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Analysis of Therapeutic Inertia and Race and Ethnicity in the Systolic Blood Pressure Intervention Trial: A Secondary Analysis of a Randomized Clinical Trial.
Zheutlin, AR, Mondesir, FL, Derington, CG, King, JB, Zhang, C, Cohen, JB, Berlowitz, DR, Anstey, DE, Cushman, WC, Greene, TH, et al
JAMA network open. 2022;(1):e2143001
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Abstract
IMPORTANCE Therapeutic inertia may contribute to racial and ethnic differences in blood pressure (BP) control. OBJECTIVE To determine the association between race and ethnicity and therapeutic inertia in the Systolic Blood Pressure Intervention Trial (SPRINT). DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study was a secondary analysis of data from SPRINT, a randomized clinical trial comparing intensive (<120 mm Hg) vs standard (<140 mm Hg) systolic BP treatment goals. Participants were enrolled between November 8, 2010, and March 15, 2013, with a median follow-up 3.26 years. Participants included adults aged 50 years or older at high risk for cardiovascular disease but without diabetes, previous stroke, or heart failure. The present analysis was restricted to participant visits with measured BP above the target goal. Analyses for the present study were performed in from October 2020 through March 2021. EXPOSURES Self-reported race and ethnicity, mutually exclusively categorized into groups of Hispanic, non-Hispanic Black, or non-Hispanic White participants. MAIN OUTCOMES AND MEASURES Therapeutic inertia, defined as no antihypertensive medication intensification at each study visit where the BP was above target goal. The association between self-reported race and ethnicity and therapeutic inertia was estimated using generalized estimating equations and stratified by treatment group. Antihypertensive medication use was assessed with pill bottle inventories at each visit. Blood pressure was measured using an automated device. RESULTS A total of 8556 participants, including 4141 in the standard group (22 844 participant-visits; median age, 67.0 years [IQR, 61.0-76.0 years]; 1467 women [35.4%]) and 4415 in the intensive group (35 453 participant-visits; median age, 67.0 years [IQR, 61.0-76.0 years]; 1584 women [35.9%]) with at least 1 eligible study visit were included in the present analysis. Among non-Hispanic White, non-Hispanic Black, and Hispanic participants, the overall prevalence of therapeutic inertia in the standard vs intensive groups was 59.8% (95% CI, 58.9%-60.7%) vs 56.0% (95% CI, 55.2%-56.7%), 56.8% (95% CI, 54.4%-59.2%) vs 54.5% (95% CI, 52.4%-56.6%), and 59.7% (95% CI, 56.5%-63.0%) vs 51.0% (95% CI, 47.4%-54.5%), respectively. The adjusted odds ratios in the standard and intensive groups for therapeutic inertia associated with non-Hispanic Black vs non-Hispanic White participants were 0.85 (95% CI, 0.79-0.92) and 0.94 (95% CI, 0.88-1.01), respectively. The adjusted odds ratios for therapeutic inertia comparing Hispanic vs non-Hispanic White participants were 1.00 (95% CI, 0.90-1.13) and 0.89 (95% CI, 0.79-1.00) in the standard and intensive groups, respectively. CONCLUSIONS AND RELEVANCE Among SPRINT participants above BP target goal, this cross-sectional study found that therapeutic inertia prevalence was similar or lower for non-Hispanic Black and Hispanic participants compared with non-Hispanic White participants. These findings suggest that a standardized approach to BP management, as used in SPRINT, may help ensure equitable care and could reduce the contribution of therapeutic inertia to disparities in hypertension. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01206062.
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A Randomized Crossover Pilot Study Examining the Effect of Carvedilol and Terazosin plus Enalapril on Urinary Symptoms of Patients with Hypertension and Benign Prostatic Hyperplasia.
