Changes In Mean Blood Pressure Research Articles

Reversal of hypertensive heart disease: a multiple linear regression model.

Background: The development of left ventricular hypertrophy in primary hypertension increases cardiovascular mortality and morbidity. Reversal of left ventricular hypertrophy through therapeutic control of blood pressure reduces the risk of adverse cardiovascular incidents. Objective: In our study, we explored for the determinants of left ventricular hypertrophy regression. Methods: A cohort (n=217) of patients with hypertensive left ventricular hypertrophy was identified by screening consecutive patients in medical outpatient unit. The primary inclusion criteria were (i) Blood pressure more than140/90 mm of Hg (ii) Left Ventricular Mass Index more than 115 and 95 gm/m2 for males and females respectively. Left Ventricular Mass Index was determined by echocardiography at the time of recruitment and after 24 weeks of standard pharmacotherapy. The change in Left Ventricular Mass Index was modelled using multiple linear regression with both categorical and continuous explanatory variables. The effect of drug therapy on change in Left Ventricular Mass Index was tested in the model with dummy coded variables for the treatment categories. Results: In simple linear regression, the variables significantly correlating with change in Left Ventricular Mass Index were baseline Left Ventricular Mass Index (r=0.62, p<0.001), change in systolic blood pressure (r=0.22, p=0.001), change in mean blood pressure (r=0.16, p=0.02), baseline systolic blood pressure (r=0.15, p=0.02), age (r=0.12, p=0.09) and diabetes (r=0.12, p=0.09). The best fit model (r2=0.408) retained baseline Left Ventricular Mass Index (β=0.59, p<0.001), change in systolic blood pressure (β=0.14, p=0.01) and diabetes (β=-0.104, p=0.05) as the significant predictors. Introduction of treatment effect into the model non-significantly increased the fit of the model (r2=0.414, p=0.27-0.98). Conclusions: Pre-treatment Left Ventricular Mass Index and reduction in systolic blood pressure were the major determinants of left ventricular hypertrophy regression. We also observed that there is lesser left ventricular hypertrophy regression in diabetic patients, warranting future research to explore glycaemic control as a modifiable factor in left ventricular hypertrophy reversal.

Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study.

Introduction: This cardiovascular magnetic resonance (CMR) study aims to determine whether changes in systemic vascular resistance (SVR), obtained from CMR flow sequences, might explain the significant long-term changes in left ventricular (LV) ejection fraction (EF) observed in subjects with no cardiac disease history.Methods: Cohort subjects without any known cardiac disease but with high rates of hypertension and obesity, underwent CMR with phase-contrast sequences both at baseline and at a median follow-up of 5.2 years. Longitudinal changes in EF were analyzed for any concomitant changes in blood pressure and vascular function, notably the indexed SVR given by the formula: mean brachial blood pressure / cardiac output x body surface area.Results: A total of 118 subjects (53 ± 12 years, 52% women) were included, 26% had hypertension, and 52% were obese. Eighteen (15%) had significant EF variations between baseline and follow-up (7 increased EF and 11 decreased EF). Longitudinal changes in EF were inversely related to concomitant changes in mean and diastolic blood pressures (p = 0.030 and p = 0.027, respectively) and much more significantly to SVR (p < 0.001). On average, these SVR changes were −8.08 ± 9.21 and +8.14 ± 8.28 mmHg.min.m2.L−1, respectively, in subjects with significant increases and decreases in EF, and 3.32 ± 7.53 mmHg.min.m2.L−1 in subjects with a stable EF (overall p < 0.001).Conclusions: Significant EF variations are not uncommon during the long-term CMR follow-up of populations with no evident health issues except for uncomplicated hypertension and obesity. However, most of these variations are linked to SVR changes and may therefore be unrelated to any intrinsic change in LV contractility. This underscores the benefits of specifically assessing LV afterload when EF is monitored in populations at risk of vascular dysfunction.Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT01716819 and NCT02430805.

Rise in Blood Pressure Observed Among US Adults During the COVID-19 Pandemic

Rise in Blood Pressure Observed Among US Adults During the COVID-19 Pandemic

Concomitant Treatment of Hypertensive Patients with Bisoprolol and Perindopril in Routine Clinical Practice: A Post Hoc Analysis of the CONFIDENCEII, PROTECTI, and PROTECTIII Observational Studies.

