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2.
Spat Spatiotemporal Epidemiol ; 43: 100538, 2022 11.
Article in English | MEDLINE | ID: mdl-36460456

ABSTRACT

BACKGROUND: Modifying the environment is considered an effective population-level approach for increasing healthy behaviours, but associations remain ambiguous. This exploratory study aims to compare researcher-defined buffers and self-drawn neighbourhoods (SDN) to objectively measured availability of physical activity (PA) facilities and greenspaces in adolescents. METHODS: Seven consecutive days of GPS data were collected in an adolescent sample of 14-18 year olds (n = 69). Using Points of Interest and greenspace data, availability of PA opportunities within activity spaces were determined. We compared 30 different definitions of researcher-defined neighbourhoods and SDNs to objectively measured availability. RESULTS: Findings showed low agreement for all researcher-defined buffers in measuring the availability of PA facilities in activity spaces. However, results were less clear for greenspace. SDNs also demonstrate low agreement for capturing availability to the PA environment. CONCLUSION: This exploratory study highlights the inadequacy of researcher-defined buffers and SDNs to define availability to environmental features.


Subject(s)
Exercise , Parks, Recreational , Humans , Adolescent , Environment , Health Status
4.
Health Place ; 69: 102569, 2021 05.
Article in English | MEDLINE | ID: mdl-33882372

ABSTRACT

BACKGROUND: There continues to be a lack of understanding as to the geographical area at which the environment exerts influence on behaviour and health. This exploratory study compares different potential methods of both researcher- and participant-defined definitions of neighbourhood reflect an adolescent's activity space. METHODS: Seven consecutive days of global positioning system (GPS) tracking data were collected at 15 s intervals using a small exploratory adolescent sample of 14-18 year olds (n = 69) in West Yorkshire, England. A total of 304,581 GPS tracking points were collected and compared 30 different definitions of researcher-defined neighbourhoods including radial, network and ellipse buffers at 400 m, 800 m, 1000 m, 1600 m and 3000 m, as well as participant-defined self-drawn neighbourhoods. RESULTS: This exploratory study supports emerging evidence cautioning against the use of static neighbourhood definitions for defining exposure. Traditional buffers (network and radial) capture at most 67% of activity space (home radial), and at worst they captured only 3.5% (school network) and range from capturing between 3 and 88% of total time. Similarly, self-drawn neighbourhoods captured only 10% of actual daily movement. Interestingly, 40% of an adolescent's self-drawn neighbourhood was not used. We also demonstrate that buffers capture a range of space (22-95%) where adolescents do not go, thus misclassifying the exposure. CONCLUSION: Our exploratory findings demonstrate that neither researcher- nor participant-defined definition of neighbourhood adequately captures adolescent activity space. Further research with larger samples are needed to confirm the findings of this exploratory study.


Subject(s)
Geographic Information Systems , Residence Characteristics , Adolescent , England , Environment , Humans , Schools
5.
Prev Med ; 143: 106334, 2021 02.
Article in English | MEDLINE | ID: mdl-33227345

ABSTRACT

Understanding the determinants of attendance at public health interventions is critical for effective policy development. Most research focuses on individual-level determinants of attendance, while less is known about environmental-level determinants. Data were obtained from the Leeds Let's Get Active public health intervention in Leeds, England. Longitudinal data (April 2015-March 2016) on attendance were obtained for n = 25,745 individuals (n = 185,245 total visits) with baseline data on sociodemographic determinants and lifestyle practices obtained for n = 3621 individuals. This resulted in a total of n = 744,468 days of attendance and non-attendance. Random forests were used to explore the relative importance of the determinants on attendance, while generalised linear models were applied to examine specific associations (n = 3621). The probability that a person will attend more than once, the number of return visits, and the probability that a person will attend on a particular day were investigated. When considering if a person returned to the same leisure centre after one visit, the most influential determinant was the distance from their home. When considering number of return visits overall however, age group was the most influential. While distance to a leisure centre was less important for predicting the number of return visits, the difference between estimates for 300 m and 15,000 m was 7-10 visits per year. Finally, calendar month was the most important determinant of daily attendance. This longitudinal study highlights the importance of both individual and environmental determinants in predicting various aspects of attendance. It has implications for strategies aiming to increase attendance at public health interventions.


