Systolic Blood Pressure Control Research Articles

Cost-effectiveness of Intensive vs Standard Blood Pressure Control Among Older Patients With Hypertension

Older patients with hypertension receiving intensive systolic blood pressure control (110-130 mm Hg) have lower incidences of cardiovascular events than those receiving standard control (130-150 mm Hg). Nevertheless, the mortality reduction is insignificant, and intensive blood pressure management results in more medical costs from treatments and subsequent adverse events. To examine the incremental lifetime outcomes, costs, and cost-effectiveness of intensive vs standard blood pressure control in older patients with hypertension from the health care payer's perspective. This economic analysis was conducted with a Markov model to examine the cost-effectiveness of intensive blood pressure management among patients aged 60 to 80 years with hypertension. Treatment outcome data from the Trial of Intensive Blood-Pressure Control in Older Patients With Hypertension (STEP trial) and different cardiovascular risk assessment models for a hypothetical cohort of STEP-eligible patients were used. Costs and utilities were obtained from published sources. The incremental cost-effectiveness ratio (ICER) against the willingness-to-pay threshold was used to evaluate whether the management was cost-effective. Extensive sensitivity, subgroup, and scenario analyses were performed to address uncertainty. The US and UK population using race-specific cardiovascular risk models were conducted in the generalizability analysis. Data for the STEP trial were collected from February 10 to March 10, 2022, and were analyzed for the present study from March 10 to May 15, 2022. Hypertension treatments with a systolic blood pressure target of 110 to 130 mm Hg or 130 to 150 mm Hg. Incremental lifetime quality-adjusted life-years (QALYs), costs, and ICER are discounted at the given rates annually. After simulating 10 000 STEP-eligible patients assumed to be 66 years of age (4650 men [46.5%] and 5350 women [53.5%]) in the model, the ICER values were ¥51 675 ($12 362) per QALY gained in China, $25 417 per QALY gained in the US, and £4679 ($7004) per QALY gained in the UK. Simulations projected that the intensive management in China being cost-effective were 94.3% and 100% below the willingness-to-pay thresholds of 1 time (¥89 300 [$21 364]/QALY) and 3 times (¥267 900 [$64 090]/QALY) the gross domestic product per capita, respectively. The US had 86.9% and 95.6% probabilities of cost-effectiveness at $50 000/QALY and $100 000/QALY, respectively, and the UK had 99.1% and 100% of probabilities of cost-effectiveness at £20 000 ($29 940)/QALY and £30 000 ($44 910)/QALY, respectively. In this economic evaluation, the intensive systolic blood pressure control in older patients produced fewer cardiovascular events and had acceptable costs per QALY gained, well below the typical willingness-to-pay thresholds. The cost-effective advantages of intensive blood pressure management in older patients were consistent over various clinical scenarios across different countries.

Systolic blood pressure, antihypertensive treatment, and cardiovascular and mortality risk in VA nursing home residents.

Optimal systolic BP (SBP) control in nursing home residents is uncertain, largely because this population has been excluded from clinical trials. We examined the association of SBP levels with the risk of cardiovascular (CV) events and mortality in Veterans Affairs (VA) nursing home residents on different numbers of antihypertensive medications. Our study included 36,634 residents aged ≥65 years with a VA nursing home stay of ≥90 days from October 2006-June 2019. SBP was averaged over the first week after admission and divided into categories. Cause-specific hazard ratios (HRs) of SBP categories with CV events (primary outcome) and all-cause mortality (secondary outcome) were examined using Cox regression and multistate modeling stratified by the number of antihypertensive medications used at admission (0, 1 or 2, and ≥3 medications). More than 76% of residents were on antihypertensive therapy and 20% received ≥3 medications. In residents on antihypertensive therapy, a low SBP < 110 mmHg (compared with SBP 130 ~ 149 mmHg) was associated with a greater CV risk (adjusted HR [95% confidence interval]: 1.47 [1.28-1.68] in 1 or 2 medications group, and 1.41 [1.19-1.67] in ≥3 medications group). In residents on no antihypertensives, both low SBP < 110 mmHg and high SBP ≥ 150 mmHg were associated with higher mortality; while in residents receiving any antihypertensives, a low SBP was associated with higher mortality and the highest point estimates were for SBP < 110 mmHg (1.36 [1.28-1.45] in 1 or 2 medications group, and 1.47 [1.31-1.64] in ≥3 medications group). The associations of SBP with CV and mortality risk varied by the intensity of antihypertensive treatment among VA nursing home residents. A low SBP among those receiving antihypertensives was associated with increased CV and mortality risk, and untreated high SBP was associated with higher mortality. More research is needed on the benefits and harms of SBP lowering in long-term care populations.

