5,075 research outputs found

    The correlation between interarm blood pressure differences and postoperative complications after peripheral vascular surgery: a prospective observational study

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    Background: A large difference in blood pressure between both arms is common in patients with disseminated atherosclerosis undergoing vascular surgery. In patients with high cardio-vascular risk, inter-arm blood pressure difference > 10mm Hg can occur in more than 38% of population, but the impact on short-term postoperative complications is still unclear. Objectives: The aim of this study was to evaluate the effect of inter-arm blood pressure asymmetry on the overall postoperative complications in Revised Cardiac Risk Index class I-II patients undergoing peripheral vascular surgery. Secondly, we established other possible risk factors for postoperative complications and duration of hospital stay. Design: Prospective observational study. Setting: Single-centre study. Patients: Ninety-five RCRI class I-II patients undergoing peripheral vascular surgery. Interventions: We measured blood pressure in brachial arteries on both arms in the operating room prior to administering anaesthesia for every patient enrolled in the study. After the surgery, all participants were followed up from the time of hospitalization for any postoperative complications. Main outcome measures: Blood pressure values Results: we did not find any correlation between overall postoperative complications and blood pressure differences (neither systolic, diastolic, nor mean) between the arms. Patients who underwent emergent surgery had highly increased risk of postoperative complications (OR 13,0; 95%CI 1,4 to 69,3; p < 0,01) and prolonged hospital stay time(HR 2,5; 95%CI 1,7 to 3,7; p < 0,01). Conclusion: although we did not find any relevant correlation between inter-arm blood pressure differences and postoperative complications, the measurement in both arms is crucial to determine adequate baseline values prior to surgery.Background: A large difference in blood pressure between both arms is common in patients with disse­minated atherosclerosis undergoing vascular surgery. In patients with high cardiovascular risk, inter-arm blood pressure difference &gt; 10 mm Hg can occur in more than 38% of the population, but the impact on short-term postoperative complications is still unclear. Material and methods: The aim of this study was to evaluate the effect of inter-arm blood pressure asymmetry on the overall postoperative complications in the Revised Cardiac Risk Index class I–II patients undergoing peripheral vascular surgery. Secondly, other possible risk factors for postoperative compli­cations and duration of hospital stay were established. Design: Prospective observational study. Setting: Single-centre study. Patients: Ninety-five RCRI class I-II patients undergoing peripheral vascular surgery. Interventions: The authors measured blood pressure in brachial arteries on both arms in the operating room prior to administering anaesthesia for every patient enrolled in the study. After the surgery, all participants were followed up from the time of hospitalization for any postoperative complications. Main outcome measures: Blood pressure values Results: There was no correlation found between overall postoperative complications and blood pressure differences (neither systolic, diastolic nor mean) between the arms. Patients who underwent emergent surgery had highly increased risk of postoperative complications (OR 13.0; 95% CI 1.4 to 69.3; p &lt; 0.01) and prolonged hospital stay time (HR 2.5; 95% CI 1.7 to 3.7; p &lt; 0.01). Conclusion: Although the authors did not find any relevant correlation between inter-arm blood pressu­re differences and postoperative complications, the measurement in both arms is crucial to determine adequate baseline values prior to surgery

    What's the Risk? Older Women Report Fewer Symptoms for Suspected Acute Coronary Syndrome than Younger Women.

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    The purpose of the study was to determine whether older (≥65 years) and younger (&lt;65 years) women presenting to the emergency department (ED) with symptoms suggestive of acute coronary syndrome (ACS) varied on risk factors, comorbid conditions, functional status, and symptoms that have implications for emergent cardiac care. Women admitted to five EDs were enrolled. The ACS Symptom Checklist was used to measure symptoms. Comorbid conditions and functional status were measured with the Charlson Comorbidity Index and Duke Activity Status Index. Logistic regression models were used to evaluate symptom differences in older and younger women adjusting for ACS diagnosis, functional status, body mass index (BMI), and comorbid conditions. Analyses were stratified by age, and interaction of symptom by age was tested. Four hundred women were enrolled. Mean age was 61.3 years (range 21-98). Older women (n = 163) were more likely to have hypertension, hypercholesterolemia, never smoked, lower BMI, more comorbid conditions, and lower functional status. Younger women (n = 237) were more likely to be members of minority groups, be college-educated, and have a non-ACS discharge diagnosis. Younger women had higher odds of experiencing chest discomfort, chest pain, chest pressure, shortness of breath, nausea, sweating, and palpitations. Lack of chest symptoms and shortness of breath (key symptoms triggering a decision to seek emergency care) may cause older women to delay seeking treatment, placing them at risk for poorer outcomes. Younger African American women may require more comprehensive risk reduction strategies and symptom management

