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Desirudin

Desirudin (Iprivask) was a real, FDA-approved recombinant hirudin analog — the first direct thrombin inhibitor approved in the US for subcutaneous use — backed by real trials showing it outperformed both unfractionated heparin and a low-molecular-weight heparin at preventing blood clots after hip replacement surgery, though it is no longer marketed in the US as of this review.

In brief

Should you care? Relevant mainly as history — it's no longer marketed in the US — though the trial evidence is a genuine example of a hirudin analog beating both older and more modern comparators.

The short version

  • A recombinant analog of hirudin, the natural anticoagulant in leech saliva — same drug class as bivalirudin, but a distinct molecule approved for a different use.
  • Approved 2003 — the first direct thrombin inhibitor cleared in the US for subcutaneous administration.
  • Real head-to-head trials found it beat both unfractionated heparin and enoxaparin at preventing DVT after hip replacement.
  • No longer marketed in the US as of this review, and its European counterpart Revasc had its marketing authorization voluntarily withdrawn in 2014.

A leech-derived anticoagulant, engineered

Desirudin is a recombinant analog of hirudin, the direct thrombin inhibitor originally isolated from the saliva of the medicinal leech. Like bivalirudin, it works by binding thrombin directly rather than acting through antithrombin the way heparin does — but desirudin is a distinct molecule, approved for a different indication (surgical DVT prophylaxis rather than the catheter-based procedures bivalirudin covers), and dosed subcutaneously rather than by continuous IV infusion.

The pivotal trials

The FDA approved desirudin (as Iprivask) in 2003 for reducing the risk of deep vein thrombosis after elective hip replacement surgery, the first direct thrombin inhibitor cleared in the US for subcutaneous use. Real comparative trials backed the approval: Eriksson et al. (Lancet 1996, PMID 8596376) randomized 1,119 hip-replacement patients to one of three desirudin doses or unfractionated heparin, finding confirmed DVT in 17.7%, 18.4%, and 23.9% of desirudin patients across the three dose arms versus 34.2% on heparin; a second trial (Eriksson et al., J Bone Joint Surg Am 1997, PMID 9070519) found confirmed DVT in 7% of 225 desirudin patients versus 23% of 220 on heparin (p<0.0001). A further trial against enoxaparin, a low-molecular-weight heparin (Eriksson et al., N Engl J Med 1997, PMID 9358126), supported desirudin's edge over the more modern comparator as well, not just older unfractionated heparin.

Current status

No longer marketed in the US as of this review — the Iprivask brand and any generics have been discontinued. Canyon Pharmaceuticals held exclusive worldwide rights and marketed it under both the Iprivask (US) and Revasc (Europe) names for a period; the European authorization for Revasc was voluntarily withdrawn in July 2014. Hospital/perioperative use only when it was available, no wellness or grey-market presence.

References

  1. Eriksson BI, Ekman S, Kälebo P, et al., "Prevention of deep-vein thrombosis after total hip replacement: direct thrombin inhibition with recombinant hirudin, CGP 39393," Lancet 1996;347(9012):635-639, PMID 8596376.
  2. Eriksson BI, Wille-Jørgensen P, Kälebo P, et al., "Prevention of Thromboembolism with Use of Recombinant Hirudin. Results of a Double-Blind, Multicenter Trial Comparing the Efficacy of Desirudin (Revasc) with That of Unfractionated Heparin in Patients Having a Total Hip Replacement," J Bone Joint Surg Am 1997;79(3):326-333, PMID 9070519.
  3. Eriksson BI, Ekman S, Lindbratt S, et al., "A Comparison of Recombinant Hirudin with a Low-Molecular-Weight Heparin to Prevent Thromboembolic Complications after Total Hip Replacement," N Engl J Med 1997;337(19):1329-1335, PMID 9358126.
  4. FDA approval history for Iprivask (desirudin), 2003; no longer marketed in the US as of this review. EMA withdrawal of Revasc's European marketing authorization, July 2014.