Farshi, A, DalirAkbari, N, Zomorrodi, A, Khalili, M, Mahmoudinezhad, M
Urology journal. 2021;(3):337-342
Abstract
PURPOSE The present study aims to assess and compare the effects of carvedilol and terazosin plus enalapril on lower urinary tract symptoms (LUTS), the urine flow, and blood pressure (BP) in patients with moderate hypertension (HTN) and benign prostatic hyperplasia (BPH). MATERIALS AND METHODS In this randomized crossover trial, a total of 40 men with HTN and LUTS symptoms were enrolled. The first group was treated with carvedilol, and the second one received terazosin plus enalapril. After eight weeks of treatment, the patients experienced a one-month washout period, and the treatments changed and continued for eight weeks. To diagnose BPH in the study, the international prostate symptom score (IPSS) questionnaire was used. Moreover, the prostate-specific antigen (PSA), the post-void residual (PVR) urine volume, and the maximum urinary flow rate (Q-max using the uroflowmetry test) were measured. RESULTS Effect assessment results in this crossover trial illustrated neither carryover effects nor significant treatment effects on all primary outcomes (P > 0.05). Moreover, the results for the period effect indicated a significant reduction in BP (systolic and diastolic), PVR, and IPSS, yet a significant raise in Qmax. CONCLUSION The effects of carvedilol are similar to those of the combination of terazosin and enalapril in patients with moderate HTN and BPH in controlling LUTS. Carvedilol could be used as an appropriative drug in patients with moderate HTN and cardiac problems with LUTS of BPH. Further studies are recommended to be conducted to investigate and compare the efficacy of carvedilol with that of other alpha-blockers with a larger sample size and over a longer period of time.
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Feasibility and acceptability of a nutritional intervention testing the effects of nitrate-rich beetroot juice and folic acid on blood pressure in Tanzanian adults with elevated blood pressure.
Kandhari, N, Prabhakar, M, Shannon, O, Fostier, W, Koehl, C, Rogathi, J, Temu, G, Stephan, BCM, Gray, WK, Haule, I, et al
International journal of food sciences and nutrition. 2021;(2):195-207
Abstract
Sub-Saharan African countries are experiencing an alarming increase in hypertension prevalence. This study evaluated the feasibility and acceptability of nitrate-rich beetroot and folate supplementation, alone or combined, for the reduction of blood pressure (BP) in Tanzanian adults with elevated BP. This was a three-arm double-blind, placebo-controlled, parallel randomised clinical trial. Forty-eight participants were randomised to one of three groups to follow a specific 60-day intervention which included a: (1) combined intervention (beetroot juice + folate), (2) single intervention (beetroot juice + placebo), and (3) control group (nitrate-depleted beetroot juice + placebo). Forty-seven participants (age: 50-70 years) completed the study. The acceptability of the interventions was high. Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms. This study provides important information for the design of high-nitrate interventions to reduce BP in Sub-Saharan African countries.
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Antihypertensives and Statin Therapy for Primary Stroke Prevention: A Secondary Analysis of the HOPE-3 Trial.
Bosch, J, Lonn, EM, Dagenais, GR, Gao, P, Lopez-Jaramillo, P, Zhu, J, Pais, P, Avezum, A, Sliwa, K, Chazova, IE, et al
Stroke. 2021;(8):2494-2501
Abstract
BACKGROUND AND PURPOSE The HOPE-3 trial (Heart Outcomes Prevention Evaluation–3) found that antihypertensive therapy combined with a statin reduced first stroke among people at intermediate cardiovascular risk. We report secondary analyses of stroke outcomes by stroke subtype, predictors, treatment effects in key subgroups. METHODS Using a 2-by-2 factorial design, 12 705 participants from 21 countries with vascular risk factors but without overt cardiovascular disease were randomized to candesartan 16 mg plus hydrochlorothiazide 12.5 mg daily or placebo and to rosuvastatin 10 mg daily or placebo. The effect of the interventions on stroke subtypes was assessed. RESULTS Participants were 66 years old and 46% were women. Baseline blood pressure (138/82 mm Hg) was reduced by 6.0/3.0 mm Hg and LDL-C (low-density lipoprotein cholesterol; 3.3 mmol/L) was reduced by 0.90 mmol/L on active treatment. During 5.6 years of follow-up, 169 strokes occurred (117 ischemic, 29 hemorrhagic, 23 undetermined). Blood pressure lowering did not significantly reduce stroke (hazard ratio [HR], 0.80 [95% CI, 0.59–1.08]), ischemic stroke (HR, 0.80 [95% CI, 0.55–1.15]), hemorrhagic stroke (HR, 0.71 [95% CI, 0.34–1.48]), or strokes of undetermined origin (HR, 0.92 [95% CI, 0.41–2.08]). Rosuvastatin significantly reduced strokes (HR, 0.70 [95% CI, 0.52–0.95]), with reductions mainly in ischemic stroke (HR, 0.53 [95% CI, 0.37–0.78]) but did not significantly affect hemorrhagic (HR, 1.22 [95% CI, 0.59–2.54]) or strokes of undetermined origin (HR, 1.29 [95% CI, 0.57–2.95]). The combination of both interventions compared with double placebo substantially and significantly reduced strokes (HR, 0.56 [95% CI, 0.36–0.87]) and ischemic strokes (HR, 0.41 [95% CI, 0.23–0.72]). CONCLUSIONS Among people at intermediate cardiovascular risk but without overt cardiovascular disease, rosuvastatin 10 mg daily significantly reduced first stroke. Blood pressure lowering combined with rosuvastatin reduced ischemic stroke by 59%. Both therapies are safe and generally well tolerated. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT00468923.
