Mean Change In Systolic Blood Pressure Research Articles

Injectable angiotensinogen inhibition therapy for hypertension: a systematic review and meta-analysis

Abstract Introduction Hypertension is the leading risk factor worldwide for cardiovascular mortality, and the development of kidney disease. Management of hypertension involves multiple approaches that involve daily tablet ingestion, with high rates of non-adherence. There is an unmet need for innovative interventions to improve adherence to treatment. Purpose We aimed to perform a systematic review and meta-analysis to investigate the role of injectable angiotensinogen (AGT) inhibitors, such as Zilebesiran and IONIS-AGT-LRx, in the treatment of hypertension. Methods PubMed, Embase, and the Cochrane Library were systematically searched for randomized controlled clinical trials (RCTs) comparing injectable AGT inhibitors versus placebo. Efficacy was assessed through mean changes in angiotensinogen, systolic blood pressure (SBP), and diastolic blood pressure (DBP). We also examined safety endpoints. We computed pooled mean differences (MD) or risk ratios (RR) for continuous and binary outcomes, respectively, under a random-effects model with a 95% confidence interval (CI). Results Four studies were included for a total of 512 patients, of whom 279 (54.5%) were male, with a mean age of 57 years old; 349 (68.2%) were white. The mean baseline SBP was 142 ± 19.9 mmHg. In a pooled analysis, mean change of AGT decreased significantly with injectable AGT inhibitor compared with placebo (MD -77.86 %; 95% CI -107.49 to -48.23; p<0.01). Similarly, mean change in SBP (MD -14.15 mmHg; 95% CI -19.53 to -8.78; p=0.30) and DBP (MD -8.49 mmHg; 95% CI -9.98 to -7.00; p=0.78) were also significantly lower in the injectable AGT inhibitor group compared with placebo. AGT inhibitors were well tolerated, without associations with serious adverse events, adverse events related to discontinuation, death, hyperkalaemia, or hypotension. However, there was an increase in injection site reaction with these agents compared with placebo (RR 5.86; 95% CI 1.14 to 30.17; p=0.83). Conclusions In this meta-analysis of RCTs, injectable AGT inhibitors were associated with a significant decrease in mean AGT, SBP, and DBP as compared with placebo. There were no significant differences between groups in serious adverse events, although injection site reaction was more common in patients treated with injectable AGT inhibitors.Forest plot of mean change in SBP

Effectiveness of community-based hypertension management on hypertension in the urban slums of Haiti: A mixed methods study.

Hypertension is a leading contributor to mortality in low-middle income countries including Haiti, yet only 13% achieve blood pressure (BP) control. We evaluated the effectiveness of a community-based hypertension management program delivered by community health workers (CHWs) and physicians among 100 adults with uncontrolled hypertension from the Haiti Cardiovascular Disease Cohort. The 12-month intervention included: community follow-up visits with CHWs (1 month if BP uncontrolled ≥140/90, 3 months otherwise) for BP measurement, lifestyle counseling, medication delivery, and dose adjustments. Primary outcome was mean change in systolic BP from enrollment to 12 months. Secondary outcomes were mean change in diastolic BP, BP control, acceptability, feasibility, and adverse events. We compared outcomes to 100 age, sex, and baseline BP matched controls with standard of care: clinic follow-up visits with physicians every 3 months. We also conducted qualitative interviews with participants and providers. Among 200 adults, median age was 59 years, 59% were female. Baseline mean BP was 154/89mmHg intervention versus 153/88mmHg control. At 12 months, the difference in SBP change between groups was -12.8mmHg (95%CI -6.9, -18.7) and for DBP -7.1mmHg (95%CI -3.3, -11.0). BP control increased from 0% to 58.1% in intervention, and 28.4% in control group. Four participants reported mild adverse events. In mixed methods analysis, we found community-based delivery addressed multiple participant barriers to care, and task-shifting with strong teamwork enhanced medication adherence. Community-based hypertension management using task-shifting with CHWs and community-based care was acceptable, and effective in reducing SBP, DBP, and increasing BP control.

Effect of health extension workers-led home-based multicomponent intervention on blood pressure reduction among hypertensive patients in rural districts of northwest Ethiopia: a cluster-randomised controlled trial.

