Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis.
ABSTRACT: Hypertension is one of the most common co-existing conditions in patients with chronic pain, and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension. The purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release (ER) treatment in patients with hypertension.We performed a post hoc analysis of data pooled from three randomized, placebo- and active-controlled, phase III studies of tapentadol ER for managing chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain (15-week, double-blind treatment period). Data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline. Heart rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) were measured at each visit.In patients with a listed medical history of hypertension (n = 1,464), least-squares mean (LSM [standard error (SE)]) changes from baseline to endpoint with placebo, tapentadol ER, and oxycodone HCl controlled release (CR), respectively, were -0.7 (0.44), 0.2 (0.43), and -0.9 (0.45) beats per minute (bpm) for heart rate; -2.4 (0.64), -2.7 (0.64), and -3.7 (0.67) mmHg for SBP; and -1.0 (0.39), -1.3 (0.39), and -2.3 (0.41) mmHg for DBP; in patients with at least one listed concomitant antihypertensive medication (n = 1,376), the LSM (SE) changes from baseline to endpoint were -0.6 (0.45), 0.1 (0.44), and -0.7 (0.47) bpm for heart rate; -1.8 (0.66), -3.3 (0.65), and -3.7 (0.69) mmHg for SBP; and -0.7 (0.40), -1.4 (0.40), and -2.3 (0.42) mmHg for DBP.No clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol ER (100-250 mg twice daily).
Project description:To determine the relationship between admission systolic blood pressure (SBP) and mortality in older patients hospitalized for heart failure (HF) and among various subgroups.We evaluated the independent association between initial SBP and 30-day and 1-year mortality, and potential interactions by age, gender, race, previous hypertension, and left ventricular dysfunction using multivariable logistic regression in the National Heart Failure Project, a database of Medicare patients >65 years old recruited from 1998 through 2001. Among 56 942 patients, mean admission SBP was 147.0 + or - 92.3 mmHg, 15% presenting with SBP >180 mmHg. Systolic blood pressure showed an inverse relationship with 30-day and 1-year mortality rates in all subgroups analysed. Using admission SBP of 120-149 mmHg as the reference, the adjusted odds ratios (95% confidence intervals) for 1-year mortality were 2.18 (1.77-2.69) for SBP <90 mmHg, 1.57 (1.47-1.69) for SBP 90-119 mmHg, 0.71 (0.67-0.76) for SBP 150-179 mmHg, 0.63 (0.57-0.68) for SBP 180-209 mmHg, and 0.51 (0.44-0.59) for SBP > or = 210 mmHg.Higher SBP on admission is associated with significant lower 30-day and 1-year mortality in patients hospitalized for HF. The relationship is strong, graded, independent of other clinical factors and consistent among subgroups.
Project description:<h4>Background</h4>The mechanisms of intradialytic increases in blood pressure are not well defined. The present study was undertaken to assess the role of autonomic nervous system activation during intradialytic hypertensive episodes.<h4>Methodology/principal findings</h4>Continuous interbeat intervals (IBI) and systolic blood pressure (SBP) were monitored during hemodialysis in 108 chronic patients. Intradialytic hypertensive episodes defined as a period of at least 10 mmHg increase in SBP between the beginning and the end of a dialysis session or hypertension resistant to ultrafiltration occurring during or immediately after the dialysis procedure, were detected in 62 out of 113 hemodialysis sessions. SBP variability, IBI variability and baroreceptor sensitivity (BRS) in the low (LF) and high (HF) frequency ranges were assessed using the complex demodulation technique (CDM). Intradialytic hypertensive episodes were associated with an increased (n?=?45) or decreased (n?=?17) heart rate. The maximal blood pressure was similar in both groups. In patients with increased heart rate the increase in blood pressure was associated with marked increases in SBP and IBI variability, with suppressed BRS indices and enhanced sympatho-vagal balance. In contrast, in those with decreased heart rate, there were no significant changes in the above parameters. End-of-dialysis blood pressure in all sessions associated with hypertensive episode was significantly higher than in those without such episodes. In logistic regression analysis, predialysis BRS in the low frequency range was found to be the main predictor of intradialytic hypertension.<h4>Conclusion/significance</h4>Our data point to sympathetic overactivity with feed-forward blood pressure enhancement as an important mechanism of intradialytic hypertension in a significant proportion of patients. The triggers of increased sympathetic activity during hemodialysis remain to be determined. Intradialytic hypertensive episodes are associated with higher end-of-dialysis blood pressure, suggesting that intradialytic hypertension may play a role in generation of interdialytic hypertension.
