Changes In Mean Blood Pressure Research Articles

Early-Onset Type 2 Diabetes and Tirzepatide Treatment: A Post Hoc Analysis From the SURPASS Clinical Trial Program.

We evaluated baseline characteristics of participants with early-onset type 2 diabetes (T2D) from the SURPASS program and tirzepatide's effects on glycemic control, body weight (BW), and cardiometabolic markers. This post hoc analysis compared baseline characteristics and changes in mean HbA1c, BW, waist circumference (WC), lipids, and blood pressure (BP) in 3,792 participants with early-onset versus later-onset T2D at week 40 (A Study of Tirzepatide [LY3298176] in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone [SURPASS-1], A Study of Tirzepatide [LY3298176] Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes [SURPASS-2]) or week 52 (A Study of Tirzepatide [LY3298176] Versus Insulin Degludec in Participants With Type 2 Diabetes [SURPASS-3]). Analyses were performed by study on data from participants while on assigned treatment without rescue medication in case of persistent hyperglycemia. At baseline in SURPASS-2, participants with early-onset versus later-onset T2D were younger with longer diabetes duration (9 vs. 7 years, P < 0.001) higher glycemic levels (8.5% vs. 8.2%, P < 0.001), higher BW (97 vs. 93 kg, P < 0.001) and BMI (35 vs. 34 kg/m2, P < 0.001), and a similarly abnormal lipid profile (e.g., triglycerides 167 vs. 156 mg/dL). At week 40, similar improvements in HbA1c (-2.6% vs. -2.4%), BW (-14 vs. -13 kg), WC (-10 vs. -10 cm), triglycerides (-26% vs. -24%), HDL (7% vs. 7%), and systolic BP (-6 vs. -7 mmHg) were observed in both subgroups with tirzepatide. Despite younger age, participants with early-onset T2D from the SURPASS program had higher glycemic levels and worse overall metabolic health at baseline versus those with later-onset T2D. In this post hoc analysis, similar improvements in HbA1c, BW, and cardiometabolic markers were observed with tirzepatide, irrespective of age at T2D diagnosis. Future studies are needed to determine long-term outcomes of tirzepatide in early-onset T2D.

Efficacy of BAY 60-2770, a soluble guanylate cyclase activator, for coronary spasm in animal models.

Ischemia with non-obstructive coronary arteries (INOCA), caused by coronary artery spasm, has gained increasing attention owing to the poor quality of life of impacted patients. Therapeutic options to address INOCA remain limited, and developing new therapeutic agents is desirable. Herein, we examined whether soluble guanylate cyclase (sGC) activators could be beneficial in preventing coronary spasms. In organ chamber experiments with isolated canine coronary arteries, prostaglandin F2α-, endothelin-1-, 5-hydroxytryptamine-, and potassium chloride-induced contractions were suppressed by the sGC activator BAY 60-2770 (0.1, 1, and 10 nM). In isolated pig coronary arteries, BAY 60-2770 (0.1, 1, and 10 nM) could prolong the cycle length of phasic contractions induced by 3,4-diaminopyridine, as well as lower the peak and bottom tension of the contraction in a concentration-dependent manner. Additionally, BAY 60-2770 (1 pM‒0.1 µM) evoked a concentration-related relaxation to a greater extent in small (first diagonal branch) coronary arteries than in large (left anterior descending) coronary arteries. In vasopressin-induced angina model rats, pretreatment with BAY 60-2770 (3 µg/kg) suppressed electrocardiogram S-wave depression induced by arginine vasopressin without affecting changes in mean blood pressure and heart rate. These findings suggest that BAY 60-2770 could be valuable in preventing both large and small coronary spasms. Therefore, sGC activators could represent a novel and efficacious therapeutic option for INOCA. Significance Statement The sGC activator BAY 60-2770 exerted antispastic effects on the coronary arteries in animal vasospasm models as proof-of-concept studies. These data can help to support potential clinical development with sGC activators, suitable for human use in patients with vasospastic angina.

Captopril to Lisinopril Conversion in Pediatric Cardiothoracic Surgery Patients Less Than 7Years of Age (RISE-7).