Current status of the rapid decline in renal function due to diabetes mellitus and its associated factors: analysis using the National Database of Health Checkups in Japan

The increasing number of patients undergoing dialysis due to diabetes mellitus (DM) is causing serious economic problems, and its reduction is an urgent policy issue in developed countries, including Japan. We aimed to assess the association between the annual rapid decline in renal function and health checkup measures, including blood pressure, to identify health guidance targets for preventing diabetic nephropathy (DN) and diabetic kidney disease (DKD) among individuals in a medical checkup system (“Tokuteikenshin” program) in 2018. This longitudinal analysis included 3,673,829 individuals who participated in the “Tokuteikenshin” program in 2018, had hemoglobin A1c (HbA1c) levels ≥5.6%, were available for follow-up, and underwent estimated glomerular filtration rate (eGFR) evaluation. We estimated the incidence of the relative annual decrease in eGFR ≥10% per 1000 person-years and odds ratios to evaluate the rapid decline in renal function and determine health guidance goals and their role in preventing DN and DKD. Overall, 20.83% of patients with DM had a rapid decline in renal function within the observation period. A rapid decline in renal function was associated with high systolic blood pressure, poor or strict DM control, increased urinary protein excretion, and decreased blood hemoglobin levels. The incidence of rapid decline in renal function is higher in DM, and appropriate systolic blood pressure and glycemic control are important to prevent the progression to DN or DKD. Our findings will be useful for researchers, clinicians, and other public health care members in establishing effective health guidance and guidelines for CKD prevention.

Effects of intensive vs. standard blood pressure control on cognitive function: Post-hoc analysis of the STEP randomized controlled trial.

The STEP (Strategy of Blood Pressure Intervention in the older Hypertensive Patients) trial showed that intensive systolic blood pressure (SBP) control resulted in a lower incidence of cardiovascular events than standard treatment. This study analyzed the effects of intensive SBP lowering on cognitive function. STEP was a multicenter, randomized controlled trial of hypertensive patients aged 60-80 years. Participants were randomly assigned (1:1) to SBP goals of 110-130 mmHg (intensive treatment) or 130-150 mmHg (standard treatment). Each individual was asked to complete a cognitive function test (Mini-Mental State Examination; MMSE) at baseline and during follow-up. The primary outcome for this study was the annual change in MMSE score. Subjects with a score less than education-specific cutoff point were categorized as cognitive decline. The analysis enrolled 6,501 participants (3,270 participants in the intensive-treatment and 3,231 participants in the standard-treatment groups). Median follow-up was 3.34 years. There was a minor change in MMSE score, with an annual change of -0.001 [95% confidence interval [CI] -0.020, 0.018] and 0.030 (95% CI 0.011, 0.049) in the intensive- and standard-treatment groups, respectively (p = 0.052). Cognitive decline occurred in 46/3,270 patients (1.4%) in the intensive-treatment group and 42/3,231 (1.3%) in the standard-treatment group (hazard ratio 0.005, 95% CI 0.654, 1.543, p = 0.983). Compared with standard treatment, intensive SBP treatment did not result in a significant change in cognitive function test score. The impact of intensive blood pressure lowering was not evident using this global cognitive function test. ClinicalTrials.gov. Unique identifier: NCT03015311.

Association of serum uric acid with benefits of intensive blood pressure control

Introduction and objectivesIntensive systolic blood pressure (SBP) control improved outcomes in the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial. Whether the serum uric acid concentration at baseline alters the benefits of intensive SBP control is unknown. MethodsThe STEP trial was a randomized controlled trial that compared the effects of intensive (SBP target of 110 to<130mmHg) and standard (SBP target of 130 to <150mmHg) SBP control in Chinese patients aged 60 to 80 years with hypertension. The primary outcome was a composite of cardiovascular disease events. This post hoc analysis was performed to examine whether the effects of intensive SBP intervention differed by the baseline uric acid concentration using 2 models: restricted cubic spline curves and subgroup analyses, both based on the Fine-Gray subdistribution hazard model in the analysis of the primary outcome and secondary outcomes (excluding all-cause death). In the analysis of all-cause death, the Cox regression model was used. We also examined the change in the follow-up uric acid concentrations. ResultsOverall, the risk of the primary outcome rose as the cumulative uric acid concentration increased in both the intensive and standard treatment groups. Patients with intensive treatment had a lower multivariable-adjusted subdistribution hazard ratio for the primary outcome, but with a wide overlap of 95%CI. Next, we stratified patients according to their baseline uric acid concentration (tertile 1 [T1], <303.0μmol/L; tertile 2 [T2], 303.0 to <375.8μmol/L; and tertile 3 [T3], ≥375.8μmol/L). Subgroup analyses using tertiles provided HRs and 95%CI in T1 (HR, 0.55; 95%CI, 0.36–0.86; P=.008), T2 (HR, 0.80; 95%CI, 0.56–1.14; P=.22) and T3 (HR, 0.86; 95%CI, 0.60–1.21; P=.39), with an interaction P value of .29. The results for most of the secondary outcomes followed the same trends. ConclusionsThere was no evidence that the benefit of the intensive SBP control differed by baseline uric acid concentrations. This trial was registered at ClinicalTrial.gov (Identifier: NCT03015311).

