Skip to main content
Top
Published in: Clinical Drug Investigation 5/2010

01-05-2010 | Original Research Article

Thromboprophylaxis with the Low-Molecular-Weight Heparin Bemiparin Sodium in Elderly Medical Patients in Usual Clinical Practice

The ANCIANOS Study

Authors: Dr Leocadio Rodríguez-Mañas, Ricardo Gómez-Huelgas, Fernando Veiga-Fernández, Gema Monteagudo Ruiz, Javier Martínez González, ANCIANOS Investigators

Published in: Clinical Drug Investigation | Issue 5/2010

Login to get access

Abstract

Background: Venous thromboembolism (VTE) is a preventable common disease in geriatric medical patients, causing substantial morbidity and mortality.
Objective: To assess the effectiveness and safety of bemiparin sodium thromboprophylaxis in non-surgical elderly medical patients (aged ≥65 years) bedridden for at least 4 days due to acute medical illness.
Methods: This was a prospective, observational, multicentre cohort study carried out in patients treated in the setting of geriatric centres (GCs) or hospital-at-home units (HHUs). The study included 507 non-surgical elderly patients recruited from 49 Spanish centres who were administered subcutaneous bemiparin sodium (Hibor®) 2500 IU/day or 3500 IU/day, depending on the degree of VTE risk —moderate or high, respectively. Rates of VTE, major and minor bleeding events, thrombocytopenia and deaths that occurred during the 3-month study period were extracted.
Results: Seventy-two percent of the subjects were women, and the mean (SD) age was 82 (8) years. Overall, 70.6% (358 patients) were treated in GCs and 29.4% (149 patients) in HHUs. The main causes of immobilization were: heart failure (30.4%), acute infectious disease (29.8%), acute respiratory insufficiency (19.9%), rheumatological disease (i.e. osteoarthritis, rheumatoid arthritis and osteoporosis) [15.4%] and acute cerebrovascular disease (14.4%). Most of the patients (63%) had a high VTE risk and received the highest dose of prophylactic bemiparin sodium (3500 IU/day) for a mean 33 days. The incidence of VTE was 0.6% (three distal deep vein thromboses confirmed by Doppler ultrasound). No cases of pulmonary embolism were reported. There were two (0.4%) major bleeding events, eight (1.6%) minor bleeding events and seven (1.4%) cases of mild thrombocytopenia; no cases of moderate or severe thrombocytopenia were reported. Twenty-four patients (4.7%) developed mild to moderate injection site complications. Twenty-one patients (4.1%) died, but all from causes not related to study medication.
Conclusions: Bemiparin sodium thromboprophylaxis for 4–5 weeks was associated with a low incidence of VTE and a low rate of bleeding and other complications in non-surgical elderly patients at risk of VTE, treated either in GCs or in HHUs, in standard clinical practice.
Literature
1.
go back to reference Geerts WH, Bergqvist D, Pineo GF, et al., American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest 2008 Jun; 133(6Suppl.):381S–453SPubMedCrossRef Geerts WH, Bergqvist D, Pineo GF, et al., American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest 2008 Jun; 133(6Suppl.):381S–453SPubMedCrossRef
2.
go back to reference American Geriatrics Society Clinical Practice Committee. The use of oral anticoagulants (warfarin) in older people: American Geriatrics Society guideline. J Am Geriatr Soc 2002; 50: 1439–45CrossRef American Geriatrics Society Clinical Practice Committee. The use of oral anticoagulants (warfarin) in older people: American Geriatrics Society guideline. J Am Geriatr Soc 2002; 50: 1439–45CrossRef
3.
go back to reference Rosendaal FR, vanHylckama Vlieg A, Doggen CJ. Venous thrombosis in the elderly. J Thromb Haemost 2007; 5Suppl. 1: 310–7PubMedCrossRef Rosendaal FR, vanHylckama Vlieg A, Doggen CJ. Venous thrombosis in the elderly. J Thromb Haemost 2007; 5Suppl. 1: 310–7PubMedCrossRef
