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BACKGROUND: Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension. OBJECTIVES: We conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety. METHODS: This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 » dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event. RESULTS: From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 » dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 » dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple », and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 » group. CONCLUSIONS: In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).
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BACKGROUND: The Ohio Cardiovascular and Diabetes Health Collaborative (Cardi-OH) unites general and subspecialty medical staff at the 7 medical schools in Ohio with community and public health partnerships to improve cardiovascular and diabetes health outcomes and eliminate disparities in Ohio's Medicaid population. Although statewide collaboratives exist to address health improvements, few deploy needs assessments to inform their work. OBJECTIVE: Cardi-OH conducts an annual needs assessment to identify high-priority clinical topics, screening practices, policy changes for home monitoring devices and referrals, and preferences for the dissemination and implementation of evidence-based best practices. The results of the statewide needs assessment could also be used by others interested in disseminating best practices to primary care teams. METHODS: A cross-sectional survey was distributed electronically via REDCap (Research Electronic Data Capture; Vanderbilt University) to both Cardi-OH grant-funded and non-grant-funded members (ie, people who have engaged with Cardi-OH but are not funded by the grant). RESULTS: In total, 88% (103/117) of Cardi-OH grant-funded members and 8.14% (98/1204) of non-grant-funded members completed the needs assessment survey. Of these, 51.5% (53/103) of Cardi-OH grant-funded members and 47% (46/98) of non-grant-funded members provided direct clinical care. The top cardiovascular medicine and diabetes clinical topics for Cardi-OH grant-funded members (clinical and nonclinical) were lifestyle prescriptions (50/103, 48.5%), atypical diabetes (38/103, 36.9%), COVID-19 and cardiovascular disease (CVD; 38/103, 36.9%), and mental health and CVD (38/103, 36.9%). For non-grant-funded members, the top topics were lifestyle prescriptions (53/98, 54%), mental health and CVD (39/98, 40%), alcohol and CVD (27/98, 28%), and cardiovascular complications (27/98, 28%). Regarding social determinants of health, Cardi-OH grant-funded members prioritized 3 topics: weight bias and stigma (44/103, 42.7%), family-focused interventions (40/103, 38.8%), and adverse childhood events (37/103, 35.9%). Non-grant-funded members' choices were family-focused interventions (51/98, 52%), implicit bias (43/98, 44%), and adverse childhood events (39/98, 40%). Assessment of other risk factors for CVD and diabetes across grant- and non-grant-funded members revealed screening for social determinants of health in approximately 50% of patients in each practice, whereas some frequency of depression and substance abuse screening occurred in 80% to 90% of the patients. Access to best practice home monitoring devices was challenging, with 30% (16/53) and 41% (19/46) of clinical grant-funded and non-grant-funded members reporting challenges in obtaining home blood pressure monitoring devices and 68% (36/53) and 43% (20/46) reporting challenges with continuous glucose monitors. CONCLUSIONS: Cardi-OH grant- and non-grant-funded members shared the following high-priority topics: lifestyle prescriptions, CVD and mental health, family-focused interventions, alcohol and CVD, and adverse childhood experiences. Identifying high-priority educational topics and preferred delivery modalities for evidence-based materials is essential for ensuring that the dissemination of resources is practical and useful for providers.
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Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these 'hypertension polypills' were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.
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Hipertensão , Indapamida , Humanos , Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Indapamida/farmacologia , Indapamida/uso terapêutico , Pressão Sanguínea , Resultado do TratamentoRESUMO
A growing appreciation of the pathophysiological interrelatedness of metabolic risk factors such as obesity and diabetes, chronic kidney disease, and cardiovascular disease has led to the conceptualization of cardiovascular-kidney-metabolic syndrome. The confluence of metabolic risk factors and chronic kidney disease within cardiovascular-kidney-metabolic syndrome is strongly linked to risk for adverse cardiovascular and kidney outcomes. In addition, there are unique management considerations for individuals with established cardiovascular disease and coexisting metabolic risk factors, chronic kidney disease, or both. An extensive body of literature supports our scientific understanding of, and approach to, prevention and management for individuals with cardiovascular-kidney-metabolic syndrome. However, there are critical gaps in knowledge related to cardiovascular-kidney-metabolic syndrome in terms of mechanisms of disease development, heterogeneity within clinical phenotypes, interplay between social determinants of health and biological risk factors, and accurate assessments of disease incidence in the context of competing risks. There are also key limitations in the data supporting the clinical care for cardiovascular-kidney-metabolic syndrome, particularly in terms of early-life prevention, screening for risk factors, interdisciplinary care models, optimal strategies for supporting lifestyle modification and weight loss, targeting of emerging cardioprotective and kidney-protective therapies, management of patients with both cardiovascular disease and chronic kidney disease, and the impact of systematically assessing and addressing social determinants of health. This scientific statement uses a crosswalk of major guidelines, in addition to a review of the scientific literature, to summarize the evidence and fundamental gaps related to the science, screening, prevention, and management of cardiovascular-kidney-metabolic syndrome.
