Home Therapy of Venous Thrombosis with Long-term LMWH versus Usual Care: Patient Satisfaction and Post-thrombotic Syndrome
Abstract
Purpose
Home-LITE compared long-term treatment at home with tinzaparin or usual care in terms of efficacy, safety, patients' treatment satisfaction, incidence of post-thrombotic syndrome, and associated venous leg ulcers.
Methods
This multicenter, randomized, controlled trial enrolled 480 patients with documented, acute, proximal deep vein thrombosis. Patients received tinzaparin 175 IU/kg subcutaneously once daily for 12 weeks, or tinzaparin for ≥5 days plus oral warfarin, commenced on day 1, international normalized ratio-adjusted, and continued for ≥12 weeks (“usual care”). Patients received 1 in-clinic injection, then home treatment.
Results
The rate of recurrent venous thromboembolism at 12 weeks was 3.3% in both groups (absolute difference 0%; 95% confidence interval −3.2-3.2), and at 1 year was 10.4%/8.3% in the tinzaparin/usual-care groups, respectively (difference 2.1%; 95% confidence interval −3.1-7.3). There were no between-group differences in deaths at 12 weeks or 1 year, or bleeding at 12 weeks. Patients in the tinzaparin group expressed significantly greater treatment satisfaction (P = .0024), particularly regarding freedom from the inconvenience of blood monitoring; were less likely to report signs/symptoms of post-thrombotic syndrome (individual odds ratios 0.66 to 0.91, overall odds ratio 0.77, P = .001); and reported fewer leg ulcers at 12 weeks: 1 (0.5%) versus 8 (4.1%) (P = .02) with usual care.
Conclusions
Long-term home treatment with tinzaparin or usual care resulted in similar rates of recurrent venous thromboembolism, death, and bleeding. The significantly lower incidence of post-thrombotic syndrome and leg ulcers observed in the tinzaparin group is a potentially important benefit and deserves further study.
dCollege of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City
Requests for reprints should be addressed to Russell D. Hull, MBBS, MSc, Thrombosis Research Unit, 601 South Tower, Foothills Hospital, 1403-29th Street NW, Calgary, AB T2N 2T9, Canada
Funding: The study was supported by grants from the Medical Research Council (now Canadian Institutes for Health Research) and industry (LEO Pharma A/S Ltd., Ballerup, Denmark). Additional funding was provided by Pharmion and Dupont Pharmaceuticals. LEO Pharma provided the study drug and drug safety monitoring. The industry sponsors did not have any influence on the design or analysis of the study. The protocol was designed by 3 investigators. The Thrombosis Research Unit, University of Calgary, coordinated the study and carried out the data management and administrative duties. Statistical analysis was carried out independently of the industry sponsors by Rollin F. Brant, PhD, Department of Community Health Sciences, University of Calgary, Canada.
Conflict of Interest: R. Hull has received grants/research support from Bayer Pharmaceuticals Corporation, LEO Pharma Inc., and sanofi-aventis; been a consultant for LEO Pharma, Inc., Pfizer Inc., and GlaxoSmithKline, and sat on advisory boards for Pfizer Inc. and sanofi-aventis. Graham Pineo is a consultant or advisory board member (or both): sanofi-aventis, Pfizer, and steering committee member for sanofi-aventis. Susan Solymoss has received honoraria from Pfizer and LEO-Pharma. Jane Liang, Man-Chiu Poon, Roy Cook, and Rollin Brant have no conflict of interest to declare. Gary Raskob receives consultant income or honoraria (or both) from the following companies: GlaxoSmithKline, Pfizer, and sanofi-aventis.
Authorship: All authors had access to the data and contributed to/critically reviewed drafts of the manuscript.
ABSTRACT