Hypertension after cardiothoracic surgery is common, often requiring pharmacologic management. The recommended first-line antihypertensives in pediatrics are angiotensin converting enzyme inhibitors. Captopril and enalapril are approved for infants and children; however, lisinopril is only approved for > 7years of age. This study evaluated safety and efficacy of converting from captopril to lisinopril in patients utilizing a pre-defined conversion of 3mg captopril to 1mg lisinopril. This was a single center, retrospective study including patients less than 7years of age admitted for cardiothoracic surgery who received both captopril and lisinopril from 01/01/2017 to 06/01/2022.The primary outcome was mean change in systolic blood pressure (SBP) from baseline for 72h after conversion of captopril to lisinopril. A total of 99 patients were enrolled. There was a significant decrease in mean SBP (99.12mmHg vs 94.86mmHg; p = 0.007) with no difference in DBP (59.23mmHg vs 61.95mmHg; p = 0.07) after conversion to lisinopril. Of the 99 patients who were transitioned to lisinopril, 79 (80%) had controlled SBP, 20 (20%) remained hypertensive, 13 (13%) received an increase in their lisinopril dose, and 2 (2%) required an additional antihypertensive agent. There was a low overall rate of AKI (3%) and hyperkalemia (4%) respectively. This study demonstrates that utilizing lisinopril with a conversion rate of 3mg of captopril to 1mg of lisinopril was safe and effective for controlling hypertension in pediatric patients following cardiothoracic surgery.

Heart on hypertension: Improving hypertension control in the FQHC setting through a group visit program

IntroductionMany solutions for increasing hypertension control rates have been proposed yet the social determinants of health create health disparities within the populations served by Federally Qualified Health Centers (FQHC) that can complicate reaching these goals. This study observes impact of a group visit program on hypertension control within the patient population served by an FQHC. MethodsRetrospective review and analysis of blood pressure data was performed for patients enrolled in the first 4 cohorts of the Heart on Hypertension Group Visit Program at the end of the program as well as 3 months, 6 months, and 12 months after the program ended. Results and discussionTwenty-two patients participated in the program. Seventeen patients achieved the goal with a statistically significant mean change in blood pressure at p > 0.001. Patients who completed the program had a statistically significant mean change in blood pressure at p > 0.001 and those who discontinued prior to completing the program had a statistically significant mean change in blood pressure at p = 0.001 systolic and p = 0.002 diastolic. Changes in patient blood pressure were sustained for 3-months (78%), 6-months (83%), and 12-months (83%). ImplicationsPatients in the Heart on Hypertension program were successful in making significant changes in hypertension control in the FQHC setting. This method was useful in improving hypertension control metrics for patients facing increased influences by the Social Determinants of Health.

Pharmacist-led hypertension management in a minority patient population

BackgroundNearly half of adults in America have hypertension (HTN), and only approximately 1 in 4 adults has their blood pressure (BP) under control. High BP is more common in African Americans adults, and BP control is lower among minority adults. Pharmacist-led interventions for HTN have been shown to be effective in improving BP control and reducing the risk of cardiovascular events. ObjectiveThis study aimed to leverage electronic health record (EHR) data to improve BP control through pharmacist-led interventions. MethodsThis was a prospective, cohort study conducted at Atrium Health Concord Internal Medicine, a large suburban practice in Concord, North Carolina. Patients with uncontrolled HTN were identified using an EHR data tool. Patients were included if they were at least 18 years of age, had sustained uncontrolled HTN, and were of a minority race or ethnicity. The primary outcome was proportion of patients achieving a BP of < 140/90 mm Hg in the intervention group compared with a control group. Secondary outcomes included mean change in BP from baseline, number and type of visits, and number and type of interventions. ResultsA total of 110 patients were enrolled in this study, 55 patients in each cohort. The baseline characteristics were generally well balanced between the 2 groups. The mean age was 62 years, and most patients were female and African American. For the primary outcome, 70.9% of the patients in the intervention group achieved a BP of < 140/90 mm Hg compared with 32.7% of the patients in the control group (P < 0.001). The most common intervention was lifestyle modifications, followed by BP monitoring technique education and medication adherence interventions. ConclusionIn this study, pharmacist-led interventions resulted in clinically and statistically significant improvements in sustained uncontrolled HTN among minority populations.

Abstract 13673: Effects of Bariatric Surgery on Blood Pressure Management in Type 2 Diabetes: Analysis From a Thirteen-Year Cohort Study

