Pradaxa Drug Information
Generic name: DABIGATRAN ETEXILATE
Uses of Pradaxa
Treatment of Venous Thromboembolic Events in Pediatric Patients PRADAXA Oral Pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days.
Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients PRADAXA Oral Pellets are indicated to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.
Dosage & Administration of Pradaxa
Important Dosage Information
Dabigatran etexilate is available in different dosage forms and not all dosage forms are approved for the same indications and age groups. In addition, there are differences between the dosage forms with respect to dosing due to differences in bioavailability. Do not substitute different dosage forms (for example, capsules) for oral pellets on a milligram-to-milligram basis and do not combine more than one dosage form to achieve the total dose.
Recommended PRADAXA Oral Pellets Dosage for Pediatric Patients PRADAXA Oral Pellets can be used in pediatric patients aged 3 months to less than 12 years as soon as they are able to swallow soft food. For the treatment of VTE in pediatric patients, treatment should be initiated following treatment with a parenteral anticoagulant for at least 5 days. For reduction in risk of recurrence of VTE, treatment should be initiated following previous treatment.
The recommended dosage of PRADAXA Oral Pellets is based on the patient's age and actual weight as shown in the tables below. PRADAXA Oral Pellets is administered twice daily. Adjust the dosage according to age and actual weight as treatment progresses.
Table 1 Age- and Weight-Based Dosage for PRADAXA Oral Pellets for Pediatric Patients less than 2 Years Old Table 2 Weight-Based Dosage for PRADAXA Oral Pellets for Pediatric Patients between 2 Years to less than 12 Years Old Evaluation of the extent of anticoagulation in pediatric patients on PRADAXA Oral Pellets may be accomplished using dTT or ECT, and not INR.
Dosage Adjustments Pediatric Patients with Renal Impairment
Assess renal function prior to initiation of treatment with PRADAXA Oral Pellets. Periodically assess renal function as clinically indicated (i.e., more frequently in clinical situations that may be associated with a decline in renal function) and adjust therapy accordingly. Discontinue PRADAXA Oral Pellets in patients who develop acute renal failure while on PRADAXA Oral Pellets and consider alternative anticoagulant therapy.
Prior to the initiation of treatment with PRADAXA Oral Pellets, estimate the glomerular filtration rate (eGFR) using the Schwartz formula, eGFR (Schwartz) = (0.413 × height in cm) / serum creatinine in mg/dL. Due to lack of data in pediatric patients with an eGFR < 50 mL/min/1.73 m 2 and the risk of increased exposure, avoid use of PRADAXA Oral Pellets in these patients. Treat patients with an eGFR > 50 mL/min/1.73 m 2 with the dosage according to Tables 1 and 2.
Administration PRADAXA Oral Pellets are administered twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible. If a dose of PRADAXA Oral Pellets is not taken at the scheduled time, the dose should be taken as soon as possible on the same day; the missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose.
The dose of PRADAXA Oral Pellets should not be doubled to make up for a missed dose. If a partial dose has been taken, a second dose should not be administered at that time. The next dose should be taken as scheduled approximately 12 hours later.
The prepared medication should be given before meals to ensure that the patient takes the full dose. PRADAXA Oral Pellets should be administered immediately after mixing or within 30 minutes after mixing. If the PRADAXA dose is not administered within 30 minutes of mixing, the dose should be discarded, and a new dose prepared.
PRADAXA Oral Pellets should be administered with only specific soft foods or apple juice. Administration with soft foods PRADAXA Oral Pellets may be mixed with two teaspoons of the following soft foods at room temperature: Mashed carrots Apple sauce Mashed banana Administration with apple juice PRADAXA Oral Pellets may be spooned directly into the patient's mouth and swallowed with apple juice or added to approximately 1-2 ounces of apple juice for drinking. PRADAXA Oral Pellets should not be administered: via syringes or feeding tubes with milk, milk products, or soft foods containing milk products Instruct patients/caregivers to discard the desiccant once the package is opened.
