Incident venous thromboembolic events in the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER)

<p>Background: Venous thromboembolic events (VTE), including deep venous thrombosis and pulmonary embolism, are common in older age. It has been suggested that statins might reduce the risk of VTE however positive results from studies of middle aged subjects may not be generalisable to elderly people. We aimed to determine the effect of pravastatin on incident VTE in older people; we also studied the impact of clinical and plasma risk variables.</p> <p>Methods: This study was an analysis of incident VTE using data from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER), a randomized, double-blind, placebo-controlled trial of pravastatin in men and women aged 70-82. Mean follow-up was 3.2 years. Risk for VTE was examined in non-warfarin treated pravastatin (n = 2834) and placebo (n = 2865) patients using a Cox's proportional hazard model, and the impact of other risk factors assessed in a multivariate forward stepwise regression analysis. Baseline clinical characteristics, blood biochemistry and hematology variables, plasma levels of lipids and lipoproteins, and plasma markers of inflammation and adiposity were compared. Plasma markers of thrombosis and hemostasis were assessed in a nested case (n = 48) control (n = 93) study where the cohort was those participants, not on warfarin, for whom data were available.</p> <p>Results: There were 28 definite cases (1.0%) of incident VTE in the pravastatin group recipients and 20 cases (0.70%) in placebo recipients. Pravastatin did not reduce VTE in PROSPER compared to placebo [unadjusted hazard ratio (95% confidence interval) 1.42 (0.80, 2.52) p = 0.23]. Higher body mass index (BMI) [1.09 (1.02, 1.15) p = 0.0075], country [Scotland vs Netherlands 4.26 (1.00, 18.21) p = 0.050 and Ireland vs Netherlands 6.16 (1.46, 26.00) p = 0.013], lower systolic blood pressure [1.35 (1.03, 1.75) p = 0.027] and lower baseline Mini Mental State Examination (MMSE) score [1.19 (1.01, 1.41) p = 0.034] were associated with an increased risk of VTE, however only BMI, country and systolic blood pressure remained significant on multivariate analysis. In a nested case control study of definite VTE, plasma Factor VIII levels were associated with VTE [1.52 (1.01, 2.28), p = 0.044]. However no other measure of thrombosis and haemostasis was associated with increased risk of VTE.</p> <p>Conclusions: Pravastatin does not prevent VTE in elderly people at risk of vascular disease. Blood markers of haemostasis and inflammation are not strongly predictive of VTE in older age however BMI, country and lower systolic blood pressure are independently associated with VTE risk.</p&gt

High "Normal" blood glucose is associated with decreased brain volume and cognitive performance in the 60s: the PATH through Life Study

Context:Type 2 diabetes is associated with cerebral atrophy, cognitive impairment and dementia. We recently showed higher glucose levels in the normal range not to be free of adverse effects and to be associated with greater hippocampal and amygdalar atrophy in older community-dwelling individuals free of diabetes.Objective:This study aimed to determine whether blood glucose levels in the normal range

Ultrasound-Guided Foam Sclerotherapy for the Treatment of Chronic Venous Ulceration: A Preliminary Study

AbstractObjectivesWhen compared to compression therapy alone, surgical correction of superficial venous reflux (SVR) reduces recurrence but does not appear to increase healing of chronic venous ulceration (CVU). The role of ultrasound-guided foam sclerotherapy (UGFS) of SVR as part of the treatment of CVU remains uncertain. The aim of this study is to describe CVU healing and recurrence rates after UGFS and to relate these outcomes to patterns of pre- and post-intervention venous reflux.MethodsA prospective study of 27 consecutive patients (28 legs) of median age 69 (interquartile range 54–79) years undergoing UGFS for SVR in addition to compression for treatment of CVU of median duration 12 (IQR 6–23) months. Prior to and 1, 6, and 12 months after treatment patients underwent clinical and duplex assessment.Results8 limbs (29%) had deep and superficial venous reflux, and 20 limbs had SVR alone. There was a history of DVT in 4 limbs, and 4 patients were on warfarin. No limbs had significant arterial disease and all received post-UGFS compression. Median volume of (3% STD) foam used was 8 (range 2–14) ml. 1, 3 and 6 months after UGFS, 22 (79%), 27 (96%) and 27 (96%) CVU had healed. At 12 months, 25 ulcers remained healed, 2 ulcers had recurred; one patient had died from carcinomatosis.DiscussionFollowing UGFS as an adjunct to compression, 96% of CVU healed within 3 months and only 2 healed ulcers (7%) had recurred at 12 months. UGFS appears to be an attractive minimally-invasive alternative to surgery to treat SVR in patients with CVU, especially the elderly and frail