Subject(s)
Exercise , Public Health , Cities , England , Humans , Longitudinal Studies
6.
Int J Obes (Lond) ; 38(10): 1343-9, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24919564

ABSTRACT

OBJECTIVES: To assess how outcomes associated with participation in a family-based weight management intervention (MEND 7-13, Mind, Exercise, Nutrition..Do it!) for childhood overweight or obesity implemented at scale in the community vary by child, family, neighbourhood and MEND programme characteristics. METHODS/SUBJECTS: Intervention evaluation using prospective service level data. Families (N=21,132) with overweight children are referred, or self-refer, to MEND. Families (participating child and one parent/carer) attend two sessions/week for 10 weeks (N=13,998; N=9563 with complete data from 1788 programmes across England). Sessions address diet and physical activity through education, skills training and motivational enhancement. MEND was shown to be effective in obese children in a randomised controlled trial (RCT). Outcomes were mean change in body mass index (BMI), age- and sex-standardised BMI (zBMI), self-esteem (Rosenberg scale) and psychological distress (Strengths and Difficulties Questionnaire) after the 10-week programme. Relationships between the outcome and covariates were tested in multilevel models adjusted for the outcome at baseline. RESULTS: After adjustment for covariates, BMI reduced by mean 0.76 kg m(-2) (s.e.=0.021, P<0.0001), zBMI reduced by mean 0.18 (s.e.=0.0038, P<0.0001), self-esteem score increased by 3.53 U (s.e.=0.13, P<0.0001) and psychological distress score decreased by 2.65 U (s.e.=0.31, P<0.0001). Change in outcomes varied by participant, family, neighbourhood and programme factors. Generally, outcomes improved less among children from less advantaged backgrounds and in Asian compared with white children. BMI reduction under service conditions was slightly but not statistically significantly less than in the earlier RCT. CONCLUSIONS: The MEND intervention, when delivered at scale, is associated with improved BMI and psychosocial outcomes on average, but may work less well for some groups of children, and so has the potential to widen inequalities in these outcomes. Such public health interventions should be implemented to achieve sustained impact for all groups.


Subject(s)
Diet , Exercise , Family/psychology , Pediatric Obesity/prevention & control , Weight Loss , Weight Reduction Programs , Adolescent , Adult , Body Mass Index , Child , Child Nutritional Physiological Phenomena , Community Participation , Evidence-Based Medicine , Female , Humans , Male , Outcome Assessment, Health Care , Pediatric Obesity/epidemiology , Pediatric Obesity/psychology , Program Evaluation , Prospective Studies , Randomized Controlled Trials as Topic , Self Concept , Surveys and Questionnaires , United Kingdom/epidemiology
7.
BMJ Open ; 3(5)2013 May 03.
Article in English | MEDLINE | ID: mdl-23645925

ABSTRACT

OBJECTIVE: The aim of this study was to report outcomes of the UK service level delivery of MEND (Mind,Exercise,Nutrition...Do it!) 5-7, a multicomponent, community-based, healthy lifestyle intervention designed for overweight and obese children aged 5-7 years and their families. DESIGN: Repeated measures. SETTING: Community venues at 37 locations across the UK. PARTICIPANTS: 440 overweight or obese children (42% boys; mean age 6.1 years; body mass index (BMI) z-score 2.86) and their parents/carers participated in the intervention. INTERVENTION: MEND 5-7 is a 10-week, family-based, child weight-management intervention consisting of weekly group sessions. It includes positive parenting, active play, nutrition education and behaviour change strategies. The intervention is designed to be scalable and delivered by a range of health and social care professionals. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was BMI z-score. Secondary outcome measures included BMI, waist circumference, waist circumference z-score, children's psychological symptoms, parenting self-efficacy, physical activity and sedentary behaviours and the proportion of parents and children eating five or more portions of fruit and vegetables. RESULTS: 274 (62%) children were measured preintervention and post-intervention (baseline; 10-weeks). Post-intervention, mean BMI and waist circumference decreased by 0.5 kg/m(2) and 0.9 cm, while z-scores decreased by 0.20 and 0.20, respectively (p<0.0001). Improvements were found in children's psychological symptoms (-1.6 units, p<0.0001), parent self-efficacy (p<0.0001), physical activity (+2.9 h/week, p<0.01), sedentary activities (-4.1 h/week, p<0.0001) and the proportion of parents and children eating five or more portions of fruit and vegetables per day (both p<0.0001). Attendance at the 10 sessions was 73% with a 70% retention rate. CONCLUSIONS: Participation in the MEND 5-7 programme was associated with beneficial changes in physical, behavioural and psychological outcomes for children with complete sets of measurement data, when implemented in UK community settings under service level conditions. Further investigation is warranted to establish if these findings are replicable under controlled conditions.