Project description:Blood pressure ranges associated with cardiovascular disease (CVD) events in advanced type 2 diabetes are not clear. Our objective was to determine whether baseline and follow-up (On-Study) systolic blood pressure (SBP), diastolic blood pressure (DBP), and SBP combined with DBP predict CVD events in the Veterans Affairs Diabetes Trial (VADT).Participants in the VADT (n = 1,791) with hypertension received stepped treatment to maintain blood pressure below the target of 130/80 mmHg in standard and intensive glycemic treatment groups. Blood pressure levels of all subjects at baseline and On-Study were analyzed to detect associations with CVD risk. The primary outcome was the time from randomization to the first occurrence of myocardial infarction, stroke, congestive heart failure, surgery for vascular disease, inoperable coronary disease, amputation for ischemic gangrene, or CVD death.Separated SBP ?140 mmHg had significant risk at baseline (hazards ratio [HR] 1.508, P < 0.001) and On-Study (HR 1.469, P = 0.002). DBP <70 mmHg increased CVD events at baseline (HR 1.482, P < 0.001) and On-Study (HR 1.491, P < 0.001). Combined blood pressure categories indicated high risk for CVD events for SBP ?140 with DBP <70 mmHg at baseline (HR 1.785, P = 0.03) and On-Study (HR 2.042, P = 0.003) and nearly all SBP with DBP <70 mmHg.Increased risk of CVD events with SBP ?140 mmHg emphasizes the urgency for treatment of systolic hypertension. Increased risk with DBP <70 mmHg, even when combined with SBP in guideline-recommended target ranges, supports a new finding in patients with type 2 diabetes. The results emphasize that DBP <70 mmHg in these patients was associated with elevated CVD risk and may best be avoided.
Project description:BACKGROUND:In many Western populations, blood pressure varies moderately with season and outdoor temperature. Relatively little is known about effects of seasonal changes in blood pressure on the detection and control of hypertension in general populations, especially in low- and middle-income countries. METHODS:We analysed cross-sectional data of 57?375 (42% men) participants aged 30-79 (mean 52.3) years who were enrolled during 2004-08, as part of the China Kadoorie Biobank, from a rural county in the south-east costal Zhejiang Province. Analyses related daily mean outdoor temperature, obtained from local Meteorological Bureau, to mean systolic (SBP) and diastolic blood pressure (DBP), rate of newly detected hypertension and, among those with self-reported physician-diagnosed hypertension, rate of adequate blood pressure control, using multiple linear and logistic regression models. RESULTS:The overall mean blood pressure was 135.9?mmHg for SBP and 80.5?mmHg for DBP. Daily outdoor temperature ranged between -2.9 and 33.7°C, with July being the hottest month (mean 29.4°C) and January the coldest (mean 4.0°C). Comparing January (the coldest month) with July (the warmest), the differences in the adjusted SBP/DBP were 19.2/7.7?mmHg. Each 10°C lower ambient temperature was associated with 6.9/2.9?mmHg higher SBP/DBP,14.1% higher prevalence of newly detected hypertension and, among those with pre-diagnosed hypertension, 13.0% lower hypertension control rate. CONCLUSION:In rural China, lower outdoor temperature is strongly associated with higher mean blood pressure and hypertension prevalence as well as poorer hypertension control, and should be considered when conducting population-based hypertension surveys and providing treatment for hypertensive patients.
