Thromboprophylaxis with the Low-molecular-weight Heparin Bemiparin Sodium in Elderly Medical Patients in Usual Clinical Practice: the ANCIANOS Study

Overview

Journal Clin Drug Investig

Date 2010 Apr 14

PMID 20384389

Citations 3

Authors

Leocadio Rodriguez-Manas

Ricardo Gomez-Huelgas

Fernando Veiga-Fernandez

Gema Monteagudo Ruiz

Javier Martinez Gonzalez

Affiliations

Soon will be listed here.

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 > or =65 years) bedridden for at least 4 days due to acute medical illness. 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.

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References

Gatt M, 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(3):538-43. DOI: 10.1160/TH03-07-0481. View

Gomes J, Shaheen W, Truong S, Brown E, Beasley B, Gajewski B . Incidence of venous thromboembolic events among nursing home residents. J Gen Intern Med. 2003; 18(11):934-6. PMC: 1494943. DOI: 10.1046/j.1525-1497.2003.21133.x. View

. The use of oral anticoagulants (warfarin) in older people. American Geriatrics Society guideline. J Am Geriatr Soc. 2002; 50(8):1439-45; discussion 1446-7. DOI: 10.1046/j.1532-5415.2002.50380.x. View

Cohen A, Davidson B, Gallus A, Lassen M, Prins M, Tomkowski W . Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006; 332(7537):325-9. PMC: 1363908. DOI: 10.1136/bmj.38733.466748.7C. View

Bugeja G, Kumar A, Banerjee A . Exclusion of elderly people from clinical research: a descriptive study of published reports. BMJ. 1997; 315(7115):1059. PMC: 2127695. DOI: 10.1136/bmj.315.7115.1059. View

Samama M, Cohen A, Darmon J, Desjardins L, Eldor A, Janbon C . 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(11):793-800. DOI: 10.1056/NEJM199909093411103. View

Belmin J, Medjahed S, Trivalle C, Lutzler P . [Heparin use in geriatrics and risk profiles of treated patients. A survey in France]. Presse Med. 2001; 30(3):101-6. View

Spencer F, Lessard D, Emery C, Reed G, Goldberg R . Venous thromboembolism in the outpatient setting. Arch Intern Med. 2007; 167(14):1471-5. PMC: 2762787. DOI: 10.1001/archinte.167.14.1471. View

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(9):1551-61. DOI: 10.1517/14656566.4.9.1551. View

10.

Jacobs L . Prophylactic anticoagulation for venous thromboembolic disease in geriatric patients. J Am Geriatr Soc. 2003; 51(10):1472-8. DOI: 10.1046/j.1532-5415.2003.51469.x. View

11.

Miras-Parra F, Navascues-Martinez E, Gomez-Outes A, Martinez-Gonzalez J, Rocha E . Utilisation and safety of bemiparin, a low-molecular-weight heparin, in medical patients : a prospective, uncontrolled cohort study. Clin Drug Investig. 2007; 25(7):463-72. DOI: 10.2165/00044011-200525070-00005. View

12.

Bergmann J, Kher A . Venous thromboembolism in the medically ill patient: a call to action. Int J Clin Pract. 2005; 59(5):555-61. DOI: 10.1111/j.1368-5031.2005.00529.x. View

13.

Tincani E, Crowther M, Turrini F, Prisco D . Prevention and treatment of venous thromboembolism in the elderly patient. Clin Interv Aging. 2007; 2(2):237-46. PMC: 2684509. View

14.

Wein L, Wein S, Haas S, Shaw J, Krum H . Pharmacological venous thromboembolism prophylaxis in hospitalized medical patients: a meta-analysis of randomized controlled trials. Arch Intern Med. 2007; 167(14):1476-86. DOI: 10.1001/archinte.167.14.1476. View

15.

Bosson J, Pouchain D, Bergmann J . 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(2):168-76. DOI: 10.1111/j.1365-2796.2006.01678.x. View

16.

Alikhan R, Cohen A, Combe S, Samama M, Desjardins L, Eldor A . Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study. Arch Intern Med. 2004; 164(9):963-8. DOI: 10.1001/archinte.164.9.963. View

17.

Lacut K, Le Gal G, Mottier D . Primary prevention of venous thromboembolism in elderly medical patients. Clin Interv Aging. 2008; 3(3):399-411. PMC: 2682373. DOI: 10.2147/cia.s832. View

18.

Sevestre M, Labarere J, Caminzuli M, Terriat B, Leroux P, Bosson J . [Venous thromboembolism in the elderly: Results of a program to improve prevention]. J Mal Vasc. 2009; 34(5):330-7. DOI: 10.1016/j.jmv.2009.06.002. View

19.

Attems J, Arbes S, Bohm G, Bohmer F, Lintner F . 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(7-8):159-62. DOI: 10.1007/s10354-004-0057-0. View

20.

Leff B, Burton J . Acute medical care in the home. J Am Geriatr Soc. 1996; 44(5):603-5. DOI: 10.1111/j.1532-5415.1996.tb01452.x. View