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Doenças Cardiovasculares , Síndrome Metabólica , Insuficiência Renal Crônica , Estados Unidos/epidemiologia , Humanos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Síndrome Metabólica/diagnóstico , Síndrome Metabólica/epidemiologia , Síndrome Metabólica/terapia , American Heart Association , Fatores de Risco , Rim , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/epidemiologia , Insuficiência Renal Crônica/terapiaRESUMO
Cardiovascular-kidney-metabolic health reflects the interplay among metabolic risk factors, chronic kidney disease, and the cardiovascular system and has profound impacts on morbidity and mortality. There are multisystem consequences of poor cardiovascular-kidney-metabolic health, with the most significant clinical impact being the high associated incidence of cardiovascular disease events and cardiovascular mortality. There is a high prevalence of poor cardiovascular-kidney-metabolic health in the population, with a disproportionate burden seen among those with adverse social determinants of health. However, there is also a growing number of therapeutic options that favorably affect metabolic risk factors, kidney function, or both that also have cardioprotective effects. To improve cardiovascular-kidney-metabolic health and related outcomes in the population, there is a critical need for (1) more clarity on the definition of cardiovascular-kidney-metabolic syndrome; (2) an approach to cardiovascular-kidney-metabolic staging that promotes prevention across the life course; (3) prediction algorithms that include the exposures and outcomes most relevant to cardiovascular-kidney-metabolic health; and (4) strategies for the prevention and management of cardiovascular disease in relation to cardiovascular-kidney-metabolic health that reflect harmonization across major subspecialty guidelines and emerging scientific evidence. It is also critical to incorporate considerations of social determinants of health into care models for cardiovascular-kidney-metabolic syndrome and to reduce care fragmentation by facilitating approaches for patient-centered interdisciplinary care. This presidential advisory provides guidance on the definition, staging, prediction paradigms, and holistic approaches to care for patients with cardiovascular-kidney-metabolic syndrome and details a multicomponent vision for effectively and equitably enhancing cardiovascular-kidney-metabolic health in the population.
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Doenças Cardiovasculares , Sistema Cardiovascular , Síndrome Metabólica , Estados Unidos/epidemiologia , Humanos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Síndrome Metabólica/diagnóstico , Síndrome Metabólica/epidemiologia , Síndrome Metabólica/terapia , American Heart Association , Fatores de Risco , RimRESUMO
Importance: There are ongoing concerns about the benefits of intensive vs standard blood pressure (BP) treatment among adults with orthostatic hypotension or standing hypotension. Objective: To determine the effect of a lower BP treatment goal or active therapy vs a standard BP treatment goal or placebo on cardiovascular disease (CVD) or all-cause mortality in strata of baseline orthostatic hypotension or baseline standing hypotension. Data Sources: Individual participant data meta-analysis based on a systematic review of MEDLINE, EMBASE, and CENTRAL databases through May 13, 2022. Study Selection: Randomized trials of BP pharmacologic treatment (more intensive BP goal or active agent) with orthostatic hypotension assessments. Data Extraction and Synthesis: Individual participant data meta-analysis extracted following PRISMA guidelines. Effects were determined using Cox proportional hazard models using a single-stage approach. Main Outcomes and Measures: Main outcomes were CVD or all-cause mortality. Orthostatic hypotension was defined as a decrease in systolic BP of at least 20 mm Hg and/or diastolic BP of at least 10 mm Hg after changing position from sitting to standing. Standing hypotension was defined as a standing systolic BP of 110 mm Hg or less or standing diastolic BP of 60 mm Hg or less. Results: The 9 trials included 29â¯235 participants followed up for a median of 4 years (mean age, 69.0 [SD, 10.9] years; 48% women). There were 9% with orthostatic hypotension and 5% with standing hypotension at baseline. More intensive BP treatment or active therapy lowered risk of CVD or all-cause mortality among those without baseline orthostatic hypotension (hazard ratio [HR], 0.81; 95% CI, 0.76-0.86) similarly to those with baseline orthostatic hypotension (HR, 0.83; 95% CI, 0.70-1.00; P = .68 for interaction of treatment with baseline orthostatic hypotension). More intensive BP treatment or active therapy lowered risk of CVD or all-cause mortality among those without baseline standing hypotension (HR, 0.80; 95% CI, 0.75-0.85), and nonsignificantly among those with baseline standing hypotension (HR, 0.94; 95% CI, 0.75-1.18). Effects did not differ by baseline standing hypotension (P = .16 for interaction of treatment with baseline standing hypotension). Conclusions and Relevance: In this population of hypertension trial participants, intensive therapy reduced risk of CVD or all-cause mortality regardless of orthostatic hypotension without evidence for different effects among those with standing hypotension.