8.
Int J Body Compos Res ; 7(1): 15-20, 2009 Feb.
Article in English | MEDLINE | ID: mdl-20396615

ABSTRACT

OBJECTIVES: To examine the validity of body composition estimates obtained using foot-to-foot bio-electrical impedance analysis (BIA) in overweight and obese children by comparison to a reference four-compartment model (4-CM). SUBJECTS/METHODS: 38 males: age (mean +/- sd) 13.6 +/- 1.3 years, body mass index 30.3 +/- 6.0 kg.m(-2) and 14 females: age 14.7 +/- 2.2 years, body mass index 32.4 +/- 5.7 kg.m(-2) participated in the study. Estimates of fat-free mass (FFM), fat mass (FM) and percentage body fat (PBF) obtained using a Tanita model TBF-310 and a 4-CM (derived from body mass, body volume, total body water and total body bone mineral measurements) were compared using bias and 95% limits of agreement (Tanita minus 4-CM estimates). RESULTS: Body composition estimates obtained with the Tanita TBF-310 were not significantly different from 4-CM assessments: for all subjects combined the bias was -0.7kg for FM, 0.7kg for FFM and -1.3% for PBF. However, the 95% limits of agreement were substantial for individual children: males, up to +/-9.3kg for FFM and FM and +/-11.0% for PBF; females, up to +/-5.5kg for FFM and FM and +/-6.5% for PBF. CONCLUSIONS: The Tanita TBF-310 foot-to-foot BIA body composition analyser with the manufacturer's prediction equations is not recommended for application to individual children who are overweight and obese although it may be of use for obtaining group mean values.

9.
Osteoporos Int ; 18(11): 1463-72, 2007 Nov.
Article in English | MEDLINE | ID: mdl-17726622

ABSTRACT

UNLABELLED: We evaluated the long-term excess mortality associated with hip fracture, using prospectively collected data on pre-fracture health and function from a nationally representative sample of U.S. elders. Although mortality was elevated for the first six months following hip fracture, we found no evidence of long-term excess mortality. INTRODUCTION: The long-term excess mortality associated with hip fracture remains controversial. METHODS: To assess the association between hip fracture and mortality, we used prospectively collected data on pre-fracture health and function from a representative sample of U.S. elders in the Medicare Current Beneficiary Survey (MCBS) to perform survival analyses with time-varying covariates. RESULTS: Among 25,178 MCBS participants followed for a median duration of 3.8 years, 730 sustained a hip fracture during follow-up. Both early (within 6 months) and subsequent mortality showed significant elevations in models adjusted only for age, sex and race. With additional adjustment for pre-fracture health status, functional impairments, comorbid conditions and socioeconomic status, however, increased mortality was limited to the first six months after fracture (hazard ratio [HR]: 6.28, 95% CI: 4.82, 8.19). No increased mortality was evident during subsequent follow-up (HR: 1.04, 95% CI: 0.88, 1.23). Hip-fracture-attributable population mortality ranged from 0.5% at age 65 among men to 6% at age 85 among women. CONCLUSIONS: Hip fracture was associated with substantially increased mortality, but much of the short-term risk and all of the long-term risk was explained by the greater frailty of those experiencing hip fracture.


