Mean Baseline Systolic Blood Pressure Research Articles

Abnormal orthostatic blood pressure control among subjects with lacunar infarction.

Hypertension is a recognised risk factor for lacunar stroke. However, their association has been evaluated using static blood pressure (BP) assessment in supine or sitting position alone. We hypothesised that impaired dynamic (orthostatic) BP control may associate with lacunar strokes. Consecutive subjects with mitral regurgitation (MR) confirmed, lacunar strokes were compared with two control groups. Firstly "normal", age and sex matched, population controls (1:3 ratio) and then 'at risk' controls matched for age, sex, hypertension history and antihypertensive medication (1:2 ratio). Orthostatic BP control was assessed by active stand tests with continuous, phasic, beat-to-beat BP measurement. Thirty-six subjects (mean 69.9 years) were compared with 108 controls in group 1 and 72 in group 2. Prevalence of syncope was higher among those with lacunar stroke (cases: 44.4%, group 1: 17.6%, p = 0.003, group 2: 12.5%, p = 0.0004, Fisher's exact). Mean baseline systolic BP (SBP) was significantly higher in cases (cases: 150 mm Hg, group 1: 140 mm Hg, p = 0.03, group 2: 143 mm Hg, p = 0.1). Ten seconds after standing, SBP dropped significantly less in cases (cases: -14.1 mm Hg, group 1: -31.4 mm Hg, p < 0.0005, group 2: -27.3 mm Hg, p = 0.001, t test). Diastolic BP also fell significantly less in cases. Cases' SBP and DBP recovered to, then persistently overshot baseline levels. Subjects with MR-defined lacunar stroke, of likely small vessel aetiology, exhibit orthostatic hypertension compared with population norms.

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis

The benefits of blood pressure lowering treatment for prevention of cardiovascular disease are well established. However, the extent to which these effects differ by baseline blood pressure, presence of comorbidities, or drug class is less clear. We therefore performed a systematic review and meta-analysis to clarify these differences. For this systematic review and meta-analysis, we searched MEDLINE for large-scale blood pressure lowering trials, published between Jan 1, 1966, and July 7, 2015, and we searched the medical literature to identify trials up to Nov 9, 2015. All randomised controlled trials of blood pressure lowering treatment were eligible for inclusion if they included a minimum of 1000 patient-years of follow-up in each study arm. No trials were excluded because of presence of baseline comorbidities, and trials of antihypertensive drugs for indications other than hypertension were eligible. We extracted summary-level data about study characteristics and the outcomes of major cardiovascular disease events, coronary heart disease, stroke, heart failure, renal failure, and all-cause mortality. We used inverse variance weighted fixed-effects meta-analyses to pool the estimates. We identified 123 studies with 613,815 participants for the tabular meta-analysis. Meta-regression analyses showed relative risk reductions proportional to the magnitude of the blood pressure reductions achieved. Every 10 mm Hg reduction in systolic blood pressure significantly reduced the risk of major cardiovascular disease events (relative risk [RR] 0·80, 95% CI 0·77-0·83), coronary heart disease (0·83, 0·78-0·88), stroke (0·73, 0·68-0·77), and heart failure (0·72, 0·67-0·78), which, in the populations studied, led to a significant 13% reduction in all-cause mortality (0·87, 0·84-0·91). However, the effect on renal failure was not significant (0·95, 0·84-1·07). Similar proportional risk reductions (per 10 mm Hg lower systolic blood pressure) were noted in trials with higher mean baseline systolic blood pressure and trials with lower mean baseline systolic blood pressure (all ptrend>0·05). There was no clear evidence that proportional risk reductions in major cardiovascular disease differed by baseline disease history, except for diabetes and chronic kidney disease, for which smaller, but significant, risk reductions were detected. β blockers were inferior to other drugs for the prevention of major cardiovascular disease events, stroke, and renal failure. Calcium channel blockers were superior to other drugs for the prevention of stroke. For the prevention of heart failure, calcium channel blockers were inferior and diuretics were superior to other drug classes. Risk of bias was judged to be low for 113 trials and unclear for 10 trials. Heterogeneity for outcomes was low to moderate; the I(2) statistic for heterogeneity for major cardiovascular disease events was 41%, for coronary heart disease 25%, for stroke 26%, for heart failure 37%, for renal failure 28%, and for all-cause mortality 35%. Blood pressure lowering significantly reduces vascular risk across various baseline blood pressure levels and comorbidities. Our results provide strong support for lowering blood pressure to systolic blood pressures less than 130 mm Hg and providing blood pressure lowering treatment to individuals with a history of cardiovascular disease, coronary heart disease, stroke, diabetes, heart failure, and chronic kidney disease. National Institute for Health Research and Oxford Martin School.

Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial

PurposeThe objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. MethodsPart 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2). FindingsOf 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were −2.0 (8.8) mm Hg in the L10 group, −6.7 (8.5) mm Hg in L10/V80 group, and −8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was −4.6 mm Hg (95% CI, −6.5 to −2.6; P < 0.001) in the L10/V80 group and −5.9 mm Hg (95% CI, −7.9 to −4.0, P < 0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were −5.6 (7.9)/−8.0 (12.0) mm Hg and −5.5 (7.0)/−8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups. ImplicationsTreatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.

PP.05.33

Objective: Liraglutide, a novel glucagon-like peptide-1 receptor agonist drug, has been associated with blood pressure decrease, but few reports exist about its role in albuminuria. In this study, we aimed to evaluate if liraglutide possesses any potential efficacy on albuminuria reduction in hypertensive obese patients with type 2 diabetes mellitus (T2DM). Design and method: Retrospective observational study, including obese hypertensive patients with T2DM and microalbuminuria who were started on liraglutide (0.6 mg/daily first week, 1.2 mg/daily afterwards). Microalbuminuria was defined as present if albumin/creatinine ratio was 30–299 mg/dl. During the study period, no modifications in antihypertensive therapy were done. Baseline and 4 months evaluations were performed Results: 17 obese (mean weight 104.8 ± 17 kg, mean BMI 40.3 ± 4.3 kg/m2) hypertensive (mean number of antihypertensives 1.86 ± 0.6) T2DM patients (mean age 50.3 ± 9.7 years, women 82.4%) were included in the study. Mean albuminuria levels were 56 ± 26.3 mg/dl and baseline eGFR was 93.9 ± 18 ml/min/1.73m2. Also, mean baseline HbA1c was 8.6 ± 1.3%, mean baseline systolic blood pressure (SBP) levels were 150.5 ± 17.7 mmHg and mean diastolic blood pressure (DBP) levels were 89.4 ± 10 mmHg. After 18 ± 4 weeks of average follow-up, albuminuria decreased 21.36 mg/dl (p = 0.04), eGFR remained unchanged, SBP was reduced 10 mmHg (p = 0.04), DBP decreased 3.2 mmHg (p = 0.23), body weight decreased 4.9 kg (p = 0.015) and HbA1c was reduced 1% (p < 0.01). Also, in 12 patients (70.5% out of total) microalbuminuria was restored to normoalbuminuria (p < 0.05). Conclusions: Liraglutide decreases albuminuria and lowers blood pressure in hypertensive obese patients with T2DM. Further clinical trials are needed to confirm the antiproteinuric effect of liraglutide.

Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis.

Lowering blood pressure (BP) is widely used to reduce vascular risk in individuals with diabetes. To determine the associations between BP-lowering treatment and vascular disease in type 2 diabetes. We searched MEDLINE for large-scale randomized controlled trials of BP-lowering treatment including patients with diabetes, published between January 1966 and October 2014. Two reviewers independently extracted study characteristics and vascular outcome data. Estimates were stratified by baseline BP and achieved BP, and pooled using fixed-effects meta-analysis. All-cause mortality, cardiovascular events, coronary heart disease events, stroke, heart failure, retinopathy, new or worsening albuminuria, and renal failure. Forty trials judged to be of low risk of bias (100,354 participants) were included. Each 10-mm Hg lower systolic BP was associated with a significantly lower risk of mortality (relative risk [RR], 0.87; 95% CI, 0.78-0.96); absolute risk reduction (ARR) in events per 1000 patient-years (3.16; 95% CI, 0.90-5.22), cardiovascular events (RR, 0.89 [95% CI, 0.83-0.95]; ARR, 3.90 [95% CI, 1.57-6.06]), coronary heart disease (RR, 0.88 [95% CI, 0.80-0.98]; ARR, 1.81 [95% CI, 0.35-3.11]), stroke (RR, 0.73 [95% CI, 0.64-0.83]; ARR, 4.06 [95% CI, 2.53-5.40]), albuminuria (RR, 0.83 [95% CI, 0.79-0.87]; ARR, 9.33 [95% CI, 7.13-11.37]), and retinopathy (RR, 0.87 [95% CI, 0.76-0.99]; ARR, 2.23 [95% CI, 0.15-4.04]). When trials were stratified by mean baseline systolic BP at greater than or less than 140 mm Hg, RRs for outcomes other than stroke, retinopathy, and renal failure were lower in studies with greater baseline systolic BP (P interaction <0.1). The associations between BP-lowering treatments and outcomes were not significantly different, irrespective of drug class, except for stroke and heart failure. Estimates were similar when all trials, regardless of risk of bias, were included. Among patients with type 2 diabetes, BP lowering was associated with improved mortality and other clinical outcomes with lower RRs observed among those with baseline BP of 140 mm Hg and greater. These findings support the use of medications for BP lowering in these patients.