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Hipertensão , Hipotensão Ortostática , Idoso , Feminino , Humanos , Masculino , Pressão Sanguínea , Determinação da Pressão Arterial , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Hipertensão/complicações , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipotensão Ortostática/complicações , Hipotensão Ortostática/diagnóstico , Hipotensão Ortostática/tratamento farmacológico , Pessoa de Meia-IdadeAssuntos
Doenças Cardiovasculares , Insuficiência Renal Crônica , Humanos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Fatores de Risco , Características de Residência , Fatores de Risco de Doenças Cardíacas , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/epidemiologiaRESUMO
Background: Having diverse representation in clinical trial participation is important. Historically, rural residents have been underrepresented in clinical trial research. Public librarians have an opportunity to promote clinical trial participation among rural residents by offering consumer health information services that help patrons to understand what clinical trials are and how they can find relevant clinical trials. Case Presentation: A consumer health library and a clinical trial center located at a large academic medical center collaborated to provide clinical trial information programming to rural public libraries. The group was awarded a Network of the National Library of Medicine (NNLM) Community Outreach Grant and was able to plan, develop, promote, and implement programs including training workshops, a speaker event, and a book discussion to rural public librarians. Discussion: Marketing the programs to rural public libraries was difficult and many barriers were encountered. Though registration and subsequent participation were low, participants expressed interest and gratitude for the programs. For any future programs targeting this population, further strategies will need to be implemented to ensure increased registrations and attendees.
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Informação de Saúde ao Consumidor , Bibliotecários , Bibliotecas Médicas , Estados Unidos , Humanos , Bibliotecários/educação , National Library of Medicine (U.S.) , População RuralRESUMO
Background Hypertension control is critical to reducing cardiovascular disease, challenging to achieve, and exacerbated by socioeconomic inequities. Few states have established statewide quality improvement (QI) infrastructures to improve blood pressure (BP) control across economically disadvantaged populations. In this study, we aimed to improve BP control by 15% for all Medicaid recipients and by 20% for non-Hispanic Black participants. Methodology This QI study used repeated cross-sections of electronic health record data and, for Medicaid enrollees, linked Medicaid claims data for 17,672 adults with hypertension seen at one of eight high-volume Medicaid primary care practices in Ohio from 2017 to 2019. Evidence-based strategies included (1) accurate BP measurement; (2) timely follow-up; (3) outreach; (4) a standardized treatment algorithm; and (5) effective communication. Payers focused on a 90-day supply (vs. 30-day) of BP medications, home BP monitor access, and outreach. Implementation efforts included an in-person kick-off followed by monthly QI coaching and monthly webinars. Weighted generalized estimating equations were used to estimate the baseline, one-year, and two-year implementation change in the proportion of visits with BP control (<140/90 mm Hg) stratified by race/ethnicity. Results For all practices, the percentage of participants with controlled BP increased from 52% in 2017 to 60% in 2019. Among non-Hispanic Whites, the odds of achieving BP control in year one and year two were 1.24 times (95% confidence interval: 1.14, 1.34) and 1.50 times (1.38, 1.63) higher relative to baseline, respectively. Among non-Hispanic Blacks, the odds for years one and two were 1.18 times (1.10, 1.27) and 1.34 times (1.24, 1.45) higher relative to baseline, respectively. Conclusions A hypertension QI project as part of establishing a statewide QI infrastructure improved BP control in practices with a high volume of disadvantaged patients. Future efforts should investigate ways to reduce inequities in BP control and further explore factors associated with greater BP improvements and sustainability.