Project description:AIMS:Data regarding the optimal systolic blood pressure (SBP) and heart rate (HR) for coronary artery disease (CAD) patients with hypertension and a history of heart failure (HF) are limited. Accordingly, using data from a large clinical trial, we investigated the association between SBP and heart rate and subsequent adverse outcomes in CAD patients with a history of HF, and we aimed to better understand how pre-existing HF impacts outcomes among patients with CAD. METHODS AND RESULTS:Among 22 576 CAD patients enrolled in the INternational VErapamil SR-Trandolapril STudy (INVEST), 1256 were identified with a history of physician-diagnosed HF New York Heart Association (NYHA) Class 1-3 at entry. The primary outcome was the first occurrence of all-cause death, myocardial infarction (MI), or stroke. Cox proportional-hazards models adjusted for pre-specified covariates were constructed to estimate risk among the HF cohort compared with a case-matched sample from the non-HF cohort. At a mean 2.5 years' follow-up, those with prior HF had a higher risk of the primary outcome (hazard ratio (HR) 2.55, 95% confidence interval 2.30-2.83, P < 0.0001). Among those with history of HF, a low (<120 mmHg) or high (>140 mmHg) SBP and heart rate ? 85 b.p.m. were associated with increased risk for adverse outcomes, which persisted after covariate adjustment. CONCLUSIONS:In patients with CAD, a physician diagnosis of HF at baseline portended a higher risk for death, MI, or stroke than in those without an HF history. Achieving SBP of 120-140 mmHg and heart rate < 85 b.p.m. was associated with a better outcome in patients with known HF and CAD.
Project description:<h4>Objectives</h4>To estimate outcomes according to attained blood pressure (BP) in the oldest adults treated for hypertension in routine family practice.<h4>Design</h4>Cohort analysis of primary care inpatient and death certificate data for individuals with hypertension.<h4>Setting</h4>Primary care practices in England (Clinical Practice Research Datalink).<h4>Participants</h4>Individuals aged 80 and older taking antihypertensive medication and free of dementia, cancer, coronary heart disease, stroke, heart failure, and end-stage renal failure at baseline.<h4>Measurements</h4>Outcomes were mortality, cardiovascular events, and fragility fractures. Systolic BP (SBP) was grouped in 10-mmHg increments from less than 125 to 185 mmHg or more (reference 145-154 mmHg).<h4>Results</h4>Myocardial infarction hazards increased linearly with increasing SBP, and stroke hazards increased for SBP of 145 mmHg or greater, although lowest mortality was in individuals with SBP of 135 to 154 mmHg. Mortality of the 13.1% of patients with SBP less than 135 mmHg was higher than that of the reference group (Cox hazard ratio=1.25, 95% confidence interval=1.19-1.31; equating to one extra death per 12.6 participants). This difference in mortality was consistent over short- and long-term follow-up; adjusting for diastolic BP did not change the risk. Incident heart failure rates were higher in those with SBP less than 125 mmHg than in the reference group.<h4>Conclusion</h4>In routine primary care, SBP less than 135 mmHg was associated with greater mortality in the oldest adults with hypertension and free of selected potentially confounding comorbidities. Although important confounders were accounted for, observational studies cannot exclude residual confounding. More work is needed to establish whether unplanned SBPs less than 135 mmHg in older adults with hypertension may be a useful clinical sign of poor prognosis, perhaps requiring clinical review of overall care.
Project description:To determine the effects of empagliflozin on blood pressure (BP) and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes mellitus (T2DM).We conducted a post hoc analysis of data from a phase III trial in patients with T2DM and hypertension receiving 12?weeks' empagliflozin and four phase III trials in patients with T2DM receiving 24?weeks' empagliflozin (cohort 1, n?=?823; cohort 2, n?=?2477). BP was measured using 24-h BP monitoring (cohort 1) or seated office measurements (cohort 2).Empagliflozin reduced systolic BP (SBP) and diastolic BP in both cohorts (p?<?0.001 vs placebo), without increasing heart rate. Empagliflozin reduced pulse pressure (PP; adjusted mean difference vs placebo cohort 1: -2.3 mmHg; cohort 2: -2.3 mmHg), mean arterial pressure (MAP; cohort 1, -2.3 mmHg; cohort 2, -2.1 mmHg) and double product (cohort 1, -385 mmHg?×?bpm; cohort 2, -369 mmHg?×?bpm) all p?<?0.001 vs placebo. There was a trend towards a reduction in the ambulatory arterial stiffness index (AASI) with empagliflozin in cohort 1 (p?=?0.059 vs placebo). AASI was not measured in cohort 2. Subgroup analyses showed that there were greater reductions in PP with increasing baseline SBP in cohort 1 (p?=?0.092). In cohort 2, greater reductions in MAP were achieved in patients with higher baseline SBP (p?=?0.027) and greater reductions in PP were observed in older patients (p?=?0.011).Empagliflozin reduced BP and had favourable effects on markers of arterial stiffness and vascular resistance.