To evaluate effects of health extension workers-led home-based multicomponent intervention on blood pressure change in hypertensive patients in rural districts of northwest Ethiopia. Two-arm cluster randomised controlled trial was conducted. Hypertensive patients' age ≥25 years were included. 20 clusters or kebeles with 456 participants were randomly assigned to the intervention group (10 clusters with 228 participants) and the control group (10 clusters with 228 participants). Participants in the intervention kebeles received health extension workers-led home-based multicomponent interventions every other month for 40-60 min for 9 months. The primary outcomes were the differences in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) changes from baseline between patients in the intervention and control groups. Intention-to-treat analysis was used for the primary analyses. Linear mixed effect model was used to evaluate the intervention's effect on change in mean SBP and DBP. Effect sizes of mean difference and relative benefit increase were used. At 9 months, the mean SBP decreased by 15.8 mm Hg (95% CI: 13.5, 18.1) in the intervention and 10.8 mm Hg (95% CI: 8.7, 12.9) in the control groups; with a 5.0 mm Hg (95% CI: 1.9, 8.1) greater reduction in the intervention group. The mean DBP decreased by 12.1 mm Hg (95% CI: 10.6, 13.5) in the intervention and 8.4 mm Hg (95% CI: 7.0, 9.8) in the control group. The proportion of optimal blood pressure control was higher in the intervention group (45.8%) than the control group (28.2%) with percentage difference of 17.6% (95% CI: 8.5, 26.7). Health extension workers-led home-based multicomponent intervention has resulted significant reduction of blood pressure and achieved a higher proportion of optimal blood pressure control. This strategy is effective, but further research is needed to determine its cost effectiveness for scaling up and integrating in primary care settings. The trial is registered with Pan African clinical trial registry (PACTR202102729454417).

Comparative Efficacy of Monotherapy of Angiotensin-converting Enzyme Inhibitors Versus Angiotensin Receptor Blockers in Treating Essential Hypertension – A Meta-analysis

Background: Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are widely used medications for treating essential hypertension, but there is limited research comparing their effectiveness. To address this gap, a recent meta-analysis was conducted to evaluate and compare the efficacy of these two drug classes in decreasing blood pressure (BP) among patients with essential hypertension. Objective: Evaluating of comparative efficacy of ACEIs versus ARBs in reducing BP in essential hypertension. Methods: An extensive literature search for randomized controlled trials (RCTs) following PRISMA guidelines (2020), with inclusion criteria of age ≥18 years, with either gender and diagnosed of essential hypertension and receiving ACEIs or ARBs for at least 4 weeks. Patients with secondary hypertension, malignancy, symptomatic cardiovascular system (CVS) disease, hepatic involvement, and studies with Fimasartan and Allisartan were excluded. For this study, all RCTs that reported changes in mean systolic BP (SBP) and diastolic BP (DBP) before and after administration of the drugs were gathered. Standardized mean difference (SMD) was calculated using RevMan 5.4.1 software. The significance level was set at a P < 0.05. Results: A total of 28 RCTs ( n = 9778) were included in our study. Both groups reduce SBP and DBP from the baseline values. Pooled analyses of studies showed that ARBs were superior to ACEIs with SMD = 0.179 in the random-effect model, 95% confidence interval (CI) (0.0975–0.260), P < 0.001, and in the fixed-effect model, SMD = 0.207, 95% CI (0.167–0.248), P < 0.001 in the mean reduction of SBP. Furthermore, for a mean reduction in DBP, ARBs were superior to ACEIs with SMD = 0.329 in the random-effect model, 95% CI (0.161–0.496), P < 0.001, and in the fixed-effect model, SMD = 0.317, 95% CI (0.276–0.357), P < 0.001. Our study included 28 RCTs with a combined sample size of 9778 participants. Both ACEIs and ARBs were found to effectively reduce SBP and DBP from their baseline values. However, our pooled analysis of the studies revealed that ARBs were more effective than ACEIs in reducing mean SBP, with an SMD of 0.179 in the random-effect model and 0.207 in the fixed-effect model. The 95% CIs for these estimates were (0.0975–0.260) and (0.167–0.248), respectively, with P < 0.001. Similarly, for a mean reduction in DBP, ARBs were found to be superior to ACEIs with a SMD of 0.329 in the random-effect model and 0.317 in the fixed-effect model, with 95% CIs of (0.161–0.496) and (0.276–0.357), respectively, and a P < 0.001. Conclusion: ARBs are more efficacious as compared to ACEIs in essential hypertension.

Use of activity trackers to improve blood pressure in young people at risk for cardiovascular disease: a pilot randomized controlled trial.

Promoting physical activity among young individuals with cardiovascular disease (CVD) risk factors such as hypertension, diabetes, or chronic kidney disease can lower systolic blood pressure (BP). We sought to determine whether a 6-month intervention using a physical activity tracker was feasible and effective, compared with usual care. Participants were recruited at a single academic medical center. Those aged 8-30years were randomized in a 2:1 ratio to either the intervention (use of a Fitbit physical activity tracker coupled with feedback regarding the participant's step count) or usual care. The primary feasibility outcomes were screening-to-enrollment ratio and 6-month retention rates; the primary clinical outcome was a change in systolic BP from 0-6months. Sixty-three participants were enrolled (57% male; mean age: 18 ± 4years). The screening-to-enrollment ratio was 1.8:1. Six-month retention was 62% in the intervention group and 86% in the control group (p = 0.08). Mean change in systolic BP in the intervention group was not significantly different from the control group at 6months (- 2.3mmHg; 95% CI - 6.5, 1.8 vs. 3.0mmHg; 95% CI - 2.5, 8.4, respectively, p = 0.12). Among children and young adults at elevated CVD risk, the use of a physical activity tracker coupled with tailored feedback regarding their step count progress was feasible but not sustained over time. Physical activity tracker use did not have a statistically significant effect on BP after 6months. Augmented strategies to mitigate risk in young patients at high risk for early-onset CVD should be explored. This trial is registered at ClinicalTrials.gov (NCT03325426).