    A phase Ib/II study of cabozantinib (XL184) with or without erlotinib in patients with non-small cell lung cancer.

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    PurposeCabozantinib is a multi-kinase inhibitor that targets MET, AXL, and VEGFR2, and may synergize with EGFR inhibition in NSCLC. Cabozantinib was assessed alone or in combination with erlotinib in patients with progressive NSCLC and EGFR mutations who had previously received erlotinib.MethodsThis was a phase Ib/II study (NCT00596648). The primary objectives of phase I were to assess the safety, pharmacokinetics, and pharmacodynamics and to determine maximum tolerated dose (MTD) of cabozantinib plus erlotinib in patients who failed prior erlotinib treatment. In phase II, patients with prior response or stable disease with erlotinib who progressed were randomized to single-agent cabozantinib 100 mg qd vs cabozantinib 100 mg qd and erlotinib 50 mg qd (phase I MTD), with a primary objective of estimating objective response rate (ORR).ResultsSixty-four patients were treated in phase I. Doses of 100 mg cabozantinib plus 50 mg erlotinib, or 40 mg cabozantinib plus 150 mg erlotinib were determined to be MTDs. Diarrhea was the most frequent dose-limiting toxicity and the most frequent AE (87.5% of patients). The ORR for phase I was 8.2% (90% CI 3.3-16.5). In phase II, one patient in the cabozantinib arm (N = 15) experienced a partial response, for an ORR of 6.7% (90% CI 0.3-27.9), with no responses for cabozantinib plus erlotinib (N = 13). There was no evidence that co-administration of cabozantinib markedly altered erlotinib pharmacokinetics or vice versa.ConclusionsDespite responses with cabozantinib/erlotinib in phase I, there were no responses in the combination arm of phase II in patients with acquired resistance to erlotinib. Cabozantinib did not appear to re-sensitize these patients to erlotinib

    Serotonin receptor agonists in the acute treatment of migraine. a review on their therapeutic potential

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    Migraine is an important socioeconomic burden and is ranked the sixth cause of years of life lost because of disability in the general population and the third cause of years of life lost in people younger than 50 years. The cornerstone of pharmacological treatment is represented by the acute therapy. The serotonin (5-hydroxytryptamine [5-HT]) receptor subtype 1B/1D agonists, called triptans, are nowadays the first-line acute therapy for patients who experience moderate-to-severe migraine attacks. Unfortunately, a high percentage of patients are not satisfied with this acute treatment, either for lack of response or side effects. Moreover, their mechanism of action based on vasoconstriction makes them unsuitable for patients with previous cardio- and cerebrovascular diseases and for those with uncontrolled hypertension. Since the introduction of triptans, no other acute drug class has passed all developmental stages. The research for a new drug lacking vasoconstrictive effects led to the development of lasmiditan, a highly selective 5-HT1F receptor agonist with minimized interactions with other 5-HT receptor subtypes. Lasmiditan is considered to be the first member of a new drug category, the neurally acting anti-migraine agent (NAAMA). Phase II and III trials had shown superiority compared to placebo and absence of typical triptan-associated adverse events (AEs). Most of the AEs were related to the central nervous system, depending on the high permeability through the blood-brain barrier and mild to moderate severity. The results of ongoing long-term Phase III trials will determine whether lasmiditan will become available in the market, and then active triptan comparator studies will assess patients’ preference. Future studies could then explore the safety during pregnancy and breastfeeding or the risk that overuse of lasmiditan leads to medication overuse headache

    Effects of intensive blood pressure lowering on cerebral ischaemia in thrombolysed patients: insights from the ENCHANTED trial