Diastolic Blood Pressure and Intensive Blood Pressure Control on Cognitive Outcomes: Insights From the SPRINT MIND Trial.

The potential benefits or harms of intensive systolic blood pressure (BP) control on cognitive function and cerebral blood flow in individuals with low diastolic blood pressure (DBP) remain unclear. We conducted a post hoc analysis of the SPRINT MIND (Systolic Blood Pressure Intervention Trial Memory and Cognition in Decreased Hypertension) that randomly assigned hypertensive participants to an intensive (<120 mm Hg; n=4278) or standard (<140 mm Hg; n=4385) systolic blood pressure target. We evaluated the effects of BP intervention on cognitive outcomes and cerebral blood flow across baseline DBP quartiles. Participants in the intensive group had a lower incidence rate of probable dementia or mild cognitive impairment than those in the standard group, regardless of DBP quartiles. The hazard ratio of intensive versus standard target for probable dementia or mild cognitive impairment was 0.91 (95% CI, 0.73-1.12) in the lowest DBP quartile and 0.70 (95% CI, 0.48-1.02) in the highest DBP quartile, respectively, with an interaction P value of 0.24. Similar results were found for probable dementia (interaction P=0.06) and mild cognitive impairment (interaction P=0.80). The effect of intensive treatment on cerebral blood flow was not modified by baseline DBP either (interaction P=0.25). Even among participants within the lowest DBP quartile, intensive versus standard BP treatment resulted in an increasing trend of annualized change in cerebral blood flow (+0.26 [95% CI, -0.72 to 1.24] mL/[100 g·min]). Intensive BP control did not appear to have a detrimental effect on cognitive outcomes and cerebral perfusion in patients with low baseline DBP. URL: https://www. gov; Unique identifier: NCT01206062.

Impact of metabolic control on all-cause mortality in a nationwide cohort of patients with diabetes from Colombia.

The magnitude of the mortality benefit conferred by good integral metabolic control in diabetes in not sufficiently known, especially among Latin American patients. We prospectively studied the association between sustained control of blood glucose (HbA1c<7%), systolic blood pressure (SBP) (<130 mmHg) and LDL (LDLc, <100mg/dL) and non-HDL (non-HDLc, <130 mg/dL) cholesterol, and death from any cause among all adult patients with diagnosed diabetes in Colombia. We retrospectively analyzed data from a nationwide, centralized, mandatory registry of all patients with diagnosed diabetes assisted by the Colombian health system between July 1, 2015, and June 30, 2019. We estimated the associations of sustained achievement of each goal, and of the joint triple goal (HbA1c + SBP + LDLc) with all-cause death. Associations were assessed after adjustment for sex, age, race, insurance type and BMI in multivariable logistic models. We studied 1 352 846 people with diabetes. Sustained SBP (OR 0.42 [0.41-0.43]), HbA1c (OR 0.25 [0.24-0.26]) and LDLc (OR 0.28 [0.27-0.29]) control had strong negative associations with death. Moreover, among the 5.4% of participants who achieved joint, sustained metabolic control, the OR for death was 0.19 (0.18-0.21). Importantly, the impact of sustained, joint metabolic control was significantly smaller for patients of black race compared to other races (OR 0.31 [0.23-0.43] versus 0.18 [0.17-0.20], p-value for interaction <0.001), mostly at the expense of a smaller impact of LDLc control. The results were similar across body-mass index categories. Sustained and simultaneous metabolic control was associated with remarkably lower odds of death.

Optimal or standard control of systolic and diastolic blood pressure across risk factor categories in patients with chronic coronary syndromes.