Introduction: Bariatric surgery (BS) is an effective intervention for both weight loss and improved metabolic health in those with Type 2 diabetes (T2D), yet there is limited data on its long-term effect on blood pressure (BP) control. Aim: This prospective cohort study aims to evaluate the long-term effect of BS on BP and metabolic health in T2D patients in a tertiary centre in North-West England. Methods: Patients who underwent BS (gastric bypass/sleeve gastrectomy) between 2009 - 2012 at a single tertiary surgical centre in North-West England were followed for up to 13 years. Preoperative and follow-up data including BP readings, HbA1c, BMI and antihypertensive medication use was obtained from electronic patient records at regular intervals to ascertain longitudinal outcomes in BP, BMI and HbA1c. Results: 119 patients were included in the study. Optimal metabolic health state was achieved at 12 months post-surgery for BMI (-14.78kg/m 2 (95%CI: 13.37-16.20, p&lt;0.001)), systolic BP (sBP) (-15.02mmHg 95%CI: 8.23-21.81mmHg, p&lt;0.001)), diastolic BP (dBP) (-8.1mmHg, 95%CI: 4.26-11.91, p&lt;0.001)) and HbA1c (-24.41mmol/mol, 95%CI: 18.25-30.58, p&lt;0.001). A sustained reduction in both sBP and dBP was maintained for up to 5 years, mirroring a reduction in concurrent use of antihypertensive medications (164 prescriptions v 66 at 5 years). However, at latest follow-up, there was an observed increase in antihypertensive prescription (95 v 66) yet there was no statistically significant change in mean BP. Furthermore, the number of patients with clinically diagnosed hypertension (BP 140/90 or more was lowest at 5 years (n=53 v 86 pre-op) before rising at the latest follow-up (n=57). Conclusions: Our study demonstrates that BS has a sustained benefit on BP as reflected by both absolute measurements and reduction in antihypertensive medication use. It remains an effective strategy not only for weight loss but also for the comprehensive management of metabolic comorbidities in T2D patients as evidenced by reductions in antihypertensive use, HbA1c, BMI and BP. However, more research is needed to explore the longer-term effects of these benefits at ≥ 10 years given the increases in antihypertensive use, BMI and HbA1c after this period.

Effect of the weight-loss program using daily self-weighing combined with personalized counseling led by village health volunteers in adults with obesity in a rural community, Thailand: a randomized controlled trial

BackgroundIn a remote rural community in central Thailand, obesity prevalence among adults significantly rose from 33.9% in 2012 to 44.8% in 2018. Limited information on weight reduction studies in Thai rural communities was available. The present study aims to evaluate the effect of daily self-weighing combined with personalized counseling in order to reduce body weight (BW) and body mass index (BMI) as well as blood pressure (BP).MethodsA randomized controlled trial was carried out in a rural community in central Thailand.One-hundred and seven adults were randomly allocated (1:2) to intervention and control groups. For 20 weeks, participants in the weight-loss program performed self-weighing twice daily and recorded their weight on the calendar. The program also offers weekly counseling visits by village health volunteers (VHV) who make home visits to participants. The primary outcomes were differences in mean change in BW at 20 weeks from baseline between the intervention and control groups.ResultsA total of 107 participants were initially recruited. Of these, 36 participants were allocated to the intervention group and 57 participants to the control group. Significant differences in mean change in BW and BMI at the twelve-, sixteen-, and twenty-week follow-up from baseline between the two groups were observed. At twenty weeks, the mean change in BW was -1.2 kg (95% CI: -2.2, -0.3) and 0.3 kg (95% CI: -0.3, 0.8) in the intervention and control groups, respectively, with p-value = 0.007. Over 20 weeks of the study period, the estimated mean change in BW among the intervention group was 1.0 kg (95% CI -1.7, -0.2) lower than in the control group, with p-value = 0.015. Furthermore, changes in mean BMI and BP over the 20-week follow-up period in intervention participants were recognized.ConclusionsOur study demonstrates that daily self-weighing combined with personalized counseling led by VHV is feasible and can induce weight loss among adults with obesity in a rural community. In addition, the weight-loss program may be a promising additional tool for reducing BP.Trial registrationTrial identification number was TCTR20201020004; first submitted date: 20/10/2020.