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    Background: Intensive blood pressure lowering may adversely affect evolving cerebral ischaemia. We aimed to determine whether intensive blood pressure lowering altered the size of cerebral infarction in the 2196 patients who participated in the Enhanced Control of Hypertension and Thrombolysis Stroke Study, an international randomised controlled trial of intensive (systolic target 130–140 mm Hg within 1 h; maintained for 72 h) or guideline-recommended (systolic target 150 mm Hg) after thrombolysis treatment for acute ischaemic stroke between March 3, 2012 and April 30, 2018. Methods: All available brain imaging were analysed centrally by expert readers. Log-linear regression was used to determine the effects of intensive blood pressure lowering on the size of cerebral infarction, with adjustment for potential confounders. The primary analysis pertained to follow-up computerised tomography (CT) scans done between 24 and 36 h. Sensitivity analysis were undertaken in patients with only a follow-up magnetic resonance imaging (MRI) and either MRI or CT at 24–36 h, and in patients with any brain imaging done at any time during follow-up. This trial is registered with ClinicalTrials.gov, number NCT01422616. Findings: There were 1477 (67.3%) patients (mean age 67.7 [12.1] y; male 60%, Asian 65%) with available follow-up brain imaging for analysis, including 635 patients with a CT done at 24–36 h. Mean achieved systolic blood pressures over 1–24 h were 141 mm Hg and 149 mm Hg in the intensive group and guideline group, respectively. There was no effect of intensive blood pressure lowering on the median size (ml) of cerebral infarction on follow-up CT at 24–36 h (0.3 [IQR 0.0–16.6] in the intensive group and 0.9 [0.0–12.5] in the guideline group; log Δmean −0.17, 95% CI −0.78 to 0.43). The results were consistent in sensitivity and subgroup analyses. Interpretation: Intensive blood pressure lowering treatment to a systolic target <140 mm Hg within several hours after the onset of symptoms may not increase the size of cerebral infarction in patients who receive thrombolysis treatment for acute ischaemic stroke of mild to moderate neurological severity. Funding: National Health and Medical Research Council of Australia; UK Stroke Association; UK Dementia Research Institute; Ministry of Health and the National Council for Scientific and Technological Development of Brazil; Ministry for Health, Welfare, and Family Affairs of South Korea; Takeda

    Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE)

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    © 2017 John Wiley & Sons Ltd.Summary : Aims/objectives: : In the BESIDE study, combination therapy (antimuscarinic [solifenacin] and β3-adrenoceptor agonist [mirabegron]) improved efficacy over solifenacin monotherapy without exacerbating anticholinergic side effects in overactive bladder (OAB) patients; however, a potential synergistic effect on the cardiovascular (CV) system requires investigation. Methods: OAB patients remaining incontinent despite daily solifenacin 5 mg during 4-week single-blind run-in, were randomised 1:1:1 to double-blind daily combination (solifenacin 5 mg/mirabegron 25 mg, increasing to 50 mg after week 4), solifenacin 5 or 10 mg for 12 weeks. CV safety assessments included frequency of CV-related treatment-emergent adverse events (TEAEs), change from baseline in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate) and electrocardiogram (ECG) parameters. Results: The frequency of hypertension, tachycardia and ECG QT prolongation, respectively, was low and comparable across combination (1.1%, 0.3%, 0.1%), solifenacin 5 mg (0.7%, 0.1%, 0.1%), and solifenacin 10 mg groups (0.8%, 0%, 0.1%). Adjusted mean (SE) change from baseline to end of treatment (EoT) in SBP, DBP, and pulse rate with combination (0.07 mm Hg [0.38], -0.35 mm Hg [0.26], 0.47 bpm [0.28]), solifenacin 5 mg (-0.93 mm Hg [0.38], -0.45 mm Hg [0.26], 0.43 bpm [0.28]) and solifenacin 10 mg (-1.28 mm Hg [0.38], -0.48 mm Hg [0.26], 0.27 bpm [0.28]) was generally comparable, with the exception of a mean treatment difference of ~1 mm Hg in SBP between combination and solifenacin monotherapy; SBP was unchanged with combination and decreased with solifenacin monotherapy. Mean changes from baseline to EoT in ECG parameters were generally similar across treatment groups, except for QT interval corrected using Fridericia's formula, which was higher with solifenacin 10 mg (3.30 mseconds) vs. combination (0.49 mseconds) and solifenacin 5 mg (0.77 mseconds). Conclusion: The comparable frequency of CV-related TEAEs, changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined

    WILL (When to induce labour to limit risk in pregnancy hypertension):Protocol for a multicentre randomised trial

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    OBJECTIVES: To address optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well.STUDY DESIGN: Pragmatic, non-masked randomised trial.INCLUSION: maternal age ≥16 years, chronic or gestational hypertension, singleton pregnancy, live fetus, 36+0-37+6 weeks' gestation, and able to give documented informed consent.EXCLUSION: contraindication to either trial arm (e.g., pre-eclampsia or another indication for birth at term), blood pressure (BP) ≥ 160/110 mmHg until controlled, major fetal anomaly anticipated to require neonatal care unit admission, or participation in another timing of birth trial. Randomisation (1:1 ratio, minimised for key prognostic variables: site, hypertension type, and prior Caesarean) to 'planned early term birth at 38+0-3 weeks' or 'usual care at term' (revised from 'expectant care until at least 40+0 weeks', Aug 2022).OUTCOMES: Maternal co-primary: composite of 'poor maternal outcome' (severe hypertension, maternal death, or maternal morbidity). Neonatal co-primary: neonatal care unit admission for ≥4 h. Each co-primary is measured until primary hospital discharge or 28 days post-birth (whichever is earlier). Key secondary: Caesarean birth.ANALYSIS: Sample of 1080 participants (540/arm) will detect an 8% reduction in the maternal co-primary (90% power, superiority hypothesis), and give 94% power for a between-group non-inferiority margin of difference of 9% in the neonatal co-primary. Analysis will be by intention-to-treat. Ethics approval has been obtained (NHS Health Research Authority London Fulham Research Ethics Committee, 18/LO/2033).CONCLUSIONS: The study will provide data for women to make informed choices about their care and allow health systems to plan services.</p

    Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE)

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    © 2017 John Wiley & Sons Ltd.Summary : Aims/objectives: : In the BESIDE study, combination therapy (antimuscarinic [solifenacin] and β3-adrenoceptor agonist [mirabegron]) improved efficacy over solifenacin monotherapy without exacerbating anticholinergic side effects in overactive bladder (OAB) patients; however, a potential synergistic effect on the cardiovascular (CV) system requires investigation. Methods: OAB patients remaining incontinent despite daily solifenacin 5 mg during 4-week single-blind run-in, were randomised 1:1:1 to double-blind daily combination (solifenacin 5 mg/mirabegron 25 mg, increasing to 50 mg after week 4), solifenacin 5 or 10 mg for 12 weeks. CV safety assessments included frequency of CV-related treatment-emergent adverse events (TEAEs), change from baseline in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate) and electrocardiogram (ECG) parameters. Results: The frequency of hypertension, tachycardia and ECG QT prolongation, respectively, was low and comparable across combination (1.1%, 0.3%, 0.1%), solifenacin 5 mg (0.7%, 0.1%, 0.1%), and solifenacin 10 mg groups (0.8%, 0%, 0.1%). Adjusted mean (SE) change from baseline to end of treatment (EoT) in SBP, DBP, and pulse rate with combination (0.07 mm Hg [0.38], -0.35 mm Hg [0.26], 0.47 bpm [0.28]), solifenacin 5 mg (-0.93 mm Hg [0.38], -0.45 mm Hg [0.26], 0.43 bpm [0.28]) and solifenacin 10 mg (-1.28 mm Hg [0.38], -0.48 mm Hg [0.26], 0.27 bpm [0.28]) was generally comparable, with the exception of a mean treatment difference of ~1 mm Hg in SBP between combination and solifenacin monotherapy; SBP was unchanged with combination and decreased with solifenacin monotherapy. Mean changes from baseline to EoT in ECG parameters were generally similar across treatment groups, except for QT interval corrected using Fridericia's formula, which was higher with solifenacin 10 mg (3.30 mseconds) vs. combination (0.49 mseconds) and solifenacin 5 mg (0.77 mseconds). Conclusion: The comparable frequency of CV-related TEAEs, changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined
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