IntroductionThe combination of angiotensin-converting enzyme inhibitors and beta-blockers is recommended in a wide range of patients with hypertension, including those with stable coronary artery disease and/or elevated heart rate. This post hoc analysis of three observational studies provides effectiveness and safety data on treatment with perindopril on top of bisoprolol-based therapy, in routine clinical practice.MethodsData were analyzed from three open-label, prospective, multicenter, observational studies of Canadian patients with mild-to-moderate hypertension, which shared the same inclusion and exclusion criteria, treatment duration, and primary outcome. This post hoc analysis focused on the subpopulation of patients treated with perindopril on top of bisoprolol-based therapy. All patients were followed for 16 weeks and underwent baseline, week 4, and week 16 visits. Primary outcomes were mean changes in blood pressure (BP) and proportion of patients achieving BP control (< 140/90 mmHg) in the full analysis set (FAS).ResultsA total of 845 patients (mean age 68.3 ± 11.3 years, mean baseline BP 151.5/86.0 mmHg) were analyzed in the FAS. After 16 weeks, mean SBP/DBP decreased by − 20.4/− 9.8 mmHg with statistically significant reductions observed at all visits in all three studies allowing 78% of patients to achieve the BP treatment goal. No statistically significant changes in heart rate were observed and no serious adverse events reported. The most frequent doses of bisoprolol and perindopril were 5 + 4 mg (34.9%), followed by 5 + 8 mg (16.9%), and 2.5 + 4 mg (12.5%).ConclusionThe addition of perindopril on top of bisoprolol-based therapy in patients with mild-to-moderate hypertension was associated with significant reductions in BP compared with baseline and with achievement of BP targets in the majority of patients. The results suggest this strategy is safe and effective for use in routine clinical practice.

Measurement of Post-Exercise Response of Local Arterial Parameters Using an Adjustable Microfluidic Tactile Sensor.

In this work, we demonstrate an adjustable microfluidic tactile sensor for measurement of post-exercise response of local arterial parameters. The sensor entailed a polydimethylsiloxane (PDMS) microstructure embedded with a 5×1 resistive transducer array. The pulse signal in an artery deflected the microstructure and registered as a resistance change by the transducer aligned at the artery. PDMS layers of different thicknesses were added to adjust the microstructure thickness for achieving good sensor-artery conformity at the radial artery (RA) and the carotid artery (CA). Pulse signals of nine (n=9) young healthy male subjects were measured at-rest and at different times post-exercise, and a medical instrument was used to simultaneously measure their blood pressure and heart rate. Vibration-model-based analysis was conducted on a measured pulse signal to estimate local arterial parameters: elasticity, viscosity, and radius. The arterial elasticity and viscosity increased, and the arterial radius decreased at the two arteries 1min post-exercise, relative to at-rest. The changes in pulse pressure (PP) and mean blood pressure (MAP) between at-rest and 1min post-exercise were not correlated with that of heart rate and arterial parameters. After the large 1min post-exercise response, the arterial parameters and PP all went back to their at-rest values over time post-exercise.Clinical Relevance- The study results show the potential application of an affordable, user-friendly device for a more comprehensive arterial health assessment.

Effect of esaxerenone on nocturnal blood pressure and natriuretic peptide in different dipping phenotypes.

There are limited data on the nighttime blood pressure (BP)-lowering effect of esaxerenone and its effect on N-terminal pro b-type natriuretic peptide (NT-proBNP), a predictor of cardiovascular risk, according to different dipping patterns of nocturnal BP. This was a post hoc analysis of a multicenter, open-label, long-term phase 3 study of esaxerenone, a new highly selective mineralocorticoid receptor blocker, in patients with essential hypertension. Patients were classified by dipping pattern (extreme dippers, dippers, non-dippers, risers). Mean changes in BP, changes in dipping pattern, mean NT-proBNP levels, and percentage of patients with normal NT-proBNP levels (<55 pg/mL) at baseline and Weeks 12 and 28 were evaluated. Nighttime systolic BP decreased in all dipping pattern groups at Week 28, with the riser group showing the greatest change (−25.5 mmHg). A significant shift in dipping pattern and riser/non-dipper pattern changes to dipper/extreme dipper pattern were found from baseline to Week 28 (p < 0.0001). The prevalence of the riser pattern decreased from 14.4% to 9.8%, and that of the non-dipper pattern from 44.7% to 39.2%. The decrease in NT-proBNP from baseline to Week 28 was statistically significant in risers, non-dippers, dippers, and extreme dippers (p < 0.001, respectively). At baseline, the proportion of patients with NT-proBNP <55 pg/mL was lowest in risers versus the other dipping pattern types, but after reductions in NT-proBNP in all groups to Week 28, these differences disappeared. Long-term administration of esaxerenone may be a useful treatment option for nocturnal hypertension, especially in patients with a riser pattern.

