The American Journal of Medicine
Volume 122, Issue 8 , Pages 762-769.e3 , August 2009

Home Therapy of Venous Thrombosis with Long-term LMWH versus Usual Care: Patient Satisfaction and Post-thrombotic Syndrome

  • Russell D. Hull, MBBS, MSc

      Affiliations

    • University of Calgary, Calgary, AB, Canada
    • Corresponding Author InformationRequests 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
    • ,
  • Graham F. Pineo, MD

      Affiliations

    • University of Calgary, Calgary, AB, Canada
    • ,
  • Rollin Brant, PhD

      Affiliations

    • University of British Columbia, Vancouver, BC, Canada
    • ,
  • Jane Liang, MSc

      Affiliations

    • University of Calgary, Calgary, AB, Canada
    • ,
  • Roy Cook, MD

      Affiliations

    • University of Calgary, Calgary, AB, Canada
    • ,
  • Susan Solymoss, MD

      Affiliations

    • McGill University, Montreal, QC, Canada
    • ,
  • Man-Chiu Poon, MD, MSc

      Affiliations

    • University of Calgary, Calgary, AB, Canada
    • ,
  • Gary Raskob, PhD

      Affiliations

    • College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City
    • ,
  • LITE Trial Investigators

  • Image Result

    Patient-reported satisfaction following 12 weeks of therapy. Patients responded to questions on a 5-point Likert scale (Strongly disagree, Disagree, Neutral, Agree, Strongly agree). These were condens

    Patient-reported satisfaction following 12 weeks of therapy. Patients responded to questions on a 5-point Likert scale (Strongly disagree, Disagree, Neutral, Agree, Strongly agree). These were condensed into 3 categories (Disagree, Neutral, Agree), assigned values of −1, 0, and +1 respectively (after reversing items where necessary, so that odds values <1 favor tinzaparin and ratios >1 favor usual care). Scores were summed for each subject to obtain an overall satisfaction score per individual, and these were compared between groups using the Wilcoxon rank-sum test with continuity correction (P = .0024). The figure compares the 11 questions that were common to both treatment groups. Three questions relating to injections were included only for the tinzaparin group, and 4 questions relating to changes in drug dosage were included only for the usual-care group. These questions could not be compared across the groups.

  • Image Result
    Symptoms/signs of the post-thrombotic syndrome following 12 weeks of therapy. Patients replied “Yes” or “No” concerning the presence of the symptoms/signs listed. Odds ratios <1 favor tinzaparin (ie,

    Symptoms/signs of the post-thrombotic syndrome following 12 weeks of therapy. Patients replied “Yes” or “No” concerning the presence of the symptoms/signs listed. Odds ratios <1 favor tinzaparin (ie, symptom/sign less likely to be present). Overall odds ratio = 0.77 (P = .001).

 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.

PII: S0002-9343(09)00330-1

doi: 10.1016/j.amjmed.2008.12.023

The American Journal of Medicine
Volume 122, Issue 8 , Pages 762-769.e3 , August 2009

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