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Arixtra

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Arixtra

Arixtra

CLINICAL PHARMACOLOGY

Mechanism Of Action

The antithrombotic activity of fondaparinux sodium is the result of antithrombin III (ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, fondaparinux sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development.

Fondaparinux sodium does not inactivate thrombin (activated Factor II) and has no known effect on platelet function. At the recommended dose, fondaparinux sodium does not affect fibrinolytic activity or bleeding time.

Pharmacodynamics

Anti-Xa Activity

The pharmacodynamics/pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations quantified via anti-Factor Xa activity. Only fondaparinux can be used to calibrate the anti-Xa assay. (The international standards of heparin or LMWH are not appropriate for this use.) As a result, the activity of fondaparinux sodium is expressed as milligrams (mg) of the fondaparinux calibrator. The anti-Xa activity of the drug increases with increasing drug concentration, reaching maximum values in approximately three hours.

Pharmacokinetics

Absorption

Fondaparinux sodium administered by subcutaneous injection is rapidly and completely absorbed (absolute bioavailability is 100%). Following a single subcutaneous dose of fondaparinux sodium 2.5 mg in young male subjects, Cmax of 0.34 mg/L is reached in approximately 2 hours. In patients undergoing treatment with fondaparinux sodium injection 2.5 mg, once daily, the peak steady-state plasma concentration is, on average, 0.39 to 0.50 mg/L and is reached approximately 3 hours post-dose. In these patients, the minimum steady-state plasma concentration is 0.14 to 0.19 mg/L. In patients with symptomatic deep vein thrombosis and pulmonary embolism undergoing treatment with fondaparinux sodium injection 5 mg (body weight < 50 kg), 7.5 mg (body weight 50 to 100 kg), and 10 mg (body weight > 100 kg) once daily, the body-weight-adjusted doses provide similar mean steady-state peaks and minimum plasma concentrations across all body weight categories. The mean peak steady-state plasma concentration is in the range of 1.20 to 1.26 mg/L. In these patients, the mean minimum steadystate plasma concentration is in the range of 0.46 to 0.62 mg/L.

Distribution

In healthy adults, intravenously or subcutaneously administered fondaparinux sodium distributes mainly in blood and only to a minor extent in extravascular fluid as evidenced by steady state and non-steady state apparent volume of distribution of 7 to 11 L. Similar fondaparinux distribution occurs in patients undergoing elective hip surgery or hip fracture surgery. In vitro, fondaparinux sodium is highly (at least 94%) and specifically bound to antithrombin III (ATIII) and does not bind significantly to other plasma proteins (including platelet Factor 4 [PF4]) or red blood cells.

Metabolism

In vivo metabolism of fondaparinux has not been investigated since the majority of the administered dose is eliminated unchanged in urine in individuals with normal kidney function.

Elimination: In individuals with normal kidney function, fondaparinux is eliminated in urine mainly as unchanged drug. In healthy individuals up to 75 years of age, up to 77% of a single subcutaneous or intravenous fondaparinux dose is eliminated in urine as unchanged drug in 72 hours. The elimination half-life is 17 to 21 hours.

Special Populations

Renal Impairment

Fondaparinux elimination is prolonged in patients with renal impairment since the major route of elimination is urinary excretion of unchanged drug. In patients undergoing prophylaxis following elective hip surgery or hip fracture surgery, the total clearance of fondaparinux is approximately 25% lower in patients with mild renal impairment (CrCl 50 to 80 mL/min), approximately 40% lower in patients with moderate renal impairment (CrCl 30 to 50 mL/min), and approximately 55% lower in patients with severe renal impairment ( < 30 mL/min) compared to patients with normal renal function. A similar relationship between fondaparinux clearance and extent of renal impairment was observed in DVT treatment patients. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Hepatic Impairment

Following a single, subcutaneous dose of 7.5 mg of ARIXTRA in patients with moderate hepatic impairment (Child-Pugh Category B), Cmax and AUC were decreased by 22% and 39%, respectively, compared to subjects with normal liver function. The changes from baseline in pharmacodynamic parameters, such as aPTT, PT/INR, and antithrombin III, were similar in normal subjects and in patients with moderate hepatic impairment. Based on these data, no dosage adjustment is recommended in these patients. However, a higher incidence of hemorrhage was observed in subjects with moderate hepatic impairment than in normal subjects [see Use in Specific Populations]. The pharmacokinetics of fondaparinux have not been studied in patients with severe hepatic impairment. [See DOSAGE AND ADMINISTRATION]