Effects of chlorpheniramine on emergence agitation after general anesthesia for ureteroscopic stone surgery: a retrospective cohort study.

BackgroundThe presence of a urinary catheter, postoperative pain, and postoperative nausea and vomiting are risk factors for emergence agitation (EA). Antimuscarinic agents are primary agents used in the prevention and treatment of urinary catheter-related bladder discomfort. Chlorpheniramine has antimuscarinic, antinociceptive, and antiemetic effects. This retrospective study investigated the role of chlorpheniramine in EA prevention following ureteroscopic stone surgery.MethodsOf 110 adult patients who underwent ureteroscopic stone surgery under general anesthesia between January and December 2019, the medical records of 93 patients were analyzed retrospectively. The patients were divided into control (n = 52) and chlorpheniramine (n = 41) groups according to the receipt of intravenous chlorpheniramine before the induction of anesthesia. The incidence and severity of EA were compared between the groups as primary and secondary endpoints, respectively. The effects of chlorpheniramine on the requirement for inhalation anesthetic (desflurane) during surgery, changes in mean blood pressure and heart rate during emergence, and adverse events were also compared.ResultsThe incidence (21.2% in the control group, 24.4% in the chlorpheniramine group) and severity of EA did not differ between groups. The intraoperative requirement for desflurane, changes in mean blood pressure and heart rate during emergence, and adverse events were also similar between groups.ConclusionsChlorpheniramine was not associated with a decrease in EA incidence or severity in patients who underwent ureteroscopic stone surgery.

Tracking blood pressure changes by means of non-invasive intermittent blood pressure measurements in clinical application

Abstract Considering accuracy/precision cut-offs of 5 ± 8 mmHg and cut-off values for inter-class correlation coefficients (ICC=0.37...1, from DIN EN ISO 81060-2), absolute and relative errors in time independent measurement of blood pressure changes with non-invasive intermittent devices (NiBP) are derived mathematically for mean arterial blood pressure range of 40-180 mmHg. As a clinically relevant value for change of arterial blood pressure 20% of the baseline blood pressure is considered. The mean ratio between the change of BP measured by the NiBP and measured by the invasive reference device (TE%) were proposed as quality measure for the evaluation of NiBP device tracking capability. The proposed measure TE%is theoretically independent of absolute accuracy but depends on precision and ICC of a device. NiBP devices show considerable maximum TE% of 41% in tracking mean blood pressure changes respectively. In 10% of the measurements in the low blood pressure range TE% exceeding 100%. The mean 50th/90th TE% percentile over the whole blood pressure range were 25/61%, respectively. Furthermore, TE% was relatively insensitive to assumed blood pressure range but sensitive to ICC. NiBP devices have high relative error in tracking blood pressure changes that make those devices not well-suited for tracking blood pressure changes. The proposed tracking error allows the definition of reasonable accuracy/precision requirements of NBP devices.

Lowering of blood pressure and pulse rate by switching from DPP-4 inhibitor to luseogliflozin in patients with type 2 diabetes complicated with hypertension: A multicenter, prospective, randomized, open-label, parallel-group comparison trial (LUNA study)

AimsSodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces clinic blood pressure (BP), but the effects on BP circadian rhythm remain unclear. The present study aimed to determine the nighttime antihypertensive effect of SGLT2i compared with dipeptidyl peptidase-4 inhibitor (DPP-4i) in patients with type 2 diabetes and hypertension. Materials and MethodsIn this randomized, open-label, parallel-group trial, patients treated with DPP-4i were either switched to luseogliflozin 2.5 mg/day (Luseo group;n = 30) or continued DPP-4i (DPP-4i group;n = 26). The patients undertook 24-h ambulatory BP monitoring before and 8 weeks after the group allocation. The primary endpoint was mean change in nighttime systolic BP (SBP). ResultsNighttime SBP, as well as daytime SBP, was significantly reduced in the Luseo group compared with the DPP-4i group (nighttime, −4.0 ± 11.4 vs. 3.6 ± 10.7 mmHg,P = 0.01; daytime, −4.4 ± 10.9 vs. 3.7 ± 11.9 mmHg,P = 0.01). Similarly, nighttimepulse rate(PR) was significantly reduced in the Luseo group (−2.0 ± 4.8 vs. 0.9 ± 4.8 bpm,P = 0.03). The proportion of patients with abnormal BP circadian rhythms (non-dipper pattern plus riser pattern) was significantly lower in the Luseo group (36.6% vs. 56.7%,P < 0.05). ConclusionsSwitching from DPP-4i to luseogliflozin decreased nighttime SBP and PR; moreover, BP circadian rhythm was improved.

Adherence to Telemonitoring Therapy for Medicaid Patients With Hypertension: Case Study.

BackgroundAlmost 50% of the adults in the United States have hypertension. Although clinical trials indicate that home blood pressure monitoring can be effective in managing hypertension, the reported results might not materialize in practice because of patient adherence problems.ObjectiveThe aims of this study are to characterize the adherence of Medicaid patients with hypertension to daily telemonitoring, identify the impacts of adherence reminder calls, and investigate associations with blood pressure control.MethodsThis study targeted Medicaid patients with hypertension from the state of Texas. A total of 180 days of blood pressure and pulse data in 2016-2018 from a telemonitoring company were analyzed for mean transmission rate and mean blood pressure change. The first 30 days of data were excluded because of startup effects. The protocols required the patients to transmit readings by a specified time daily. Patients not transmitting their readings received an adherence reminder call to troubleshoot problems and encourage transmission. The patients were classified into adherent and nonadherent cohorts; adherent patients were those who transmitted data on at least 80% of the days.ResultsThe mean patient age was 73.2 (SD 11.7) years. Of the 823 patients, 536 (65.1%) were women, and 660 (80.2%) were urban residents. The adherent cohort (475/823, 57.7%) had mean transmission rates of 74.9% before the adherence reminder call and 91.3% after the call, whereas the nonadherent cohort (348/823, 42.3%) had mean transmission rates of 39% and 58% before and after the call, respectively. From month 1 to month 5, the transmission rates dropped by 1.9% and 10.2% for the adherent and nonadherent cohorts, respectively. The systolic and diastolic blood pressure values improved by an average of 2.2 and 0.7 mm Hg (P<.001 and P=.004), respectively, for the adherent cohort during the study period, whereas only the systolic blood pressure value improved by an average of 1.6 mm Hg (P=.02) for the nonadherent cohort.ConclusionsAlthough we found that patients can achieve high levels of adherence, many experience adherence problems. Although adherence reminder calls help, they may not be sufficient. Telemonitoring lowered blood pressure, as has been observed in clinical trials. Furthermore, blood pressure control was positively associated with adherence.

Abstract P109: A Promising Novel Hypertension Drug Candidate

This study tests the hypothesis that RMJH-111b, a novel drug candidate, can improve blood pressure (BP) in hypertensive adults without the gastrointestinal distress that is often experienced with oral magnesium (Mg) treatment. A Phase 1 / 2 study tested the clinical tolerability, safety and efficacy as well as pharmacokinetics of RMJH-111b softgels. Each softgel contains 110 mg elemental Mg as inverted micellar nanodroplets designed to enhance intestinal uptake and cell delivery of active constituents. Forty-one hypertensive people were screened, twenty-two qualified to be enrolled and twenty-one completed the 10 day inpatient trial. In the study, after a 7 day washout period, participants were admitted and had a 3 day run in on only placebo followed by a 7 day double blind treatment period. Fifteen people received active treatment with 440 mg of elemental Mg BID (a total of 880 mg daily) and six received placebo. Data collected include daily seated blood pressure as well as 24h ambulatory blood pressure (ABPM) measurements. In addition, ECG, routine laboratory tests including serum Mg levels and 24h urinary Mg excretion were performed on days 3 and 10.ABPM 24h mean blood pressure changes day, night and 24° are as follows: SBP day :-6.2, DBP day :-2.3, SBP night :-4.9 , DBP night :-1.3 , SBP 24° :-6.6 , DBP 24° :-2.8 , SBP+DBP 24° :-9.4. One individual was excluded because her SBP decreased from 155 to 108 mm Hg after five days on protocol, below the 110 mm SBP protocol exclusion criteria. No symptoms of hypotension were observed. A correlation was noted between 24h levels of urinary Mg excretion and the 24h ABPM BP reduction. There were no adverse effects in the study group. A trend correlating serum Mg levels increase and BP decrease across the study population was noted. Based on retroactive statistical analysis of data presented, if 100 people had been studied using the same protocol, a statistical significance with a p value.