Guidelines have lowered blood pressure (BP) targets to <130/80 mmHg. We examined the benefit of intensive control for each BP component, vs. the burden of other modifiable risk factors, in patients with chronic coronary syndromes (CCS). The CLARIFY registry (ISRCTN43070564) enrolled 32 703 patients with CCS, from 2009 to 2010, with a 5-year follow-up. Patients with either BP component below European guideline safety boundaries (120/70 mmHg) were excluded, leaving 19 167 patients (mean age: 63.8 ± 10.1 years, 78% men) in the present analysis. A multivariable-adjusted Cox proportional hazards model showed a gradual increase in cardiovascular risk (cardiovascular death, myocardial infarction, or stroke) when the number of uncontrolled risk factors (active smoking, no physical activity, low-density lipoprotein cholesterol ≥100 mg/dL, and diabetes with glycated haemoglobin ≥7%) increased [adjusted hazard ratio (HR): 1.34; 95% confidence interval (CI): 1.17-1.52, 1.65 (1.40-1.94), and 2.47 (1.90-3.21) for 1, 2, and 3 or 4 uncontrolled risk factors, respectively, vs. 0], without significant interaction with BP. Although uncontrolled systolic (≥140 mmHg) and diastolic (≥90 mmHg) BP were both associated with higher risk than standard BP, standard BP was associated with higher risk than optimal control for only the diastolic component (adjusted HR: 1.08; 95% CI: 0.94-1.25 for systolic BP 130-139 vs. 120-129 mmHg and 1.43; 95% CI: 1.27-1.62 for diastolic BP 80-89 vs. 70-79 mmHg). Our results suggest that the optimal BP target in CCS may be ≤139/79 mmHg and that optimizing the burden of other risk factors should be prioritized over the further reduction of systolic BP.

PS-C20-3: MOBILE MEDICAL APP CAN BE MORE EFFECTIVE IN LONG-TERM MANAGEMENT OF HYPERTENSION PATIENTS

Objective: The application of mobile medical application, APP, to manage patients with hypertension makes the contact between doctors and patients more convenient, saves the economic cost and time cost of patients, and also makes it easier for doctors to manage patients and improve their compliance. This study investigated the effect of APP on long-term management of hypertension patients. Design and method: This trial was a randomized, single-blind, parallel, controlled study. A total of 302 patients with hypertension were included in this study and observed for one year. All the enrolled patients received antihypertensive treatment of nifedipine controlled release tablets with or without telmisartan in outpatient or ward. The APP of the experimental group could be used to push health education information, remind patients to measure their own blood pressure and take medication, and consult doctors online. Blood pressure, improvement of hypertensive target organ injury, and sodium intake were assessed in both groups after one year treatment. Results: There were no significant differences in blood pressure, urinary microalbumin and 24-hour urinary sodium levels between the two groups at baseline. APP information push was more helpful to the control of blood pressure, systolic and diastolic blood pressure decreased significantly, after treatment, systolic blood pressure of experimental group vs control group 133 ± 6mmHg vs 141 ± 11mmHg, P &lt; 0.05; Diastolic pressure 83 ± 7mmHg vs 89 ± 9mmHg, P &lt; 0.05. APP information push was more helpful to improve target organ injury (decrease of microalbuminuria), and microalbuminuria after treatment was 31 ± 12 mg/L vs 47 ± 14 mg/L, P &lt; 0.05. APP information push helped control sodium intake, and the urine sodium level at 24 hours after treatment was 123 ± 31 mmol/24 h vs 148 ± 28 mmol/24 h, P &lt; 0.05. Conclusions: Using mobile medical APP for patient management can help control patients’ blood pressure level, improve the degree of renal damage caused by hypertension, and help control sodium intake. APP can be used as an auxiliary means for long-term management of hypertension patients, which can improve the quality of blood pressure management of patients more effectively, conveniently and economically.

Meta Analysis the Effect of Electronic Health-based Self Management in Controlling Blood Pressure in Hipertensive Patients