Cost effectiveness of renal denervation therapy for the treatment of resistant hypertension in the UK.

Patients with resistant hypertension are at a high risk for developing serious cardiovascular events and renal complications. Catheter-based renal denervation (RDN) is a procedure with the potential to normalize systolic blood pressure (SBP). The overall objective of the study was to estimate the cost effectiveness of RDN in the UK for patients with diagnosed resistant hypertension, expressed as a standard cost per quality-adjusted life-year (QALY) ratio. A patient lifetime, economic, Markov heath-state model was developed, linking expected changes in SBP to reductions in risks for cardiovascular events and renal complications, using the Framingham, PROCAM, and other published risk equations. The model was developed from the perspective of the healthcare payer in the UK using relevant cost data from 2012. Clinical effectiveness for RDN (a mean reduction of 32 mmHg in SBP) was taken from the phase III Symplicity HTN-2 trial, in patients with a mean baseline SBP of 178 mmHg. HTN-2 was the largest, multicenter randomized controlled trial on the effectiveness of RDN therapy at the time of the model development. A systematic review identified UK-specific sources for utility, mortality, and cost parameter values, and included recently published UK guidelines for the clinical management of hypertension. RDN therapy resulted in an increase in health benefit over a patient's lifetime compared with anti-hypertensive pharmacological treatment alone (12.77 vs. 12.16 QALYs; discounted). Additional lifetime costs per patient were modeled at £2,961; equivalent to an incremental cost per additional QALY of £4,805. This result was robust to full probabilistic sensitivity and scenario analyses. RDN is an effective clinical procedure that offers patients a meaningful and cost-effective alternative for achieving SBP control, where traditional combination, anti-hypertensive pharmacologic strategies have been proven to be ineffective.

Abstract W P258: Magnitude of Acute Blood Pressure Decrease Does Not Predict the Presence of Diffusion-Restricted Lesions in Patients With Intracerebral Hemorrhage

Introduction: Recent studies have shown an association between aggressive blood pressure (BP) reduction in intracerebral hemorrhage (ICH) and the presence of acute ischemic lesions on diffusion-weighted MR imaging (DWI). However, these findings were based on admission or nadir BP measurements. We tested the hypothesis that the magnitude of acute BP decrease is associated with DWI lesions Methods: We conducted a retrospective analysis of 51 ICH patients who underwent MR imaging with DWI sequences. DWI lesion volumes were measured using planimetric methods. Systolic BP (SBP), diastolic (DBP), and MAP were recorded at baseline, 1,2,6,12, and 24h. Weighted average BP was calculated as the area under the curve of BP measures over 24h. High SBP, low SBP, and high MAP load (calculated as the fraction of time spent &gt;180, &lt;150, or &gt;130 mmHg, respectively) were also determined. Results: Median (IQR) time to MRI was 3.0(4.5) days. Seven patients (14%) demonstrated DWI lesions. Mean DWI volume was 0.97±0.62 ml; 50% of lesions were cortical and 60% were ipsilateral to the hematoma. Median hematoma volume (ml) (16.0(45) vs. 10.5(22), p=0.23) and leukoaraoisis volume (1.8(5.5) vs. 5.6(15.9), p=0.25) did not differ between DWI+ and DWI- patients, respectively. Mean baseline SBP was similar in both groups (171±28 vs. 161.9±28), p=0.44). Weighted mean average SBP in DWI+ patients (158.3±7.5 ml) was similar to that in DWI- patients (143.6±20.4, p=0.21) as was the weighted mean average MAP (102.8±4.3 vs. 98.4±16, p=0.12, respectively). The median 24h decrease in SBP in DWI+ (-20.3 (40.1) mmHg) was similar to that in DWI- patients (-12.7(21), p=0.91). Similarly, high SBP load (5.8% vs. 7.4%, p=0.82), low SBP load (22.5% vs. 60.0%, p=0.16) and high MAP load (6.3% vs. 4.2%,p=0.71) did not differ between groups. Treatment with IV antihypertensive agents was similar in DWI+ (28.6%) and DWI- (29.5%) patients (p=1.00). Conclusions: The magnitude of BP decrease, IV treatment and BP load over 24 hours are not predictive of sub-acute ischemic lesion development. These data do not support a hemodynamic mechanism of DWI lesion formation.