See Instructions for Use.
Converting from or to Warfarin
When converting patients from warfarin therapy to PRADAXA Oral Pellets, discontinue warfarin and start PRADAXA Oral Pellets when the INR is below 2.0. When converting from PRADAXA Oral Pellets to warfarin, adjust the starting time of warfarin as follows: For eGFR ≥ 50 mL/min/1.73 m 2, start warfarin 3 days before discontinuing PRADAXA Oral Pellets. Patients with an eGFR < 50 mL/min/1.73 m 2 have not been studied.
Because PRADAXA Oral Pellets can increase INR, the INR will better reflect warfarin's effect only after PRADAXA Oral Pellets have been stopped for at least 2 days.
Converting from or to Parenteral Anticoagulants
For pediatric patients currently receiving a parenteral anticoagulant, start PRADAXA Oral Pellets 0 to 2 hours before the time that the next dose of the parenteral drug was to have been administered or at the time of discontinuation of a continuously administered parenteral drug (e.g., intravenous unfractionated heparin). For pediatric patients currently taking PRADAXA Oral Pellets, wait 12 hours after the last dose before switching to a parenteral anticoagulant.
Discontinuation for Surgery and Other Interventions
If possible, discontinue PRADAXA Oral Pellets before invasive or surgical procedures because of the increased risk of bleeding. Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, in whom complete hemostasis may be required. If surgery cannot be delayed, there is an increased risk of bleeding.
This risk of bleeding should be weighed against the urgency of intervention. In adults, a specific reversal agent (idarucizumab) is available in case of emergency surgery or urgent procedures when reversal of the anticoagulant effect of dabigatran is needed. Efficacy and safety of idarucizumab have not been established in pediatric patients.
Refer to the idarucizumab prescribing information for additional information. Restart PRADAXA Oral Pellets as soon as medically appropriate.
| Actual Weight (kg) | Age (in months) | Dosage (mg) twice daily | Number of Packets Needed |
|---|---|---|---|
| 3 kg to less than 4 kg | 3 to less than 6 months | 30 mg | one 30 mg packet twice daily |
| 4 kg to less than 5 kg | 3 to less than 10 months | 40 mg | one 40 mg packet twice daily |
| 5 kg to less than 7 kg | 3 to less than 5 months | 40 mg | one 40 mg packet twice daily |
| 5 to less than 24 months | 50 mg | one 50 mg packet twice daily | |
| 7 kg to less than 9 kg | 3 to less than 4 months | 50 mg | one 50 mg packet twice daily |
| 4 to less than 9 months | 60 mg | two 30 mg packets twice daily | |
| 9 to less than 24 months | 70 mg | one 30 mg packet plus one 40 mg packet twice daily | |
| 9 kg to less than 11 kg | 5 to less than 6 months | 60 mg | two 30 mg packets twice daily |
| 6 to less than 11 months | 80 mg | two 40 mg packets twice daily | |
| 11 to less than 24 months | 90 mg | one 40 mg packet plus one 50 mg packet twice daily | |
| 11 kg to less than 13 kg | 8 to less than 18 months | 100 mg | two 50 mg packets twice daily |
| 18 to less than 24 months | 110 mg | one 110 mg packet twice daily | |
| 13 kg to less than 16 kg | 10 to less than 11 months | 100 mg | two 50 mg packets twice daily |
| 11 to less than 24 months | 140 mg | one 30 mg packet plus one 110 mg packet twice daily | |
| 16 kg to less than 21 kg | 12 to less than 24 months | 140 mg | one 30 mg packet plus one 110 mg packet twice daily |
| 21 kg to less than 26 kg | 18 to less than 24 months | 180 mg | one 30 mg packet plus one 150 mg packet twice daily |
| Actual Weight (kg) | Dosage (mg) twice daily | Number of Packets Needed |
|---|---|---|
| 7 kg to less than 9 kg | 70 mg | one 30 mg packet plus one 40 mg packet twice daily |
| 9 kg to less than 11 kg | 90 mg | one 40 mg packet plus one 50 mg packet twice daily |
| 11 kg to less than 13 kg | 110 mg | one 110 mg packet twice daily |
| 13 kg to less than 16 kg | 140 mg | one 30 mg packet plus one 110 mg packet twice daily |
| 16 kg to less than 21 kg | 170 mg | one 20 mg packet plus one 150 mg packet twice daily |
| 21 kg to less than 41 kg | 220 mg | two 110 mg packets twice daily |
| 41 kg or greater | 260 mg | one 110 mg packet plus one 150 mg packet twice daily |
Side Effects of Pradaxa
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pediatric Trials Treatment of VTE in Pediatric Patients The safety of PRADAXA in the treatment of VTE in pediatric patients was studied in one phase III trial (DIVERSITY). The DIVERSITY study was a randomized, open-label, active-controlled, parallel-group trial comparing PRADAXA with standard of care – SOC (vitamin K antagonists, low molecular weight heparin, or fondaparinux).