Chronic venous disease in a cohort of healthy UK Asian men.

ObjectivesThis group has previously reported that UK Asians are significantly less likely to undergo surgery for lower limb venous disease than age and sex matched Caucasians. The aim of the present study was to estimate the prevalence of lower limb chronic venous disease (CVD) in the UK Asian male population.DesignA prospective, epidemiological survey.Materials and methods100 unselected Asian men attending a local Mosque were assessed for the evidence of lower limb CVD, involving the collection of data on history and clinical signs and objective assessments of venous pathophysiology using lower limb venous ultrasonography and venous photoplethysmography (PPG).ResultsOn clinical examination, 80 limbs (in 50 subjects) had clinical evidence of CVD, the majority of cases consisting of varicose veins (CEAP C2). No limbs had either healed or active ulceration (C5/6), and only 2 limbs had thread veins (C1). Eight subjects had had previous venous surgery. The venous refill time (vRT) measured by PPG was lower in limbs with CVD. On venous ultrasound, reflux was present in 73/200 limbs, affecting primarily the GSV system, with only 7 limbs having deep venous reflux.ConclusionsPresent data strongly suggest that the low rates of superficial venous surgery in UK Asians is not because they are inherently less likely to develop CVD

Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument.

OBJECTIVE To evaluate the psychometric properties of the VVSymQ(®) instrument, a new 5-item patient-reported outcome (PRO) measure for symptoms of varicose veins. METHOD The VVSymQ(®) electronic daily diary was administered to outpatients who received routine treatment for varicose veins (N = 40). Compliance with diary administration and item score variability, reliability, construct validity, sensitivity to change, and clinically meaningful change were evaluated. RESULTS Patients completed >97 % of scheduled diary assessments (at screening, baseline, and week 8). The VVSymQ(®) instrument captured patients' pre-treatment symptoms (all VVSymQ(®) symptoms were endorsed by ≥75 % of patients at baseline), and the change post-treatment (mean change in score -6.1), with a large Cohen effect size (1.6). Test-retest reliability was high (intraclass correlation coefficient 0.96); internal consistency was good (Cronbach's alpha ≥0.76; baseline, week 8). VVSymQ(®) scores were more strongly associated with PRO scores that reflect symptoms and symptom impact (the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms [VEINES-QOL/Sym] instrument and the Chronic Venous Insufficiency Quality-of-Life Questionnaire [CIVIQ-20]) than with PRO scores that reflect appearance (the Patient Self-Assessment of Appearance of Visible Varicose Veins [PA-V(3)]) or clinician-reported outcome scores (the Clinical-Etiology-Anatomy-Pathophysiology [CEAP] Classification of Venous Disorders and Venous Clinical Severity Score [VCSS]), demonstrating construct validity. Patients reporting that symptoms were "moderately" or "much improved" on the Patient Global Impression of Change (PGIC) anchor (i.e., >97 % of patients) had mean improvements of -6.3 VVSymQ(®) points, while a cumulative distribution curve showed that 50 % of patients improved by ≥-5.8 points; thus, a score change of approximately -6 demonstrated a clinically meaningful change in this study. The clinically meaningful change in the VVSymQ(®) score was greater in patients with a greater baseline VVSymQ(®) symptom burden, and the VVSymQ(®) instrument captured clinically meaningful treatment benefit even in patients with a low baseline symptom burden. CONCLUSION The 5-item VVSymQ(®) instrument is a brief, psychometrically sound, useful tool for evaluating patient-reported varicose veins symptoms