Hypertension on Target with TENORMIN (HOTT) Study-Evaluation of the Effectiveness and Safety of Atenolol in Indian Population

Background: Atenolol is a widely used anti-hypertensive drug worldwide. Despite well-studied from other population, due to the paucity of data from Indians, this study was conducted. Materials and Methods: This was a prospective cohort study conducted in 566 tertiary care hospitals in India. Adult male or female naïve patients with Stage I 1 or Stage II 2 (Seventh Report of the Joint National Committee) essential hypertension or patients uncontrolled on current monotherapy or other combination therapy. Demographic details, blood pressure and heart rate readings (weeks 2, 8, and 12) and drug-related details of the study participants were collected and analyzed. Results: A total of 2657 participants were evaluated. The mean (standard deviation [SD]) baseline systolic and diastolic blood pressure of the study participants were 161.73 (15.13) and 99.21 (11.37), respectively. Mean (SD) of the baseline heart rate was 84.39 (10.17) beats/min. Statistically significant reductions (P < 0.05) were noted in both the blood pressures and heart rate at all the follow-up visits in comparison to baseline. Of the total 632 patients with Stage I hypertension, 153 (24.21%) achieved a reduction in blood pressure <120/80 mmHg, while 245 (38.77%) had their blood pressure between 121 and 140 mmHg systolic and/or 81-90 mmHg diastolic at 12 weeks of therapy. Global assessment of the efficacy and tolerability were found to be at least satisfactory in the majority of the study participants. Conclusion: To conclude, atenolol as an anti-hypertensive agent seems to be promising both in terms of effectiveness and safety profile in the Indian population.

Effect of polyphenol-rich grape seed extract on ambulatory blood pressure in subjects with pre- and stage I hypertension

Dietary polyphenols, such as those from grape products, may exert beneficial effects on cardiovascular health, including anti-hypertensive effects. We investigated the effect of a specific grape seed extract (GSE) rich in low-molecular-weight polyphenolic compounds on ambulatory blood pressure (ABP) in untreated subjects with pre- and stage I hypertension. In addition, potential mechanisms that could underlie the hypothesised effect of GSE on blood pressure (BP), and platelet aggregation, were explored. The study was designed as a double-blind, placebo-controlled, randomised, parallel-group intervention study including seventy healthy subjects with systolic BP between 120 and 159 mmHg. A 1-week run-in period was followed by an 8-week intervention period, during which subjects consumed capsules containing either 300 mg/d of GSE or a placebo (microcrystalline cellulose). Before and after the intervention, daytime ABP readings, 24 h urine samples and fasting and non-fasting blood samples were taken. The mean baseline systolic BP was 135.8 (SE 1.3) mmHg and diastolic BP was 81.5 (SE 0.9) mmHg. BP values were modestly, but not significantly, affected by the polyphenol-rich GSE treatment v. placebo with an effect of - 3.0 mmHg for systolic BP (95% CI - 6.5, 0.5) and - 1.4 mmHg for diastolic BP (95% CI - 3.5, 0.6). Vasoactive markers including endothelin-1, NO metabolites and asymmetric dimethylarginine, plasma renin activity and platelet aggregation were not affected by the GSE intervention. Our findings show that consumption of polyphenol-rich GSE does not significantly lower ABP in untreated subjects with pre- and stage I hypertension.

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: Results from a randomized controlled trial in African Americans with diabetes

Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes. We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence. The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes. This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.