Clinical Decision Support for Hypertension Management in Chronic Kidney Disease

Chronic kidney disease (CKD) affects 37 million adults in the United States, and for patients with CKD, hypertension is a key risk factor for adverse outcomes, such as kidney failure, cardiovascular events, and death. To evaluate a computerized clinical decision support (CDS) system for the management of uncontrolled hypertension in patients with CKD. This multiclinic, randomized clinical trial randomized primary care practitioners (PCPs) at a primary care network, including 15 hospital-based, ambulatory, and community health center-based clinics, through a stratified, matched-pair randomization approach February 2021 to February 2022. All adult patients with a visit to a PCP in the last 2 years were eligible and those with evidence of CKD and hypertension were included. The intervention consisted of a CDS system based on behavioral economic principles and human-centered design methods that delivered tailored, evidence-based recommendations, including initiation or titration of renin-angiotensin-aldosterone system inhibitors. The patients in the control group received usual care from PCPs with the CDS system operating in silent mode. The primary outcome was the change in mean systolic blood pressure (SBP) between baseline and 180 days compared between groups. The primary analysis was a repeated measures linear mixed model, using SBP at baseline, 90 days, and 180 days in an intention-to-treat repeated measures model to account for missing data. Secondary outcomes included blood pressure (BP) control and outcomes such as percentage of patients who received an action that aligned with the CDS recommendations. The study included 174 PCPs and 2026 patients (mean [SD] age, 75.3 [0.3] years; 1223 [60.4%] female; mean [SD] SBP at baseline, 154.0 [14.3] mm Hg), with 87 PCPs and 1029 patients randomized to the intervention and 87 PCPs and 997 patients randomized to usual care. Overall, 1714 patients (84.6%) were treated for hypertension at baseline. There were 1623 patients (80.1%) with an SBP measurement at 180 days. From the linear mixed model, there was a statistically significant difference in mean SBP change in the intervention group compared with the usual care group (change, -14.6 [95% CI, -13.1 to -16.0] mm Hg vs -11.7 [-10.2 to -13.1] mm Hg; P = .005). There was no difference in the percentage of patients who achieved BP control in the intervention group compared with the control group (50.4% [95% CI, 46.5% to 54.3%] vs 47.1% [95% CI, 43.3% to 51.0%]). More patients received an action aligned with the CDS recommendations in the intervention group than in the usual care group (49.9% [95% CI, 45.1% to 54.8%] vs 34.6% [95% CI, 29.8% to 39.4%]; P < .001). These findings suggest that implementing this computerized CDS system could lead to improved management of uncontrolled hypertension and potentially improved clinical outcomes at the population level for patients with CKD. ClinicalTrials.gov Identifier: NCT03679247.

Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study

BackgroundA fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP monitoring (ABPM) may be a better predictor of cardiovascular disease risk than in-clinic BP. MethodsThis randomized, multicenter, double-blind study enrolled 565 adults with overweight/obesity. Inclusion criteria included participants willing to wear ABPM device for 24 h. Exclusion criteria included screening blood pressure >140/90 mmHg and antihypertensive medications not stable for 3 months prior to randomization. Participants received placebo (n = 184), phentermine 30 mg; (n = 191), or PHEN 15 mg/TPM 92 mg; (n = 190). 24-hour ABPM was performed at baseline and at week 8. The primary endpoint was mean 24-h systolic BP (SBP) as measured by ABPM, in the per protocol population. ResultsParticipants were mostly female (73.5 ​%) and White (81.6 ​%), with a mean age of 53.4 years; 32.4 ​% had no hypertension diagnosis or treatment, 62.5 ​% had hypertension using 0 to 2 antihypertensive medications, and 5.1 ​% had hypertension using ≥ 3 antihypertensive medications. Baseline mean SBP/diastolic BP (DBP) was 123.9/77.6 ​mmHg. At week 8, mean SBP change was −0.1 ​mmHg (placebo), +1.4 ​mmHg (phentermine 30 ​mg), and −3.3 ​mmHg (PHEN/TPM). Between-group difference for PHEN/TPM versus placebo was −3.2 ​mmHg (95 ​% CI: -5.48, -0.93 ​mmHg; p ​= ​0.0059). The between-group difference for PHEN/TPM versus phentermine 30 ​mg was −4.7 ​mmHg (95 ​% CI: −6.96, −2.45 ​mmHg; p ​< ​0.0001). Common (>2 ​% in any treatment group) adverse events (i.e., dry mouth, constipation, nausea, dizziness, paresthesia, dysgeusia, headache, COVID-19, urinary tract infection, insomnia, and anxiety) were mostly mild or moderate. ConclusionsIn this randomized, multicenter, double-blind ABPM study, PHEN/ TPM reduced SBP compared to either placebo or phentermine 30 mg (Funding: Vivus LLC; ClinicalTrials.gov: NCT05215418).