4.
go back to reference Cohen AT, Davidson BL, Gallus AS, et al., ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ 2006; 332: 325–9PubMedCrossRef Cohen AT, Davidson BL, Gallus AS, et al., ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ 2006; 332: 325–9PubMedCrossRef
5.
go back to reference Samama MM, Cohen AT, Darmon JY, et al. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients: prophylaxis in medical patients with Enoxaparin Study Group. N Engl J Med 1999; 341: 793–800PubMedCrossRef Samama MM, Cohen AT, Darmon JY, et al. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients: prophylaxis in medical patients with Enoxaparin Study Group. N Engl J Med 1999; 341: 793–800PubMedCrossRef
6.
go back to reference López- Jiménez L, Montero M, González-Fajardo JA, et al., RIETE Investigators. Venous thromboembolism in very elderly patients: findings from a prospective registry (RIETE). Haematologica 2006; 91: 1046–51 López- Jiménez L, Montero M, González-Fajardo JA, et al., RIETE Investigators. Venous thromboembolism in very elderly patients: findings from a prospective registry (RIETE). Haematologica 2006; 91: 1046–51
7.
go back to reference Stein PD, Hull RD, Kayali F, et al. Venous thromboembolism according to age: the impact of an aging population. Arch Intern Med 2004; 164: 2260–5PubMedCrossRef Stein PD, Hull RD, Kayali F, et al. Venous thromboembolism according to age: the impact of an aging population. Arch Intern Med 2004; 164: 2260–5PubMedCrossRef
8.
go back to reference Attems J, Arbes S, Bohm G, et al. The clinical diagnostic accuracy rate regarding the immediate cause of death in a hospitalized geriatric population; an autopsy study of 1594 patients. Wien Med Wochenschr 2004; 154: 159–62PubMedCrossRef Attems J, Arbes S, Bohm G, et al. The clinical diagnostic accuracy rate regarding the immediate cause of death in a hospitalized geriatric population; an autopsy study of 1594 patients. Wien Med Wochenschr 2004; 154: 159–62PubMedCrossRef
9.
go back to reference Kammoun S, Gold G, Bouras C, et al. Immediate causes of0 death of demented and non-demented elderly. Acta Neurol Scand 2000; 102: 96–9CrossRef Kammoun S, Gold G, Bouras C, et al. Immediate causes of0 death of demented and non-demented elderly. Acta Neurol Scand 2000; 102: 96–9CrossRef
10.
go back to reference Leff B, Burton JR. Acute medical care in the home. J Am Geriatr Soc 1996; 44: 603–5PubMed Leff B, Burton JR. Acute medical care in the home. J Am Geriatr Soc 1996; 44: 603–5PubMed
11.
go back to reference Montalto M. Hospital in the home: principles and practice. Melbourne (VIC): Art-Words Publishing, 2002 Montalto M. Hospital in the home: principles and practice. Melbourne (VIC): Art-Words Publishing, 2002
12.
go back to reference Planes A. Review of bemiparin sodium: a new second-generation low molecular weight heparin and its applications in venous thromboembolism. Expert Opin Pharmacother 2003; 4: 1551–61PubMed Planes A. Review of bemiparin sodium: a new second-generation low molecular weight heparin and its applications in venous thromboembolism. Expert Opin Pharmacother 2003; 4: 1551–61PubMed
13.
go back to reference Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports [letter]. BMJ 1997; 315: 1059PubMedCrossRef Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports [letter]. BMJ 1997; 315: 1059PubMedCrossRef
14.
go back to reference Gomes JP, Shaheen WH, Truong SV, et al. Incidence of venous thromboembolic events among nursing home residents. J Gen Intern Med 2003; 18: 934–6PubMedCrossRef Gomes JP, Shaheen WH, Truong SV, et al. Incidence of venous thromboembolic events among nursing home residents. J Gen Intern Med 2003; 18: 934–6PubMedCrossRef
15.