Subject(s)
Health Status , Hip Fractures/mortality , Activities of Daily Living , Age Distribution , Aged , Aged, 80 and over , Epidemiologic Methods , Female , Health Status Indicators , Hip Fractures/ethnology , Humans , Male , Sex Distribution , Socioeconomic Factors , Time Factors , United States/epidemiology
10.
Pediatr Crit Care Med ; 7(6): 576-9, 2006 Nov.
Article in English | MEDLINE | ID: mdl-16878051

ABSTRACT

OBJECTIVES: We review physiology and pharmacology relating to the use of octreotide for chylothorax in infants and children. We review the published experience of octreotide dosing in this context. DATA SOURCE: Systematic review of the literature, including PubMed (English-only journals), citations from relevant articles, major textbooks, and personal files. CONCLUSIONS: Octreotide has been used as a successful therapeutic adjunct in a small number of neonatal cases and a larger number of pediatric cases. No consensus has been reached as to the optimal route of administration, dose, duration of therapy, or strategy for discontinuation of therapy. We suggest using higher doses (80-100 microg/kg/day) and initiating therapy early rather than using a low initial dose with upward titration. Duration of therapy required to elicit a significant response may vary between patients.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Chylothorax/drug therapy , Octreotide/therapeutic use , Antineoplastic Agents, Hormonal/administration & dosage , Child , Chylothorax/therapy , Humans , Infant , Infant, Newborn , Octreotide/administration & dosage
11.
J Appl Physiol (1985) ; 95(5): 2039-46, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14555670

ABSTRACT

The objective of the present study was to investigate the accuracy of percent body fat (%fat) estimates from dual-energy X-ray absorptiometry, air-displacement plethysmography (ADP), and total body water (TBW) against a criterion four-compartment (4C) model in overweight and obese children. A volunteer sample of 30 children (18 male and 12 female), age of (mean +/- SD) 14.10 +/- 1.83 yr, body mass index of 31.6 +/- 5.5 kg/m, and %fat (4C model) of 41.2 +/- 8.2%, was assessed. Body density measurements were converted to %fat estimates by using the general equation of Siri (ADPSiri) (Siri WE. Techniques for Measuring Body Composition. 1961) and the age- and gender-specific constants of Lohman (ADPLoh) (Lohman TG. Exercise and Sport Sciences Reviews. 1986). TBW measurements were converted to %fat estimates by assuming that water accounts for 73% of fat-free mass (TBW73) and by utilizing the age- and gender-specific water contents of Lohman (TBWLoh). All estimates of %fat were highly correlated with those of the 4C model (r > or = 0.95, P < 0.001; SE < or = 2.14). For %fat, the total error and mean difference +/- 95% limits of agreement compared with the 4C model were 2.50, 1.8 +/- 3.5 (ADPSiri); 1.82, -0.04 +/- 3.6 (ADPLoh); 2.86, -2.0 +/- 4.1 (TBW73); 1.90, -0.3 +/- 3.8 (TBWLoh); and 2.74, 1.9 +/- 4.0 DXA (dual-energy X-ray absorptiometry), respectively. In conclusion, in overweight and obese children, ADPLoh and TBWLoh were the most accurate methods of measuring %fat compared with a 4C model. However, all methods under consideration produced similar limits of agreement.


Subject(s)
Absorptiometry, Photon/methods , Body Composition , Obesity/diagnostic imaging , Obesity/pathology , Plethysmography/methods , Absorptiometry, Photon/standards , Adolescent , Body Fluid Compartments , Body Water , Child , Female , Humans , Male , Plethysmography/standards , Reproducibility of Results
12.
Eur J Clin Nutr ; 57(11): 1402-10, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14576753

