project description:BACKGROUND:Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia. OBJECTIVE:To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes. DESIGN:Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328). SETTING:Diabetes clinics in India and Pakistan. PATIENTS:1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ?8% plus systolic blood pressure [BP] ?140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ?130 mg/dL). INTERVENTION:Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records. MEASUREMENTS:Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes). RESULTS:Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (-0.50% [CI, -0.69% to -0.32%]), systolic BP (-4.04 mm Hg [CI, -5.85 to -2.22 mm Hg]), diastolic BP (-2.03 mm Hg [CI, -3.00 to -1.05 mm Hg]), and LDLc level (-7.86 mg/dL [CI, -10.90 to -4.81 mg/dL]) and reported higher HRQL and treatment satisfaction. LIMITATION:Findings were confined to urban specialist diabetes clinics. CONCLUSION:Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics. PRIMARY FUNDING SOURCE:National Heart, Lung, and Blood Institute and UnitedHealth Group.
Project description:<h4>Importance</h4>Poorly controlled hypertension is a leading global public health problem requiring new treatment strategies.<h4>Objective</h4>To assess whether a low-dose triple combination antihypertensive medication would achieve better blood pressure (BP) control vs usual care.<h4>Design, setting, and participants</h4>Randomized, open-label trial of a low-dose triple BP therapy vs usual care for adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg; or in patients with diabetes or chronic kidney disease: >130 mm Hg and/or >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy. Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017.<h4>Interventions</h4>A once-daily fixed-dose triple combination pill (20 mg of telmisartan, 2.5 mg of amlodipine, and 12.5 mg of chlorthalidone) therapy (n = 349) or usual care (n = 351).<h4>Main outcomes and measures</h4>The primary outcome was the proportion achieving target systolic/diastolic BP (<140/90 mm Hg or <130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 months. Secondary outcomes included mean systolic/diastolic BP difference during follow-up and withdrawal of BP medications due to an adverse event.<h4>Results</h4>Among 700 randomized patients (mean age, 56 years; 58% women; 29% had diabetes; mean baseline systolic/diastolic BP, 154/90 mm Hg), 675 (96%) completed the trial. The triple combination pill increased the proportion achieving target BP vs usual care at 6 months (70% vs 55%, respectively; risk difference, 12.7% [95% CI, 3.2% to 22.0%]; P < .001). Mean systolic/diastolic BP at 6 months was 125/76 mm Hg for the triple combination pill vs 134/81 mm Hg for usual care (adjusted difference in postrandomization BP over the entire follow-up: systolic BP, -9.8 [95% CI, -7.9 to -11.6] mm Hg; diastolic BP, -5.0 [95% CI, -3.9 to -6.1] mm Hg; P < .001 for both comparisons). Overall, 419 adverse events were reported in 255 patients (38.1% for triple combination pill vs 34.8% for usual care) with the most common being musculoskeletal pain (6.0% and 8.0%, respectively) and dizziness, presyncope, or syncope (5.2% and 2.8%). There were no significant between-group differences in the proportion of patient withdrawal from BP-lowering therapy due to adverse events (6.6% for triple combination pill vs 6.8% for usual care).<h4>Conclusions and relevance</h4>Among patients with mild to moderate hypertension, treatment with a pill containing low doses of 3 antihypertensive drugs led to an increased proportion of patients achieving their target BP goal vs usual care. Use of such medication as initial therapy or to replace monotherapy may be an effective way to improve BP control.<h4>Trial registration</h4>anzctr.org.au Identifier: ACTRN12612001120864; slctr.lk Identifier: SLCTR/2015/020.