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial.

AimsDigital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication.Methods and resultsThis prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension [office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg] were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population. Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group (n = 199) or control (n = 191) group. Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were −2.4 (95% confidence interval −4.5 to −0.3), −4.3 (−6.7 to −1.9), and −3.6 (−6.2 to −1.0) mmHg, respectively. No major programme-related safety events occurred up to 24 weeks.ConclusionThe HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.

Comparison between methyldopa and combination of methyldopa and nifedipine in terms of mean change in blood pressure in pregnancy induced hypertension

Objective: Comparison between Methyldopa and combination of Methyldopa and Nifedipine in terms of mean change in blood pressure in pregnancy induced hypertension. Material and methods: This randomized controlled trial was conducted at Department of Obstetrics and Gynecology, Combined Military Hospital Bahawalpur from February 2020 to August 2020 over the period of 6 months. Total 80 patients with pregnancy induced hypertension as per operational definition having age 20-40 years and having gestational age ≥ 20 weeks assessed on LMP were selected. Results: Mean age of the patients was 30.81 ± 5.670 years, mean age of patients of group A was 31.50 ± 5.809 years and mean age of group B was 30.13 ± 5.515 years. Mean gestational age was 30.17 ± 5.981 weeks, mean gestational age of patients of group A was 29.70 ± 6.329 weeks and mean gestational age of patients of group B was 30.65 ± 5.65 weeks. In group A, mean diastolic blood pressure was decrease from 101.2250 ± 4.97938 to 84.5000 ± 3.26599 and in group B from 107.7750 ± 7.18434 to 82.5000 ± 2.25320. Comparison of mean decrease in diastolic blood pressure between group A (High dose Methyldopa) and group B (Low dose Low dose Methyldopa with Nifedipine) was done. Mean decrease in diastolic blood pressure in group A was 16.72 ± 3.935 and in group B was 25.28 ± 6.876. Statistically significant difference of mean decrease in diastolic blood pressure between the both groups was noted with p value 0.000. Conclusion: Results of this study showed that Low dose Methyldopa with Nifedipine combination is more effective as compared to High dose Methyldopa to reduce diastolic blood pressure in pregnant women suffering from pregnancy induced hypertension. Keywords: Diastolic blood pressure, Methyldopa, Nifedipine, Pregnancy induced hypertension, Systolic blood pressure

7-LB: Lowering of Blood Pressure and Pulse Rate by Switching from DPP-4 Inhibitor to Luseogliflozin in Patients with Type 2 Diabetes and Hypertension: A Multicenter, Prospective, Randomized, Open-Label, Parallel-Group Comparison Trial