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Background Peripheral artery disease (PAD) increases the risk of cardiovascular events and limb events including amputations. PAD is twice as prevalent in Black compared with non-Hispanic White individuals, especially among men. Screening for PAD using the ankle-brachial index in community settings, such as the barbershop, could lead to earlier diagnosis and treatment. Methods and Results A pilot study was conducted at 2 barbershops in Cleveland, OH from June to December 2020 to assess the feasibility of screening for PAD in the barbershop setting and the effect of an educational intervention on PAD awareness. After screening with both automated and Doppler ankle-brachial index, PAD was identified in 5/31 (16.1%) of participants. Baseline systolic blood pressure, low-density lipoprotein cholesterol, and random blood glucose were higher in participants who screened positive for PAD (P<0.001). PAD awareness was low overall. There was a significant improvement in PAD awareness assessment scores obtained at the initial and exit visits (9.93±4.23 to 12.50±4.41, P=0.004). An association was found between PAD awareness at baseline and highest education level achieved: compared with those with some college/associate's degree or higher, non-high school graduates scored lower on PAD awareness (P=0.022), as did those who only had a high school diploma or tests of General Educational Development (P=0.049). Conclusions In a pilot study, barbershop-based screening for PAD among Black men revealed a higher than expected PAD prevalence and low PAD awareness. An educational video was effective at increasing PAD awareness. Ankle-brachial index screening and educational outreach in the barbershop may be a feasible and effective tool to diagnose PAD and reduce PAD disparities among Black men at highest risk.
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Glicemia , Doença Arterial Periférica , Masculino , Humanos , Projetos Piloto , Índice Tornozelo-Braço , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , LDL-Colesterol , Prevalência , Fatores de RiscoRESUMO
Importance: The Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive blood pressure control reduced cardiovascular morbidity and mortality. However, the legacy effect of intensive treatment is unknown. Objective: To evaluate the long-term effects of randomization to intensive treatment with the incidence of cardiovascular and all-cause mortality approximately 4.5 years after the trial ended. Design, Setting, and Participants: In this secondary analysis of a multicenter randomized clinical trial, randomization began on November 8, 2010, the trial intervention ended on August 20, 2015, and trial close-out visits occurred through July 2016. Patients 50 years and older with hypertension and increased cardiovascular risk but without diabetes or history of stroke were included from 102 clinic sites in the US and Puerto Rico. Analyses were conducted between October 2021 and February 2022. Interventions: Randomization to systolic blood pressure (SBP) goal of less than 120 mm Hg (intensive treatment group; n = 4678) vs less than 140 mm Hg (standard treatment group; n = 4683). Main Outcomes and Measures: Extended observational follow-up for mortality via the US National Death Index from 2016 through 2020. In a subset of 2944 trial participants, outpatient SBP from electronic health records during and after the trial were examined. Results: Among 9361 randomized participants, the mean (SD) age was 67.9 (9.4) years, and 3332 (35.6%) were women. Over a median (IQR) intervention period of 3.3 (2.9-3.9) years, intensive treatment was beneficial for both cardiovascular mortality (hazard ratio [HR], 0.66; 95% CI, 0.49-0.89) and all-cause mortality (HR, 0.83; 95% CI, 0.68-1.01). However, at the median (IQR) total follow-up of 8.8 (8.3-9.3) years, there was no longer evidence of benefit for cardiovascular mortality (HR, 1.02; 95% CI, 0.84-1.24) or all-cause mortality (HR, 1.08; 95% CI, 0.94-1.23). In a subgroup of participants, the estimated mean outpatient SBP among participants randomized to intensive treatment increased from 132.8 mm Hg (95% CI, 132.0-133.7) at 5 years to 140.4 mm Hg (95% CI, 137.8-143.0) at 10 years following randomization. Conclusions and Relevance: The beneficial effect of intensive treatment on cardiovascular and all-cause mortality did not persist after the trial. Given increasing outpatient SBP levels in participants randomized to intensive treatment following the trial, these results highlight the importance of consistent long-term management of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.
