Abstract
This multicenter, prospective, open label, observational study evaluated practice patterns of physicians using tinzaparin, a low-molecular-weight heparin (LMWH), and warfarin for the treatment of deep venous thrombosis (DVT) with or without pulmonary embolism (PE). Short-term recurrence of venous thromboembolism (VTE) and safety were also evaluated.
Patients with an objective diagnosis of DVT, with or without PE, were invited by their physician to participate in this study. Treatment was given according to the approved U.S. package inserts for tinzaparin (175 IU/kg SQ QD) and warfarin and the clinical judgment of the prescribing physician. Baseline patient history including demographic information and the results of tests to confirm the diagnosis of DVT, with or without PE, were collected. Follow-up information included the treatment setting in which each dose of tinzaparin was administered, medical training of the person administering tinzaparin doses, timing of initiation of warfarin with respect to that of tinzaparin, length of overlap of tinzaparin and warfarin therapy, and adverse experiences.
A total of 334 patients were enrolled at 65 sites. Patients across a wide age (range 18–93 years old) and body weight (range 40–261 kg) were included. Overall, 27.3% of patients had cancer, and 50% of the overall study population reported more than one VTE risk factor. Mean duration of tinzaparin treatment was 7.61 days. Therapy at home was more common in suburban and rural settings than in urban settings. High proportions of patient, even among the small group with concurrent PE, were treated at home with self-injection. Severity of disease was the primary reason for hospitalization.
Home treatment of DVT, with or without PE, with self administration of tinzaparin at 175 IU SQ once-daily was safe and resulted in an acceptably low rate of recurrent venous thromboembolism and adverse events. Home therapy in the usual practice setting should achieve substantial overall cost savings in the treatment of DVT.
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References
Hull RD, Raskob GE, Pineo GF, Green D, Trowbridge AA, Elliott CG et al (1992) Subcutaneous low-molecular-weight heparin compared with continuous intravenous heparin in the treatment of proximal-vein thrombosis. N Engl J Med 326:975–82
Simonneau G, Sors H, Charbonnier B, Page Y, Laaban J-P, Azarian R et al, for The Thésée Study Group (1997) A comparison of low-molecular-weight heparin with unfractionated heparin for acute pulmonary embolism. N Engl J Med 337:663–669
Levine M, Gent M, Hirsh J, Leclerc J, Anderson D, Weitz J et al (1996) A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med 334:677–681
Koopman MMW, Prandoni P, Piovella F, Ockelford PA, Brandjes DPM, van der Meer J et al, for the Tasman Study Group (1996) Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. N Engl J Med 1996; 334:682–687 (original); 1997; 337:1251 (correction)
Tillman DJ, Charland SL, Witt DM (2000) Effectiveness and economic impact associated with a program for outpatient management of acute deep vein thrombosis in a group model health maintenance organization. Arch Intern Med 160:2926–2932
Dedden P, Change B, Nagel D (1997) Pharmacy-managed program for home treatment of deep vein thrombosis with Enoxaparin. Am J Health Syst Pharm 54:1968–1972
Groce JB III (1998) Patient outcomes and cost analysis associated with an outpatient DVT treatment program. Pharmacotherapy 18:175S–180S
Pearson SD, Blair R, Halpert A et al (1999) An outpatient program to treat DVT with LMWH. Eff Clin Pract 2:21–217
Boccalon H, Elias A, Chaléne A et al (2000) for the Vascular Midi-Pyrenees Network Group. Clinical outcome and cost of hospital vs home treatment of proximal deep vein thrombosis with a low-molecular-weight heparin. Arch Intern Med 160:1769–1773
Ting SB, Ziegenbein RW, Gan TE et al (1998) Dalteparin for DVT: a hospital-in-the-home program. Med J Aust 168:272–276
Lindmarker P, Holmström M (1996) Use of low molecular weight heparin (dalteparin), once daily, for the treatment of deep vein thrombosis. A feasibility and health economic study in an outpatient setting. J Int Med 240:395–401