Pediatric

The pharmacokinetics of fondaparinux have not been investigated in pediatric patients. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and Pediatric Use]

Geriatric

Fondaparinux elimination is prolonged in patients older than 75 years. In studies evaluating fondaparinux sodium 2.5 mg prophylaxis in hip fracture surgery or elective hip surgery, the total clearance of fondaparinux was approximately 25% lower in patients older than 75 years as compared to patients younger than 65 years. A similar relationship between fondaparinux clearance and age was observed in DVT treatment patients. [See Use in Specific Populations]

Patients Weighing Less Than 50 kg

Total clearance of fondaparinux sodium is decreased by approximately 30% in patients weighing less than 50 kg [see DOSAGE AND ADMINISTRATION and CONTRAINDICATIONS].

Gender

The pharmacokinetic properties of fondaparinux sodium are not significantly affected by gender.

Race

Pharmacokinetic differences due to race have not been studied prospectively. However, studies performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects. Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopedic surgery.

Clinical Studies

Prophylaxis Of Thromboembolic Events Following Hip Fracture Surgery

In a randomized, double-blind, clinical trial in patients undergoing hip fracture surgery, ARIXTRA 2.5 mg SC once daily was compared to enoxaparin sodium 40 mg SC once daily, which is not approved for use in patients undergoing hip fracture surgery. A total of 1,711 patients were randomized and 1,673 were treated. Patients ranged in age from 17 to 101 years (mean age 77 years) with 25% men and 75% women. Patients were 99% Caucasian, 1% other races. Patients with multiple traumas affecting more than one organ system, serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm3 were excluded from the trial. ARIXTRA was initiated after surgery in 88% of patients (mean 6 hours) and enoxaparin sodium was initiated after surgery in 74% of patients (mean 18 hours). For both drugs, treatment was continued for 7 ± 2 days. The primary efficacy endpoint, venous thromboembolism (VTE), was a composite of documented deep vein thrombosis (DVT) and/or documented symptomatic pulmonary embolism (PE) reported up to Day 11. The efficacy data are provided in Table 7 and demonstrate that under the conditions of the trial ARIXTRA was associated with a VTE rate of 8.3% compared with a VTE rate of 19.1% for enoxaparin sodium for a relative risk reduction of 56% (95% CI: 39%, 70%; P < 0.001). Major bleeding episodes occurred in 2.2% of patients receiving ARIXTRA and 2.3% of enoxaparin sodium patients [see ADVERSE REACTIONS].

Table 7: Efficacy of ARIXTRA in the Peri-operative Prophylaxis of Thromboembolic Events Following Hip Fracture Surgery

Endpoint Peri-operative Prophylaxis
(Day 1 to Day 7 ± 2 post-surgery)
ARIXTRA 2.5 mg SC once daily Enoxaparin Sodium 40 mg SC once daily
n/Na %
(95% CI)
n/Na %
(95% CI)
VTE 52/626 8.3%b
(6.3, 10.8)
119/624 19.1%
(16.1, 22.4)
All DVT 49/624 7.9%b
(5.9, 10.2)
117/623 18.8%
(15.8, 22.1)
Proximal DVT 6/650 0.9%b
(0.3, 2.0)
28/646 4.3%
(2.9, 6.2)
Symptomatic PE 3/831 0.4%c
(0.1, 1.1)
3/840 0.4%
(0.1, 1.0)
a N = all evaluable hip fracture surgery patients. Evaluable patients were those who were treated and underwent the appropriate surgery (i.e., hip fracture surgery of the upper third of the femur), with an adequate efficacy assessment up to Day 11.
b P value versus enoxaparin sodium < 0.001.
c P value versus enoxaparin sodium: NS.

