Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients. Subgroup analysis from the EXCLAIM randomised trial.

The EXCLAIM study enrolled hospitalised acutely ill medical patients with age >40 years and recently-reduced mobility into a trial of extended-duration anticoagulant thromboprophylaxis. This post-hocanalysis evaluated the impact of age on patient outcomes. After completion of open-label therapy with enoxaparin 40 mg once-daily (10 ± 4 days), eligible patients underwent randomisation to receive double-blind therapy of enoxaparin (n=2,975) or placebo (n=2,988) for 28 ± 4 days. During follow-up, the venous thromboembolism (VTE) risk increased with age in both treatment groups. In patients with age >75 years, those who received extended-duration enoxaparin had lower incidence of VTE (2.5% vs 6.7%; absolute difference [AD] [95% confidence interval]: -4.2% [-6.5, -2.0]), proximal deep-vein thrombosis (2.5% vs 6.6%; AD -4.1% [-6.2, -2.0]), and symptomatic VTE (0.3% vs 1.5%; AD -1.2% [-2.2, -0.3]), in comparison to those who received placebo. In patients with age ≤75 years, those who received enoxaparin had reduced VTE (2.4% vs 2.8%; AD -0.4% [-1.5, 0.7]) and symptomatic VTE (0.2% vs 0.7%; AD -0.6% [-1.0, -0.1]) in comparison to those who received placebo. In both age subgroups, patients who received enoxaparin had increased rates of major bleeding versus those who received placebo: age >75 years (0.6% vs 0.2%; AD +0.3% [-0.2, 0.9], respectively); age ≤75 years (0.7% vs 0.2%; AD +0.5% [0.1, 0.9]). Patients in both age subgroups that received enoxaparin had similar low bleeding rates (0.6% and 0.7%, respectively). VTE risk increased with age, though the bleeding risk did not. Patients with age >75 years had a more favourable benefit-to-harm profile than younger patients.

[Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): results obtained in France]. / Risque thromboembolique veineux et pratique de prévention hospitalière : résultats obtenus en France de l'étude internationale ENDORSE.

AIM: Information about the variation in the risk for venous thromboembolism (VTE) and in prophylaxis practices in France and around the world is scarce. METHODS: The Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting (ENDORSE) study is a multinational cross-sectional survey designed to assess the prevalence of VTE risk in the acute hospital care setting, and to determine the proportion of at-risk patients who receive effective prophylaxis, in accordance with the 2004 American College of Chest Physicians (ACCP) guidelines. This paper gives the results of the ENDORSE study in the French centres in comparison with the global worldwide results of the ENDORSE study and with other Western Europe countries. RESULTS: In France, 18 randomized hospitals participated to the study between august 2006 and January 2007. 2844 patients were evaluated (917 from chirurgical wards and 1927 from medical wards). One thousand four hundred and nineteen patients (49.9%) were at VTE risk (78.3% in chirurgical wards and 36.4% in medical wards). Of the 1419 patients at VTE risk, 62.4% received ACCP-recommended VTE prophylaxis (71.2% in chirurgical wards and 53.5% in medical wards). VTE Prophylaxis in France (62.4%) is more frequent than worldwide in the international ENDORSE study (50.2%) and similar to the majority of the other western European countries and the USA. It is also more used in university hospitals (66.9%) than in other hospitals (58.9%). Prophylaxis in patients at risk for VTE was presented in 43% patients with acute heart failure, 53% with non-infectious acute respiratory failure, 57% in patients with pulmonary infection, 56% in patients with stroke, 55% in patients with active cancer and 48% in patients with non-pulmonary sepsis. CONCLUSIONS: The ENDORSE study has shown a high level of patients at risk for VTE in the population of hospitalized patients in France. The rate of prophylaxis for VTE remained low, in particular in Medicine wards. Our data reinforced the rationale for the use of hospital-wide strategies to assess patients' VTE risk and to implement measures that ensure that at-risk patients receive appropriate prophylaxis, in particularly in medical patients.

Improving Practices in US Hospitals to Prevent Venous Thromboembolism: lessons from ENDORSE.