INDEKS KOLAPSIBILITAS (CI) SEBAGAI PREDIKTOR HIPOTENSI PADA PASIEN DENGAN ANESTESI UMUM

Intraoperative hypotension (IOH) is important to identify early because it is associated with high morbidity and mortality in old age. Ultrasonographic measurement of the inferior vena cava collapsibility index (IVCCI) can detect volume responsiveness in circulatory shock. The purpose of this study was to examine the collapsibility index (CI) as a predictor of hypotension in patients under general anesthesia. This study was an observational cross-sectional design in adult patients who underwent elective surgery under general anesthesia at Sanglah General Hospital from December 2021 to January 2022 using a consecutive sampling technique. Immediate postinduction changes in systolic and mean blood pressure were compared. The performance of the IVC CI as a diagnostic tool for predicting hypotension (systolic pressure?&lt;?90?mmHg or a???30% drop from the baseline) was evaluated by ROC curve analysis. At the point of collapsibility index (CI) ? 47, there were 29 patients (96.7%) with hypotension. At the point of collapsibility index (CI) &lt; 47, there was 1 patient (3.3%) with hypotension and 24 patients (100%) without hypotension. The cut-off level of collapsibility index (CI) is obtained with the Receiver Operating Curve (ROC) curve, below 0.985. The cut-off CI level for hypotension was 47.0 with a sensitivity of 96.7% and specificity of 100%. There is a significant relationship between IVC CI with a decrease in MAP before and after induction at 4,8, and 10 minutes (p&lt;0,05). The collapsibility index (CI) 50 can be used as a predictor of the incidence of hypotension in patients under general anesthesia.&#x0D; Keywords : hypotension, collapsibility index, general anesthesia.

Abstract P171: Does Sleep Loss Affect Sympatho-excitatory Reactivity Of Blood Pressure In The Morning In People With Untreated Hypertension? A Preliminary Analysis.

Objective: To determine the effect of sleep on the morning sympatho-excitatory reactivity of blood pressure (BP) in patients with untreated hypertension while controlling for the effects of the circadian system. Methods: Four participants (aged 50-63 y) underwent a randomized cross-over trial consisting of an 8-h overnight sleep opportunity and a night of 8-h supine rested wakefulness in dim light. After each trial, we measured beat-to-beat BP and heart rate (HR) at rest and during 2 min of the sympatho-excitatory stress, isometric handgrip exercise (IHG at 30% of maximal voluntary contraction), followed by 2 min of post-exercise ischemia (PEI). Sympathetic vasomotor modulation was analyzed at rest by the low-frequency band of systolic BP variability (LF SBP , mmHg 2 ). The effect size (ES) for repeated measures (Cohen’s d rm ) was used to compare absolute values at rest and the change in HR and mean BP during IHG and PEI as not meaningful (&lt;0.2), small (0.2-0.49), moderate (0.50-0.79), or large (≥0.80). Results: After wakefulness, resting mean BP and sympathetic vasomotor modulation were both higher than after sleep with large ES (151±21 vs. 137±17 mmHg: ES=0.9, 95%CI [+1.3, +0.4]) and (12±9 vs. 6±2 mmHg 2 ; ES=0.9 95%CI [+1.7, +0.1]), respectively. BP reactivity was higher after wakefulness than after sleep with large ES at IHG min 2 and PEI min 1 and moderate ES at PEI min 2 (Figure 1), while HR was higher only at IHG min 2 with large ES. Conclusion: Our data suggest that sleep loss increases sympathetic vasomotor modulation and sympatho-excitatory reactivity of BP to morning physical stress in patients with untreated hypertension increasing their risk for adverse cardiovascular events.

Clinical, polysomnographic, and heart rate variability in highland obstructive sleep apnea patients responding to one-night nocturnal oxygen supplementation: A post-hoc analysis from a randomized, crossover trial

Objective/Background: This study aimed to explore the clinical, polysomnographic, and heart rate variability (HRV) characteristics of highland obstructive sleep apnea (OSA) patients receiving one-night nocturnal oxygen supplementation (NOS) and to identify factors predicting response. Patients/methodsThirty-four highland OSA patients living in Shangri-La were randomly assigned to receive NOS and sham oxygen in a randomized, placebo-controlled, crossover trial. Clinical assessments, polysomnography, and HRV were measured. A responder was defined as a ≥50% reduction in apnea-hypopnea index (AHI) with NOS compared with sham oxygen. ResultsEighteen participants responded and 16 did not respond, with a median (interquartile range [IQR]) age of 46.5 (36.5-53.0) and 48.0 (44.3-53.3) years, respectively. The median treatment effect (95% CI) on total AHI was -23.2/h (-30.0 to -17.5) and -12.0/h (-16.6 to -7.6) in responders and non-responders (p = 0.004), with similar effects on oxygen desaturation index. The mean OAH duration was prolonged by 7 s in responders together with improved sleep quality and daytime blood pressure. The mean OAH duration at baseline predicted responses to NOS with a sensitivity and specificity of 88.9% and 68.7% (AUC 0.809) at a cut-off point of 24.9 s. Changes in HRV parameters were negatively correlated with changes in mean oxygen saturation and daytime systolic blood pressure only in responders. ConclusionsNOS significantly improved OSA severity and clinical outcomes in responders, which was related to improvements in parasympathetic activity. Highlanders with shorter mean OAH may be suitable candidates for NOS. These findings provide new information about tailored treatment strategies for highland OSA patients.