TEAhM—Technologies for Enhancing Access to Health Management: A Pilot Study of Community-Based Telehealth

To explore implementation of nurse-mediated telehealth in community-based senior centers. Two senior centers had telehealth kiosks installed, and two other centers served as control sites. Participants with diagnosed hypertension were instructed to use the equipment at least once per week to measure blood pressure (BP). Nurses monitored BP data for 10 months and made referrals based on primary care physicians' protocols. Participants' mean age was 74.1 years, 75% were women, and mean baseline systolic BPs were 131 and 138 mm Hg in the intervention and control groups, respectively. At baseline, 64% and 85% of participants reported ever having owned a home computer and cell phone, respectively, and 84% reported having used an automated BP device outside of a doctor's office. At 10 months, mean systolic BP was 126 and 132 mm Hg in the intervention and control groups, respectively. Intervention participants used the telehealth station once per week during 69% of all follow-up weeks, and 71% of high readings received nurse follow-up within 24 h. Kiosk use increased steadily during the follow-up period, peaking at 80%, but declined over time to 47% at 10 months. Nearly all intervention group participants reported being "very comfortable" with the technology at study end, 81% reported it was "very easy" to use, and 89% would recommend it to friends. Senior center staff reported that the technology was consistent with their organizational mission and that clients and boards of directors were enthusiastic about it. This pilot study demonstrates that telehealth was embraced by clients and staff of community-based senior centers. A larger study is needed to determine the clinical impact and cost-effectiveness of using senior centers as a venue for telehealth-based management of hypertension and other common chronic conditions.

Abstract P298: The Impact of JNC VII Recommendations for Controlling Blood Pressure in a Heart Failure Disease Management Program

Background: A significant correlation between hypertension (HTN) and long-term risk for heart failure (HF) exists. The aim of this study was (i) to assess what percent of patients enrolled in a heart failure disease management program (HFDMP) reach the JNC VII target goals for blood pressure control; (ii) to assess if there is a disparity in HTN control by race or ethnicity; (iii) and to assess the impact of reaching JNC VII targets for blood pressure control on survival. Methods: Patients with an ejection fraction ≤40% were enrolled into HFDMPs and screened for HTN, defined as blood pressure (BP) ≥ 130/80. Patients were titrated to beta blocker therapy and ace inhibitor therapy following the ACC/AHA HF guidelines. Final BP was measured after one year. Results: Mean baseline systolic BP (SBP) (N = 648) was 149.9 mmHg and mean baseline diastolic BP (DBP) was 90.5 mmHg. At one year, mean SBP decreased to 138.0 mmHg, DBP to 81.8 mmHg. There was no significant increase in survival for patients with BP ≤130 and ≤80 versus patients with HTN. There was a significant disparity in BP control in Blacks and Hispanics compared to whites (p&lt;0.001) Conclusion: Disease management programs are an effective way to reduce BP in hypertensive patients, as well as keeping normotensive patients within JNC VII guidelines however health disparities persisted by race and ethnicity. Mean SBP and DBP of cohort at baseline Vs. 12 Month Follow up Blood pressure ≤ 130/80 mmHg Baseline Visit Last Visit P-Value SBP,m sd 110.9 (12.6%) 120.9 (22.2%) &lt;0.001 DBP , m sd 67.1 (8.6%) 72.4 (13.7%) &lt;0.001 Blood pressure &gt; 130/80 mmHg Baseline Visit Last Visit P-Value SBP , m sd 149.9 (21.4%) 138.0 (24.6%) &lt;0.001 DBP , m sd 90.5 (16.3%) 81.8 (16.8%) &lt;0.001

Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation

Patients can expect a cure from atrial fibrillation (AF) with ablation. Procedural safety and success depend on patient comfort, compliance, and immobility. This is difficult to achieve with benzodiazepine and opiate boluses that are the mainstay of current practice. We sought to determine the safety and efficacy of propofol infusion sedation administered to patients without assisted ventilation for AF ablation. Procedural data from 1000 consecutive patients undergoing AF ablation were analysed. Sedation with 2% propofol was used in all procedures without assisted ventilation and was administered, monitored, and controlled by electrophysiologists. Primary outcome measures were adverse sedative affects including (i) respiratory depression (SpO(2)< 90% for >20 s) and (ii) persistent hypotension [systolic blood pressure (SBP)<90 mmHg at minimum sedation level]. Secondary endpoints included full recovery within 60 min and procedural complications. Of 1000 ablations, 506 ablations were performed for persistent and 494 for paroxysmal AF. Average patient age was 60.1 ± 11.3 years (72.3% male). Propofol was commenced in all patients at a mean infusion rate of 18.5 ± 4.8 mL/h with a mean baseline SBP of 140.3 ± 19.9 mmHg. Mean procedure time was 148.7 ± 57.7 min. Adverse sedative effects necessitating cessation of propofol and switch to midazolam bolus sedation occurred in 15.6% of patients (13.6% due to persistent hypotension, 1.9% due to respiratory depression, and 0.1% due to hypersalivation). Patients who had persistent hypotension were older (62.9 ± 11.2 vs. 60.0 ± 11.4 years, P= 0.011) and more likely to be female (39.5 vs. 23.7%, P< 0.001) than those who tolerated propofol. Patient age correlated to maximum blood pressure drop with propofol (R(2)= 0.101, P< 0.001) and inversely correlated to mean propofol infusion rate (R(2)= 0.066, P< 0.001). No procedures were abandoned due to adverse effects of sedation. All patients recovered within 60 min. Serious procedural complications, unrelated to sedation, occurred in 0.5%, all of whom had pericardial tamponade successfully treated with percutaneous pericardiocentesis. Sedation with 2% propofol infusion administered by cardiologists without assisted ventilation is safe, effective, and practical for use in AF ablation without serious or residual complications. In this setting, persistent hypotension is the most common acute adverse effect requiring cessation of propofol in ∼14%.

Eliminating Disparities in Hypertension Care for Hispanics and Blacks Using a Heart Failure Disease Management Program

This study assessed if patients enrolled in a heart failure disease management program (HFDMP) reach the JNC VII target goals for blood pressure (BP) control, eliminate disparities in hypertension control by race/ ethnicity and the impact BP control has on survival. Patients (N = 898) with an ejection fraction <40% were enrolled into two HFDMPs and screened for hypertension, defined as BP > 130/80. Mean baseline systolic BP (SBP) 132 ± 25.5 mm Hg and diastolic BP (DBP) 79 ± 16.8 mm Hg. Final mean SBP decreased to 129.6 mm Hg, DBP 77.6 mm Hg. Whites had the highest rate of achieving BP goals. Mortality reduction was associated with minority race, history of hypertension, increase ejection fraction and statin use. HFDMPs are an effective way to reduce BP in hypertensive patients. Disparities by race and ethnicity were not seen after adjustment for disease modifiers. There was no mortality difference in those who reached BP goal.

Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis

To provide safety and performance goals for prospective single-arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis. To date, there have been no US Pre-Market Approval (PMA) bare metal renal stent device trials which have focused on improvement of blood pressure control as a primary effectiveness endpoint. Analysis of subject-level data from three large industry sponsored pre-market approval (PMA) trials was performed. Hypertensive patients (≥ 155 mmHg) with a ≥ 50% atherosclerotic renal artery stenosis were included. Thirty day and 9-month systolic and diastolic blood pressure measurements, renal function and 9-month duplex ultrasound assessment of renal artery patency were analyzed. Initial data analysis of 600 patients from the 3 PMA trials identified 286 patients who met inclusion criteria. The mean baseline systolic blood pressure was 177.8 ± 19.3 mmHg with a mean 68.1% diameter renal artery stenosis. Nine months after successful stenting, the mean SBP was 156.7 ± 24.1 mmHg; the 9 month restenosis rate was 14.4%. Based on the statistical modeling of these data and a priori established performance criteria, the co-primary endpoints of 9 month reduction in blood pressure and in-stent restenosis are proposed. The reduction in blood pressure will be analyzed as a continuous variable and will be compared to this performance goal.