Extended Prophylaxis Of Thromboembolic Events Following Hip Fracture Surgery

In a noncomparative, unblinded manner, 737 patients undergoing hip fracture surgery were initially treated during the peri-operative period with ARIXTRA 2.5 mg once daily for 7 ± 1 days. Eighty-one (81) of the 737 patients were not eligible for randomization into the 3-week double-blind period. Three hundred twenty-six (326) patients and 330 patients were randomized to receive ARIXTRA 2.5 mg once daily or placebo, respectively, in or out of the hospital for 21 ± 2 days. Patients ranged in age from 23 to 96 years (mean age 75 years) and were 29% men and 71% women. Patients were 99% Caucasian and 1% other races. Patients with multiple traumas affecting more than one organ system or serum creatinine level more than 2 mg/dL (180 micromol/L) were excluded from the trial. The primary efficacy endpoint, venous thromboembolism (VTE), was a composite of documented deep vein thrombosis (DVT) and/or documented symptomatic pulmonary embolism (PE) reported for up to 24 days following randomization. The efficacy data are provided in Table 8 and demonstrate that extended prophylaxis with ARIXTRA was associated with a VTE rate of 1.4% compared with a VTE rate of 35.0% for placebo for a relative risk reduction of 95.9% (95% CI = [98.7; 87.1], P < 0.0001). Major bleeding rates during the 3-week extended prophylaxis period for ARIXTRA occurred in 2.4% of patients receiving ARIXTRA and 0.6% of placebo-treated patients [see ADVERSE REACTIONS].

Table 8: Efficacy of ARIXTRA Injection in the Extended Prophylaxis of Thromboembolic Events Following Hip Fracture Surgery

Endpoint Extended Prophylaxis
(Day 8 to Day 28 ± 2 post-surgery)
ARIXTRA 2.5 mg SC once daily Placebo SC once daily
n/Na %
(95% CI)
n/Na %
(95% CI)
VTE 3/208 1.4%b
(0.3, 4.2)
77/220 35.0%
(28.7, 41.7)
All DVT 3/208 1.4%b
(0.3, 4.2)
74/218 33.9%
(27.7, 40.6)
Proximal DVT 2/221 0.9%b
(0.1, 3.2)
35/222 15.8%
(11.2, 21.2)
Symptomatic VTE (all) 1/326 0.3%c
(0.0, 1.7)
9/330 2.7%
(1.3, 5.1)
Symptomatic PE 0/326 0.0%d
(0.0, 1.1)
3/330 0.9%
(0.2, 2.6)
a N = all randomized evaluable hip fracture surgery patients. Evaluable patients were those who were treated in the post-randomization period, with an adequate efficacy assessment for up to 24 days following randomization.
b P value versus placebo < 0.001
c P value versus placebo = 0.021.
dP value versus placebo = NS.

Prophylaxis Of Thromboembolic Events Following Hip Replacement Surgery

In 2 randomized, double-blind, clinical trials in patients undergoing hip replacement surgery, ARIXTRA 2.5 mg SC once daily was compared to either enoxaparin sodium 30 mg SC every 12 hours (Study 1) or to enoxaparin sodium 40 mg SC once a day (Study 2). In Study 1, a total of 2,275 patients were randomized and 2,257 were treated. Patients ranged in age from 18 to 92 years (mean age 65 years) with 48% men and 52% women. Patients were 94% Caucasian, 4% black, < 1% Asian, and 2% others. In Study 2, a total of 2,309 patients were randomized and 2,273 were treated. Patients ranged in age from 24 to 97 years (mean age 65 years) with 42% men and 58% women. Patients were 99% Caucasian, and 1% other races. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm3 were excluded from both trials. In Study 1, ARIXTRA was initiated 6 ± 2 hours (mean 6.5 hours) after surgery in 92% of patients and enoxaparin sodium was initiated 12 to 24 hours (mean 20.25 hours) after surgery in 97% of patients. In Study 2, ARIXTRA was initiated 6 ± 2 hours (mean 6.25 hours) after surgery in 86% of patients and enoxaparin sodium was initiated 12 hours before surgery in 78% of patients. The first post-operative enoxaparin sodium dose was given within 12 hours after surgery in 60% of patients and 12 to 24 hours after surgery in 35% of patients with a mean of 13 hours. For both studies, both study treatments were continued for 7 ± 2 days. The efficacy data are provided in Table 9. Under the conditions of Study 1, ARIXTRA was associated with a VTE rate of 6.1% compared with a VTE rate of 8.3% for enoxaparin sodium for a relative risk reduction of 26% (95% CI: -11%, 53%; P = NS). Under the conditions of Study 2, fondaparinux sodium was associated with a VTE rate of 4.1% compared with a VTE rate of 9.2% for enoxaparin sodium for a relative risk reduction of 56% (95% CI: 33%, 73%; P < 0.001). For the 2 studies combined, the major bleeding episodes occurred in 3.0% of patients receiving ARIXTRA and 2.1% of enoxaparin sodium patients [see ADVERSE REACTIONS].