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Antihypertensive and pleiotropic effects of Phyllanthus emblica extract as an add-on therapy in patients with essential hypertension-A randomized double-blind placebo-controlled trial.
Shanmugarajan, D, Girish, C, Harivenkatesh, N, Chanaveerappa, B, Prasanna Lakshmi, NC
Phytotherapy research : PTR. 2021;(6):3275-3285
Abstract
Essential hypertension is an important cause of cardiovascular morbidity and mortality that is compounded by concomitant risk factors like diabetes mellitus and dyslipidemia. Phyllanthus emblica is a rich source of antioxidants, tannins, and vitamin C and is used in treating various ailments in traditional medicine. This study aimed to elucidate the effects of aqueous extract of Phyllanthus emblica on essential hypertension and other protective actions. This randomized controlled trial was conducted on 150 patients with essential hypertension. Participants were randomly assigned to receive Phyllanthus emblica capsule (500 mg) or placebo twice daily, added to their routine medications for 12 weeks. Blood pressure was assessed at baseline, 2, 4, 8, and 12 weeks after beginning treatment or placebo. Other investigations like lipid parameters, oxidant and antioxidant enzyme levels, hs-CRP levels, HbA1C, LFT, RFT, uric acid, and endothelial function were measured at baseline and 12 weeks. Both Phyllanthus emblica and placebo groups were comparable at baseline. Phyllanthus emblica had a good safety profile in patients with essential hypertension. However, the treatment with Phyllanthus emblica failed to produce any additional reduction in systolic and/or diastolic blood pressure levels and did not exhibit improvement in oxidant status, antioxidant capacity, lipid profile, HbA1C, arterial stiffness parameters, or hs-CRP levels.
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Association of Angiotensin II-Stimulating Antihypertensive Use and Dementia Risk: Post Hoc Analysis of the PreDIVA Trial.
van Dalen, JW, Marcum, ZA, Gray, SL, Barthold, D, Moll van Charante, EP, van Gool, WA, Crane, PK, Larson, EB, Richard, E
Neurology. 2021;(1):e67-e80
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OBJECTIVE To assess whether angiotensin II-stimulating antihypertensives (thiazides, dihydropyridine calcium channel blockers, and angiotensin I receptor blockers) convey a lower risk of incident dementia compared to angiotensin II-inhibiting antihypertensives (angiotensin-converting enzyme inhibitors, β-blockers, and nondihydropyridine calcium channel blockers), in accordance with the "angiotensin hypothesis." METHODS We performed Cox regression analyses of incident dementia (or mortality as competing risk) during 6-8 years of follow-up in a population sample of 1,909 community-dwelling individuals (54% women) without dementia, aged 70-78 (mean 74.5 ± 2.5) years. RESULTS After a median of 6.7 years of follow-up, dementia status was available for 1,870 (98%) and mortality for 1,904 (>99%) participants. Dementia incidence was 5.6% (27/480) in angiotensin II-stimulating, 8.2% (59/721) in angiotensin II-inhibiting, and 6.9% (46/669) in both antihypertensive type users. Adjusted for dementia risk factors including blood pressure and medical history, angiotensin II-stimulating antihypertensive users had a 45% lower incident dementia rate (hazard ratio [HR], 0.55; 95% CI, 0.34-0.89) without excess mortality (HR, 0.86; 95% CI, 0.64-1.16), and individuals using both types had a nonsignificant 20% lower dementia rate (HR, 0.80; 95% CI,0.53-1.20) without excess mortality (HR, 0.97; 95% CI, 0.76-1.24), compared to angiotensin II-inhibiting antihypertensive users. Results were consistent for subgroups based on diabetes and stroke history, but may be specific for individuals without a history of cardiovascular disease. CONCLUSIONS Users of angiotensin II-stimulating antihypertensives had lower dementia rates compared to angiotensin II-inhibiting antihypertensive users, supporting the angiotensin hypothesis. Confounding by indication must be examined further, although subanalyses suggest this did not influence results. If replicated, dementia prevention could become a compelling indication for older individuals receiving antihypertensive treatment.