Spyropoulos AC, Hurley JS, Ciesla GN et al (2002) Management of Acute Proximal deep vein thrombosis: pharmacoeconomic evaluation of outpatient treatment with Enoxaparin vs inpatient treatment with unfractionated heparin. Chest 122:108–114
Chong BH, Brighton TA, Baker RI et al (2005) Once-daily Enoxaparin in the outpatient setting versus unfractionated heparin in hospital for the treatment of symptomatic deep-vein thrombosis. J Thromb Thrombolysis 19:173–81
Harrison L, McGinnis J, Crowther M et al (1998) Assessment of outpatient treatment of deep-vein thrombosis with low-molecular-weight heparin. Arch Intern Med 158:2001–2003
Kovacs MJ, Ander D, Morrow B et al (2000) Outpatient treatment of pulmonary embolism with Dalteparin. Thromb Haemost 83:209–211
Wells P, Kovacs MJ, Bormanis J et al (1998) Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low-molecular-weight heparin. Arch Intern Med 158:1809–1812
Bishop B, Wilson AG, Post D et al (2006) A pilot study of home treatment of deep vein thrombosis with subcutaneous once-daily enoxaparin plus warfarin. J Manag Care Pharm 12:70–75
Ramacciotti E, Araújo GR, Lastoria S et al (2004) An open-label, comparative study of the efficacy and safety of once-daily dose of Enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis. Thromb Res 114:149–153
Wells PS, Anderson DR, Rodger MA et al (2005) A randomized trial comparing 2 low-molecular-weight heparins for the outpatient treatment of deep vein thrombosis and pulmonary embolism. Arch Intern Med 165:733–738
Tapson VF, Hyers TM, Waldo AL et al (2005) Antithrombotic practices in U.S. hospitals in an era of practice guidelines. Arch Intern Med 165:1458–1464
Schwarz T, Schmidt B, Beyer J et al (2001) Eligibility for home treatment of deep vein thrombosis: a prospective study in 202 consecutive patients. Vasc Surg 34:1065–1070
van den Belt AGM, Bossuy PMM, Prius MH et al (1998) Replacing inpatient care by out-patient care in the treatment of deep venous thrombosis: an economic evaluation. Thromb Haemost 79:259–263
Gould MK, Dembitzer AD, Sanders GD, Garber AM (1999) Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis: a cost-effectiveness analysis. Ann Intern Med 130:789–799
O’Brien B, Levine M, Willian A, Goeree R, Haley S, Blackhouse G et al (1999) Economic evaluation of outpatient treatment with low-molecular-weight heparin for proximal vein thrombosis. Arch Intern Med 159:2298–2304
Hull RD, Raskob GE, Brant RF, Pineo GF, Elliott G, Stein PD et al (2000) for the American-Canadian Thrombosis Study Group. Low-molecular weight heparin vs heparin in the treatment of patients with pulmonary embolism. Arch Intern Med 160:229–236
Quinlan DJ, McQuillan A, Eikelboom JW (2004) Low-molecular-weight heparin compared with intravenous unfractionated heparin for treatment of pulmonary embolism: a meta-analysis of randomized, controlled trials. Ann Intern Med 140:175–183
Lee AYY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M et al, for the Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators (2003) Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 349:146–153
Hull RD, Pineo GF, Brant RF et al (2006) Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 119:1062–1072
Büller HM, Agnello G, Hull RD, Hyers TM, Prins MH, Raskob GE (2004) Antithrombotic therapy for venous thromboembolic disease. The Seventh ACCP conference on antithrombotic and thrombolytic therapy. Chest 126:401S–428S
Kearon C, Ginsberg JS, Julian JA et al (2006) Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular weight heparin for acute treatment of venous thromboembolism. JAMA 296:935–942
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Hyers, T.M., Spyropoulos, A.C. & For the INNOVATE Investigators. Community-based treatment of venous thromboembolism with a low-molecular-weight heparin and warfarin. J Thromb Thrombolysis 24, 225–232 (2007). https://doi.org/10.1007/s11239-007-0020-1
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DOI: https://doi.org/10.1007/s11239-007-0020-1