go back to reference Gatt ME, Paltiel O, Bursztyn M. Is prolonged immobilization a risk factor for symptomatic venous thromboembolism in elderly bedridden patients? Results of a historical-cohort study. Thromb Haemost 2004; 91: 538–43PubMed Gatt ME, Paltiel O, Bursztyn M. Is prolonged immobilization a risk factor for symptomatic venous thromboembolism in elderly bedridden patients? Results of a historical-cohort study. Thromb Haemost 2004; 91: 538–43PubMed
16.
go back to reference Prieto Seva AJ. Eficacia y seguridad de bemiparina en la prevención de la enfermedad tromboembólica venosa en pacientes de una residencia geriátrica. Rev Esp Geriatr Gerontol 2007; 42: 20–6CrossRef Prieto Seva AJ. Eficacia y seguridad de bemiparina en la prevención de la enfermedad tromboembólica venosa en pacientes de una residencia geriátrica. Rev Esp Geriatr Gerontol 2007; 42: 20–6CrossRef
17.
go back to reference Bosson JL, Labarere J, Sevestre MA, et al. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med 2003; 163: 2613–8PubMedCrossRef Bosson JL, Labarere J, Sevestre MA, et al. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med 2003; 163: 2613–8PubMedCrossRef
18.
go back to reference Bosson JL, Pouchain D, Bergmann F, for the ETAPE Study Group. A prospective observational study of a cohort of outpatients with an acute medical event and reduced mobility: incidence of symptomatic thromboembolism and description of thromboprophylaxis practices. J Intern Med 2006; 260: 168–76PubMedCrossRef Bosson JL, Pouchain D, Bergmann F, for the ETAPE Study Group. A prospective observational study of a cohort of outpatients with an acute medical event and reduced mobility: incidence of symptomatic thromboembolism and description of thromboprophylaxis practices. J Intern Med 2006; 260: 168–76PubMedCrossRef
19.
go back to reference Miras-Parra F, Navascués-Martýnez E, Gómez-Outes A, et al. Utilisation and safety of bemiparin, a low-molecular-weight heparin, in medical patients: a prospective, uncontrolled cohort study. Clin Drug Investig 2005; 25: 463–72PubMedCrossRef Miras-Parra F, Navascués-Martýnez E, Gómez-Outes A, et al. Utilisation and safety of bemiparin, a low-molecular-weight heparin, in medical patients: a prospective, uncontrolled cohort study. Clin Drug Investig 2005; 25: 463–72PubMedCrossRef
20.
go back to reference Hull RD, Schellong SM, Tapson VF, et al. Late breaking clinical trial: extended-duration venous thromboembolism (VTE) prophylaxis in acutely ill medical patients with recent reduced mobility. The EXCLAIM study. J Thromb Haemost 2007; 5Suppl. 2: O–S–001 Hull RD, Schellong SM, Tapson VF, et al. Late breaking clinical trial: extended-duration venous thromboembolism (VTE) prophylaxis in acutely ill medical patients with recent reduced mobility. The EXCLAIM study. J Thromb Haemost 2007; 5Suppl. 2: O–S–001
21.
go back to reference Kucher N, Leizorovicz A, Vaitkus PT, et al. Efficacy and safety of fixed low-dose dalteparin in preventing venous thromboembolism among obese or elderly hospitalized patients: a subgroup analysis of the PREVENT trial. Arch Intern Med 2005; 165: 341–5PubMedCrossRef Kucher N, Leizorovicz A, Vaitkus PT, et al. Efficacy and safety of fixed low-dose dalteparin in preventing venous thromboembolism among obese or elderly hospitalized patients: a subgroup analysis of the PREVENT trial. Arch Intern Med 2005; 165: 341–5PubMedCrossRef
22.
go back to reference Thromboembolic Risk Factors (THRIFT) Consensus Group. Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ 1992 Sep 5; 305(6853): 567–74CrossRef Thromboembolic Risk Factors (THRIFT) Consensus Group. Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ 1992 Sep 5; 305(6853): 567–74CrossRef
23.