ABSTRACT

OBJECTIVE: To evaluate the accuracy of percentage body fat (%fat) estimates from air displacement plethysmography (ADP) against an increasingly recognised criterion method, dual-energy X-ray absorptiometry (DXA), in young adolescents. DESIGN: Cross-sectional evaluation. SETTING: Leeds General Infirmary, Centre for Bone and Body Composition Research, Leeds, UK. SUBJECTS: In all, 28 adolescents (12 males and 16 females), age (mean+/-s.d.) 14.9+/-0.5 y, body mass index 21.2+/-2.9 kg/m(2) and body fat (DXA) 24.2+/-10.2% were assessed. RESULTS: ADP estimates of %fat were highly correlated with those of DXA in both male and female subjects (r=0.84-0.95, all P<0.001; s.e.e.=3.42-3.89%). Mean %fat estimated by ADP using the Siri (1961) equation (ADP(Siri)) produced a nonsignificant overestimation in males (0.67%), and a nonsignificant underestimation in females (1.26%). Mean %fat estimated by ADP using the Lohman (1986) equations (ADP(Loh)) produced a nonsignificant underestimation in males (0.90%) and a significant underestimation in females (3.29%; P<0.01). Agreement between ADP and DXA methods was examined using the total error (TE) and methods of Bland and Altman (1986). Males produced a smaller TE (ADP(Siri) 3.28%; ADP(Loh) 3.49%) than females (ADP(Siri) 3.81%; ADP(Loh) 4.98%). The 95% limits of agreement were relatively similar for all %fat estimates, ranging from +/-6.57 to +/-7.58%. Residual plot analyses, of the individual differences between ADP and DXA, revealed a significant bias associated with increased %fat (DXA), only in girls (P<0.01). CONCLUSIONS: We conclude that ADP, at present, has unacceptably high limits of agreement compared to a criterion DXA measure. The ease of use, suitability for various populations and cost of ADP warrant further investigation of this method to establish biological variables that may influence the validity of body fat estimates.


Subject(s)
Absorptiometry, Photon/methods , Adipose Tissue/metabolism , Body Composition/physiology , Plethysmography/methods , Adolescent , Air , Cross-Sectional Studies , Female , Humans , Male , Reproducibility of Results , Sensitivity and Specificity , Sex Factors
13.
Int J Cardiol ; 80(2-3): 201-7, 2001.
Article in English | MEDLINE | ID: mdl-11578715

ABSTRACT

BACKGROUND: Aspirin is the most widely prescribed agent used in prevention of coronary thrombosis. Thus, many patients presenting with acute coronary syndromes have a history of aspirin usage. METHODS: To assess response to medical therapy in patients taking aspirin prior to admission with an acute coronary syndrome, we reviewed outcomes data from the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-wave Coronary Events (ESSENCE) and Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) studies. RESULTS: Patients with acute coronary syndromes who had taken aspirin prior to enrollment were less likely to have non-Q-wave myocardial infarction on admission (ESSENCE: 16.0% vs. 29.2%, p<0.001; PRISM-PLUS: 34.2% vs. 57.7%, p<0.001). However, prior aspirin users were more likely to be failed by standard medical therapy with unfractionated heparin than non-prior aspirin users (ESSENCE: 21.5% vs. 16.5%, p=0.017; PRISM-PLUS: 23.5% vs. 12.1%, p<0.001). Prior aspirin users received greater benefit from both enoxaparin (21.5% vs. 16.8%, p=0.009) and tirofiban with unfractionated heparin (23.5% vs. 16.0%, p=0.007) than from unfractionated heparin alone. Non-prior aspirin users presented with higher rates of non-Q-wave myocardial infarction. CONCLUSIONS: Prior aspirin users admitted with acute coronary syndromes may have a more benign presentation, but are more likely to be failed by medical therapy with unfractionated heparin and should be considered as a high-risk group. Enoxaparin or the combination of tirofiban and unfractionated heparin are both more effective than unfractionated heparin in this group.


Subject(s)
Angina, Unstable/drug therapy , Anticoagulants/adverse effects , Aspirin/adverse effects , Myocardial Infarction/drug therapy , Aged , Angina, Unstable/complications , Angina, Unstable/prevention & control , Anticoagulants/therapeutic use , Aspirin/therapeutic use , Female , Humans , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/prevention & control , Risk Factors , Survival Analysis , Treatment Outcome
15.
J Thromb Thrombolysis ; 12(3): 199-206, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11981102

