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  • Eriksson, Bengt I.,1946Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences (författare)

Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty

  • Artikel/kapitelEngelska2008

Förlag, utgivningsår, omfång ...

  • 2008

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/82018
  • https://gup.ub.gu.se/publication/82018URI

Kompletterande språkuppgifter

  • Språk:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • BACKGROUND: This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. METHODS: In this randomized, double-blind study, we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep-vein thrombosis (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism, or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding. RESULTS: A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P<0.001). Major venous thromboembolism occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2.0%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in 6 of 2209 patients (0.3%) in the rivaroxaban group and in 2 of 2224 patients (0.1%) in the enoxaparin group (P=0.18). CONCLUSIONS: A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles. (ClinicalTrials.gov number, NCT00329628.)

Ämnesord och genrebeteckningar

  • MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
  • MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
  • Adolescent
  • Adult
  • Aged
  • Aged
  • 80 and over
  • Anticoagulants/adverse effects/*therapeutic use
  • *Arthroplasty
  • Replacement
  • Hip
  • Double-Blind Method
  • Enoxaparin/adverse effects/*therapeutic use
  • Factor Xa/*antagonists & inhibitors
  • Female
  • Humans
  • Male
  • Middle Aged
  • Morpholines/adverse effects/*therapeutic use
  • Pulmonary Embolism/epidemiology/prevention & control
  • Thiophenes/adverse effects/*therapeutic use
  • Venous Thromboembolism/mortality/*prevention & control
  • Venous Thrombosis/epidemiology/prevention & control

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Borris, L. C. (författare)
  • Friedman, R. J. (författare)
  • Haas, S. (författare)
  • Huisman, M. V. (författare)
  • Kakkar, A. K. (författare)
  • Bandel, T. J. (författare)
  • Beckmann, H. (författare)
  • Muehlhofer, E. (författare)
  • Misselwitz, F. (författare)
  • Geerts, W. (författare)
  • Göteborgs universitetInstitutionen för kliniska vetenskaper (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:New England Journal of Medicine358:26, s. 2765-751533-4406

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