go back to reference Alikhan R, Cohen AT, Combe S, et al., MEDENOX Study. Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study. Arch Intern Med 2004 May 10; 164(9): 963–8PubMedCrossRef Alikhan R, Cohen AT, Combe S, et al., MEDENOX Study. Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study. Arch Intern Med 2004 May 10; 164(9): 963–8PubMedCrossRef
24.
go back to reference Tincani E, Crowther MA, Turrini F, et al. Prevention and treatment of venous thromboembolism in the elderly patient. Clin Interv Aging 2007; 2(2): 237–46PubMed Tincani E, Crowther MA, Turrini F, et al. Prevention and treatment of venous thromboembolism in the elderly patient. Clin Interv Aging 2007; 2(2): 237–46PubMed
25.
go back to reference Sevestre MA, Labarére J, Caminzuli M, et al., Association des Médecins Vasculaires Jospitaliers (Amevah). Venous thromboembolism in the elderly: results of a program to improve prevention. J Mal Vasc 2009 Nov; 34(5): 330–7PubMedCrossRef Sevestre MA, Labarére J, Caminzuli M, et al., Association des Médecins Vasculaires Jospitaliers (Amevah). Venous thromboembolism in the elderly: results of a program to improve prevention. J Mal Vasc 2009 Nov; 34(5): 330–7PubMedCrossRef
26.
go back to reference Lacut K, LeGal G, Mottier D. Primary prevention of venous thromboembolism in elderly medical patients. Clin Interv Aging 2008; 3(3): 399–411PubMed Lacut K, LeGal G, Mottier D. Primary prevention of venous thromboembolism in elderly medical patients. Clin Interv Aging 2008; 3(3): 399–411PubMed
27.
go back to reference Belmin J, Medjahed S, Trivalle C, et al. Groupe de Reserche sur l’héparine en Gériatrie (GRENG). Heparin use in geriatrics and risk profiles of treated patients: a survey in France. Press Med 2001; 30: 101–6 Belmin J, Medjahed S, Trivalle C, et al. Groupe de Reserche sur l’héparine en Gériatrie (GRENG). Heparin use in geriatrics and risk profiles of treated patients: a survey in France. Press Med 2001; 30: 101–6
28.
go back to reference Wein L, Wein S, Haas SJ, et al. Pharmacological venous thromboembolism prophylaxis in hospitalized medical patients: a meta-analysis of randomized controlled trials. Arch Intern Med 2007; 167: 1476–86PubMedCrossRef Wein L, Wein S, Haas SJ, et al. Pharmacological venous thromboembolism prophylaxis in hospitalized medical patients: a meta-analysis of randomized controlled trials. Arch Intern Med 2007; 167: 1476–86PubMedCrossRef
29.
go back to reference Jacobs LG. Prophylactic anticoagulation for venous thromboembolic disease in geriatric patients. J Am Geriatr Soc 2003; 51: 1472–8PubMedCrossRef Jacobs LG. Prophylactic anticoagulation for venous thromboembolic disease in geriatric patients. J Am Geriatr Soc 2003; 51: 1472–8PubMedCrossRef
30.
go back to reference Bergmann JF, Kher A. Venous thromboembolism in the medically ill patient: a call to action. Int J Clin Pract 2005; 59: 555–61PubMedCrossRef Bergmann JF, Kher A. Venous thromboembolism in the medically ill patient: a call to action. Int J Clin Pract 2005; 59: 555–61PubMedCrossRef
31.
go back to reference Spencer FA, Lessard D, Emery C, et al. Venous thromboembolism in the outpatient setting. Arch Intern Med 2007; 167: 1471–5PubMedCrossRef Spencer FA, Lessard D, Emery C, et al. Venous thromboembolism in the outpatient setting. Arch Intern Med 2007; 167: 1471–5PubMedCrossRef
Metadata
Title
Thromboprophylaxis with the Low-Molecular-Weight Heparin Bemiparin Sodium in Elderly Medical Patients in Usual Clinical Practice
The ANCIANOS Study
Authors
Dr Leocadio Rodríguez-Mañas
Ricardo Gómez-Huelgas
Fernando Veiga-Fernández
Gema Monteagudo Ruiz
Javier Martínez González
ANCIANOS Investigators
Publication date
01-05-2010
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 5/2010
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.2165/11535460-000000000-00000

Other articles of this Issue 5/2010

Clinical Drug Investigation 5/2010 Go to the issue