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Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial.
Towfighi, A, Cheng, EM, Ayala-Rivera, M, Barry, F, McCreath, H, Ganz, DA, Lee, ML, Sanossian, N, Mehta, B, Dutta, T, et al
JAMA network open. 2021;(2):e2036227
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IMPORTANCE Few stroke survivors meet recommended cardiovascular goals, particularly among racial/ethnic minority populations, such as Black or Hispanic individuals, or socioeconomically disadvantaged populations. OBJECTIVE To determine if a chronic care model-based, community health worker (CHW), advanced practice clinician (APC; including nurse practitioners or physician assistants), and physician team intervention improves risk factor control after stroke in a safety-net setting (ie, health care setting where all individuals receive care, regardless of health insurance status or ability to pay). DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial included participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial. Inclusion criteria were age 40 years or older; experience of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) no more than 90 days prior; systolic blood pressure (BP) of 130 mm Hg or greater or 120 to 130 mm Hg with history of hypertension or using hypertensive medications; and English or Spanish language proficiency. The exclusion criterion was inability to consent. Among 887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion. The study was conducted from February 2014 to September 2018, and data were analyzed from October 2018 to November 2020. INTERVENTIONS Participants randomized to intervention were offered a multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools. Participants randomized to the control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials. MAIN OUTCOMES AND MEASURES The primary outcome was change in systolic BP at 12 months. Secondary outcomes were non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months. Potential mediators assessed included access to care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use. RESULTS Among 487 participants included, the mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian. A total of 246 participants were randomized to usual care, and 241 participants were randomized to the intervention. Mean (SD) systolic BP improved from 143 (17) mm Hg at baseline to 133 (20) mm Hg at 12 months in the intervention group and from 146 (19) mm Hg at baseline to 137 (22) mm Hg at 12 months in the usual care group, with no significant differences in the change between groups. Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0]; P = .004) and serum CRP level (difference in log CRP, -0.4 [95% CI, -0.7 to -0.1] mg/dL; P = .003); there were no differences in other secondary outcomes. Although 216 participants (89.6%) in the intervention group received some of the 3 core components, only 35 participants (14.5%) received the intended full dose. CONCLUSIONS AND RELEVANCE This randomized clinical trial of a complex multilevel, multimodal intervention did not find vascular risk factor improvements beyond that of usual care; however, further studies may consider testing the SUCCEED intervention with modifications to enhance implementation and participant engagement. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01763203.
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Effectiveness of a stepwise cardiometabolic disease prevention program: Results of a randomized controlled trial in primary care.
Stol, DM, Badenbroek, IF, Hollander, M, Nielen, MMJ, Kraaijenhagen, RA, Schellevis, FG, de Wit, NJ
Preventive medicine. 2020;:105984
Abstract
Effective preventive strategies for cardiometabolic disease (CMD) are needed. We aim to establish the effectiveness of a stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. We conducted a RCT between 2014 and 2017. Individuals (45-70 years) without CMD or CMD risk factors were invited for stepwise CMD risk assessment through a risk score (step1), additional risk assessment at the practice in case of high-risk (step2) and individualized follow-up treatment if indicated (step3). We compared newly detected CMD and newly prescribed drugs during one-year follow-up, and change in CMD risk profile between baseline and one-year follow-up among participants who completed step2 to matched controls. A CMD was diagnosed almost three times more often (OR 2.90, 95% CI 2.25: 3.72) in the intervention compared to the control group, in parallel with newly prescribed antihypertensive and lipid lowering drugs (OR 2.85, 95% CI 1.96: 4.15 and 3.23, 95% CI 2.03: 5.14 respectively). Waist circumference significantly decreased between the intervention compared to the control group (mean -3.08 cm, 95% CI -3.73: -2.43). No differences were observed for changes in BMI and smoking. Systolic blood pressure (mean -2.26 mmHg, 95% CI -4.01: -0.51) and cholesterol ratio (mean -0.11, 95% CI -0.19: -0.02) significantly decreased within intervention participants between baseline and one-year follow-up. In conclusion, implementation of the CMD prevention program resulted in the detection of two- to threefold more patients with CMD. A significant drop in systolic blood pressure and cholesterol levels was found after one year of treatment. Modelling of these results should confirm the effect on long term endpoints. Trial registration: Dutch trial Register number NTR4277.