Background Consistent application of self-management is important in efforts to improve the quality of life and health status of hypertensive patients. Electronic health is here to facilitate self-management of hypertensive patients and provide health information to health workers in real time and promote lifestyle modifications. The purpose of this study was to analyze the influence of electronic health-based self-management on blood pressure control in hypertensive patients. Subjects and Method: : This study is a meta-analysis using PICO namely Population: Hypertensive patients; Intervention: Self-management based on electronic health; Comparison: No self-management based on electronic health; Outcome: Systolic and diastolic blood pressure. This study uses articles from several databases, i.e Pubmed, Google Scholar, Science Direct and the Cochrane Library using the following keywords “Hypertension” OR “Hypertensive” OR “Blood Pressure” OR “High Blood Pressure” AND “Self Management” OR “Self Care” OR “Self Monitoring” AND “Electronic Health” OR “eHealth” OR “Telemedicine” OR “Telehealth” OR “mHealth” OR “Mobile Health” OR “Mobile Application” OR “Message Text” OR “Phone Calls”. Articles included in the research are articles that use English with an RCT study design whose publication is within the period of 2012-2022. The steps in the systematic review are carried out based on the PRISMA flow diagram guidelines. Quantitative analysis was carried out using Review Manager (Revman) 5.3. Results: There were 9 articles from South Africa, America, South Korea, Spanish, England, Scotland, and Honduras, with a sample size of 3,071 hypertensive patients concluded that electronic health-based self-management could reduce systolic blood pressure by 0.38 units and was statistically significant (SMD= -0.38; 95% CI = -0.55 to -0.20; p&lt;0.001 ). The meta-analysis synthesized 9 studies with a total sample size = 2.095 hypertensive patients concluded that electronic health-based self-management could reduce diastolic blood pressure by 0.21 units and was statistically significant (SMD= -0.21; 95% CI = -0.29 to -0.12; p&lt; 0.001). Conclusion: Electronic health-based self-management can reduce systolic and diastolic blood pressure control in hypertensive patients. Keywords: Self management, electronic health, blood pressure, hypertension

Fixed dose combination drugs for cardiovascular disease in a prolonged humanitarian crisis in Lebanon: an implementation study

ObjectivesThis pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.SettingTwo Médecins sans Frontières...

Impact of Blood Pressure Control on Graft Survival in Kidney Transplant Recipients

Cardiovascular disease is the primary driver of morbidity and mortality in kidney transplant recipients. Hypertension is an important risk factor for development of cardiovascular disease in this population. Despite its important role in post-transplant outcomes, the blood pressure goals for kidney transplant recipients remain elusive. Current guidelines are based on observational data or data extrapolated from the chronic kidney disease population. We followed 5-year blood pressure control of 378 kidney-alone transplant recipients at a single center and evaluated patient survival, graft survival, proteinuria, and rate of decline of kidney graft function. We found that a mean systolic blood pressure (BP) of 121 to 130 mm Hg was associated with better graft survival, slower decline of kidney allograft function, and lower degree of proteinuria when compared with a mean systolic BP ≤120 or >130 mm Hg. This study provides evidence for strict blood pressure control, systolic BP between 121 and 130 mm Hg, and also cautions against intensive control of systolic BP <120 mm Hg in kidney transplant recipients.

S-52-4: BLOOD PRESSURE CATEGORIES AND PROGRESSION OF COMMON CAROTID ARTERY STENOSIS DEGREE IN A JAPANESE URBAN POPULATION: THE SUITA STUDY

Objective: Little is known about the impacts of systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels on the risk of a common carotid artery (CCA) stenosis degree progression in the general population. The objective of the present study was to examine the impact of blood pressure levels on the progression of CCA stenosis degree in the general population. Design and method: We studied 3,823 Japanese men and women without CCA stenosis at baseline whose CCA was measured by carotid ultrasonography on both sides (April 1994 to March 2005). We confirmed stenosis by Doppler and calculated the stenosis degree as a percentage of the stenotic area of the lumen in the cross-section perpendicular to the long axis. We measured BPs twice more than one min apart and used the average of two measurements of BPs for the analyses. The Cox proportional hazard model was used to calculate the multivariable-adjusted hazard ratios (HRs) with 95 % confidence intervals (CIs) of CCA stenosis degree progression according to the BP categories defined by the ESC/ESH 2018 guideline. Results: During 22,877 person-years of follow-up, we observed 74 cases of new progression of CCA stenosis (25 % or more). The high BP was associated with increased risks of CCA stenosis (25 % or more) progression; the multivariable-adjusted HRs with 95 % CIs were 1.34 (0.68-2.65) for participants with normal BP (120–139 and/or 80–89 mm Hg) and 2.13 (1.05–4.30) for those with hypertension (SBP ≧ 140 mm Hg and/or DBP ≧ 90 mm Hg), compared to those with optimal BP (SBP &lt; 120 mm Hg and DBP &lt; 80 mm Hg). Similar positive associations were observed between SBP and DBP and the risk of carotid stenosis incidence, but only statistically significant for SBP; the multivariable-adjusted HRs per 10 mm Hg increase were 1.15 (1.02–1.31) for SBP and 1.18 (0.94–1.49) for DBP. Conclusions: This is the first study to show that high BP was associated with increased risks of CCA stenosis degree progression in the general population, independent of cholesterol levels. A stronger association was found with SBP than DBP. In addition to managing dyslipidemia, adequate control of SBP can prevent the development of CCA stenosis.