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Anti-Hipertensivos , Hipertensão , Humanos , Feminino , Idoso , Masculino , Pressão Sanguínea/fisiologia , Anti-Hipertensivos/uso terapêutico , Hipertensão/fisiopatologia , Incidência , Modelos de Riscos ProporcionaisRESUMO
Background Cardiovascular risk factor control is challenging, especially in disadvantaged populations. However, few statewide efforts exist to tackle this challenge. Therefore, our objective is to describe the formation of a unique statewide cardiovascular health collaborative so others may learn from this approach. Methodology With funding from the Ohio Department of Medicaid's Ohio Medicaid Technical Assistance and Policy Program, we used a collective impact model to link the seven medical schools in Ohio, primary care clinics across the state, the Ohio Department of Medicaid, and Ohio's Medicaid Managed Care Plans in a statewide health improvement collaborative for expanding primary care capacity to improve cardiovascular health in Ohio. Results Initial dissemination activities for primary care teams included a virtual case-based learning series focused on hypertension and social determinants of health, website resources, a monthly newsletter with clinical tips, webinars, and in-person conferences. The collaborative is aligned with a separately funded hypertension quality improvement project for paired implementation. Conclusions The collective impact model is a useful framework for developing a statewide collaborative focused on the dissemination and implementation of evidence-based best practices for cardiovascular health improvement and disparity reduction. Statewide collaboratives bringing payers, clinicians, and academic partners together have the potential to substantially impact cardiovascular health.
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BACKGROUND: Communication of the benefits and harms of blood pressure lowering strategy is crucial for shared decision-making. OBJECTIVES: To quantify the effect of intensive versus standard systolic blood pressure lowering in terms of the number of event-free days DESIGN: Post hoc analysis of the Systolic Blood Pressure Intervention Trial PARTICIPANTS: A total of 9361 adults 50 years or older without diabetes or stroke who had a systolic blood pressure of 130-180 mmHg and elevated cardiovascular risk INTERVENTIONS: Intensive (systolic blood pressure goal <120 mmHg) versus standard blood pressure lowering (<140 mmHg) MAIN MEASURES: Days free of major adverse cardiovascular events (MACE), serious adverse events (SAE), and monitored adverse events (hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, or acute kidney injury) over a median follow-up of 3.33 years KEY RESULTS: The intensive treatment group gained 14.7 more MACE-free days over 4 years (difference, 14.7 [95% confidence interval: 5.1, 24.4] days) than the standard treatment group. The benefit of the intensive treatment varied by cognitive function (normal: difference, 40.7 [13.0, 68.4] days; moderate-to-severe impairment: difference, -15.0 [-56.5, 26.4] days; p-for-interaction=0.009) and self-rated health (excellent: difference, -22.7 [-51.5, 6.1] days; poor: difference, 156.1 [31.1, 281.2] days; p-for-interaction=0.001). The mean overall SAE-free days were not significantly different between the treatments (difference, -14.8 [-35.3, 5.7] days). However, the intensive treatment group had 28.5 fewer monitored adverse event-free days than the standard treatment group (difference, -28.5 [-40.3, -16.7] days), with significant variations by frailty status (non-frail: difference, 38.8 [8.4, 69.2] days; frail: difference, -15.5 [-46.6, 15.7] days) and self-rated health (excellent: difference, -12.9 [-45.5, 19.7] days; poor: difference, 180.6 [72.9, 288.4] days; p-for-interaction <0.001). CONCLUSIONS: Over 4 years, intensive systolic blood pressure lowering provides, on average, 14.7 more MACE-free days than standard treatment, without any difference in SAE-free days. Whether this time-based effect summary improves shared decision-making remains to be elucidated. TRIAL REGISTRATION: ClinicalTrials.gov Registration: NCT01206062.