BACKGROUND: venous thromboembolism prophylaxis is suboptimal in the US despite long-standing evidence-based recommendations. The aim of this subset analysis of the Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting (ENDORSE) study was to identify characteristics of hospitals with high guideline-recommended prophylaxis use. METHODS: between September and November 2006, charts from eligible patients aged ≥ 40 years with an acute medical illness or age ≥ 18 years and undergoing a surgical procedure were reviewed from randomly selected US acute-care hospitals. Hospitals were ranked based on the proportion of at-risk patients who received American College of Chest Physicians-recommended types of prophylaxis. Hospital characteristics were compared to determine factors related to more frequent prophylaxis use. Hospitals were followed up 1 year after the chart audit. RESULTS: overall, 9257 patients were evaluated from 81 hospitals. Appropriate types of prophylaxis were prescribed to more at-risk patients in hospitals in the highest quartile compared with the lowest quartile of prophylaxis use (74% vs 36%). All quartiles had a similar percentage of at-risk patients (61%-65%). Significantly more hospitals in the highest quartile had residency training programs (43% vs 5%), a larger median number of beds (277 vs 140), and had adopted hospital-wide prophylaxis protocols (76% vs 40%). In the follow-up survey, more hospitals overall had adopted hospital-wide written guidelines for venous thromboembolism prevention. CONCLUSIONS: these findings support the value of hospital-wide protocols and local audits for VTE prevention, as recommended by several national quality-of-care groups.

Venous thromboembolism risk and prophylaxis in hospitalised medically ill patients. The ENDORSE Global Survey.

Limited data are available regarding the risk for venous thromboembolism (VTE) and VTE prophylaxis use in hospitalised medically ill patients. We analysed data from the global ENDORSE survey to evaluate VTE risk and prophylaxis use in this population according to diagnosis, baseline characteristics, and country. Data on patient characteristics, VTE risk, and prophylaxis use were abstracted from hospital charts. VTE risk and prophylaxis use were evaluated according to the 2004 American College of Chest Physicians (ACCP) guidelines. Multivariable analysis was performed to identify factors associated with use of ACCP-recommended prophylaxis. Data were evaluated for 37,356 hospitalised medical patients across 32 countries. VTE risk varied according to medical diagnosis, from 31.2% of patients with gastrointestinal/hepatobiliary diseases to 100% of patients with acute heart failure, active non-infectious respiratory disease, or pulmonary infection (global rate, 41.5%). Among those at risk for VTE, ACCP-recommended prophylaxis was used in 24.4% haemorrhagic stroke patients and 40-45% of cardiopulmonary disease patients (global rate, 39.5%). Large differences in prophylaxis use were observed among countries. Markers of disease severity, including central venous catheters, mechanical ventilation, and admission to intensive care units, were strongly associated with use of ACCP-recommended prophylaxis. In conclusion, VTE risk varies according to medical diagnosis. Less than 40% of at-risk hospitalised medical patients receive ACCP-recommended prophylaxis. Prophylaxis use appears to be associated with disease severity rather than medical diagnosis. These data support the necessity to improve implementation of available guidelines for evaluating VTE risk and providing prophylaxis to hospitalised medical patients.

Venous thromboembolism risk and prophylaxis in the acute care hospital setting (ENDORSE survey): findings in surgical patients.

OBJECTIVE: To evaluate venous thromboembolism (VTE) risk in patients who underwent a major operation, including the use of, and factors influencing, American College of Chest Physicians-recommended types of VTE prophylaxis. SUMMARY BACKGROUND DATA: The Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting (ENDORSE) survey, conducted in 358 hospitals in 32 countries, reported that globally, more than 40% of at-risk patients do not receive VTE prophylaxis. Limited data are available regarding VTE prophylaxis practices according to surgery type and patient characteristics. METHODS: Patients aged >or=18 years undergoing major surgery were included in this prespecified subanalysis. VTE risk and use of prophylaxis were determined from hospital medical records according to the 2004 American College of Chest Physicians guidelines. Multivariable analyses were performed to identify factors associated with VTE prophylaxis use. RESULTS: Of the 18,461 patients in ENDORSE who had undergone major surgery, 17,084 (92.5%) were at-risk for VTE and 10,638 (62.3%) received prophylaxis. Use of prophylaxis varied according to major surgery type from 86.0% for orthopedic surgery to 53.8% in urologic/gynecologic and 53.6% in other procedures. Major orthopedic surgery was most strongly associated with prophylaxis use (hip replacement: odds ratio 6.2, 95% confidence interval [CI] 5.0-7.6; knee replacement: odds ratio 5.9, 95% CI 4.6-7.8). CONCLUSIONS: The majority of surgical patients are at high-risk for VTE. Despite long-standing recognition of the high-risk for VTE in surgical patients, thromboprophylaxis remains underutilized.

Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study.