Table 9: Efficacy of ARIXTRA in the Prophylaxis of Thromboembolic Events Following Hip Replacement Surgery

Endpoint Study 1
n/Na %
(95% CI)
Study 2
n/Na %
(95% CI)
ARIXTRA 2.5 mg SC once daily Enoxaparin Sodium 30 mg SC every 12 hr ARIXTRA 2.5 mg SC once daily Enoxaparin Sodium 40 mg SC once daily
VTEb 48/787 66/797 37/908 85/919
6.1%c
(4.5, 8.0)
8.3%
(6.5, 10.4)
4.1%e
(2.9, 5.6)
9.2%
(7.5, 11.3)
All DVT 44/784 65/796 36/908 83/918
5.6%d
(4.1, 7.5)
8.2%
(6.4, 10.3)
4.0%e
(2.8, 5.4)
9.0%
(7.3, 11.1)
Proximal DVT 14/816 10/830 6/922 23/927
1.7%c
(0.9, 2.9)
1.2%
(0.6, 2.2)
0.7%f
(0.2, 1.4)
2.5%
(1.6, 3.7)
Symptomatic PE 5/1,126 1/1,128 2/1,129 2/1,123
0.4%c
(0.1, 1.0)
0.1%
(0.0, 0.5)
0.2%c
(0.0, 0.6)
0.2%
(0.0, 0.6)
a N = all evaluable hip replacement surgery patients. Evaluable patients were those who were treated and underwent the appropriate surgery
(i.e., hip replacement surgery), with an adequate efficacy assessment up to Day 11.
bVTE was a composite of documented DVT and/or documented symptomatic PE reported up to Day 11.
c P value versus enoxaparin sodium: NS.
d P value versus enoxaparin sodium in study 1: < 0.05.
e P value versus enoxaparin sodium in study 2: < 0.001.
fP value versus enoxaparin sodium in study 2: < 0.01.

Prophylaxis Of Thromboembolic Events Following Knee Replacement Surgery

In a randomized, double-blind, clinical trial in patients undergoing knee replacement surgery (i.e., surgery requiring resection of the distal end of the femur or proximal end of the tibia), ARIXTRA 2.5 mg SC once daily was compared to enoxaparin sodium 30 mg SC every 12 hours. A total of 1,049 patients were randomized and 1,034 were treated. Patients ranged in age from 19 to 94 years (mean age 68 years) with 41% men and 59% women. Patients were 88% Caucasian, 8% black, < 1% Asian, and 3% others. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm were excluded from the trial. ARIXTRA was initiated 6 ± 2 hours (mean 6.25 hours) after surgery in 94% of patients, and enoxaparin sodium was initiated 12 to 24 hours (mean 21 hours) after surgery in 96% of patients. For both drugs, treatment was continued for 7 ± 2 days. The efficacy data are provided in Table 10 and demonstrate that under the conditions of the trial, ARIXTRA was associated with a VTE rate of 12.5% compared with a VTE rate of 27.8% for enoxaparin sodium for a relative risk reduction of 55% (95% CI: 36%, 70%; P < 0.001). Major bleeding episodes occurred in 2.1% of patients receiving ARIXTRA and 0.2% of enoxaparin sodium patients [see ADVERSE REACTIONS].