Objective: Sodium-glucose cotransporter-2 inhibitor (SGLT2i) treatment had the effect of reducing blood pressure (BP) and cardiovascular events in recent mega-scale trials, but the effects on BP circadian rhythm remained unclear. The present study aimed to determine the nocturnal antihypertensive effect of SGLT2i compared with dipeptidyl peptidase-4 inhibitor (DPP-4i) in patients with type 2 diabetes and hypertension. Research Design and Methods: In this randomized, open-label, parallel-group trial, patients treated with DPP-4i were either switched to luseogliflozin 2.5 mg/day (Luseo group; n=30) or continued DPP-4i (DPP-4i group; n=26). The patients undertook 24-h ambulatory BP monitoring before and 8 weeks after the group allocation. The primary endpoint was mean change in nighttime systolic BP (SBP). Results: Changes in both nighttime and daytime SBP were significantly reduced in the Luseo group compared with the DPP-4i group (nighttime, −4.0±11.4 vs. 3.6±10.7 mmHg, P=0.01; daytime, −4.4±10.9 vs. 3.7±11.9 mmHg, P=0.01). Similarly, nighttime pulse rate (PR) was significantly reduced in the Luseo group compared with the DPP-4i group (−2.0±4.8 vs. 0.9±4.8 bpm, P=0.03). Abnormal BP circadian rhythms (non-dipper and riser types) were significantly decreased in the Luseo group (56.7% to 36.6%, P&amp;lt;0.05). Conclusions: Switching from DPP-4i to luseogliflozin decreased not only daytime but also nighttime SBP and PR, and improved BP circadian rhythm. These improvements could be some of the factors involved in the cardiovascular event suppression observed with SGLT2i therapy. Disclosure R. Hashimoto-kameda: None. K. Cho: None. H. Nomoto: None. A. Nakamura: Research Support; Self; Boehringer Ingelheim International GmbH, Kissei Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K. K., Taisho Pharmaceutical Co., Ltd. K. Omori: None. S. Kawata: None. H. Kameda: None. T. Atsumi: Research Support; Self; Alexion Pharmaceuticals, Inc., Astellas Pharma Inc., Bristol-Myers Squibb Company, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo, Eisai Co., Ltd., Eli Lilly Japan K. K., Gilead Sciences, Inc., Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., UCB Japan Co. Ltd., Speaker’s Bureau; Self; AbbVie Inc., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K. K., Mitsubishi Tanabe Pharma Corporation, Pfizer Inc., Takeda Pharmaceutical Co., UCB Japan Co. Ltd. H. Miyoshi: Research Support; Self; Abbott Japan Co., Ltd., Astellas Pharma Inc., Daiichi Sankyo, Eli Lilly Japan K. K., Kowa Company, Ltd., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Speaker’s Bureau; Self; Astellas Pharma Inc., Eli Lilly Japan K. K., Kowa Company, Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K. K., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K. K., Sumitomo Dainippon Pharma Co., Ltd. Funding Taisho Pharmaceutical Co., Ltd.

Comparison of perioperative analgesia between intravenous paracetamol and fentanyl for rigid hysteroscopy: A randomised control trial.

To compare efficacy of intravenous paracetamol and fentanyl for intra-operative and post-operative analgesia in patients undergoing rigid hysteroscopy. The prospective randomised control trial was conducted at Aga Khan University Hospital, Karachi, from October 2016 to June 2017, and comprised patients aged 18-65 years with American Society of Anesthesiologists grade I or II undergoing hysteroscopy who were randomised into paracetamol group P and fentanyl group F. Anaesthesia induction technique was standardised and analgesia in group P was paracetamol 15mg/Kg administered 15-30 minutes pre-surgery, and in group F, it was fentanyl 2mcg/kg administered at induction of anaesthesia. Intra-operative pain was assessed by changes in heart rate, systolic, diastolic and mean arterial blood pressure, and post-operative pain was assessed using the visual analogue scale. Data was analysed using SPSS 19. Of the 60 patients, there were 30(50%) in each of the two groups. Baseline parameters were similar in the groups except for age differences (p<0.011). In group P, mean systolic blood pressure at 10,15, 20, 25 and 30 minutes, mean diastolic blood pressure at 20, 25 minutes, and mean arterial blood pressure at 20 minutes were statistically significant (p<0.05) compared to group F. The mean heart rate was not significant between the groups (p>0.05). Post-operative pain scores were similar at 0, 15 and 30 minutes (p>0.05). Rescue analgesia was needed in 3(10%) patients in each group on arrival in the recovery room. Intravenous paracetamol offered analgesic efficacy similar to fentanyl for rigid hysteroscopy in ambulatory surgery.

