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PRADAXA Real-World
Data Portal

map representing different U.S. managed care and health system populations that cover over 100 million lives
  • PRADAXA has proven safety and efficacy across 5 pivotal trials* involving over 27,000 patients2
  • PRADAXA safety in NVAF is supported by over 4 years of clinical study experience2-4
  • Safety reinforced in 3 real-world assessments with over 210,000 patients with NVAF
    • FDA Mini-Sentinel5
    • FDA Medicare Assessment6
    • Department of Defense (DoD)7

Join your peers in accessing data of real-world analyses, representing different U.S. managed care and health system populations that cover over 100 million lives.

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*PRADAXA—Clinical trial descriptions for NVAF, DVT, and PE

RE-LY® Trial: Clinical evidence for the efficacy of PRADAXA—Multicenter, multinational, randomized, parallel-group trial

Study Objective: To demonstrate non-inferiority of blinded PRADAXA (110 mg twice daily§ and 150 mg twice daily) compared to open-label warfarin (INR target range 2.0-3.0) in stroke and systemic embolism prevention (PROBE design). After non-inferiority was established, statistical superiority was analyzed. Methodology: RE-LY enrolled 18,113 patients with NVAF with at least one risk factor for stroke (previous stroke, TIA, systemic embolism, LVEF <40%, symptomatic heart failure, NYHA Class ≥2, age ≥75 years, or age ≥65 years and one of the following: diabetes mellitus, verified CAD, or hypertension). Patients with severe heart valve disorder, stroke within 14 days or severe stroke within 6 months before screening, increased risk of bleeding, CrCl <30 mL/min, and active liver disease were excluded. Patients' mean age was 71.5 years and the mean CHADS2 score was 2.1.

RELY-ABLE® Extension: Long-term, multicenter, observational safety study

Study Objective: To provide a long-term safety evaluation of ongoing therapy with PRADAXA in patients with non-valvular AF following RE-LY. Methodology: Among patients randomized to PRADAXA in RE-LY, 6792 were eligible to participate. Patients enrolled in RELY-ABLE continued therapy with PRADAXA as in RE-LY. 5851 patients participated: 2914 received the 110-mg dose BID§ and 2937 received the 150-mg dose BID. Follow-up: Median duration of follow-up was 2.3 years. Total mean duration of follow-up from start of the original RE-LY Trial was 4.3 years. Study Limitations: Warfarin patients were not followed as a comparator group. Only half of patients continued from RE-LY into RELY-ABLE. No event adjudication was done. Data analysis was not intention to treat. Data represent prespecified 28 months of follow-up after RE-LY.

RE-COVER® and RE-COVER II: Pivotal, parallel, randomized, double-blind, active-controlled trials for treatment of DVT and PE

Study Objective: To demonstrate non-inferiority of PRADAXA to warfarin based on the primary composite endpoint of fatal PE or symptomatic non-fatal PE and/or DVT. Methodology: Patients received 5-10 days of an approved parenteral anticoagulant therapy followed by 6 months of oral-only treatment. Warfarin was overlapped with parenteral therapy. RE-COVER enrolled 2539 patients (30.9% of patients with symptomatic PE with or without DVT; 68.9% with symptomatic DVT only): 2286 patients (90%) received LMWH for parenteral anticoagulation; 1274 received PRADAXA 150 mg BID and 1265 received warfarin (INR target range 2.0-3.0); patients randomized to warfarin had a mean percentage of time in the INR target range of 60%; mean age was 54.7 years. RE-COVER II enrolled 2568 patients (31.8% with symptomatic PE with or without DVT; 68.1% with symptomatic DVT only): 2280 patients (89%) received LMWH for parenteral anticoagulation; 1279 received PRADAXA 150 mg BID and 1289 received warfarin (INR target range 2.0-3.0); patients randomized to warfarin had a mean percentage of time in the INR target range of 57%; mean age was 54.9 years. Median duration of treatment: 174 days.