Table 10: Efficacy of ARIXTRA in the Prophylaxis of Thromboembolic Events Following

Endpoint ARIXTRA 2.5 mg SC once daily Enoxaparin Sodium 30 mg SC every 12 hours
n/Na %
(95% CI)
n/Na %
(95% CI)
VTEb 45/361 12.5%c
(9.2, 16.3)
101/363 27.8%
(23.3, 32.7)
All DVT 45/361 12.5%c
(9.2, 16.3)
98/361 27.1%
(22.6, 32.0)
Proximal DVT 9/368 2.4%d
(1.1, 4.6)
20/372 5.4%
(3.3, 8.2)
Symptomatic PE 1/517 0.2%d
(0.0, 1.1)
4/517 0.8%
(0.2, 2.0)
a N = all evaluable knee replacement surgery patients. Evaluable patients were those who were treated and underwent the appropriate surgery
(i.e., knee replacement surgery), with an adequate efficacy assessment up to Day 11.
bVTE was a composite of documented DVT and/or documented symptomatic PE reported up to Day 11.
c P value versus enoxaparin sodium < 0.001.
dP value versus enoxaparin sodium: NS.

Prophylaxis Of Thromboembolic Events Following Abdominal Surgery In Patients At Risk For Thromboembolic Complications

Abdominal surgery patients at risk included the following: Those undergoing surgery under general anesthesia lasting longer than 45 minutes who are older than 60 years with or without additional risk factors; and those undergoing surgery under general anesthesia lasting longer than 45 minutes who are older than 40 years with additional risk factors. Risk factors included neoplastic disease, obesity, chronic obstructive pulmonary disease, inflammatory bowel disease, history of deep vein thrombosis (DVT) or pulmonary embolism (PE), or congestive heart failure.

In a randomized, double-blind, clinical trial in patients undergoing abdominal surgery, ARIXTRA 2.5 mg SC once daily started postoperatively was compared to dalteparin sodium 5,000 IU SC once daily, with one 2,500 IU SC preoperative injection and a 2,500 IU SC first postoperative injection. A total of 2,927 patients were randomized and 2,858 were treated. Patients ranged in age from 17 to 93 years (mean age 65 years) with 55% men and 45% women. Patients were 97% Caucasian, 1% black, 1% Asian, and 1% others. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm were excluded from the trial. Sixty-nine percent (69%) of study patients underwent cancerrelated abdominal surgery. Study treatment was continued for 7 ± 2 days. The efficacy data are provided in Table 11 and demonstrate that prophylaxis with ARIXTRA was associated with a VTE rate of 4.6% compared with a VTE rate of 6.1% for dalteparin sodium (P = NS).

Table 11: Efficacy of ARIXTRA In Prophylaxis of Thromboembolic Events Following Abdominal Surgery

Endpoint ARIXTRA 2.5 mg SC once daily Dalteparin Sodium 5,000 IU SC once daily
n/Na %
(95% CI)
n/Na %
(95% CI)
VTEb 47/1,027 4.6%c
(3.4, 6.0)
62/1,021 6.1%
(4.7, 7.7)
All DVT 43/1,024 4.2%
(3.1, 5.6)
59/1,018 5.8%
(4.4, 7.4)
Proximal DVT 5/1,076 0.5%
(0.2, 1.1)
5/1,077 0.5%
(0.2, 1.1)
Symptomatic VTE 6/1,465 0.4%
(0.2, 0.9)
5/1,462 0.3%
(0.1, 0.8)
a N = all evaluable abdominal surgery patients. Evaluable patients were those who were randomized and had an adequate efficacy assessment up to Day 10; non-treated patients and patients who did not undergo surgery did not get a VTE assessment.
b VTE was a composite of venogram positive DVT, symptomatic DVT, non-fatal PE and/or fatal PE reported up to Day 10.
c P value versus dalteparin sodium: NS.

Treatment Of Deep Vein Thrombosis

In a randomized, double-blind, clinical trial in patients with a confirmed diagnosis of acute symptomatic DVT without PE, ARIXTRA 5 mg (body weight < 50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight > 100 kg) SC once daily (ARIXTRA treatment regimen) was compared to enoxaparin sodium 1 mg/kg SC every 12 hours. Almost all patients started study treatment in hospital. Approximately 30% of patients in both groups were discharged home from the hospital while receiving study treatment. A total of 2,205 patients were randomized and 2,192 were treated. Patients ranged in age from 18 to 95 years (mean age 61 years) with 53% men and 47% women. Patients were 97% Caucasian, 2% black, and 1% other races. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm3 were excluded from the trial. For both groups, treatment continued for at least 5 days with a treatment duration range of 7 ± 2 days, and both treatment groups received vitamin K antagonist therapy initiated within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular dose adjustments to achieve an INR of 2 to 3. The primary efficacy endpoint was confirmed, symptomatic, recurrent VTE reported up to Day 97. The efficacy data are provided in Table 12.