S-10-6: BLOOD PRESSURE TARGETS FOR SECONDARY PREVENTION OF STROKE

The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) showed the benefits of blood pressure (BP) lowering for secondary stroke prevention in stroke survivors for the first time after a long dispute in the last century and triggered active hypertensive therapy for stroke patients globally in this century. A post hoc analysis of PROGRESS demonstrated that both the lowest risks of ischemic stroke and of hemorrhagic stroke were among the one-quarter of patients with the lowest achieved follow-up BP levels (median 112/72 mmHg), and that these risks increased progressively with higher follow-up BP levels in the large cohort of patients with previous stroke or transient ischemic attack. A similar tendency for an increased risk of ischemic/hemorrhagic stroke by higher follow-up BP levels was reproduced in subsequent stroke trials. Several trials sought to clarify the preventive effect against recurrent stroke by randomizing patients into two groups with different BP lowering targets. In patients with recent lacunar stroke in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial, lowering systolic BP to &lt; 130 mmHg significantly reduced the risk of intracerebral hemorrhage (ICH) by 63% and insignificantly reduced the risk of ischemic stroke by 16% compared to lowering to 130–149 mmHg. The Recurrent Stroke Prevention Clinical Outcome (RESPECT) Study, involving patients having a history of stroke within the previous 3 years showed similar results: lowering BP to &lt; 120/80 mmHg, relative to &lt; 140/90 mmHg, reduced the risk of ICH by 91% and that of ischemic stroke by only 9%. These trials failed to demonstrate a significant reduction in the risk of any stroke as the primary outcome by intensive BP lowering, since the incidence of ischemic stroke was much higher than that of ICH for both trials. A meta-analysis of these two trials and two more small studies finally succeeded in showing a statistically significant 22% reduced risk for any stroke recurrence by lowering systolic BP to at least &lt; 130 mmHg. The current guidelines recommend systolic BP control aiming at &lt; 130 mmHg or 120–130 mmHg for adults who experience ischemic stroke. RESPECT is epochal as the first large population trial to examine the importance of systolic BP lowering to &lt; 120 mmHg. Such strict control would undoubtedly decrease incidental ICH, especially for patients taking antithrombotic agents. However, the necessity of strict BP control for protection of brain tissues from ischemic injury is still an unresolved matter that needs to be addressed in future studies.

PS-C17-9: RELEVANT BLOOD PRESSURE REDUCTION WITH ORAL SEMAGLUTIDE IN PATIENTS WITH TYPE 2 DIABETES AND OBESITY, INDEPENDENT OF PREVIOUS ANTIHYPERTENSIVE TREATMENT

Objective: The antihypertensive effect of oral semaglutide is apparently modest in published trials but it has not been explored in uncontrolled hypertensive patients. We sought to assess whether oral semaglutide may elicit a clinically relevant reduction of systolic blood pressure (SBP) in patients with type 2 diabetes (T2D), obesity and uncontrolled hypertension, and whether the attained SBP reduction is diluted by the previous antihypertensive treatment. Design and Methods: Retrospective analysis of the SBP and antihypertensive medication data were performed in consecutive patients with T2D and obesity who started therapy with oral semaglutide. Data were obtained from a baseline visit in which oral semaglutide was initiated, and a second visit after 3–4 months. Patients who initiated or changed antihypertensive medication simultaneously with oral semaglutide were excluded. Consent for anonymous analysis and reporting of data were obtained from all included subjects. Results: 50 patients with T2D (by usual clinical criteria) and obesity (BMI &lt; 30 kg/m2) were included; their age was 56 ± 11 years. 32 (64%) were female, and their diabetes duration was 6.9 ± 2.9 years. 41 (82%) of them were diagnosed with hypertension (sitting office SBP &gt; 140 and/or taking antihypertensive drugs). Globally there was a significant but modest reduction in SBP (149.8 ± 11.7 to 146.7 ± 12.4 mmHg, p = 0.041, paired t-test), but this reduction was strongly correlated with the baseline SBP (Pearson's r 0.39, p &lt; 0.001). In the Figure (A) the reductions in SBP for patients with controlled SBP (&lt; 140 mmHg), stage 1 (SBP 140–159 mmHg), stage 2 (160–179 mmHg) and stage 3 hypertension (&gt; 180 mmHg) are shown (p = 0.0056 for differences among SBP categories, one-way ANOVA). The Figure (B) also shows the reductions in SBP for patients taking 0, 1, 2 or &gt; 3 different antihypertensive drugs, but there are no significant differences (p = 0.2312, one-way ANOVA). In the second visit the number of patients with SBP &lt; 140 mmHg had increased from 19 (38%) to 25 (50%). Conclusions: Treatment with oral semaglutide in patients with T2D, obesity and uncontrolled hypertension elicits a clinically significant decrease in SBP, enough to bring about acceptable SBP control in a relevant fraction. As expected, the reduction in SBP was strongly dependent on the baseline SBP. Interestingly, this reduction does not seem to be diluted by the use of multiple antihypertensive drugs, suggesting that oral semaglutide could be considered as an add-on in patients with apparent resistant hypertension.