Project description:To evaluate the ocular-surface safety of a 0.001% benzalkonium chloride-containing tafluprost/timolol fixed combination (TTFC) in patients with primary open-angle glaucoma (POAG) or ocular hypertension who have inadequate intraocular pressure (IOP) control with latanoprost monotherapy.This study is a multicenter, prospective, single-arm, open-label clinical study. Patients with POAG or ocular hypertension who have inadequate IOP control with latanoprost monotherapy were considered eligible. After providing informed consent, patients continued latanoprost monotherapy for 12 weeks, followed by a switch to TTFC. We evaluated the extent of ocular-surface damage using superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), hyperemia score, IOP, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate at 0, 4, and 12 weeks after switching.A total of 68 patients were enrolled, of whom, 64 patients were included in the final analysis. No significant changes in SPK score, TBUT, or hyperemia score were observed at 4 and 12 weeks compared with week 0. IOP decreased significantly at 4 (13.9±2.5 mmHg) and 12 (14.1±2.5 mmHg) weeks, relative to week 0 (15.3±2.7 mmHg). No significant changes in either SBP or DBP were observed during the study, although patients' mean heart rate decreased significantly after switching to TTFC. Adverse drug reactions to TTFC occurred in seven patients including two incidences of asthma and one of arrhythmia, and no events were serious.The ocular-surface safety of TTFC is not significantly different to that of latanoprost. Furthermore, switching from latanoprost to TTFC in patients with insufficient IOP control has additive IOP-lowering effects. TTFC is an effective approach for patients receiving latanoprost monotherapy who require more intensive IOP reduction.
Project description:The initial systolic blood pressure (SBP) in patients presenting to the hospital with acute heart failure (AHF) informs prognosis, diagnosis, and guides initial treatment. However, over time AHF presentations with elevated SBP appear to have declined. The present study examined whether the frequency of AHF presentations with systolic hypertension (SBP >160 mmHg) declined over a nearly two-decade time interval.This study compares four historical, cross-sectional cohorts with AHF who were admitted to tertiary care medical centres in the North-eastern USA in 1995, 2000, 2006, and 2011-13. The main outcome was the proportion of AHF patients presenting with an initial SBP >160 mmHg.2,366 patients comprised the study sample. The average age was 77 years, 55% were female, 94% white, and 75% had prior heart failure. In 1995, 34% of AHF patients presented with an initial SBP >160 mmHg compared to 20% in 2011-2013 (p<0.01). Multivariate logistic regression demonstrated reduced odds of presenting with a SBP >160 mmHg in 2006 (0.64, 95% CI 0.42-0.96) and 2011-13 (0.46, 95% CI 0.28-0.74) compared with patients in 1995.The proportion of patients with AHF and initial SBP >160 mmHg significantly declined over the study time period. There are several potential reasons for this observation and these findings highlight the need for ongoing surveillance of patients with AHF as changing clinical characteristics can impact early treatment decisions.
Project description:Treatment of hypertension post-stroke preserves cognition through prevention of recurrent stroke, but it is not clear whether it prevents cognitive decline through other mechanisms. We aimed to describe changes in blood pressure from baseline to 1 year post-stroke and to evaluate the association between achieved blood pressure targets and cognitive function, mild cognitive impairment (MCI), and dementia.We included patients with first-ever stroke, and defined achieved blood pressure goals as systolic blood pressure (SBP) in the categories ?125 mmHg, ?140 mmHg, and ?160 mmHg, SBP reduction of ?10 mmHg, and diastolic blood pressure (DBP) reduction of ?5 mmHg. The main outcome variables were cognitive assessments 1 year post stroke. Secondary outcomes were diagnoses of MCI or dementia.Forty-one of 166 patients (25%) reached SBP ?125 mmHg after 1 year, 92/166 (55%) reached SBP ?140 mmHg, and 150/166 (90%) reached SBP ?160 mmHg. SBP was reduced by ?10 mmHg in 44/150 (29%) and DBP by ?5 mmHg in 57/150 (38%). We did not find any statistically significant associations between cognitive test performances and different blood pressure goals (P=0.070-1.0). Nor was there any significant association between achieved goal blood pressure or blood pressure reduction after 1 year and the diagnoses of MCI or dementia (P=0.32-0.56).Treatment of hypertension is important for primary and secondary prevention of stroke. Showing a potential beneficial effect of blood pressure control on cognitive function, however, probably needs longer follow-up.