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Injúria Renal Aguda , Doenças Cardiovasculares , Hipertensão , Acidente Vascular Cerebral , Adulto , Humanos , Pressão Sanguínea/fisiologia , Anti-Hipertensivos/efeitos adversos , Hipertensão/tratamento farmacológico , Injúria Renal Aguda/induzido quimicamente , Doenças Cardiovasculares/tratamento farmacológicoRESUMO
BACKGROUND: The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reductions in major cardiovascular disease events and mortality with an intensive systolic blood pressure (SBP) goal intervention. However, a detailed description of the blood pressure intervention, antihypertensive medication usage, blood pressure levels, and rates and predictors of blood pressure control has not been reported previously. METHODS: Hypertensive participants (n=9361) 50 years and older with elevated cardiovascular disease risk were randomized 1:1 to SBP goal <120 mm Hg or SBP goal <140 mm Hg. Guideline-recommended antihypertensive medications and dosing were provided at no cost. Intensive group participants were started on at least 2 medications, and medications were adjusted monthly until SBP goal was achieved, if feasible. Standard group participants were treated to achieve SBP 135 to 139 mm Hg. RESULTS: Baseline blood pressure (median±interquartile range) was 138±19/78±16 mm Hg. For intensive group participants, percent at goal rose from 8.9% at baseline to 52.4% at 6 months and average antihypertensive medications rose from 2.2 to 2.7; SBP was <120 mm Hg in 61.6% and <130 mm Hg in 80.0% at their final visit. For the standard group participants, percent at goal rose from 53.0% at baseline to 68.6% at 6 months, while antihypertensive medications fell from 1.9 to 1.8. From 6 to 36 months, median SBP was stable at 119±14 mm Hg for intensive and 136±15 mm Hg for standard participants, with stable numbers of medications. Few predictors of SBP control were found in multiple regression models. CONCLUSIONS: These results may inform and help replicate the benefits of SPRINT in clinical practice. REGISTRATION: URL: http://www. CLINICALTRIALS: gov; Unique identifier: NCT01206062.
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Doenças Cardiovasculares , Hipertensão , Anti-Hipertensivos/farmacologia , Pressão Sanguínea , Doenças Cardiovasculares/tratamento farmacológico , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Effective management of hypertension (HTN) is a priority in primary care, necessary to decrease the costs, morbidity, and mortality associated with cardiovascular disease. Strategies to support quality improvement (QI) efforts in primary care are needed to make significant improvements in population health, especially for patients who experience socioeconomic inequalities. LOCAL PROBLEM: To address the high rate (>50%) of uncontrolled HTN in the state of Ohio, a statewide QI project was implemented in high-volume Medicaid practices, aimed at improving blood pressure control and addressing racial disparities. The initiative expanded to include coaching QI to support efforts in primary care practices. METHODS: The Model for Improvement guided development of Plan-Do-Study-Act (PDSA) cycles facilitated by QI coaching and APRN collaboration to implement key components of HTN guidelines: accurate blood pressure measurement, effective treatment, and timely follow-up. INTERVENTIONS: Interventions were implemented after PDSA cycles over 18 months in two practice sites to address HTN control. Linking multiple PDSA test cycles and review of data bimonthly allowed for reflection on the impact of interventions for non-Hispanic Black patients and the overall patient population. RESULTS: The percentage of patients with controlled HTN, repeat blood pressure measurement, and timely follow-up improved in an urban primary care practice associated with an academic medical center and in a rural federally qualified health center. CONCLUSIONS: Primary care practices can benefit from the external support of coaching when implementing QI processes to make meaningful change. APRNs are key collaborators for expanding QI efforts in primary care.