ABSTRACT

BACKGROUND: Two large-scale phase III clinical trials, the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-wave Coronary Events (ESSENCE) trial and the Thrombolysis in Myocardial Infarction (TIMI) 11B study, have shown the low-molecular-weight heparin, enoxaparin, to be more effective than unfractionated heparin (UFH) in reducing the risk of death and severe cardiac events in patients with rest unstable angina and/or non-ST-segment elevation myocardial infarction (NSTEMI). However, patients with NSTEMI acute coronary syndromes are a heterogeneous group. METHODS: A meta-analysis using pooled data from ESSENCE and TIMI 11B was performed to examine the efficacy of enoxaparin in different patient subgroups. In addition, a statistical model was developed to test which factors best predicted an enhanced treatment effect. RESULTS: Enoxaparin was more effective than intravenous dose-adjusted UFH in reducing the incidence of the composite endpoint (including death, myocardial infarction or recurrent angina prompting urgent revascularization) in the majority of subgroups at 43 days after randomization. Univariate analyses revealed that there was a greater benefit with enoxaparin in patients with ST-segment deviation or elevated cardiac enzyme markers on admission, women, nonsmokers and patients with characteristics indicative of higher cardiac risk, including prior percutaneous coronary interventions, being at least 65 years old, prior angina and prior aspirin use. Multivariate statistical modelling of treatment effect revealed that ST-segment depression and electrocardiographic changes were the best predictors of an enhanced treatment effect. CONCLUSIONS: These data reinforce previous evidence suggesting that enoxaparin administered subcutaneously twice daily may be considered as an alternative to intravenous UFH in the acute treatment of a broad range of patients with unstable coronary artery disease.


Subject(s)
Angina, Unstable/drug therapy , Enoxaparin/administration & dosage , Myocardial Infarction/drug therapy , Adult , Aged , Angina, Unstable/mortality , Clinical Trials, Phase III as Topic , Electrocardiography , Female , Heparin/administration & dosage , Humans , Male , Middle Aged , Models, Statistical , Myocardial Infarction/mortality , Odds Ratio , Risk Factors , Secondary Prevention , Therapeutic Equivalency , Treatment Outcome
16.
J Am Coll Cardiol ; 36(3): 693-8, 2000 Sep.
Article in English | MEDLINE | ID: mdl-10987586

ABSTRACT

OBJECTIVES: We sought to determine whether the observed benefits of enoxaparin were maintained beyond the early phase; a one-year follow-up survey was undertaken for patients enrolled in the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events (ESSENCE) study. BACKGROUND: We have previously reported a significant benefit of low molecular weight as compared with unfractionated heparin (UFH) in the 14- and 30-day incidence of a composite end point of death, myocardial infarction (MI) or recurrent angina in patients with unstable angina or non-Qwave MI. METHODS: The study recruited 3,171 patients with recent-onset rest angina and underlying ischemic heart disease. All patients received oral aspirin daily and were randomized to receive enoxaparin subcutaneously every 12 h or UFH (intravenous bolus followed by continuous infusion) in a double-blind, double-dummy fashion for a median of 2.6 days. RESULTS: The incidence of the composite triple end point at one year was lower among patients receiving enoxaparin as compared with those receiving UFH (32.0% vs. 35.7%, p = 0.022), with a trend toward a lower incidence of the secondary composite end point of death or MI (11.5% vs. 13.5%, p = 0.082). At one year, the need for diagnostic catheterization and coronary revascularization was lower in the enoxaparin group (55.8% vs. 59.4%, p = 0.036 and 35.9% vs. 41.2%, p = 0.002, respectively). CONCLUSIONS: In patients with unstable angina or non-Qwave MI, enoxaparin therapy significantly reduced the rates of recurrent ischemic events and invasive diagnostic and therapeutic procedures in the short term with sustained benefit at one year.


Subject(s)
Angina, Unstable/drug therapy , Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Myocardial Infarction/drug therapy , Adult , Aged , Angina, Unstable/complications , Cardiac Catheterization/statistics & numerical data , Double-Blind Method , Female , Follow-Up Studies , Humans , Incidence , Injections, Intravenous , Injections, Subcutaneous , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Myocardial Revascularization/statistics & numerical data , Secondary Prevention
17.
Am J Cardiol ; 86(5): 553-6, A9, 2000 Sep 01.
Article in English | MEDLINE | ID: mdl-11009278

ABSTRACT

A subgroup meta-analysis from the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events (ESSENCE) and the Thrombolysis in Myocardial Infarction (TIMI) 11B studies has shown that enoxaparin is superior to unfractionated heparin in reducing the composite end points of death, myocardial infarction, and emergency revascularization in patients with Q-wave myocardial infarction. The beneficial treatment effect was significant at 43 days.