CHANGES IN CAROTID LOCAL STIFFNESS DURING A SIX-YEARS FOLLOW UP IN A GENERAL POPULATION: THE VOBARNO STUDY

Objective: Local carotid stiffness (Carotid PWV) is an independent predictor of cardiovascular events but few data are available on the progression of Carotid stiffness over time. The aim of the present longitudinal study was to analyze the progression of local carotid stiffness over a 6-year period in a general population in Northern Italy (Vobarno Study). Design and method: 123 subjects, age 55 ± 4 years (42% males, hypertension in 43% at baseline visit), underwent a baseline (BL) and a follow up (FU) visit, 6.2 ± 0.5 years apart. In all subjects laboratory examinations, measurements of blood pressure (BP) and of Carotid PWV (using an echotracking approach) were performed at BL and at FU. Progression rate of Carotid PWV (δCarotid_PWV/Year) was defined as (Carotid PWV at FU-Carotid PWV at BL)/years of FU. Results: In the overall population, Carotid PWV increased from 6.39 ± 1.41 at BL to 6.79 ± 1.18 m/s at FU (p &lt; 0.05). δCarotid_PWV/Year was inversely related to BP (mean BP: r = -0.193, p &lt; 0.05; pulse pressure: r = -0.1.81, p &lt; 0.05) and to Carotid PWV at BL (r = -0.669, p &lt; 0.001). No other correlation was observed between δCarotid_PWV/Year and demographic or laboratory parameters at BL. δCarotid_PWV/Year was also related to changes over time in BP values (δSystolicBP: r = 0.291, p &lt; 0.01; δDiastolicBP: r = 0.266, p &lt; 0.01; δMeanBP: r = 0.310, p &lt; 0.0001). At multivariate analysis the variables independently related to the annual progression rate of Carotid PWV were Carotid PWV and mean BP at BL (beta -0.68, p &lt; 0.0001, and beta 0.20, p &lt; 0.05, respectively) and changes in mean BP during follow-up (beta 0.18, p &lt; 0.05). Conclusions: In a general population sample in Northern Italy the main determinants of the increase in local carotid stiffness during a 6 years FU were local carotid stiffness and mean BP at BL and change in mean BP over time.

The nonpharmacological sequence method provides a reliable evaluation of baroreflex sensitivity in fish.

The most commonly used technique to study the barostatic regulation of blood pressure in ectothermic vertebrates consists of determining the heart rate response to pharmacological manipulations of blood pressure, the so-called "Oxford method."Although well established, the Oxford method has some important limitations, such as induction of hypervolemia in small animals and undesired effects of vasoactive drugs on central and peripheral baroreflex components. As an alternative, the sequence method, which consists in the computerized evaluation of naturally-occurring baroreflex adjustments of heart rate without the need for pharmacological administrations, was developed to study baroreflexes. In the present study, we compare this sequence method with the Oxford technique in two teleost species with different life styles, and we assess the optimal software configuration for the employment of the sequence method in fish. Calculation of baroreflex gain through the sequence method was adequate and reliable when the software was configured to search for baroreflex sequences with a minimum length of three cardiac cycles with a delay of one cardiac cycle between fluctuations in mean ventral aortic blood pressure and reflex changes in pulse interval. When properly configured, the sequence and the Oxford methods yielded similar determinations of the baroreflex gain in fish.

Effects of Switching from Liraglutide or Dulaglutide to Subcutaneous Semaglutide on Glucose Metabolism and Treatment Satisfaction in Patients with Type 2 Diabetes: Protocol for a Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Comparison Study (The SWITCH-SEMA 1 Study).