Bayesian longitudinal modeling of blood pressure measurements of hypertensive patients at Wachemo University Nigist Elleni Mohamed Memorial Teaching and Referral Hospital Hosanna, Southern Ethiopia

Hypertension is characterized by the persistent elevation of blood pressure (BP) above the normal range or the use of antihypertensive medication. It represents a major global health issue and serves as a significant risk factor for conditions such as stroke, myocardial infarction, vascular disease, and chronic kidney disease. This study aimed to model the longitudinal measurements of diastolic blood pressure and systolic blood pressure in hypertensive patients using a Bayesian approach. The data were obtained from the records of Wachemo University Nigist Elleni Mohamed Memorial Teaching and Referral Hospital. It encompassed the basic demographic and clinical characteristics of 200 hypertensive patients who commenced antihypertensive treatment between September 2015 and March 2020. Descriptive analysis and a Linear mixed-effects model were employed to analyze the data, utilizing the Bayesian approach with the JMbayes package in R software. The results of this study revealed significant associations between age, time, family history, related diseases, and the mean change of systolic blood pressure (SBP) measurements within the bivariate linear mixed model. Likewise, time, residence, related diseases, and the interaction of time with sex and diabetes demonstrated a significant effect on the mean change of diastolic blood pressure (DBP) measurements in antihypertensive patients. By employing a bivariate linear mixed model, an association of 0.8565 was observed between the evolution (AE) of SBP and DBP. Based on the study findings, we can summarize that age, time, family history, and related diseases have a significant impact on the mean change of SBP, while time, residence, related diseases, and the interaction of time with sex and diabetes affect the mean change of DBP. Furthermore, a strong association exists between the evolution of SBP and DBP.

The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-world Observational Study.

Objectives: The Indian Registry on Current Patient Profiles and Treatment Trends in Hypertension (Record) evaluated the current trends and outcomes related to hypertension (HTN) management at 3, 6, 12, and 24 months in India. This study highlights and evaluates the outcomes and trends noted at 24 months. Materials and methods: The detailed study methodology is provided in the earlier publication (interim analysis at 12 months). Aspects such as changes in the quality of life (QOL), percentage of patients reaching target blood pressure (BP), treatment pattern among patients with comorbid conditions, and difference in treatment patterns between public and private healthcare settings, at 24 months, were evaluated in the current study. Results: The study population included 2,000 patients (55.7% males) with a mean age of 54.45 years. Telmisartan (43.7%) and amlodipine + telmisartan (16.4%) were the most prescribed monotherapy and combination therapy among patients with newly diagnosed HTN. A significant decrease in both systolic BP (SBP) and diastolic BP (DBP) was noted in the overall patient population at 24 months (p < 0.001). The mean change in SBP and DBP was slightly higher at 24 months compared to 12 months. This was more evident among patients on combination therapy. A significant improvement in QOL was noted at 24 months. Conclusion: Treatment strategies in HTN management are changing and are associated with effective HTN control and improvements in QOL. However, there is a further need for improved awareness regarding the optimal usage of combination therapy for better management of uncontrolled HTN. How to cite this article: Rajadhyaksha GC, Reddy H, Singh AK, et al. The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-World Observational Study. J Assoc Physicians India 2023;71(11):43-49.

Digitally Based Blood Pressure Self-Monitoring Program That Promotes Hypertension Self-Management and Health Education Among Patients With Low-Income: Usability Study.

According to evidence-based clinical guidelines, adults with hypertension are advised to self-monitor their blood pressure (BP) twice daily. Self-measured BP monitoring is a recommended strategy for improving hypertension management. We aimed to determine the feasibility and acceptability of a digitally based BP self-monitoring program that promotes hypertension self-management and health education among low-income patients. We hypothesized that the program would be highly feasible and acceptable and that at least 50% of the patients would use the monitor at the rate required for the reimbursement of the device's cost (16 days of measurements in any 30-day period). Withings BPM Connect was deployed to patients at Family Health Centers of San Diego. Program elements included training, SMS text message reminders, and physician communication. Compliance, use, mean BP, and BP control status were calculated. A Kaplan-Meier time-to-event analysis was conducted to compare time to compliance between a strict definition (≥16 days in any rolling 30-day window) and a lenient definition (≥1 day per week for 4 consecutive weeks). A log-rank test was performed to determine whether the difference in time to compliance between the definitions was statistically significant. Mean systolic BP (SBP) and diastolic BP (DBP) before the intervention and after the intervention and mean change in SBP and DBP across patients were calculated. Paired sample t tests (2-tailed) were performed to assess the changes in SBP and DBP from before to after the intervention. A total of 179 patients received the monitors. The mean changes in SBP and DBP from before to after the intervention were +2.62 (SE 1.26) mmHg and +3.31 (SE 0.71) mmHg, respectively. There was a statistically significant increase in both SBP and DBP after the intervention compared with before the intervention (P=.04 and P<.001). At the first and last measurements, 37.5% (63/168) and 48.8% (82/168) of the patients had controlled BP, respectively. During the observation period, 83.3% (140/168) of the patients had at least 1 controlled BP measurement. Use decreased over time, with 53.6% (90/168) of the patients using their monitor at week 2 and only 25% (42/168) at week 11. Although only 25.6% (43/168) achieved the strict definition of compliance, 42.3% (71/168) achieved the lenient definition of compliance. The median time to compliance was 130 days for the strict definition and 95 days for the lenient definition. The log-rank test showed a statistically significant difference in time to compliance between the compliance definitions (P<.001). Only 26.8% (45/168) complied with the measurement rate that would result in device cost reimbursement. Few patients used the monitors at a rate that would result in reimbursement, raising financial feasibility concerns. Plans for sustaining costs among low-income patients need to be further evaluated.