BACKGROUND: Information about the variation in the risk for venous thromboembolism (VTE) and in prophylaxis practices around the world is scarce. The ENDORSE (Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting) study is a multinational cross-sectional survey designed to assess the prevalence of VTE risk in the acute hospital care setting, and to determine the proportion of at-risk patients who receive effective prophylaxis. METHODS: All hospital inpatients aged 40 years or over admitted to a medical ward, or those aged 18 years or over admitted to a surgical ward, in 358 hospitals across 32 countries were assessed for risk of VTE on the basis of hospital chart review. The 2004 American College of Chest Physicians (ACCP) evidence-based consensus guidelines were used to assess VTE risk and to determine whether patients were receiving recommended prophylaxis. FINDINGS: 68 183 patients were enrolled; 30 827 (45%) were categorised as surgical, and 37 356 (55%) as medical. On the basis of ACCP criteria, 35 329 (51.8%; 95% CI 51.4-52.2; between-country range 35.6-72.6) patients were judged to be at risk for VTE, including 19 842 (64.4%; 63.8-64.9; 44.1-80.2) surgical patients and 15 487 (41.5%; 41.0-42.0; 21.1-71.2) medical patients. Of the surgical patients at risk, 11 613 (58.5%; 57.8-59.2; 0.2-92.1) received ACCP-recommended VTE prophylaxis, compared with 6119 (39.5%; 38.7-40.3; 3.1-70.4) at-risk medical patients. INTERPRETATION: A large proportion of hospitalised patients are at risk for VTE, but there is a low rate of appropriate prophylaxis. Our data reinforce the rationale for the use of hospital-wide strategies to assess patients' VTE risk and to implement measures that ensure that at-risk patients receive appropriate prophylaxis.

[Epidemiology of seasonal spring-time allergic rhinitis in adults in France]. / Epidémiologie des rhinites allergiques saisonnières printanières chez l'adulte en France.

OBJECTIVE: Describe the profile of patients consulting a general practitioner or allergologist for seasonal spring-time allergic rhinitis (SAR) in France. METHODS: 3.348 physicians (3.284 general practitioners and 64 allergologists) recruited in 4 monthly episodes from March to June 1998, 34.851 patients consulting for SAR. Using a questionnaire, demographical data concerning the practitioners consulted and all the patients were collected. For 12,420 patients the symptomatology, history of asthma and ongoing treatment for SAR were analysed by comparing the population consulting a general practitioner (A) or an allergologist (B). RESULTS: Mean age for all patients with suspected SAR was of 37.1 +/- 15.7 years with a majority of women (54.90%). For 1,441 patients, it was the first consultation for this disorder, notably with a general practitioner, (11.1 vs. 2.4%). Aqueous rhinorrhea, sneezing and nasal obstruction were the most frequent symptoms noted, without significant difference between the type of practitioner consulted. 5.711 patients had undergone previous allergy tests, with more skin tests in the group consulting an allergologist (78 vs. 44.9%). Association with history of asthma was similar in both groups (30%). Impact on daily life was almost identical, whether isolated or associated with past history of asthma (56 vs. 51.6%), but differed with regard to sleep (56.7 vs. 21.1%). During the consultation, 5.889 patients were already treated with antihistamines (83.2%), whatever the type of practitioner consulted. CONCLUSION: Seasonal spring-time allergic rhinitis is a frequent pathology, which significantly impairs quality of life. There is little difference in patients' profile whether they consult a general practitioner or an allergologist.

Similar rapid onset of action and magnitude of effect of fexofenadine and cetirizine as assessed by inhibition of histamine-induced wheal-and-flare reaction.

BACKGROUND: Histamine-induced wheal-and-flare studies are useful, objective tests for determining differences in the peripheral H1-receptor blockade activities of antihistamines. OBJECTIVE: To evaluate the time of occurrence of 95% inhibition of histamine-induced wheal and flare after administration of fexofenadine hydrochloride, 180 mg, or cetirizine, 10 mg. METHODS: Forty-two volunteers (aged 18-60 years) were included in a randomized, double-blind, crossover study. Skin prick tests were undertaken using histamine (100 mg/mL) before treatment and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, and 4.0 hours after treatment. Wheal and flare areas were evaluated, and the time to occurrence of 95% inhibition and the frequency of subjects exhibiting 95% inhibition before median time to 95% inhibition were calculated. RESULTS: Mean +/- SD time to 95% wheal inhibition was 2.46 +/- 0.71 hours with fexofenadine and 2.55 +/- 0.57 hours with cetirizine. The estimated mean difference between fexofenadine and cetirizine (-7 minutes in favor of fexofenadine; 2-sided 95% confidence interval, -21 to +7 minutes) was not statistically significant (P = .34). For wheal, 29% of subjects receiving fexofenadine and 24% receiving cetirizine achieved 95% inhibition before the median time of inhibition (2.5 hours). An exact permutation test yielded a P = .37. For flare, 26% of subjects receiving fexofenadine and 10% receiving cetirizine achieved 95% inhibition before the median time of inhibition (3 hours; P = .12 by exact permutation test). CONCLUSIONS: Fexofenadine and cetirizine have comparable onset of action times and similar frequencies of inhibition, as evaluated by the occurrence of 95% inhibition of histamine-induced wheal and flare.