Table 12: Efficacy of ARIXTRA in the Treatment of Deep Vein Thrombosis (All Randomized)

Endpoint ARIXTRA 5, 7.5, or 10 mg SC once daily
N = 1,098
Enoxaparin Sodium 1 mg/kg SC every 12 hours
N = 1,107
n %
(95% CI)
n %
(95% CI)
Total VTEa 43 3.9%
(2.8, 5.2)
45 4.1%
(3.0, 5.4)
  DVT only 18 1.6%
(1.0, 2.6)
28 2.5%
(1.7, 3.6)
  Non-fatal PE 20 1.8%
(1.1, 2.8)
12 1.1%
(0.6, 1.9)
  Fatal PE 5 0.5%
(0.1, 1.1)
5 0.5%
(0.1, 1.1)
a VTE was a composite of symptomatic recurrent non-fatal VTE or fatal PE reported up to Day 97. The 95% confidence interval for the treatment difference for total VTE was:
(-1.8% to 1.5%).

During the initial treatment period, 18 (1.6%) of patients treated with fondaparinux sodium and 10 (0.9%) of patients treated with enoxaparin sodium had a VTE endpoint (95% CI for the treatment difference [fondaparinux sodium-enoxaparin sodium] for VTE rates: -0.2%; 1.7%).

Treatment Of Pulmonary Embolism

In a randomized, open-label, clinical trial in patients with a confirmed diagnosis of acute symptomatic PE, with or without DVT, ARIXTRA 5 mg (body weight < 50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight > 100 kg) SC once daily (ARIXTRA treatment regimen) was compared to heparin IV bolus (5,000 USP units) followed by a continuous IV infusion adjusted to maintain 1.5 to 2.5 times aPTT control value. Patients with a PE requiring thrombolysis or surgical thrombectomy were excluded from the trial. All patients started study treatment in hospital. Approximately 15% of patients were discharged home from the hospital while receiving ARIXTRA therapy. A total of 2,213 patients were randomized and 2,184 were treated. Patients ranged in age from 18 to 97 years (mean age 62 years) with 44% men and 56% women. Patients were 94% Caucasian, 5% black, and 1% other races. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm3 were excluded from the trial. For both groups, treatment continued for at least 5 days with a treatment duration range 7 ± 2 days, and both treatment groups received vitamin K antagonist therapy initiated within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular dose adjustments to achieve an INR of 2 to 3. The primary efficacy endpoint was confirmed, symptomatic, recurrent VTE reported up to Day 97. The efficacy data are provided in Table 13.

Table 13: Efficacy of ARIXTRA in the Treatment of Pulmonary Embolism (All Randomized)

Endpoint ARIXTRA 5, 7.5, or 10 mg SC once daily
N = 1,103
Heparin aPTT adjusted IV
N = 1,110
n %
(95% CI)
n %
(95% CI)
Total VTEa 42 3.8%
(2.8, 5.1)
56 5.0%
(3.8, 6.5)
  DVT only 12 1.1%
(0.6, 1.9)
17 1.5%
(0.9, 2.4)
  Non-fatal PE 14 1.3%
(0.7, 2.1)
24 2.2%
(1.4, 3.2)
  Fatal PE 16 1.5%
(0.8, 2.3)
15 1.4%
(0.8, 2.2)
a VTE was a composite of symptomatic recurrent non-fatal VTE or fatal PE reported up to Day 97. The 95% confidence interval for the treatment difference for total VTE was:
(-3.0% to 0.5%).

During the initial treatment period, 12 (1.1%) of patients treated with fondaparinux sodium and 19 (1.7%) of patients treated with heparin had a VTE endpoint (95% CI for the treatment difference [fondaparinux sodium-heparin] for VTE rates: -1.6%; 0.4%).

Last reviewed on RxList: 7/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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