Systolic blood pressure reduction with tirzepatide in patients with type 2 diabetes: insights from SURPASS clinical program

BackgroundTirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide/ glucagon-like peptide-1 receptor agonist, is approved in the United States, Europe and Japan for the treatment of type 2 diabetes. Across the SURPASS-1 to -5 clinical studies, tirzepatide 5, 10 and 15 mg demonstrated significant improvements in glycated haemoglobin A1c (HbA1c) (− 1.9 to − 2.6%), body weight (− 6.6 to − 13.9%) and systolic blood pressure (SBP) (− 2.8 to − 12.6 mmHg) at the end of study treatment.MethodsPost-hoc mediation analyses were conducted to evaluate weight-loss dependent and weight-loss independent effects of tirzepatide on SBP reductions across the 5 SURPASS studies. The safety population (all randomized patients who took at least 1 dose of study drug) of each study was analyzed. Additional analyses were conducted at individual study level or pooled across 5 SURPASS trials.ResultsThe difference in mean SBP change from baseline at 40 weeks (total effect) between the tirzepatide and comparator groups was − 1.3 to − 5.1 mmHg (tirzepatide 5 mg), − 1.7 to − 6.5 mmHg (tirzepatide 10 mg) and − 3.1 to − 11.5 mmHg (tirzepatide 15 mg). These SBP reductions were primarily mediated through weight loss, with different degrees of contributions from weight-loss independent effects across the different trials. In the SURPASS-4 study, which enrolled patients with established cardiovascular disease, weight-loss independent effects explained 33% to 57% of difference in SBP change between tirzepatide and insulin glargine groups. In a pooled analysis of the SURPASS-1 to -5 studies, there was a significant (p < 0.001) but weak correlation (r = 0.18 to 0.22) between change in body weight and SBP. Reductions in SBP with tirzepatide were not dependent on concomitant antihypertensive medications at baseline as similar reductions were observed whether participants were receiving them or not (interaction p = 0.77). The largest SBP reductions were observed in the highest baseline category (> 140 mmHg), while those in the first quartile of baseline SBP category (< 122 mmHg) observed no further decrease in SBP.ConclusionsTirzepatide-induced SBP reduction was primarily mediated through weight loss, with different degrees of contributions from weight-loss independent effects across the different trials. SBP reduction was not dependent on antihypertensive medication use but dependent on baseline SBP value, alleviating theoretical concerns of hypotension.

Effect of Exercise Training on Blood Pressure in Healthy Postmenopausal Females: A Systematic Review with Meta-analysis.

The prevalence of hypertension is greater in postmenopausal females compared with males of similar age. Previous meta-analyses of normotensive and hypertensive adults have shown that aerobic exercise training reduces systolic blood pressure (SBP) and/or diastolic blood pressure (DBP). However, the effect of aerobic exercise training on blood pressure specifically within healthy postmenopausal females remains unclear. This systematic review with meta-analysis quantified the effect of aerobic exercise training on resting SBP and DBP in healthy postmenopausal females. The systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Review and Meta-analyses guidelines and was registered in PROSPERO (CRD42020198171). The literature search was done in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL Plus, and SPORTDiscus. Randomized controlled trials involving healthy postmenopausal females with normal or high normal blood pressure and undergoing ≥4 wk of aerobic exercise training were included. The total weighted mean change in SBP and DBP was compared between the exercise and the control interventions. A random-effects model was used to calculate the overall effect sizes of the weighted mean differences and the 95% confidence interval (CI). Twelve studies were included in the meta-analysis (exercise interventions: n = 357, age = 60 ± 4 yr, baseline SBP/DBP = 128 ± 13/79 ± 8 mm Hg; control interventions: n = 330, age = 60 ± 4 yr, baseline SBP/DBP = 126 ± 11/77 ± 6 mm Hg). Compared with the change observed in response to the control interventions, exercise training significantly reduced SBP (-0.43 mm Hg, 95% CI = -0.78 to -0.09, P = 0.02) and DBP (-0.39 mm Hg, 95% CI = -0.73 to -0.05, P = 0.05). Aerobic exercise training significantly reduces resting SBP and DBP in healthy postmenopausal females with normal or high normal blood pressure. However, this reduction is small and of uncertain clinical significance.

