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Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Total Hip and Knee Replacement Surgery — RECORD Programme

RECORD programme: effective and well tolerated VTE prevention

The RECORD clinical programme (REgulation of Coagulation in ORthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) consists of 4 phase III clinical studies evaluating Xarelto® compared to enoxaparin in more than 12,500 patients from 39 countries undergoing total hip replacement (THR) or total knee replacement (TKR).9 Patients enrolled in the programme reflect a wide range of men and women whose age (18 to 93 years) and weight (33 to 190 kg) reflect the patient population commonly seen in clinical practice. These studies evaluated the efficacy and safety of Xarelto® in the prevention of venous thromboembolism (VTE). Xarelto® was administered as one 10 mg tablet once daily and compared to subcutaneous enoxaparin.2, 3, 4



 

Efficacy and safety endpoints in the RECORD studies

In all 4 studies, the primary efficacy endpoint total VTE comprised a composite of:
  • Any deep vein thrombosis (DVT) diagnosed by mandatory venography
  • Non-fatal pulmonary embolism (PE)
  • All-cause mortality
The main safety endpoint was major bleeding.2, 3, 4, 21

THR: Xarelto® provided significant risk reduction and comparable safety

In the RECORD1 and RECORD2 studies, patients undergoing total hip replacement surgery who were treated with Xarelto® benefited from significantly lower rates of the primary efficacy endpoint (composite of any DVT, non-fatal PE, and all-cause mortality) in head-to-head comparisons with enoxaparin when both drugs were given over the same time period (RECORD1 over 5 weeks) and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). This superior efficacy was accompanied by a good safety profile comparable to that of enoxaparin.2, 3

TKR: Xarelto® provided significant risk reduction and comparable safety

In RECORD3 and RECORD4, Xarelto® was associated with a significantly lower risk for the primary efficacy endpoint (composite of any DVT, non-fatal PE, and all-cause mortality) compared to enoxaparin, together with a safety profile comparable to that of enoxaparin in patients undergoing TKR surgery.4, 9

  • 9 - International Congress on Thrombosis: Rivaroxaban is first novel oral anticoagulant to significantly reduce the composite outcome of symptomatic VTE and death [press release]. Leverkusen, Germany: Bayer HealthCare AG; June 30, 2008.
  • 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  • 3 - Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  • 4 - Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  • 21 - RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE: a Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement. Available at http://clinicaltrials.gov/ct2/show/NCT00362232. Accessed 13 August 2008.
Efficacy
The ability of a drug to produce the desired effect.
Subcutaneous
Introduced beneath the skin.
Thrombosis
Formation of a clot inside a blood vessel.
Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Deep vein thrombosis
A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
Pulmonary embolism
A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.

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