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Ash poster 2822 erikssonA Pooled Analysis of Four Pivotal Studies of Rivaroxaban for the Prevention of
Venous Thromboembolism after Orthopaedic Surgery: Effects of Specified Co-medications
Bengt I Eriksson1, Alexander GG Turpie2, Michael R Lassen3, Ajay K Kakkar3,4,5, Frank Misselwitz6, Tiemo J Bandel6, Martin Homering6, Torsten Westermeier6, Michael Gent2 1Sahlgrenska University Hospital Östra, Gothenburg, Sweden; 2McMaster University, Hamilton, Canada; 3Nordsjællands Hospital, Hoersholm, Denmark; 4Barts and the London School of Medicine, London, UK; 5Thrombosis Research Institute, London, UK; 6Bayer HealthCare AG, Wuppertal, Germany ◆ There was no restriction on the choice of a specific drug or on the ◆ Co-medication prevalence (proportion of patient-days with ◆ Rate ratios for use versus non-use of concomitant NSAIDs were Introduction
dose of NSAIDs and platelet aggregation inhibitors or ASA in the co-medication) of NSAID use decreased over time (62% vs 62% for similar between the rivaroxaban and the enoxaparin/placebo days 1–3, 51% vs 52% for days 4–7, and 29% vs 28% for the time groups for any bleeding and major or clinically relevant non-major period after day 7 for the rivaroxaban and enoxaparin/placebo treatment groups). Prevalence of co-medication with platelet ◆ The concomitant use of platelet aggregation inhibitors or ASA in RECORD is a pivotal clinical trial program investigating
aggregation inhibitors or ASA stayed more constant over the the rivaroxaban group also showed rate ratios similar to those treatment period with small increases from approximately 3% to rivaroxaban – an oral, direct Factor Xa inhibitor – for the
obtained in the enoxaparin/placebo group for both bleeding 5% over these time intervals in both groups prevention of venous thromboembolism (VTE) after
◆ Approximately 70% of patients reported concomitant use (at least elective total hip or knee replacement (THR and TKR)
once) of NSAIDs and 9% reported concomitant use of platelet aggregation inhibitors or ASA in both groups (Table 1) Table 2. Relative bleeding rates for co-medication use versus non-use: RECORD1–4 pool
◆ It comprised four multinational, randomized,
Type of co-medication
Rivaroxaban 10 mg od
double-blind, double-dummy phase III studies
Table 1. Number and proportion (%) of subjects with co-medication use
(RECORD1, 2, 3, and 4) in patients undergoing THR or
TKR surgery, and compared rivaroxaban 10 mg once daily
(od) with enoxaparin 40 mg od or 30 mg twice daily (bid)1–4
Figure 1. Illustration of RECORD1–4 study pools.
Patients (N=12,729) were randomized to receive oral
rivaroxaban 10 mg od starting 6–8 hours after surgery, or
subcutaneous enoxaparin 40 mg od starting the evening
before surgery (RECORD1–3), or 30 mg bid starting
12–24 hours after wound closure or adequate
◆ The prespecified analyses focused on adjudicated bleeding hemostasis (RECORD4)
events – the composite of major bleeding and non-major bleeding, ◆ Those patients undergoing THR received rivaroxaban or
as well as the composite of major bleeding and clinically relevant non-major bleeding – after the first postoperative tablet intake enoxaparin for 31–39 days in RECORD1, and rivaroxaban
(rivaroxaban or matching placebo) and up to 2 days after the last for 31–39 days or enoxaparin for 10–14 days followed by
placebo in RECORD2
◆ Co-medication use was evaluated over time and relative bleeding rates with and without the co-medication were calculated for the In RECORD3 and 4 (TKR), prophylaxis was for 10–14 days
rivaroxaban and enoxaparin/placebo groups separately ◆ A pooled analysis of the results of all four RECORD
◆ Days between co-medication start and stop and the 2 days following studies evaluated the effect of rivaroxaban on the
the co-medication stop date (if stopped) were analyzed as being composite of symptomatic VTE and all-cause mortality,
*Post-tablet definition excludes bleeding prior to the first (blinded) postoperative tablet intake. Rate ratio (relative rates) calculated for the period from date of surgery to final ◆ The time relative to surgery (day of surgery was day 1) was stratified medication date +2 days or until bleeding onset. ASA, acetylsalicylic acid; CI, confidence interval; NSAID, non-steroidal anti-inflammatory drug; od, once daily.
into three time periods (days 1–3, days 4–7, and day 7 onwards), based on the consideration that the risk of a first bleeding event decreases over time after surgery, and the prevalence of References and Disclosures
Analyses were conducted in all subjects who underwent surgery and 1. Eriksson BI et al. N Engl J Med 2008;358:2765–2775.
had a tablet (rivaroxaban or matching placebo) administered.
2. Kakkar AK et al. Lancet 2008;372:31–39.
Bleeding rates were recorded for each time period and rate ratios inhibitors or ASA‡
3. Lassen MR et al. N Engl J Med 2008;358:2776–2786.
(relative rates) were derived using stratified Mantel–Haenszel 4. Turpie AGG et al. Available at: http://www.efort.org/cdrom2008/F85.pdf.
The aim of the present subgroup analysis was to investigate ◆ This RECORD1–4 analysis shows that the concomitant use
This study was supported by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research & potential drug–drug interactions with specified co-medications, by ◆ Bleeding events starting post-tablet intake and during the at-risk of NSAIDs, or platelet aggregation inhibitors or ASA was
Development, L.L.C. Bengt I Eriksson and Michael R Lassen are consultants for and have received honoraria describing the risk of bleeding after first tablet intake in the total period, which extended from the day of surgery until the last day of from Bayer HealthCare. Alexander GG Turpie is a consultant for, has received honoraria from, and has associated with a small increase in bleeding risk. The
membership on the board of directors or advisory committees of Bayer HealthCare and Johnson & Johnson.
study duration pool of all four RECORD studies (Figure 1) study medication intake +2 days or until event onset (recurrent bleedings were not included in the analyses), were considered Ajay K Kakkar is a consultant for and received honoraria and research funding from Bayer HealthCare. Frank magnitude of the increase was similar in patients treated
Misselwitz, Tiemo J Bandel, Martin Homering, and Tortsen Westermeier are employed by Bayer HealthCare AG.
◆ The co-medications investigated were non-steroidal ◆ Co-medications were defined via the WHO-Drug Dictionary: NSAIDs Michael Gent has no relevant conflicts of interest to disclose. The data contained within this poster do not with rivaroxaban 10 mg od and the studied enoxaparin
anti-inflammatory drugs (NSAIDs) and platelet aggregation *Co-medication used at least once between the date of surgery and the last date of study support or recommend the use of rivaroxaban in any countries in which it is not approved.
(Anatomical Therapeutic Chemical [ATC] code M01A) and platelet medication intake +2 days. †Drugs/ingredients used by at least 50 rivaroxaban subjects.
inhibitors or acetylsalicylic acid (ASA) – frequently used medications aggregation inhibitors or ASA (ATC code B01AC or ‡Drugs/ingredients used by at least five rivaroxaban subjects. ASA, acetylsalicylic acid; Abstract 1986 presented at the American Society of Hematology (ASH) 50th Annual Meeting and Exposition, known to have a pharmacodynamic effect on bleeding multiple-ingredient drugs containing ASA) NSAID, non-steroidal anti-inflammatory drug; od, once daily.
San Francisco, CA, USA; December 6–9, 2008
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