There were 266 pediatric patients who received study treatment, 176 patients treated with PRADAXA and 90 patients treated with SOC. Patients on PRADAXA received age- and weight-adjusted dosages of an age-appropriate formulation of PRADAXA (capsules, pellets, or oral solution) twice daily. Following at least 5 days of parenteral anticoagulant therapy, the median duration of treatment with PRADAXA was 85 days (range: 1-105).
Patients with estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m 2 were excluded from the trial. Bleeding Data on adjudicated major bleeding, clinically relevant non-major (CRNM) bleeding, and minor bleeding events for the PRADAXA group and the SOC group in the DIVERSITY study are reported in Table 3. There was no statistically significant difference in the time to first major bleeding event.
Table 3 Summary of All Adjudicated Bleeding Events During On-Treatment Period in DIVERSITY 38 22 Site-specific bleeding rates were comparable between the two arms, with the exception of the rate of any gastrointestinal bleeds (5.7% in PRADAXA arm vs 1.8% in SOC arm). Reduction in Risk of Recurrence of VTE in Pediatric Patients The safety of PRADAXA in the reduction in the risk of recurrence of VTE in pediatric patients was studied in one open-label single-arm trial (Study 2). Study 2 enrolled patients who required further anticoagulation due to the presence of a clinical risk factor after completing the initial treatment for confirmed VTE (for at least 3 months) or after completing the DIVERSITY study and received PRADAXA until the clinical risk factor resolved, or up to a maximum of 12 months.
There were 213 pediatric patients treated with PRADAXA, in a similar fashion as in the DIVERSITY trial. The adverse reaction profile in pediatric patients was generally consistent with that of adult patients. Hypersensitivity Reactions in Adult PRADAXA Trials In adult DVT/PE pivotal studies, drug hypersensitivity (including urticaria, rash, and pruritus), allergic edema, anaphylactic reaction, and anaphylactic shock were reported in 0.1% of patients receiving PRADAXA Capsules.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of PRADAXA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, thrombocytopenia Gastrointestinal Disorders: Esophageal ulcer Immune System Disorders: Angioedema Renal and Urinary Disorders: Anticoagulant-related nephropathy Skin and Subcutaneous Tissue Disorders: Alopecia
| PRADAXA N (%) | Standard of Care (SOC) N (%) | |
|---|---|---|
| Patients | N=176 | N=90 |
| 1 Major bleeding event if at least one of the following criteria applied: fatal bleeding, symptomatic bleeding in a critical area or organ (intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding, or pericardial bleeding), bleeding causing a fall in hemoglobin level of 2.0 g/dL (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells. | ||
| Major bleeding event 1 | 4 (2.3) | 2 (2.2) |
| Fatal bleeding | 0 | 1 (1.1) |
| Clinically relevant non-major bleeding | 2 (1.1) | 1 (1.1) |
| Minor bleeding | 33 (19) | 21 (23) |
| Major and clinically relevant non-major bleeding | 6 (3.4) | 3 (3.3) |
| Any bleeding | 38 (22) | 22 (24) |
Warnings & Cautions for Pradaxa
Increased Risk of Thrombotic
Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA Oral Pellets are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA Oral Pellets as soon as medically appropriate.