The association between arterial hypertension and menarcheal age.

Menarche, as a milestone of puberty, may have a long-term effect on health. The present study investigated the association of age at menarche with the incidence of arterial hypertension. A total of 4747 post-menarcheal participants of the Tehran Lipid and Glucose Study who met the eligibility criteria were selected. Demographic, lifestyle, reproductive, and anthropometric data, as well as risk factors for cardiovascular diseases, were collected. Participants were classified according to their age at menarche: group I: ≤11years, group II: 12-15years, and group III: ≥16years. A Cox proportional hazards regression model was used to estimate the associations between age at menarche and arterial hypertension outcomes. The generalized estimating equation models were used to compare the trend of changes in systolic and diastolic blood pressure between the three groups. The mean age of participants at baseline was 33.9 (13.0). At the end of the study, 1261 (26.6%) participants had arterial hypertension. Women in group III had a 2.04-fold higher risk of arterial hypertension than those in group II. The mean changes in systolic and diastolic blood pressure were 29% (95% CI: 0.02-0.57) and 16% (95% CI: 0.00-0.38) higher for women in group III compared with group II. Late menarche could be a risk factor for arterial hypertension, so it is necessary to pay more attention to age at menarche in cardiovascular risk assessment programs.

Alkalized lidocaine in a tapered cuff suppresses endotracheal tube-induced hemodynamic changes: a randomized controlled trial.

The use of an endotracheal tube (ET) cuff filled with alkalized lidocaine (AL) can suppress ET-induced emergence phenomena, such as hypertension, tachycardia and coughing, and postoperative sore throat (POST) and hoarseness (PH). The efficacy of intracuff lidocaine may vary depending on the cuff shape, but there has been no study on the effects of a tapered cuff filled with AL. We examined whether intracuff AL suppresses ET-induced emergence phenomena, POST and PH. Sixty-two patients were enrolled in this study and the patients were randomly allocated to a group in which the tapered cuff was filled with AL (Group AL) and a group in which the tapered cuff was filled with normal saline (Group S). The primary outcomes of this study were changes in mean blood pressure (MBP) and heart rate (HR) at extubation. MBP, HR and the number of coughs were recorded before and up to 10min after extubation. The degree of POST and the incidences of POST and PH were recorded at 15min, 2h and 24h after extubation. Changes in MBP before extubation and HR before and after extubation were significantly lower in Group AL than in Group S (p < 0.025). The number of coughs at extubation and the incidence of PH at 2h after extubation were significantly lower in Group AL than in Group S (p < 0.0001 and p = 0.014, respectively). AL in a tapered cuff significantly suppresses ET-induced cardiovascular changes in MBP and HR.

Home Blood Pressure Telemonitoring Technology for Patients With Asymptomatic Elevated Blood Pressure Discharged From the Emergency Department: Pilot Study.

Hypertension affects 1 in 5 Canadians and is the leading cause of morbidity and mortality globally. Hypertension control is declining due to multiple factors including lack of access to primary care. Consequently, patients with hypertension frequently visit the emergency department (ED) due to high blood pressure (BP). Telehealth for Emergency-Community Continuity of Care Connectivity via Home-Telemonitoring Blood Pressure is a pilot project that implements and evaluates a comprehensive home blood pressure telemonitoring (HBPT) and physician case management protocol designed as a postdischarge management strategy to support patients with asymptomatic elevated BP as they transition from the ED to home. Our objective was to conduct a feasibility study of an HBPT program for patients with asymptomatic elevated BP discharged from the ED. Patients discharged from an urban, tertiary care hospital ED with asymptomatic elevated BP were recruited in Vancouver, British Columbia, Canada, and provided with HBPT technology for 3 months of monitoring post discharge and referred to specialist hypertension clinics. Participants monitored their BP twice in the morning and evenings and tele-transmitted readings via Bluetooth Sensor each day using an app. A monitoring clinician received these data and monitored the patient's condition daily and adjusted antihypertensive medications. Feasibility outcomes included eligibility, recruitment, adherence to monitoring, and retention rates. Secondary outcomes included proportion of those who were defined as having hypertension post-ED visits, changes in mean BP, overall BP control, medication adherence, changes to antihypertensive medications, quality of life, and end user experience at 3 months. A total of 46 multiethnic patients (mean age 63, SD 17 years, 69%, n=32 women) found to have severe hypertension (mean 191, SD 23/mean 100, SD 14 mm Hg) in the ED were recruited, initiated on HBPT with hypertension specialist physician referral and followed up for 3 months. Eligibility and recruitment rates were 40% (56/139) and 88% (49/56), respectively. The proportion of participants that completed ≥80% of home BP measurements at 1 and 3 months were 67% (31/46) and 41% (19/46), respectively. The proportion of individuals who achieved home systolic BP and diastolic BP control at 3 months was 71.4% (30/42) and 85.7% (36/42) respectively. Mean home systolic and diastolic BP improved by -13/-5 mm Hg after initiation of HBPT to the end of the study. Patients were prescribed 1 additional antihypertensive medication. No differences in medication adherence from enrollment to 3 months were noted. Most patients (76%, 25/33) were highly satisfied with the HBPT program and 76% (25/33) found digital health tools easy to use. HBPT intervention is a feasible postdischarge management strategy and can be beneficial in supporting patients with asymptomatic elevated BP from the ED. A randomized trial is underway to evaluate the efficacy of this intervention on BP control.