Prospective evaluation of digital therapeutic intervention on blood pressure control in Indian patients with uncontrolled primary hypertension

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Terrals Technologies Private Limited Background Digital therapeutics (DTx) has emerged as a new approach in recent years making use of connected devices, smartphone software and electronic communication tools to help manage chronic cardiovascular diseases such as hypertension. Considering its nascent stage, many questions still remain with respect to its applicability, effectiveness and limitations. Purpose Assess the effectiveness of digital therapeutic intervention in controlling blood pressure in Indian patients with primary hypertension Methods We conducted a prospective, 12 week, single arm, interventional study, including 125 subjects at multiple sites in India. Subjects with uncontrolled primary hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic) in the age group of 30-65 years who were under routine antihypertensive treatment were enrolled. They were provided supplementary DTx intervention comprising of smartphone application based personalized management of diet, exercise, self monitoring and health education by nutritionists and health coaches. Efficacy endpoints such as blood pressure (BP), body mass index (BMI), lipids, etc. were measured before and after the intervention. Results A total of 122 subjects who completed the trial had mean age of 47.44 ± 9.43 years, comprising 58 (48%) male and 64 (52%) female patients and mean BMI of 27.21 ±4.7 kg/m². Post-intervention change in mean systolic BP (SBP) was -25.61 mmHg (95% CI 22.55 - 28.66, 154.98 mmHg vs 129.37 mmHg, P&amp;lt;.001). The post-intervention change in mean diastolic BP (DBP) was -18.62 mmHg (95% CI 16.29 - 20.96, 100.04 mmHg vs 81.42 mmHg, P&amp;lt;.001). Patients with stage 1 hypertension (69.6%) achieved mean systolic reduction of 20.87 ± 13.9 mmHg, (148.54 mmHg vs 127.67 mmHg, P&amp;lt;.001). The patients with stage 2 (27.04%) and stage 3 (3.27%) hypertension achieved a higher mean SBP reduction of 34.67 ± 15.19 mmHg (167.24 mmHg vs 132.58 mmHg, P&amp;lt;.001) and 51.5 ± 40.45 mmHg (190.75 mmHg vs 139.25 mmHg, P=.084), respectively. Male and female patients showed almost similar reduction in systolic BP of 25.47 ± 14.72 and 25.73 ± 19.39 mmHg, respectively. Also, the subjects with other chronic comorbidities (23.9%) achieved a mean systolic BP reduction of 29.51 ± 15.25 mmHg. A total of 79.51% (n=97) patients achieved the SBP &amp;lt;140 mmHg, while 59.84% (n=73) patients achieved SBP &amp;lt;130 mmHg. Combining both the systolic and diastolic targets together, 65.57% (n=80) patients achieved the target of &amp;lt;140/90 mmHg, while ESC/ESH 2018 recommended BP target of &amp;lt;130/80 mmHg was achieved by 31.15% (n=38) patients. Conclusion The implementation of Digital therapeutic application integrated with primary healthcare resulted in significant reduction in blood pressure in participants with uncontrolled hypertension. Greater improvement was observed in participants with higher baseline blood pressure.

The effect of listening to Al-Quran recitation among uncontrolled hypertensive Muslim patient attending Primary Care Clinic in Kelantan, Malaysia: A randomised control trial

Introduction: Prevalence of hypertension in Malaysia has been increasing over the years. Despite varieties of treatment, a large proportion of hypertensive patients still have uncontrolled blood pressure. Several non-pharmacological approaches have been used as non-pharmacological management to reduce blood pressure. This study intended to determine the effect of listening to Quran recitation on blood pressure among Muslim patients with uncontrolled hypertension. Material and Method: This study was a randomized controlled trial involving 202 Muslim patients with uncontrolled hypertension. They were randomly allocated to either listening to Quran recitation group or control group. Blood pressure (BP) and heart rate were measured at baseline and after the intervention. Results: In the intervention group, the mean changes in systolic BP and diastolic BP were -5.9 and -3.8mmHg respectively while for heart rate was -4.06 bpm. In the control group, the mean changes in systolic BP and diastolic BP were -1.68 and -1.84 mmHg respectively while for heart rate was -1.39 bpm. ANCOVA analysis showed that the mean changes in systolic blood pressure, diastolic blood pressure and heart rate between intervention and control group were statistically significant (P values = 0.001). Conclusions: This study showed a reduction of blood pressure immediately after listening to Quran recitation. However, a longer study on listening to Quran needs to be done to show a sustained decrease of BP of the patient.

Effectiveness of a community-based education and peer support led by women’s self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial

BackgroundWith less than 20% of people with hypertension achieving their target blood pressure (BP) goals, uncontrolled hypertension remains a major public health problem in India. We conducted a study to...

A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease.