Subject(s)
Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Myocardial Infarction/drug therapy , Aged , Heparin/therapeutic use , Humans , Middle Aged , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Treatment Outcome
18.
JAMA ; 284(7): 835-42, 2000 Aug 16.
Article in English | MEDLINE | ID: mdl-10938172

ABSTRACT

CONTEXT: Patients with unstable angina/non-ST-segment elevation myocardial infarction (MI) (UA/NSTEMI) present with a wide spectrum of risk for death and cardiac ischemic events. OBJECTIVE: To develop a simple risk score that has broad applicability, is easily calculated at patient presentation, does not require a computer, and identifies patients with different responses to treatments for UA/NSTEMI. DESIGN, SETTING, AND PATIENTS: Two phase 3, international, randomized, double-blind trials (the Thrombolysis in Myocardial Infarction [TIMI] 11B trial [August 1996-March 1998] and the Efficacy and Safety of Subcutaneous Enoxaparin in Unstable Angina and Non-Q-Wave MI trial [ESSENCE; October 1994-May 1996]). A total of 1957 patients with UA/NSTEMI were assigned to receive unfractionated heparin (test cohort) and 1953 to receive enoxaparin in TIMI 11B; 1564 and 1607 were assigned respectively in ESSENCE. The 3 validation cohorts were the unfractionated heparin group from ESSENCE and both enoxaparin groups. MAIN OUTCOME MEASURES: The TIMI risk score was derived in the test cohort by selection of independent prognostic variables using multivariate logistic regression, assignment of value of 1 when a factor was present and 0 when it was absent, and summing the number of factors present to categorize patients into risk strata. Relative differences in response to therapeutic interventions were determined by comparing the slopes of the rates of events with increasing score in treatment groups and by testing for an interaction between risk score and treatment. Outcomes were TIMI risk score for developing at least 1 component of the primary end point (all-cause mortality, new or recurrent MI, or severe recurrent ischemia requiring urgent revascularization) through 14 days after randomization. RESULTS: The 7 TIMI risk score predictor variables were age 65 years or older, at least 3 risk factors for coronary artery disease, prior coronary stenosis of 50% or more, ST-segment deviation on electrocardiogram at presentation, at least 2 anginal events in prior 24 hours, use of aspirin in prior 7 days, and elevated serum cardiac markers. Event rates increased significantly as the TIMI risk score increased in the test cohort in TIMI 11B: 4.7% for a score of 0/1; 8.3% for 2; 13. 2% for 3; 19.9% for 4; 26.2% for 5; and 40.9% for 6/7 (P<.001 by chi(2) for trend). The pattern of increasing event rates with increasing TIMI risk score was confirmed in all 3 validation groups (P<.001). The slope of the increase in event rates with increasing numbers of risk factors was significantly lower in the enoxaparin groups in both TIMI 11B (P =.01) and ESSENCE (P =.03) and there was a significant interaction between TIMI risk score and treatment (P =. 02). CONCLUSIONS: In patients with UA/NSTEMI, the TIMI risk score is a simple prognostication scheme that categorizes a patient's risk of death and ischemic events and provides a basis for therapeutic decision making. JAMA. 2000;284:835-842


Subject(s)
Angina, Unstable/complications , Angina, Unstable/drug therapy , Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Myocardial Infarction/complications , Myocardial Infarction/drug therapy , Risk Assessment , Thrombolytic Therapy , Aged , Angina, Unstable/mortality , Decision Making , Double-Blind Method , Humans , Logistic Models , Middle Aged , Multivariate Analysis , Myocardial Infarction/mortality , Prognosis , Reproducibility of Results
19.
Circulation ; 100(15): 1593-601, 1999 Oct 12.
Article in English | MEDLINE | ID: mdl-10517729