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Hipertensão , Tutoria , Centros Médicos Acadêmicos , Humanos , Hipertensão/terapia , Atenção Primária à Saúde , Melhoria de QualidadeRESUMO
IMPORTANCE: Antihypertensive treatments benefit cerebrovascular health and cognitive function in patients with hypertension, but it is uncertain whether an intensive blood pressure target leads to potentially harmful cerebral hypoperfusion. OBJECTIVE: To investigate the association of intensive systolic blood pressure (SBP) control vs standard control with whole-brain cerebral blood flow (CBF). DESIGN, SETTING, AND PARTICIPANTS: This substudy of the Systolic Blood Pressure Intervention Trial (SPRINT) randomized clinical trial compared the efficacy of 2 different blood pressure-lowering strategies with longitudinal brain magnetic resonance imaging (MRI) including arterial spin labeled perfusion imaging to quantify CBF. A total of 1267 adults 50 years or older with hypertension and increased cardiovascular risk but free of diabetes or dementia were screened for the SPRINT substudy from 6 sites in the US. Randomization began in November 2010 with final follow-up MRI in July 2016. Analyses were performed from September 2020 through December 2021. INTERVENTIONS: Study participants with baseline CBF measures were randomized to an intensive SBP target less than 120 mm Hg or standard SBP target less than 140 mm Hg. MAIN OUTCOMES AND MEASURES: The primary outcome was change in whole-brain CBF from baseline. Secondary outcomes were change in gray matter, white matter, and periventricular white matter CBF. RESULTS: Among 547 participants with CBF measured at baseline, the mean (SD) age was 67.5 (8.1) years and 219 (40.0%) were women; 315 completed follow-up MRI at a median (IQR) of 4.0 (3.7-4.1) years after randomization. Mean whole-brain CBF increased from 38.90 to 40.36 (difference, 1.46 [95% CI, 0.08-2.83]) mL/100 g/min in the intensive treatment group, with no mean increase in the standard treatment group (37.96 to 37.12; difference, -0.84 [95% CI, -2.30 to 0.61] mL/100 g/min; between-group difference, 2.30 [95% CI, 0.30-4.30; P = .02]). Gray, white, and periventricular white matter CBF showed similar changes. The association of intensive vs standard treatment with CBF was generally similar across subgroups defined by age, sex, race, chronic kidney disease, SBP, orthostatic hypotension, and frailty, with the exception of an indication of larger mean increases in CBF associated with intensive treatment among participants with a history of cardiovascular disease (interaction P = .05). CONCLUSIONS AND RELEVANCE: Intensive vs standard antihypertensive treatment was associated with increased, rather than decreased, cerebral perfusion, most notably in participants with a history of cardiovascular disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01206062.
Assuntos
Doenças Cardiovasculares , Hipertensão , Idoso , Anti-Hipertensivos/farmacologia , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Circulação Cerebrovascular , Feminino , Humanos , Hipertensão/complicações , Hipertensão/diagnóstico por imagem , Hipertensão/tratamento farmacológicoRESUMO
Hypertension treatment and control prevent more cardiovascular events than management of other modifiable risk factors. Although the age-adjusted proportion of US adults with controlled blood pressure (BP) defined as <140/90 mm Hg, improved from 31.8% in 1999-2000 to 48.5% in 2007-2008, it remained stable through 2013-2014 and declined to 43.7% in 2017-2018. To address the rapid decline in hypertension control, the National Heart, Lung, and Blood Institute and the Division for Heart Disease and Stroke Prevention of the Centers for Disease Control and Prevention convened a virtual workshop with multidisciplinary national experts. Also, the group sought to identify opportunities to reverse the adverse trend and further improve hypertension control. The workshop immediately preceded the Surgeon General's Call to Action to Control Hypertension, which recognized a stagnation in progress with hypertension control. The presentations and discussions included potential reasons for the decline and challenges in hypertension control, possible "big ideas," and multisector approaches that could reverse the current trend while addressing knowledge gaps and research priorities. The broad set of "big ideas" was comprised of various activities that may improve hypertension control, including: interventions to engage patients, promotion of self-measured BP monitoring with clinical support, supporting team-based care, implementing telehealth, enhancing community-clinical linkages, advancing precision population health, developing tailored public health messaging, simplifying hypertension treatment, using process and outcomes quality metrics to foster accountability and efficiency, improving access to high-quality health care, addressing social determinants of health, supporting cardiovascular public health and research, and lowering financial barriers to hypertension control.