Development and In vivo Pharmacokinetic and Pharmacodynamic Evaluation of an Oral Innovative Cyclodextrin Complexed Lipid Nanoparticles of Irbesartan Formulation for Enhanced Bioavailability

Background: Irbesartan (IR) is used in the treatment of hypertension, heart failure, and nephropathy in Type II diabetes. IR bioavailability is limited by poor solubility and presystemic metabolism. In our previous investigations, cyclodextrin (HPβCD) complexed solid lipid nanoparticles (SLNs) of IR were prepared, optimized, and characterized. The current study aimed to confirm the reproducibility of the previous methodology and to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) performance of the selected lead formulations in an experimental animal model. Methods: SLNs were prepared by hot homogenization followed by probe sonication with IR/HPβCD inclusion complex loaded into a solid lipid (Dynasan 112). SLNs were evaluated for physical characteristics, drug content, entrapment efficiency, in vitro release profile, and surface morphology. The pharmacokinetic and pharmacodynamic behavior of the SLNs were evaluated in Wistar rats. Results: Photon correlation spectroscopy, drug content, entrapment efficiency, and dissolution studies results were reproducible and consistent with our earlier investigation. PK studies showed 2.1-, 6.6-, and 9.9-fold improvement in the relative oral bioavailability of the drug from IR-HPβCD, IR-SLN, and IR-HPβCD-SLN formulations, respectively compared to IR suspension. However, IR-HPβCD-SLNs showed 1.5- and 4.7-fold improvement in the relative oral bioavailability of the drug compared to IR-SLN and IR-HPβCD formulations, respectively. PD studies in hypertensive Wistar rats showed a good control over systolic blood pressure for 48 h for SLN formulations compared to 2 h for IR suspension. However, the IR-HPβCD inclusion complex exhibited immediate antihypertensive activity (0.5 h) with a period of systolic blood pressure control similar to IR suspension. Conclusions: The current approach exhibited improved oral bioavailability along with improved and prolonged pharmacodynamic effect.

S-28-8: THE ASCOT LEGACY COHORT: THE LONG-TERM EFFECTS OF BLOOD PRESSURE AND BLOOD PRESSURE VARIABILITY ON CARDIOVASCULAR AND RENAL OUTCOMES

Introduction: We have previously shown that visit to visit systolic blood pressure variability (BPV) was the major predictor of cardiovascular outcomes in ASCOT, a trial in hypertensive participants randomised to amlodipine based or atenolol based treatment. Treatment differences in BPV accounted for the benefits of the amlodipine based regimen over the atenolol based regimen on cardiovascular (CV) events during the trial. We now report observations from the 20 yr follow up of UK participants to determine the long term impact of mean systolic blood pressure control during the trial and BPV on CV and renal outcomes. Methods: In the ASCOT Legacy Cohort, 7,092 hypertensive participants with hypertension, aged 40 to 79 years, with at least three other CV risk factors have been followed for up to 20 years. All available SBP visit records (n = 100,933) were included after excluding the first six months observations. The mean of SBP as a measure of BP control and the standard deviation (SD) of all SBPs as an estimate of visit to visit BPV were calculated for the five years of the trial. Participants were then followed for up to 15 years after the end of the trial using the UK National Health Service (NHS) electronic health records. CV and renal outcomes were measured using Cox proportional hazards model adjusted for confounding variables. Results: Although in trial mean SBP predicted long term CV and renal outcomes, SBP variability independent of mean SBP was a strong predictor of both CV and renal outcomes. (Table) Those originally assigned amlodipine based (vs. atenolol based) treatment had a significantly reduced long term risk of risk of stroke [0.82, 0.72 to 0.93, p = 0.003], total CV events and procedures [0.93, 0.88 to 0.98, p = 0.008], total coronary events [0.92, 0.86 to 0.99, p = 0.024] and atrial fibrillation [0.91, 95% CI, 0.83 to 0.99, p = 0.030]. There was no significant difference in the incidence of heart failure, non fatal myocardial infarction and fatal CHD or renal events. Conclusions: Amlodipine based treatment conferred long term advantages over atenolol based treatment on several CV outcomes. Both mean SBP and BPV are strong predictors of long term CV and renal outcomes, but BPV, independent of mean BP, confers a significant additional risk and should be considered for future preventive and therapeutic strategies.