Mineralocorticoid receptor antagonists (MRAs) reduce systolic blood pressure (SBP) and increase serum potassium concentration ([K+]). This indirect comparison investigated any differences in SBP-lowering and hyperkalemia risk between finerenone, a nonsteroidal MRA, and the steroidal MRA spironolactone±a potassium binder. In FIDELITY (a pooled analysis of FIDELIO-DKD and FIGARO-DKD), a subgroup of patients with treatment-resistant hypertension (TRH) and chronic kidney disease meeting eligibility criteria of the AMBER trial were identified (FIDELITY-TRH). The main outcomes were mean change in SBP, incidence of serum [K+] ≥5.5mmol/L and hyperkalemia-associated treatment discontinuation. Results at ∼17weeks were compared with 12weeks from AMBER. In 624 FIDELITY-TRH patients and 295 AMBER patients, the least squares mean change in SBP (mmHg) from baseline was -7.1 for finerenone and -1.3 for placebo {between-group difference -5.74 [95% confidence interval (CI) -7.99 to -3.49], P<.0001} versus -11.7 for spironolactone+patiromer and -10.8 for spironolactone+placebo [between-group difference -1.0 (95% CI -4.4-2.4), P=.58]. The incidence of serum [K+] ≥5.5mmol/L was 12% for finerenone and 3% for placebo versus 35% with spironolactone+patiromer and 64% with spironolactone+placebo. Treatment discontinuation due to hyperkalemia was 0.3% for finerenone and 0% for placebo versus 7% for spironolactone+patiromer and 23% for spironolactone+placebo. In patients with TRH and chronic kidney disease compared with spironolactone with or without patiromer, finerenone was associated with a lower SBP reduction and lower risk of hyperkalemia and treatment discontinuation.Trial Registration: AMBER (NCT03071263), FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049).

Home-based transcutaneous electrical acupoint stimulation for high-normal blood pressure: A randomized controlled trial.

The authors investigated the effectiveness of home‐based transcutaneous electrical acupoint stimulation (TEAS) combined with lifestyle modification on blood pressure (BP) control and explored the feasibility of the trial design in this prospective, randomized controlled trial. The authors recruited individuals with high‐normal BP who had a systolic blood pressure (SBP) of 120–139 mm Hg and a diastolic blood pressure (DBP) of 80–89 mm Hg, or both. Participants were randomly assigned to receive either lifestyle modification combined with TEAS four times weekly for 12 weeks at home (intervention group) or solely lifestyle modification (control group). The primary outcome was the change in mean SBP at week 12 from the baseline measurement. A total of 60 participants were randomized in a 1:1 ratio, and an intention‐to‐treat analysis was performed on all of the outcomes. The mean difference in the change in SBP for the intervention group (compared to the control) at week 12 was −3.85 mm Hg (95% CI: −7.58 to −.12; p = .043); for the DBP, the change was −2.27 mm Hg (95% CI: −5.76 to 1.23; p = .199). There was no difference in the proportion of progression to hypertension, quality of life, body mass index (BMI) or waist circumference. In addition, two participants reported TEAS‐related adverse events. The authors found a reduction in SBP control in the pragmatic, home‐based intervention by using TEAS combined with lifestyle modification in adults with high‐normal BP. Trial Registration: The study was registered in the Chinese Clinical Trial Registry (ChiCTR 1900024982) on August 6, 2019.

563-P: A Community Health Worker–Led Hypertension and Diabetes Management Program for South Asians in Atlanta: The DREAM Atlanta Study

Background: South Asians are disproportionately affected by type 2 diabetes (DMII) and comorbid hypertension (HTN) , which increases the risk of stroke and myocardial infarction. In Atlanta, South Asians represent one of the fastest growing immigrant populations. Community health worker (CHW) interventions have been shown to improve chronic disease outcomes, yet few tailored interventions have addressed the high burden of cardiovascular disease among South Asians. Objective: To test the effectiveness of an evidence-based, CHW-led, and culturally-tailored HTN and DMII management program for South Asian adults with DMII and comorbid HTN. Methods and Study Design: Randomized-Waitlist Controlled Trial Setting/intervention: The treatment group received 5 group virtual DMII and HTN education sessions as well as 2 one-on-one goal setting sessions. The waitlist control group received 3 group virtual sessions at the end of study. Measures: Primary outcomes included feasibility, acceptability, and change in BP control (systolic blood pressure (SBP) &amp;lt;130 and diastolic blood pressure (DBP) &amp;lt;80) . Secondary outcomes included changes in glycated hemoglobin (HbA1c) , weight, diabetes self-efficacy, healthy eating, and physical activity. Results: A total of 199 South Asian adults were randomized to treatment or control groups. At 6-month follow-up, 40.2% of the treatment group had controlled BP, compared to 24.2% of the control group (p=0.020) . Absolute change in mean SBP and DBP was significantly greater for the treatment group vs. control group. Weight change was -4.8lbs in the treatment group, compared to +0.6lbs in the control group (p=0.007) . The intervention had an overall retention of 95% (treatment = 92, control=91) . Conclusions: A culturally-tailored CHW-led intervention is feasible, acceptable, and can significantly improve diabetes and HTN among South Asians. Further study will evaluate the implementation and scalability of the intervention. Disclosure M.K.Shah: None. L.Wyatt: None. C.C.Gibbs: None. S.Mammen: None. F.M.Mohsin: None. N.Islam: None. Funding NIMHD: K23 MD015088-and 3U54MD000538-17S1