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Efficacy of Acupuncture in the Treatment of Elderly Patients with Hypertension in Home Health Care: A Randomized Controlled Trial.
Huang, KY, Huang, CJ, Hsu, CH
Journal of alternative and complementary medicine (New York, N.Y.). 2020;(4):273-281
Abstract
Objective: To evaluate the efficacy of acupuncture in helping antihypertensive drugs lower the hypertension of elderly patients in home health care. Design: Randomized controlled trial. Setting: Subjects were recruited from Branch of Linsen, Chinese Medicine, and Kunming, Taipei City Hospital, Taipei, Taiwan. Subjects: A total of 70 participants with hypertension in home health care were assigned randomly to the acupuncture group (35 participants) or the control group (35 participants). Interventions: The acupuncture group received antihypertensive drugs plus acupuncture twice a week for 12 weeks, and the control group received antihypertensive drugs only. Acupuncture points SP10, SP6, LR3, ST36, and LI4 were used bilaterally. Each acupuncture treatment session lasted 30 min. All the subjects were instructed not to alter their diet, physical activity, or use of drugs. Outcome measurements: Blood pressure (BP), heart rate variability, and the Constitution in Chinese Medicine Questionnaire (CCMQ) were assessed at baseline and at 6 and 12 weeks from the baseline between 9 am and 10 am in all subjects. Results: A total of 31 participants in each group completed the study. Within-group differences were observed in systolic BP (SBP) (p < 0.001), diastolic BP (p < 0.001), standard deviation of normal sinus beat intervals (SDNN) (p = 0.01), low frequency (p = 0.05), high frequency (p = 0.01), total power (TP) (p = 0.01), percentage of successive intervals that differ by more than 50 msec (PNN50) (p = 0.01), qi deficiency (p = 0.003), blood stasis (p = 0.02), and qi depression (p = 0.03) constitution. Significant between-group differences were observed in SBP (p = 0.001), SDNN (p = 0.008), and TP (p = 0.04). Conclusions: This study suggested that in the home health care hypertension population, antihypertensive drugs plus acupuncture may be more beneficial in lowering BP and in regulating autonomic nervous system activity than drugs alone. A longer follow-up and larger sample size should be considered in future studies to reveal the precise effect of acupuncture followed by evidence-based practice.
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Personalized text message and checklist support for initiation of antihypertensive medication: the cluster randomized, controlled check and support trial.
Tahkola, A, Korhonen, P, Kautiainen, H, Niiranen, T, Mäntyselkä, P
Scandinavian journal of primary health care. 2020;(2):201-209
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Objective: To assess whether the use of a checklist combined with text message support improves systolic blood pressure (SBP) control.Design and setting: A cluster randomized controlled trial in Finnish primary care.Interventions: Personalized text message support and a checklist for initiation of antihypertensive medication.Patients: 111 newly diagnosed hypertensive patients aged 30-75 years.Main outcome measures: The proportion of patients achieving 1) the office SBP target <140 mmHg or 2) the home SBP target <135 mmHg at 12 months.Results: 28% (n = 16) and 31% (n = 17) of patients in the intervention and control groups met the office SBP target, respectively (p = 0.51). The corresponding proportions were 36% (n = 18) and 42% (n = 21) for the home SBP target (p = 0.21). Office SBP decreased 23 mmHg (95% CI: 29-17) in the intervention group and 21 mmHg (95% CI: 27-15) in the control group (p = 0.61). Medication changes, number of antihypertensives at 12 months and health care utilization were similar in both study groups. Patients considered checklist and text message support useful and important.Conclusion: Only a small proportion of patients in the intervention and control groups reached their treatment target despite multiple health care contacts and medication changes. The study interventions did not improve SBP control. However, this study demonstrates new information about hypertension control, antihypertensive medication and health service utilization during the first treatment year.