Changes in blood pressure after catheter-based renal denervation in South Africa.

Renal denervation (RDN) is an interventional treatment for patients with uncontrolled hypertension. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, world-wide registry designed to assess the safety and efficacy of RDN. We evaluated the outcomes in South African patients in the GSR over 12 months. Eligible patients with hypertension had a daytime mean blood pressure (BP) > 135/85 mmHg or night-time mean BP > 120/70 mmHg. Office and 24-hour ambulatory systolic BP reduction and adverse events over 12 months were evaluated. South African patients (n = 36) in the GSR had a mean age of 54.4 ± 9.9 years with a median of four prescribed antihypertensive medication classes. At 12 months, mean changes in office and 24-hour ambulatory systolic BP were -16.9 ± 24.2 and -15.3 ± 18.5 mmHg, respectively, with only one adverse event recorded. RDN safety and efficacy in South African patients were consistent with world-wide GSR results.

Incidence, severity and detection of blood pressure and heart rate perturbations in postoperative ward patients after noncardiac surgery

Study objectiveWe sought to determine changes in continuous mean and systolic blood pressure and heart rate in a cohort of non-cardiac surgical patients recovering on the postoperative ward. Furthermore, we estimated the proportion of vital signs changes that would remain undetected with intermittent vital signs checks. DesignRetrospective cohort. SettingPost-operative general ward. Patients14,623 adults recovering from non-cardiac surgical procedures. Interventions & measurementsUsing a wireless, noninvasive monitor, we recorded postoperative blood pressure and heart rate at 15-s intervals and encouraged nursing intervention as clinically indicated. Main results7% of our cohort of 14,623 patients spent >15 sustained minutes with a MAP <65 mmHg, and 23% had MAP <75 mmHg for 15 sustained minutes. Hypertension was more common, with 67% of patients spending at least 60 sustained minutes with MAP >110 mmHg. Systolic pressures <90 mmHg were present for 15 sustained minutes in about a fifth of all patients, and 40% of patients had pressures >160 mmHg sustained for 30 min. 40% of patients were tachycardic with heart rates >100 beats/min for at least continuous 15 min and 15% of patients were bradycardic at a threshold of <50 beats/min for 5 sustained minutes. Conventional vital sign assessments at 4-h intervals would have missed 54% of mean pressure episodes <65 mmHg sustained >15 min, 20% of episodes of mean pressures >130 mmHg sustained >30 min, 36% of episodes of heart rate > 120 beats/min sustained <10 min, and 68% of episodes of heart rate sustained <40 beats per minute for >3 min. ConclusionsSubstantial hemodynamic disturbances persisted despite implementing continuous portable ward monitoring coupled with nursing alarms and interventions. A significant proportion of these changes would have gone undetected using traditional intermittent monitoring. Better understanding of effective responses to alarms and appropriate interventions on hospital wards remains necessary.