ABSTRACT

BACKGROUND: Low-molecular-weight heparins are attractive alternatives to unfractionated heparin (UFH) for management of unstable angina/non-Q-wave myocardial infarction (UA/NQMI). METHODS AND RESULTS: Patients (n=3910) with UA/NQMI were randomized to intravenous UFH for >/=3 days followed by subcutaneous placebo injections or uninterrupted antithrombin therapy with enoxaparin during both the acute phase (initial 30 mg intravenous bolus followed by injections of 1.0 mg/kg every 12 hours) and outpatient phase (injections every 12 hours of 40 mg for patients weighing <65 kg and 60 mg for those weighing >/=65 kg). The primary end point (death, myocardial infarction, or urgent revascularization) occurred by 8 days in 14.5% of patients in the UFH group and 12.4% of patients in the enoxaparin group (OR 0.83; 95% CI 0.69 to 1.00; P=0. 048) and by 43 days in 19.7% of the UFH group and 17.3% of the enoxaparin group (OR 0.85; 95% CI 0.72 to 1.00; P=0.048). During the first 72 hours and also throughout the entire initial hospitalization, there was no difference in the rate of major hemorrhage in the treatment groups. During the outpatient phase, major hemorrhage occurred in 1.5% of the group treated with placebo and 2.9% of the group treated with enoxaparin (P=0.021). CONCLUSIONS: Enoxaparin is superior to UFH for reducing a composite of death and serious cardiac ischemic events during the acute management of UA/NQMI patients without causing a significant increase in the rate of major hemorrhage. No further relative decrease in events occurred with outpatient enoxaparin treatment, but there was an increase in the rate of major hemorrhage.


Subject(s)
Angina, Unstable/drug therapy , Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Myocardial Infarction/drug therapy , Thrombolytic Therapy , Acute Disease , Aged , Angina, Unstable/complications , Angina, Unstable/surgery , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Creatine Kinase/blood , Double-Blind Method , Electrocardiography , Emergencies , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Europe/epidemiology , Factor Xa Inhibitors , Female , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Hemorrhage/chemically induced , Heparin/administration & dosage , Heparin/adverse effects , Humans , Isoenzymes , Life Tables , Male , Middle Aged , Mortality , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Myocardial Infarction/prevention & control , Myocardial Infarction/surgery , Myocardial Revascularization/statistics & numerical data , North America/epidemiology , Partial Thromboplastin Time , Recurrence , Safety , South America/epidemiology , Thrombolytic Therapy/adverse effects , Treatment Outcome
20.
Circulation ; 100(15): 1602-8, 1999 Oct 12.
Article in English | MEDLINE | ID: mdl-10517730

ABSTRACT

BACKGROUND: Two phase III trials of enoxaparin for unstable angina/non-Q-wave myocardial infarction have shown it to be superior to unfractionated heparin for preventing a composite of death and cardiac ischemic events. A prospectively planned meta-analysis was performed to provide a more precise estimate of the effects of enoxaparin on multiple end points. METHODS AND RESULTS: Event rates for death, the composite end points of death/nonfatal myocardial infarction and death/nonfatal myocardial infarction/urgent revascularization, and major hemorrhage were extracted from the TIMI 11B and ESSENCE databases. Treatment effects at days 2, 8, 14, and 43 were expressed as the OR (and 95% CI) for enoxaparin versus unfractionated heparin. All heterogeneity tests for efficacy end points were negative, which suggests comparability of the findings in TIMI 11B and ESSENCE. Enoxaparin was associated with a 20% reduction in death and serious cardiac ischemic events that appeared within the first few days of treatment, and this benefit was sustained through 43 days. Enoxaparin's treatment benefit was not associated with an increase in major hemorrhage during the acute phase of therapy, but there was an increase in the rate of minor hemorrhage. CONCLUSIONS: The accumulated evidence, coupled with the simplicity of subcutaneous administration and elimination of the need for anticoagulation monitoring, indicates that enoxaparin should be considered as a replacement for unfractionated heparin as the antithrombin for the acute phase of management of patients with high-risk unstable angina/non-Q-wave myocardial infarction.


Subject(s)
Angina, Unstable/drug therapy , Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Myocardial Infarction/drug therapy , Aged , Angina, Unstable/complications , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Dalteparin/therapeutic use , Double-Blind Method , Electrocardiography , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Factor Xa Inhibitors , Female , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Heparin/administration & dosage , Heparin/adverse effects , Hirudin Therapy , Humans , Infusions, Intravenous , Injections, Subcutaneous , Male , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/prevention & control , Nadroparin/therapeutic use , Prospective Studies
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