Sisters in Motion: A Randomized Controlled Trial of a Faith‐Based Physical Activity Intervention

To evaluate a faith-based intervention (Sisters in Motion) intended to increase walking in older, sedentary African-American women. Randomized controlled trial using within-church randomization. Three Los Angeles churches. Sixty-two African-American women aged 60 and older who reported being active less than 30 minutes three times per week and walked less than 35,000 steps per week as measured using a baseline pedometer reading. Intervention participants received a multicomponent curriculum including scripture readings, prayer, goal-setting, a community resource guide, and walking competitions. Intervention and control participants both participated in physical activity sessions. The primary outcome was change in weekly steps walked as measured using the pedometer. Secondary outcomes included change in systolic blood pressure (SBP). Outcomes were assessed at baseline and 6 months after the intervention. Eighty-five percent of participants attended at least six of eight sessions. Intervention participants averaged 12,727 steps per week at baseline, compared with 13,089 steps in controls. Mean baseline SBP was 156 mmHg for intervention participants and 147 mmHg for controls (P=.10). At 6 months, intervention participants had increased their weekly steps by 9,883 on average, compared with an increase of 2,426 for controls (P=.02); SBP decreased on average by 12.5 mmHg in intervention participants and only 1.5 mmHg in controls (P=.007). The Sisters in Motion intervention led to an increase in walking and a decrease in SBP at 6 months. This is the first randomized controlled trial of a faith-based physical activity program to increase physical activity in older African-American women and represents an attractive approach to stimulate lifestyle change in this population.

Ephedrine and Phenylephrine Use during Cesarean Delivery

Ephedrine and Phenylephrine Use during Cesarean Delivery

All Thiazide‐Like Diuretics Are Not Chlorthalidone: Putting the ACCOMPLISH Study Into Perspective

All Thiazide‐Like Diuretics Are Not Chlorthalidone: Putting the ACCOMPLISH Study Into Perspective

Antihypertensive efficacy and tolerability of irbesartan/hydrochlorothiazide in hypertensive patients stratified by body mass index and type 2 diabetes mellitus status: A post hoc subgroup analysis of the Irbesartan/HCTZ Blood Pressure Reductions in Diverse Patient Populations trial

Objective: This was a post hoc subgroup analysis of efficacy and tolerability data from the Irbesartan/HCTZ Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial stratified by baseline body mass index (BMI). The BMI subgroup data were also analyzed according to the presence or absence of type 2 diabetes mellitus (T2DM) at baseline. Methods: The 18-week, prospective, multicenter, open-label, single-arm INCLUSIVE trial evaluated the efficacy and tolerability of a fixed-dose combination of irbesartan/hydrochlorothiazide (HCTZ) in adult hypertensive patients with systolic blood pressure (SBP) that was uncontrolled after ≥4 weeks of monotherapy. Patients received placebo for 4 to 5 weeks, HCTZ 12.5 mg for 2 weeks, irbesartan/HCTZ 150/12.5 mg for 8 weeks, and irbesartan/HCTZ 300/25 mg for 8 weeks. Patients were stratified into BMI subgroups based on values at screening. Normal weight was defined as a BMI ≤24.9 kg/m 2, overweight as a BMI of 25 to 29.9 kg/m 2, and obesity as a BMI ≥30 kg/m 2. The primary efficacy end point was the mean change in SBP from baseline (end of the placebo phase) to week 18 in the overall intent-to-treat (ITT) population. Secondary efficacy end points were the mean changes in SBP and diastolic blood pressure (DBP) from baseline to week 18 in each BMI subgroup, the proportions of patients in each BMI subgroup achieving their SBP target (<140 mm Hg [<130 mm Hg for patients with T2DM]) and DBP target (<90 mm Hg [<80 mm Hg for patients with T2DM]), and the mean SBP and DBP responses at the end of each treatment period. Results: The ITT population included 736 patients, of whom 99 (13.5%) were normal weight, 243 (33.0%) were overweight, and 394 (53.5%) were obese. Mean baseline SBP and DBP values were similar across BMI subgroups. Obese patients were generally younger than normal-weight and overweight patients, and numerically more obese patients had T2DM and metabolic syndrome. The mean reductions in SBP and DBP at week 18 were statistically significant in all subgroups (all, P < 0.001); SBP and DBP goals were achieved by a respective 83.8% and 93.9% of normal-weight patients, 75.3% and 87.7% of overweight patients, and 76.9% and 77.2% of obese patients. Rates of SBP/DBP control to <140/90 mm Hg in normalweight, overweight, and obese patients without T2DM were 88.2%, 79.8%, and 80.9%, respectively; the corresponding rates of control to <130/80 mm Hg in patients with T2DM were 50.0%, 41.5%, and 38.5%. Conclusion: In this post hoc subgroup analysis of the INCLUSIVE trial, irbesartan/HCTZ combination therapy had comparable antihypertensive efficacy and tolerability regardless of BMI or diabetes status.