RE-MEDY and RE-SONATE®: Pivotal, parallel, randomized, double-blind, active-controlled trials in patients with prior acute VTE

RE-MEDY Study Objective: To demonstrate non-inferiority of PRADAXA to warfarin based on the primary composite endpoint of fatal PE or symptomatic non-fatal PE and/or DVT. Methodology: RE-MEDY enrolled 2856 patients following 3-12 months of pre-treatment with anticoagulation for an acute VTE followed by a planned treatment duration of up to 36 months: 1430 received PRADAXA 150 mg BID and 1426 received warfarin (INR target range 2.0-3.0); patients randomized to warfarin had a mean percentage of time in the INR target range of 62%; mean age was 54.6 years. Median duration of treatment: 534 days. RE-SONATE Study Objective: To demonstrate superiority of PRADAXA to placebo based on the primary composite endpoint of fatal PE, unexplained death, or symptomatic non-fatal PE and/or DVT. Methodology: RE-SONATE enrolled 1343 patients following 6-18 months of pre-treatment with anticoagulation for an acute VTE followed by a planned treatment duration of up to 6 months: 681 received PRADAXA 150 mg BID and 662 received placebo; mean age was 55.8 years; follow-up was 12 months after completion of the study treatment phase. Median duration of treatment: 182 days.

PRADAXA–Real-world assessments in NVAF

Mini-Sentinel: An FDA Drug Safety review of post-market reports of serious bleeding events with PRADAXA

Objective: To compare rates of certain bleeding events in 50,000+ patients receiving PRADAXA or warfarin, FDA assessed the actual rates of gastrointestinal and intracranial hemorrhage using health insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. Methodology: The Mini-Sentinel database was queried to identify inpatient diagnosis codes for intracranial and gastrointestinal hemorrhage events (ICH and GIH, combined and separately) associated with new use of PRADAXA or warfarin during the time period from October 19, 2010 (FDA approval date of PRADAXA), through December 31, 2011. Limitations: The estimates do not account for possible differences in the patient populations for the two drugs that may relate to bleeding outcomes, such as age and the presence of other medical conditions. It is also not known whether the codes for ICH, GIH, and atrial fibrillation actually reflect the existence of those conditions in patients using anticoagulants; such information can only be gained through detailed review of medical records.

FDA Medicare: A retrospective observational study of 134,000+ NVAF patients comparing PRADAXA and warfarin for rates of key clinical outcomes

Study Objective: To compare the risk of stroke, major gastrointestinal and intracranial bleeding, acute myocardial infarction (AMI), and mortality in elderly Medicare beneficiaries with nonvalvular AF who initiated therapy with warfarin or dabigatran. Methodology: New-user cohorts were formed of propensity score-matched elderly patients enrolled in Medicare who initiated dabigatran or warfarin for treatment of nonvalvular atrial fibrillation between October 2010 and December 2012. Study Limitations: This study was observational and may be subject to confounding from factors not adjusted for in the analysis, such as over-the-counter aspirin or nonsteroidal anti-inflammatory drug use. To reduce this possibility, an extensive number of variables were included in the propensity score model. Medicare data do not capture laboratory results, so there was no basis on which to assess the quality of warfarin anticoagulation. Additionally, ≈50% of patients in each cohort received only a single prescription of their study anticoagulant representing the ambulatory care experience in Medicare.

DoD: A retrospective observational study of 25,000+ NVAF patients evaluating the safety and effectiveness of PRADAXA vs. warfarin

Study Objective: To evaluate the safety and effectiveness of dabigatran versus warfarin for stroke risk reduction in patients with NVAF in routine clinical care using the U.S. Department (DoD) Military Health System Database. Methodology: The study comprised patients with NVAF from the DoD database. The overall study period was from October 1, 2009 to July 31, 2013. The index date was the first prescription claim for dabigatran etexilate or warfarin between October 1, 2010 and July 31, 2012. The baseline period was the 12 months prior to and including the index date. The follow-up period began on the day after the index date and ended on the earliest of the following: the day of treatment discontinuation, the day before a switch to a different anticoagulant, the end of continuous eligibility of the patients in the health plan (disenrollment), the end of the study period, or death of patient. Exposure to index drug was considered discontinued if there was a treatment gap longer than 30 days past the end of the continuous treatment episode, derived from the number of days of supply of the last prescription.


