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

Ramacciotti, Eduardo; Araújo, Gilson Roberto de; Lastória, Sidnei; Maffei, Francisco H.A.; Moura, Liberato Karaoglan de; Michaelis, Wilson; Sandri, João Luis; Dietrich-Neto, F

doi:10.1016/j.thromres.2004.05.009

Cited by 34 publications

(29 citation statements)

References 5 publications

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“…Patients with acute deep vein thrombus (DVT) can safely be treated as outpatients [1][2][3][4]. Outpatient treatment of DVT is recommended with grade 1B evidence in the most recent American College of Chest Physicians (ACCP) guidelines [5].…”

Section: Introductionmentioning

confidence: 99%

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Piran

Gal

Wells

et al. 2013

Thrombosis Research

134

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Background: Patients with acute deep vein thrombus (DVT) can safely be treated as outpatients. However the role of outpatient treatment in patients diagnosed with a pulmonary embolism (PE) is controversial. We sought to determine the safety of outpatient management of patients with acute symptomatic PE. Materials and Methods: A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Pooled proportions for the different outcomes were calculated. Results: A total of 1258 patients were included in the systematic review. The rate of recurrent venous thromboembolism (VTE) in patients with PE managed as outpatients was 1.47% (95% CI: 0.47 to 3.0%; I 2 : 65.4%) during the 3 month follow-up period. The rate of fatal PE was 0.47% (95% CI: 0.16 to 1.0%; I 2 : 0%). The rates of major bleeding and fatal intracranial hemorrhage were 0.81% (95% CI: 0.37 to 1.42%; I 2 : 0%) and 0.29% (95% CI: 0.06 to 0.68%; I 2 : 0%), respectively. The overall 3 month mortality rate was 1.58% (95% CI: 0.71 to 2.80%; I 2 : 45%). The event rates were similar if employing risk stratification models versus using clinical gestalt to select appropriate patients for outpatient management. Conclusions: Independent of the risk stratification methods used, the rate of adverse events associated with outpatient PE treatment seems low. Based on our systematic review and pooled meta-analysis, low-risk patients with acute PE can safely be treated as outpatients if home circumstances are adequate.

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Section: Introductionmentioning

confidence: 99%

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Piran

Gal

Wells

et al. 2013

Thrombosis Research

134

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“…14,17,18 This observational study adds to the accumulating evidence to support the use of outpatient enoxaparin once daily and is in accord with a recent position statement encouraging the development and documentation of outpatient DVT treatment programs. 13 Once-daily administration offers obvious advantages over twice-daily treatment in terms of greater convenience for both patients and nursing staff.…”

Section: Ss Discussionmentioning

confidence: 56%

“…While large randomized trials have shown that twice-daily LMWH treatment at home is effective and well tolerated compared with UFH treatment in the hospital, [14][15][16] less data are available to support once-daily dosage of enoxaparin on an outpatient basis. 17,18 We carried out a pilot study in patients with acute DVT to evaluate the convenience, efficacy, and safety of the LMWH enoxaparin, 1.5 mg/kg, given once daily in a real-world U.S. patient population eligible for home treatment.…”

mentioning

confidence: 99%

A Pilot Study of Home Treatment of Deep Vein Thrombosis With Subcutaneous Once-Daily Enoxaparin Plus Warfarin

Bishop¹,

Wilson²,

Post³

et al. 2006

JMCP

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“…More recent large multicenter studies showed feasibility of once-daily LMWH in mostly outpatient treatment of DVT compared with in-hospital intravenous UFH [13,18]. Limitations of the present study included its non-randomized design and lack of a control group, the lack of a prespecified protocol in determination of outpatient treatment eligibility, and the relatively short duration of safety and efficacy measurements post-treatment.…”

Section: Discussionmentioning

confidence: 91%

“…Observational studies have described the feasibility and cost-effectiveness of outpatient VTE treatment programs that were associated with good clinical outcomes [5][6][7][8][9][10][11][12][13][14][15][16][17][18], but these studies represent for the most part single-institution experiences encompassing patients with DVT in defined clinical settings. There is little multicenter published experience with the use of once-daily LMWH in a variety of usual practice settings that encompasses a wide spectrum of patients with DVT receiving home therapy including those with concurrent PE.…”

Section: Introductionmentioning

confidence: 99%

Community-based treatment of venous thromboembolism with a low-molecular-weight heparin and warfarin

Hyers¹,

Spyropoulos

2007

J Thromb Thrombolysis

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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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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

Cited by 34 publications

References 5 publications

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

A Pilot Study of Home Treatment of Deep Vein Thrombosis With Subcutaneous Once-Daily Enoxaparin Plus Warfarin

Community-based treatment of venous thromboembolism with a low-molecular-weight heparin and warfarin

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