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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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Information on how to access Fragmin® (dalteparin sodium) prescribing information and adverse event reporting can be found at the bottom of the page.

Renally Impaired Patients

Renal impairment is common in hospitalised patients1,2

As can be seen in the pie chart above, a quarter of medical inpatients have some degree of renal impairment (Stage ≥3).1,2

VTE treatment with UFH is associated with higher mortality rates than LMWH in patients with renal impairment3*

In one study, compared with LMWH, initial VTE treatment with UFH in patients with severe renal impairment (CrCl <30 ml/min) resulted in:3

  • ​​​​​​​significantly higher mortality
  • higher rates of fatal PE

    ​​​​​​​*P<0.05 vs. LMWH

VTE risk in renally impaired patients4–6

While patients with VTE who have renal insufficiency are at higher risk of both fatal bleeding and fatal pulmonary embolism (PE)4, an analysis of this group found the risk of fatal PE far exceeded the risk of fatal bleeding.5

A post hoc analysis of the CLOT study found high-dose, extended treatment with Fragmin significantly reduced the risk of recurrent VTE in cancer patients with renal impairment. Compared with VKA, Fragmin significantly reduced risk of recurrent VTE in patients with cancer and renal impairment (p=0.01) while exhibiting a comparable safety profile.6 

Advantages of LMWH vs UFH

The advantages of VTE treatment with LMWH compared with UFH in renal impairment7–11

More predictable anticoagulant response7,8
Better bioavailability at low doses7,8
Dose-independent clearance mechanism7
Longer half-life7,8
Lower incidence of bleeding complications8
Lower incidence of heparin-induced thrombocytopenia (HIT)8,9
Decreased tendency to produce osteopenia on prolonged administration10
Ease of administration8,11
No daily anticoagulation monitoring in the majority of patients8
Outpatient use8

LMWHs are not clinically interchangeable11

LMWH = low-molecular-weight heparin; PE= pulmonary embolism; UFH = unfractioned heparin; VKA = vitamin K antagonists; VTE = venous thromboembolism;

Monitoring anti-Xa levels

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References
  1. Schmid P et al. Swiss Med Wkly 2007;137:514.
  2. Schmid P et al. Swiss Med Wkly 2009;139:438–452.
  3. Trujillo-Santos J et al. Am J Med 2013;126:425–434.
  4. Schmid P et al. Swiss Med Wkly 2009;139:438–452.
  5. Monreal M et al. Am J Med 2006;119:1073–1079.
  6. Woodruff S et al. J Thromb Thrombolysis 2016;42:494–504.
  7. Weitz JI. N Eng J Med 1997;337:688–698.
  8. Quader MA et al. J Am Coll Surg 1998;187:641–658.
  9. Warkentin TE et al. N Eng J Med 1995;332:1330–1335.
  10. Pineo GF and Hull RD. Eur J Med Res 2004;9:215–224.
  11. Fragmin SmPC [Surgical Thromboprophylaxis (2,500 IU and 5,000 IU syringes)]. Available at: https://www.medicines.org.uk/emc/product/4246 and https://www.medicines.org.uk/emc/product/4247
PP-FRA-GBR-0257. March 2021

Fragmin Tolerability

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Fragmin Guidelines

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PP-PFE-GBR-2688. December 2020

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