Quantification of risk factors for diabetic retinopathy progression.

To determine the importance of blood sugar control, blood pressure, and other key systemic factors on the risk of progression from no retinopathy to various stages of diabetic retinopathy. Restrospective cohort analysis of patients (N = 99, 280) in the Kaiser Permanente Northern California healthcare system with a baseline retina photographic screening showing no evidence of retinopathy and a minimum follow-up surveillance period of 3 years from 2008 to 2019. We gathered longitudinal data on diabetic retinopathy progression provided by subsequent screening fundus photographs and data captured in the electronic medical record over a mean surveillance of 7.3 ± 2.2 (mean ± SD) years. Progression from an initial state of no diabetic retinopathy to any of four outcomes was determined: (1) any incident retinopathy, (2) referable (moderate or worse) retinopathy, (3) diabetic macular edema, and (4) proliferative diabetic retinopathy.Multiple predictors, including age, race, gender, glycosylated hemoglobin (HbA1c), systolic blood pressure (SBP), cholesterol, chronic renal disease, and type of diabetes were investigated. Among modifiable risk factors, the average HbA1c had the strongest impact on the progression of diabetic retinopathy, followed by average SBP control and total cholesterol. Patients with an average HbA1c of 10.0% or greater (≥ 97mmol/mol) had a risk ratio of 5.72 (95% CI 5.44-6.02) for progression to any retinopathy, 18.84 (95% CI 17.25-20.57) for referable retinopathy, 22.85 (95% CI 18.87-27.68) for diabetic macular edema, and 25.96 (95% CI 18.75-36.93) for proliferative diabetic retinopathy compared to those with an average HbA1c of 7.0% (53mmol/mol) or less. Non-white patients generally had a higher risk of progression to all forms of diabetic retinopathy, while Asian patients were less likely to develop diabetic macular edema (HR 0.76, 95% CI 0.66-0.87). We confirm the critical importance of glucose control as measured by HbA1c on the risk of development of diabetic retinopathy.

Drug therapy of arterial hypertension: assessment of the senior students’ basic knowledge. Final results of the PHYSTARH project

Introduction. Arterial hypertension (AH) is the main correctable cause of the development of cardiovascular diseases, leading to dysfunction of many organs, including the heart, blood vessels and kidneys. Lack of adequate control of systolic and/or diastolic blood pressure can lead to life-threatening conditions and death.The aim of study is to analyze the senior medical students’ knowledge from different regions of Russia in the basic issues of hypertension therapy.Materials and methods. The article presents the results of the first stage of the PHYSTARH multicenter study (the full name of the project is Physicians’ and undergraduates’ knowledge in arterial hypertension treatment): an anonymous survey among 285 senior medical students from 4 cities of Russia. In this article, the authors analyzed the questions of the second part of the questionnaire.Results. The average level of correct answers on the questionnaire was 57.7%. The minimum level of correct answers was obtained in questions about the effectiveness of combined therapy, as well as the choice of absolute contraindications to the use of antihypertensive drugs. The maximum level of correct answers was registered in the question about determining the drug to its pharmacological group.Conclusion. The obtained results testify to the insufficiently level of students’ knowledge in the basic issues of arterial hypertension therapy.

Association between Dietary Carbohydrate Intake and Control of Blood Pressure in Patients with Essential Hypertension.

Both high and low percentages of carbohydrate diets were associated with increased mortality and new-onset hypertension. However, few studies have aggregated to explore the association between carbohydrate intake and blood pressure (BP) control in patients with hypertension. This study aimed to explore the association between carbohydrate-to-energy proportion (CEP) and the rate of poorly controlled BP in patients with hypertension. A cross-sectional survey was conducted in one comprehensive hospital and one community clinic in China. Dietary CEP was obtained through two-24 h dietary recalls. According to the quintiles of CEP, the participants were divided into Q1-Q5 groups. The average of two BP values was adopted as the final BP value, and poorly controlled BP was defined as systolic BP (SBP) ≥140 mmHg and/or diastolic BP (DBP) ≥ 90 mmHg. A total of 459 hypertensive patients were recruited. In univariate analyses, CEP was associated with the control of SBP and DBP. After the covariates were adjusted for, fewer CEPs in Q1 (OR, 4.335; 95% CI, 1.663, 11.299) and Q2 (OR, 2.482; 95% CI, 1.234, 4.989) were significantly associated with higher rates of poor SBP control. A lower dietary CEP is a risk factor for SBP control, whereas an appropriate CEP of 56% to 66% is beneficial for BP control in patients with essential hypertension.