716-P: Systolic Blood Pressure Reduction with Tirzepatide across SURPASS Program: A Mediation Analysis Using Weight Loss as a Factor

Tirzepatide (TZP) is a novel dual GIP/GLP-1 receptor agonist for the treatment of type 2 diabetes. Across the SURPASS 1-5 clinical studies, TZP 5, and 15 mg demonstrated significant improvements in HbA1c (-1.9 to -2.6%) , body weight (-6.6 to -13.9%) and systolic blood pressure (SBP) (-2.8 to -12.6 mmHg) at primary endpoint. Post-hoc mediation analyses were conducted to evaluate weight loss dependent (WL-D) and independent (WL-IND) effects of TZP on SBP reductions across 5 SURPASS studies. The difference in mean SBP change from baseline at 40-weeks (Total effect) between TZP and comparator group was -1.3 to -5.1 mmHg (TZP 5 mg) , -1.7 to -6.5 mmHg (TZP mg) and -3.1 to -11.5 mmHg (TZP 15 mg) . The contribution of WL-D and WL-IND effects on these treatment differences are presented below (Figure) . In SURPASS-4 study which enrolled patients with established cardiovascular disease, WL-IND effects explained 33% to 57% of difference in SBP change between TZP and insulin glargine groups, with the remainder of 67% to 43% of the effect being WL-D. In a pooled analysis of SURPASS 1-5 studies, there was a significant (p&amp;lt;0.001) but weak correlation (r = 0.18 to 0.22) between change in body weight and SBP. In conclusion, TZP induced SBP reduction was primarily mediated through weight loss, with different degrees of contributions from weight loss independent effects across the different trials. Disclosure I. Lingvay: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly, Mannkind, TARGET PharmaSolutions; Valeritas;; Altimmune; DataRevive; Click; Medscape Duke CRI; Janssen Pharma; Bayer; Intercept, Novo Nordisk, Sanofi, Zealand Pharma A/S. Consultant; Novo Nordisk. Research Support; NovoNordisk; Mylan; Merck, Sanofi. O. Mosenzon: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, BOL Pharma, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk, Sanofi. Research Support; AstraZeneca, Novo Nordisk. Speaker's Bureau; AstraZeneca, Bayer AG, Eli Lilly and Company, Novo Nordisk, Sanofi. K. Brown: Employee; Eli Lilly and Company. X. Cui: Employee; Eli Lilly and Company. L. Fernandez Lando: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. H. Patel: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Impact of Home Telemonitoring and Management Support on Blood Pressure Control in Nondialysis CKD: A Systematic Review and Meta-Analysis.

Background:Hypertension is a major cause of cardiovascular disease, chronic kidney disease (CKD), and death. Several studies have demonstrated the efficacy of home blood pressure telemonitoring (HBPT) for blood pressure (BP) control and outcomes, but the effects of this intervention remain unclear in patients with CKD.Objective:To determine the impact of HBPT on cardiovascular–related and kidney disease–related outcomes in patients with CKD.Design:Systematic review and meta-analysis.Setting:All studies that met our criteria regardless of country of origin.Participants:Patients with chronic kidney disease included in studies using HBPT for BP assessment and control.Measurements:Descriptive and quantitative analysis of our primary and secondary outcomes.Methods:We searched MEDLINE, Embase, CINAHL Plus, PsycINFO, Cochrane CENTRAL, Web of Science, and gray literature from inception for observational and randomized controlled studies in nondialysis (ND) CKD using HBPT for BP control. We selected studies that used HBPT as intervention (with or without a control arm) for BP control in ND-CKD populations. The primary outcome was change in mean systolic BP (SBP) and mean diastolic BP (DBP).Results:We selected 7 studies from 1669 articles that were initially identified. Overall, pooled estimates in the mean difference (MD) for SBP and DBP were −8.8 mm Hg; 95% confidence interval (CI): −16.2 to −1.4; P = .02 and −2.4 mm Hg; 95% CI: −3.8 to −1.0; P < .001, respectively. For studies comparing intervention with usual care (UC), pooled estimate in MD for SBP was −8.0 mm Hg (P = .02) with no significant reduction for DBP (−2.6 mm Hg; P = .18). In studies without a UC arm, both SBP and DBP were not significantly reduced (P > .05). The pooled estimate in MD for estimated glomerular filtration rate showed a significant improvement (5.4 mL/min/1.73 m2; P < .001).Limitations:Heterogeneity and few available studies for inclusion limited our ability to identify a robust link between HBPT use and BP and kidney function improvement.Conclusion:Home blood pressure telemonitoring is associated with mild lowering of BP and moderately improved kidney function in patients with CKD. However, larger studies with improved designs and prolonged interventions are still needed to assess the effects of HBPT on patients’ outcomes.PROSPERO registration ID CRD42020190705