Risk of Bleeding
PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA Oral Pellets in patients with active pathological bleeding.
Risk factors for bleeding include the concomitant use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA's anticoagulant activity and half-life are increased in patients with renal impairment. Reversal of Anticoagulant Effect Hemodialysis can remove dabigatran; however the clinical experience supporting the use of hemodialysis as a treatment for bleeding is limited.
Prothrombin complex concentrates or recombinant Factor VIIa may be considered but their use has not been evaluated in clinical trials. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of dabigatran. Consider administration of platelet concentrates in cases where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
In adults, a specific reversal agent (idarucizumab) for PRADAXA is available when reversal of the anticoagulant effect of dabigatran is needed. In pediatric patients, the efficacy and safety of idarucizumab have not been established.
Spinal/Epidural Anesthesia or Puncture
When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. To reduce the potential risk of bleeding associated with the concurrent use of PRADAXA and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of dabigatran. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of dabigatran is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), and bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves The safety and efficacy of PRADAXA Capsules in adult patients with bileaflet mechanical prosthetic heart valves was evaluated in the RE-ALIGN trial, in which patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than three months prior to enrollment) were randomized to dose-adjusted warfarin or 150 mg, 220 mg, or 300 mg of PRADAXA Capsules twice a day. RE-ALIGN was terminated early due to the occurrence of significantly more thromboembolic events (valve thrombosis, stroke, transient ischemic attack, and myocardial infarction) and an excess of major bleeding (predominantly postoperative pericardial effusions requiring intervention for hemodynamic compromise) in the PRADAXA treatment arm as compared to the warfarin treatment arm. These bleeding and thromboembolic events were seen both in patients who were initiated on PRADAXA Capsules postoperatively within three days of mechanical bileaflet valve implantation, as well as in patients whose valves had been implanted more than three months prior to enrollment.
Therefore, the use of PRADAXA is contraindicated in all patients with mechanical prosthetic valves. The use of PRADAXA for the prophylaxis of thromboembolic events in patients with atrial fibrillation in the setting of other forms of valvular heart disease, including the presence of a bioprosthetic heart valve, has not been studied and is not recommended.
Effect of P-gp Inducers and Inhibitors on Dabigatran Exposure The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone.
The concomitant use of PRADAXA Oral Pellets with P-gp-inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran.
Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome Direct-acting oral anticoagulants (DOACs), including PRADAXA, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple-positive ), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Drug Interactions with Pradaxa
The concomitant use of PRADAXA with P-gp inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran.
Pregnancy Safety for Pradaxa
Pregnancy Risk Summary The limited available data on PRADAXA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see Clinical Considerations ). In pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure.
At a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation Day 6). Dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. However, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. Fetal/Neonatal adverse reaction Use of anticoagulants, including PRADAXA, may increase the risk of bleeding in the fetus and neonate.
Monitor neonates for bleeding. Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. PRADAXA use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas.
Consider discontinuation or use of shorter acting anticoagulant as delivery approaches. Treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. Death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation Day 7) to weaning (lactation Day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at MRHD of 300 mg/day based on AUC comparisons).
Pediatric Use of Pradaxa
Pediatric Use The safety and effectiveness of PRADAXA Oral Pellets for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients less than 12 years of age. Use of PRADAXA Oral Pellets for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. These studies included an open-label, randomized, parallel-group study and an open-label, single-arm safety study.
Other age-appropriate pediatric formulations of dabigatran etexilate are available for pediatric patients aged 12 years and older for these indications. Safety and effectiveness of PRADAXA have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery.
Contraindications for Pradaxa
PRADAXA is contraindicated in patients with: Active pathological bleeding History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) Mechanical prosthetic heart valve Active pathological bleeding History of serious hypersensitivity reaction to PRADAXA Mechanical prosthetic heart valve
Overdosage Information for Pradaxa
Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with PRADAXA, and investigate the source of bleeding. A specific reversal agent (idarucizumab) is available for adult patients.
Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%. Hemodialysis can remove dabigatran; however, data supporting this approach are limited. At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates.
Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran's plasma concentration would be expected to vary based on patient specific characteristics. Measurement of aPTT or ECT may help guide therapy.
Clinical Studies of Pradaxa
Treatment of VTE in Pediatric Patients The DIVERSITY study was conducted to demonstrate the efficacy and safety of PRADAXA compared to standard of care (SOC) for the treatment of venous thromboembolism (VTE) in pediatric patients from birth to less than 18 years of age. The study was designed as an open-label, randomized, parallel-group, non-inferiority study. Patients enrolled were randomized according to a 2:1 scheme to either an age-appropriate formulation (capsules, oral pellets, or oral solution) of PRADAXA (dosages adjusted for age and weight) after at least 5 days and no longer than 21 days of treatment with a parenteral anticoagulant, or to SOC comprised of low molecular weight heparins (LMWH) or vitamin K antagonists (VKA) or fondaparinux.
For patients on PRADAXA, drug concentration was determined prior to the 7 th dose and a single titration was permitted to achieve drug target levels of 50-250 ng/ml. Inability to achieve target, after one up-titration, resulted in premature termination of study drug in 12 patients (6.8%). The median treatment duration during the treatment period was 85 days.
The number of patients taking concomitant medications with hemostatic effects was similar in both treatment groups (PRADAXA: 15%; SOC: 16%). The efficacy of PRADAXA was established based on a composite endpoint of patients with complete thrombus resolution, freedom from recurrent venous thromboembolic event, and freedom from mortality related to venous thromboembolic event (composite primary endpoint). Table 5 Efficacy Results DIVERSITY Study Subgroup analyses showed that there were no outliers in the treatment effect for the subgroups by age, sex, region, and presence of certain risk factors (central venous line, congenital heart disease, malignant disease).
For the 3 different age strata, the proportions of patients that met the efficacy endpoint in the PRADAXA and SOC groups, respectively, were for patients from birth to < 2 years, for patients aged 2 to < 12 years, and for patients aged 12 to < 18 years.
Reduction in the Risk of Recurrence of VTE in Pediatric Patients Study 2 was an open-label, single-arm safety study to assess the safety of PRADAXA for the prevention of recurrent VTE in pediatric patients from birth to < 18 years. Patients who required further anticoagulation due to the presence of a clinical risk factor after completing the initial treatment for confirmed VTE (for at least 3 months) or after completing the DIVERSITY study were included in the study. Eligible patients received age- and weight-adjusted dosages of an age-appropriate formulation (capsules or oral pellets) of PRADAXA until the clinical risk factor resolved, or up to a maximum of 12 months.
The primary endpoints of the study included the recurrence of VTE, major and minor bleeding events, and mortality (overall and related to thrombotic or thromboembolic events) at 6 and 12 months. The overall probability of being free from recurrence of VTE during the on-treatment period was months, months, and months. The probability of being free from bleeding events during the on-treatment period was months, months, and months.
No on-treatment deaths occurred.
| PRADAXA | Standard of Care | |||
|---|---|---|---|---|
| 1 Mantel-Haenszel weighted difference with age group as stratification factor | ||||
| Number of patients randomized (%) | 177 (100.0) | 90 (100.0) | ||
| Complete thrombus resolution | 81 | (45.8) | 38 | (42.2) |
| Freedom from recurrent VTE | 170 | (96.0) | 83 | (92.2) |
| Freedom from mortality related to VTE | 177 | (100.0) | 89 | (98.9) |
| Composite endpoint met | 81 | (45.8) | 38 | (42.2) |
| Difference in rate (95% CI) 1 | -0.038 (-0.161, 0.086) | |||
| p-value for non-inferiority | < 0.0001 | |||
| p-value for superiority | 0.2739 | |||
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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