Number reflects total covered lives within the specific plans and is not specific to dabigatran patients.
§Although studied in the RE-LY® and RELY-ABLE® trials, the 110-mg dose is not approved for use in patients with NVAF.
The protocol specified non-inferiority margin (2.75) for the HR was derived based on the upper limit of the 95% CI of the historical warfarin effect.
Oral-only treatment period; does not include treatment period with parenteral anticoagulant.
The protocol specified non-inferiority margin (2.85) for the HR was derived based on the point estimate of the historical warfarin effect.

References: 1. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. 2. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 3. Connolly SJ, Exekowitz MD, Yusuf S, et al; and the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151. 4. Connolly SJ, Wallentin L, Ezekowitz MD, et al. The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. 2013;128(3):237-243. 5. Southworth MR, Reichman ME, Unger EF. Dabigatran and Postmarketing Reports of Bleeding. N Engl J Med. 2013;368:1272-1274. 6. Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for non-valvular atrial fibrillation. Circulation. 2015;131(2):157‑164. 7. Villines TC, Schnee J, Fraeman K, et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114(6):1290-1298.
Page revised 12/2016: PC-PX-0190-F114-R1

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR PRADAXA

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • use of indwelling epidural catheters
  • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • a history of traumatic or repeated epidural or spinal punctures
  • a history of spinal deformity or spinal surgery
  • optimal timing between the administration of PRADAXA and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with:

  • active pathological bleeding;
  • known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA;
  • mechanical prosthetic heart valve

WARNINGS & PRECAUTIONS

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 is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA 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 in patients with active pathological bleeding.
  • Risk factors for bleeding include concomitant use of medications 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: A specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed:
    • For emergency surgery/urgent procedures
    • In life-threatening or uncontrolled bleeding

    Hemodialysis can remove dabigatran; however clinical experience for 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. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves

The use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.

Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure

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 major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.

Reduction of Risk of Stroke/Systemic Embolism in NVAF
  • For patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.
Treatment and Reduction in the Risk of Recurrence of DVT/PE & Prophylaxis of DVT/PE Following Hip Replacement Surgery
  • For patients with CrCl <50 mL/min, avoid use of PRADAXA and concomitant P-gp inhibitors

ADVERSE REACTIONS

The most serious adverse reactions reported with PRADAXA were related to bleeding.

NVAF

  • Most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding & gastrointestinal (GI) events
  • PRADAXA 150 mg resulted in higher rates of major and any GI bleeds compared to warfarin
  • In patients ≥75 years of age, the risk of major bleeding may be greater with PRADAXA vs warfarin
  • Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer)

DVT/PE

  • Rates of any GI bleeds were higher in patients receiving PRADAXA 150 mg vs warfarin and placebo
  • In the active-controlled studies, there was a higher rate of clinical myocardial infarction (MI) in PRADAXA patients [20 (0.66/100) patient-years)] vs warfarin [5 (0.17/100 patient-years)]. In the placebo-controlled study, there was similar rate of non-fatal and fatal clinical MI in PRADAXA patients [1 (0.32/100 patient-years)] vs placebo [1 (0.34/100 patient-years)]
  • GI adverse reactions were similar in patients receiving PRADAXA 150 mg vs warfarin. They were dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage)

DVT/PE After Hip Replacement Surgery

  • Rate of major GI bleeds in patients receiving PRADAXA 220 mg and enoxaparin was the same; rate of any GI bleeds was higher in patients receiving PRADAXA 220 mg vs enoxaparin
  • GI adverse reactions were the same in patients receiving PRADAXA 220 mg vs enoxaparin. These were dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage)
  • Clinical MI was reported in 2 (0.1%) patients who received PRADAXA 220 mg and 6 (0.3%) patients who received enoxaparin

Other Measures Evaluated

In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

INDICATIONS AND USAGE

Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:

  • to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation;
  • for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days;
  • to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated
  • for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients who have undergone hip replacement surgery

Please see full Prescribing Information, including boxed WARNING and Medication Guide.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, PRADAXA with associated design ®, RE-LY®, RELY-ABLE®, RE-COVER®, RE-COVER II, RE-MEDY and RE-SONATE® under license.