IntroductionGlucagon-like peptide (GLP)-1 receptor agonists exert potent hypoglycemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent manner. Once-weekly subcutaneous administration of the GLP-1 receptor agonist semaglutide has beneficial effects on glycemic and body weight control, but it is currently unclear if semaglutide provides superior glycemic control compared to conventional GLP-1 receptor agonists in the Japanese population. We aim to compare the effects of once-weekly subcutaneous semaglutide with those of liraglutide or dulaglutide administration in Japanese patients with T2D.MethodsThis study is a multicenter, prospective, randomized, open-label, blinded-endpoint, parallel-group trial. In total, 100 participants with T2D who have been treated with liraglutide (0.9–1.8 mg/day in plan A) or dulaglutide (0.75 mg/week in plan B) for more than 12 weeks and have a glycated hemoglobin (HbA1c) level of 6.0–9.9% and a body mass index (BMI) of ≥ 22 kg/m2 will be randomized to either continue using their existing GLP-1 receptor agonist or switch to subcutaneous semaglutide once weekly for 24 weeks. Biochemical analysis, physical assessment, and a quality-of-life questionnaire (DTSQ) will be completed at baseline and at the end of the study. The primary endpoint is the effect of semaglutide on the change in HbA1c. The secondary endpoints are the mean changes in total DTSQ score, body mass, abdominal circumference, systolic and diastolic blood pressure, pulse rate, factors associated with improvement in HbA1c and secondary endpoints, side effects, and other laboratory parameters.Planned OutcomesThe results of the study will provide useful information regarding the effects of switching to semaglutide from other GLP-1 receptor agonists on glycemic control in patients with T2D.Ethics and DisseminationThe Hokkaido University Certified Review Board (CRB no. 1180001) has approved the protocol (no. 018-005). The results will be disseminated in peer-reviewed journals and at scientific conferences.Trial RegistrationUMIN000042369 in the University Hospital Medical Information Network (UMIN); jRCT1011200008 in the Japan Registry of Clinical Trials (jRCT); pre-results.

Effectiveness of a pathway-driven eHealth-based integrated care model (PEICM) for community-based hypertension management in China: study protocol for a randomized controlled trial

BackgroundThe prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in traditional care settings. Integrated care combined with information technology can promote high-quality healthcare services across the life-course. However, few studies have applied a customized integrated care model in community-based hypertension management in China, catering to the emerging “three-manager” mode. This study aims to identify the effectiveness of a pathway-driven eHealth-based integrated model that implemented as a full-featured telehealth system to facilitate standardized management of hypertension in China.MethodsThe trial has been designed as a 1-year, non-blinded superiority trial with two parallel groups. A total of 402 hypertensive patients who meet the eligibility criteria will be recruited and randomized with a 1:1 allocation. All the participants will receive a mobile device for self-management, which is a part of our telehealth system. Participants in the control group will only use the device for BP measurement and receive regular follow-ups from care providers according to the guidelines. Participants in the intervention group will gain full access to the system and receive intervention based on the proposed model (a well-designed coordinated care pathway consisting of 9 tasks). Outcomes will be measured mainly on three occasions (at inclusion, at 6 months, and at 12 months). The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes include changes in diastolic blood pressure, biochemical indexes related to hypertension, lifestyles, self-management adherence, and hypertension awareness, as well as work efficiency of care providers.DiscussionThis study aims to investigate whether a pathway-driven eHealth-based integrated care model based on the “three-manager” mode will improve hypertension control in China. Success of the model would help improve the quality of present community-based management procedures and benefit more patients with uncontrolled hypertension.Trial registrationChinese Clinical Trial Registry ChiCTR1900027645. Registered on November 22, 2019.

Urinary proteomics reveals key markers of salt sensitivity in hypertensive patients during saline infusion.

Hypertension is a complex disease and is the major cause of cardiovascular complications. In the vast majority of individuals, the aetiology of elevated blood pressure (BP) cannot be determined, thus impairing optimized therapies and prognosis for individual patients. A more precise understanding of the molecular pathogenesis of hypertension remains a pressing priority for both basic and translational research. Here we investigated the effect of salt on naive hypertensive patients in order to better understand the salt intake-blood pressure relationship. Patients underwent an acute saline infusion and were defined as salt-sensitive or salt-resistant according to mean blood pressure changes. Urinary proteome changes during the salt load test were analysed by a label-free quantitative proteomics approach. Our data show that salt-sensitive patients display equal sodium reabsorption as salt-resistant patients, as major sodium transporters show the same behaviour during the salt load. However, salt-sensitive patients regulate the renin angiotensin system (RAS) differently from salt-resistant patients, and upregulate proteins, as epidermal growth factor (EGF) and plasminogen activator, urokinase (PLAU), involved in the regulation of epithelial sodium channel ENaC activity. Salt-sensitive and salt-resistant subjects have similar response to a saline/volume infusion as detected by urinary proteome. However, we identified glutamyl aminopeptidase (ENPEP), PLAU, EGF and Xaa-Pro aminopeptidase 2 precursor XPNPEP2 as key molecules of salt-sensitivity, through modulation of ENaC-dependent sodium reabsorption along the distal tubule.