THE EFFECT OF ALLOPURINOL AND FEBUXOSTAT ON BLOOD PRESSURE IN ADULTS WITH CHRONIC HYPERURICEMIA

Objective: To observe the effect of the xanthine oxidase inhibitors Allopurinol and Febuxostat on blood pressure in adults with chronic hyperuricemia. Design and method: This was a sub-study of the Febuxostat versus Allopurinol Streamlined Trial (FAST). FAST was a randomised controlled trial comparing the cardiovascular safety of febuxostat and allopurinol in individuals with symptomatic hyperuricemia previously receiving allopurinol. At the screening visit, patients were invited to participate in the Blood Pressure (BP) sub-study. A validated BP monitor and an instruction booklet were provided. Each set of home BP measurements was taken over four consecutive days, three times each in the morning and evening. BP was recorded at baseline (on allopurinol therapy), after 7-days allopurinol washout, and 8 weeks after randomisation to febuxostat or allopurinol. Differences in BP in the allopurinol and febuxostat group were evaluated. The relationship between serum uric acid level reductions and BP changes was also assessed. Results: Between December 2012 and January 2014, 298 FAST participants consented to the BP sub-study. 223 participants who submitted a complete set of BP data were included in the analysis; 104 were randomised to Allopurinol and 119 to Febuxostat. Baseline characteristics were balanced between groups. Overall mean change in BP from washout to 8 weeks of randomised treatment was not significant in either group [Mean BP change in Allopurinol arm: SBP -0.10 mmHg (95% CI -1.76,1.56), p = 0.9; DBP 0.50 mmHg (95% CI -1.82,2.81), p = 0.6. Mean BP change in Febuxostat arm: SBP -0.77 mmHg (95% CI -4.20,2.67), p = 0.7; DBP -0.41 mmHg (95% CI -2.56,1.73), p = 0.7]. No significant BP differences were observed between groups at each time point. Reduction in serum uric acid by &gt; 60 μmol/L at 8 weeks on either therapy was not associated with statistically significant changes in BP. Conclusions: There was no significant difference in the effect of allopurinol or febuxostat on blood pressure after 8 weeks of randomised therapy in the FAST study. Larger reductions in serum uric acid at 8 weeks had no effect on BP change.

The effect of urgent blood pressure reduction on left atrial strain in patients with hypertensive attack : Blood pressure lowering affects LA strain.

Left atrial (LA) strain is a robust measure of LA function and is a useful parameter to assess left ventricular filling pressure. While initially considered as a "load-independent" parameter of LA function, later studies have found that acute changes in LA preload may affect LA reservoir and contractile strains. Acute alterations in blood pressure (BP) induces a change in left ventricular (LV) filling pressure without imposing a volume load, thus providing an opportunity to assess the effects of the change in LA afterload on LA mechanics. This study aims to understand the effect of acute BP changes on LA strain. A total of 40 patients admitted to the emergency department with hypertensive urgency were included. All patients underwent a comprehensive echocardiographic examination including measurement of LA reservoir, conduit and contractile strains. A repeat set of measurements were obtained after BP lowering. Average drop in mean BP following intervention was 18.1 ± 5.4%. LV end-systolic and end-diastolic volumes, as well as maximum and minimum LA volumes were decreased significantly after BP reduction. The absolute increases in reservoir and contractile strains were 2.3 ± 4.7% (7.9% ± 13.8% relative to baseline) and 2.5 ± 3.3% (13.5 ± 19.0% relative to baseline), respectively, with both changes being statistically significant (p = 0.003 for reservoir and p < 0.001 for contractile strains). There were no significant changes in conduit strain after BP intervention (p = 0.79). The change in both LA reservoir and contractile strains were more evident in those with a previous diagnosis of hypertension and those with a smaller degree of change in mean BP after intervention. In patients with an acute hypertension, lowering BP leads to an acute improvement in LA reservoir and contractile strains. Thus, acute changes in systemic BP should be considered when LA mechanics are evaluated.

Factors affecting intradialytic hepatic oxygenation: Associations between ultrafiltration rate and changes in systemic blood pressure

Hepato-splanchnic circulation influences the oxygenation of abdominal organs and is important in preventing a reduction in intradialytic blood volume. However, the association between changes in intradialytic hepato-splanchnic circulation and clinical factors remain unknown. We enrolled 91 hemodialysis (HD) patients (20 with intradialytic hypotension (IDH) and 71 without IDH). During HD, hepatic regional oxygen saturation (rSO2), a marker of hepatic oxygenation reflecting hepato-splanchnic circulation and oxygenation, was monitored. Changes in hepatic rSO2 at the lowest systolic blood pressure (BP) during HD were analyzed to identify associations with clinical factors. Hepatic rSO2 levels were 55.8 ± 15.3% before HD and 53.8 ± 14.9% at the lowest systolic BP; therefore, % changes in hepatic rSO2 were -2.7 ± 11.3%. These values were significantly lower in patients with IDH than in those without IDH (-13.8 ± 9.3% vs 0.4 ± 9.8%, p < 0.001). Multivariable regression analysis showed that % changes in hepatic rSO2 were independently associated with % changes in systolic BP (standardized coefficient: 0.416) and ultrafiltration rate (-0.206). Furthermore, % changes in mean BP (0.304) were identified as affecting % changes in hepatic rSO2 instead of those in systolic BP. Changes in intradialytic hepatic oxygenation is associated with ultrafiltration rate and changes in systemic BP. Further studies are required to clarify the directionality of the association between changes in hepatic oxygenation and changes in systemic BP during HD.