Use of this Site is subject to the Internet Site Legal Notices and Disclaimers and Privacy Notice. This Site is intended for U.S. healthcare professionals only. Products discussed herein may have different labeling in different countries.

COPYRIGHT © 2016 BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ALL RIGHTS RESERVED. [04/16]
PC-PX-0190-F114

IMPORTANT SAFETY INFORMATION AND INDICATIONS

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • use of indwelling epidural catheters
  • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • a history of traumatic or repeated epidural or spinal punctures
  • a history of spinal deformity or spinal surgery
  • optimal timing between the administration of PRADAXA and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with:

  • active pathological bleeding;
  • known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA;
  • mechanical prosthetic heart valve

WARNINGS & PRECAUTIONS

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 is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA 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 in patients with active pathological bleeding.
  • Risk factors for bleeding include concomitant use of medications 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: A specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed:
    • For emergency surgery/urgent procedures
    • In life-threatening or uncontrolled bleeding
  • Hemodialysis can remove dabigatran; however clinical experience for 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. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves

The use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.

Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure

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 major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.

Reduction of Risk of Stroke/Systemic Embolism in NVAF
  • For patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.
Treatment and Reduction in the Risk of Recurrence of DVT/PE & Prophylaxis of DVT/PE Following Hip Replacement Surgery
  • For patients with CrCl <50 mL/min, avoid use of PRADAXA and concomitant P-gp inhibitors

ADVERSE REACTIONS

The most serious adverse reactions reported with PRADAXA were related to bleeding.

NVAF

  • Most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding & gastrointestinal (GI) events
  • PRADAXA 150 mg resulted in higher rates of major and any GI bleeds compared to warfarin
  • In patients ≥75 years of age, the risk of major bleeding may be greater with PRADAXA vs warfarin
  • Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer)

DVT/PE

  • Rates of any GI bleeds were higher in patients receiving PRADAXA 150 mg vs warfarin and placebo
  • In the active-controlled studies, there was a higher rate of clinical myocardial infarction (MI) in PRADAXA patients [20 (0.66/100) patient-years)] vs warfarin [5 (0.17/100 patient-years)]. In the placebo-controlled study, there was similar rate of non-fatal and fatal clinical MI in PRADAXA patients [1 (0.32/100 patient-years)] vs placebo [1 (0.34/100 patient-years)]
  • GI adverse reactions were similar in patients receiving PRADAXA 150 mg vs warfarin. They were dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage)

DVT/PE After Hip Replacement Surgery

  • Rate of major GI bleeds in patients receiving PRADAXA 220 mg and enoxaparin was the same; rate of any GI bleeds was higher in patients receiving PRADAXA 220 mg vs enoxaparin
  • GI adverse reactions were the same in patients receiving PRADAXA 220 mg vs enoxaparin. These were dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage)
  • Clinical MI was reported in 2 (0.1%) patients who received PRADAXA 220 mg and 6 (0.3%) patients who received enoxaparin

Other Measures Evaluated

In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

INDICATIONS AND USAGE

Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:

  • to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation;
  • for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days;
  • to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated
  • for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients who have undergone hip replacement surgery

Please see full Prescribing Information, including boxed WARNING and Medication Guide.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, PRADAXA with associated design ®, RE-LY®, RELY-ABLE®, RE-COVER®, RE-COVER II, RE-MEDY and RE-SONATE® under license.

Use of this Site is subject to the Internet Site Legal Notices and Disclaimers and Privacy Notice. This Site is intended for U.S. healthcare professionals only. Products discussed herein may have different labeling in different countries.

COPYRIGHT © 2016 BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ALL RIGHTS RESERVED. [04/16]
PC-PX-0190-F114