Long-Term Lumateperone Treatment in Bipolar Disorder: Six-Month Open-Label Extension Study

AbstractIntroductionApproved therapeutics for bipolar depression are associated with a range of undesirable side effects. Lumateperone (LUMA), a mechanistically novel antipsychotic that simultaneously modulates serotonin, dopamine, and glutamate neurotransmission, is FDA-approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or bipolar II disorder. The efficacy of LUMA in bipolar depression was previously established in two Phase 3 trials, as monotherapy (NCT03249376) and as adjunctive to lithium or valproate (NCT02600507).A recent Phase 3 multi-center trial, Study 401 (NCT02600494) investigated the efficacy and safety of LUMA in bipolar depression and comprised a 6-week, randomized, double-blind, placebo-controlled period and a 6-month open-label extension (OLE) period. Here, we report the results of the OLE period, examining long-term safety.MethodsPatients, aged 18–75 years, with a clinical diagnosis of bipolar I or II disorder who were experiencing a major depressive episode (Montgomery-Åsberg Depression Rating Scale [MADRS] Total score ≥20 and a Clinical Global Impression Scale-Bipolar Version, Severity [CGI-BP-S] score ≥4) were eligible for Study 401. Patients who completed the double-blind study were eligible for direct rollover into the OLE or were re-screened if completing the double-blind period prior to the initiation of the OLE. During the OLE, LUMA 42 mg was administered once-daily in the evening for 25 weeks.The primary objective was safety and tolerability of LUMA as measured by incidences of adverse events (AEs) and changes in laboratory parameters, cardiometabolic measurements, electrocardiogram (ECG), and vital signs. The secondary objective was improvement/maintenance of symptoms of depression as measured MADRS and CGI-BP-S Total scores.ResultsA total of 127 patients were enrolled in the OLE, with 74 (58.3%) completing the study. Treatment-emergent AEs (TEAEs) occurred in 73 patients (57.5%) with 54 (42.5%) experiencing a drug-related TEAE. TEAEs that occurred in ≥5% of patients were headache, dry mouth, dizziness, nausea, somnolence, anxiety, and irritability. Most TEAEs were mild or moderate in severity. Extrapyramidal-symptom-related TEAEs were rare. Most patients who had normal metabolic laboratory values at baseline remained normal during the treatment period. Mean changes in blood pressure, pulse rate, ECG, and body morphology were minimal. Symptoms of depression improved as measured by the mean change from baseline to Day 175 in MADRS Total score (−8.9) and CGI-BP-S Total score (−2.3).ConclusionIn patients with bipolar depression, long-term LUMA treatment was generally well tolerated with low risk of extrapyramidal symptoms, weight gain, and cardiometabolic effects. These data further support the safety, tolerability, and effectiveness of LUMA in patients with bipolar depression.FundingIntra-Cellular Therapies, Inc.

Changes in Mean Arterial and Blood Pressure in Using Nicardipine in Hypertensive Crisis Patients at the Hajj General Hospital Surabaya from August to December 2021

Hypertension crisis is one of the most common disease problems; it will cause complications and death. Therapeutic management guidelines that the calcium channel blocker group, one of which is nicardipine, can increase the achievement of goals in mean arterial pressure (MAP) in preventing the progression of organ damage. This study aimed to evaluate the use of nicardipine therapy on the MAP and blood pressure (BP) in patients with hypertension crisis. The research design was cross-sectional with statistical analysis—retrospective data collection at Hajj General Hospital Surabaya for August to December 2021. The number of samples in this study matched the inclusion criteria; 20 patients were obtained, 16 with a diagnosis of hypertension emergency, and four with hypertension urgency who received single or combined intravenous nicardipine therapy &lt;0.005 with an average BP decrease of pre 20.375±31.492/103.50±10.400 mmHg and post 121.34±14.364/81.80±11.186 so that intravenous nicardipine therapy was significant in reducing systolic and diastolic BP. In the profile of the MAP value statistically using the paired T-test, it was found that the P-value was 0.000 &lt; 0.005 with a decrease in the MAP pre-value of 135.028±13.8857 mmHg and post 93.650±8.9499 mmHg, showing a reduction in MAP as expected. In conclusion, using nicardipine intravenously at a 5 mg/hour dose has shown an optimal decrease in BP and MAP in hypertensive emergency and urgency patients.