On August 23, 2016 Bristol-Myers Squibb Company (link is external) (NYSE: BMY) and Pfizer Inc.(NYSE: PFE) reported that 19 abstracts (late-breaking, rapid-fire, oral and poster presentations) will be presented at ESC Congress 2016, to be held August 27–31 in Rome, Italy (Press release, Pfizer, AUG 23, 2016, View Source [SID:1234514680]). These new data from post-hoc analyses from ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) and retrospective real-world data analyses continue to underscore the Alliance’s commitment to the evaluation of Eliquisfor patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). Of note, several of the real-world data analyses are part of ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), a global real-world data research program designed to further evaluate the effectiveness and safety of apixaban in routine clinical practice.
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"The Bristol-Myers Squibb and Pfizer Alliance is pleased to share 19 abstracts, which include new real-world analyses, as well as new sub-analyses from the pivotal Phase 3 ARISTOTLE trial," said Rory O’Connor, M.D., Chief Medical Officer, Internal Medicine, Pfizer Innovative Health. "We look forward to the opportunity to contribute to the scientific discussion and continued research during ESC Congress 2016."
"As patient and provider needs continue to evolve, it’s essential that we deepen our understanding of how medicines are working in real-world situations," said Jack Lawrence, M.D., Vice President, Cardiovascular Specialty Development, Bristol-Myers Squibb. "This year at ESC Congress 2016, we’ll be discussing new NVAF and VTE data that complement our robust body of clinical trial data."
The complete list of Bristol-Myers Squibb and Pfizer Alliance presentations is included below. Abstracts can be accessed on the ESC Congress 2016 website (link is external).
Title Presenting Author/Type Date/Time (BST) Location/Session
Phase 3 Clinical Trial Sub-Analyses
Patients with Atrial Fibrillation and History of Falls Are at High Risk for Bleeding but Have Less Bleeding with Apixaban than Warfarin: Results from the ARISTOTLE Trial
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Rao et al. /
Oral, Rapid Fire
Aug. 28,
11:10
Agora 1 – Poster Area
Efficacy and Safety of Apixaban versus Warfarin in Patients with Atrial Fibrillation and Active Cancer: Insights from the ARISTOTLE Trial
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Melloni et al. /
Oral, Rapid Fire
Aug. 28,
11:20
Agora 1 – Poster Area
Patients with Atrial Fibrillation Treated with Apixaban Are Less Likely to Discontinue Study Drug When Compared with Warfarin: Insights from the ARISTOTLE Trial
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Xavier et al. /
Poster
Aug. 28,
14:00
Poster Area
Real-World Data and Other Analyses
Contemporary Results from EHR Study of Real-World Bleeding Risk among Elderly and Overall Non-Valvular Atrial Fibrillation Patients Prescribed Apixaban, Dabigatran, Rivaroxaban and Warfarin
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Horblyuk et al. /
Oral, Rapid Fire
Aug. 28,
12:00
Agora 1 – Poster Area
Real-World Comparisons of Major Bleeding Risk and Major Bleeding-Related Hospitalization Costs among Elderly Non-Valvular Atrial Fibrillation Patients Newly Initiated on Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Is Major Bleeding Risk for Oral Anticoagulants Similar Between Non-Valvular Atrial Fibrillation Patients Newly Initiated on Warfarin and Propensity-Score Matched NOAC Initiators? A Real World Study
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Major Bleeding Risk in Patients 75 Years of Age or Older with Non-Valvular Atrial Fibrillation Initiating Oral Anticoagulants: A ‘Real-World’ Comparison of Warfarin, Apixaban, Dabigatran, or Rivaroxaban
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Is There a Difference in Treatment Persistence Across Oral Anticoagulants? Results of a UK Cohort Study Evaluating Oral Anticoagulation Therapy in an Atrial Fibrillation Population
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Stynes et al. /
Poster
Aug. 28,
14:00
Poster Area
Real-World Comparison of Major Bleeding and Associated Costs among Treatment-Naïve Non-Valvular Atrial Fibrillation Patients Initiating Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Trocio et al. /
Poster
Aug. 28,
14:00
Poster Area
Aspirin, not without Bleeding Risk in the Real World: Results of a UK Cohort Study Evaluating the Use of Antiplatelet Therapy for Stroke Prevention in Atrial Fibrillation (AF)
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Ridha et al. / Poster
Aug. 28,
14:00
Poster Area
Is Aspirin Monotherapy Effective for Stroke Prevention in the Real World? A UK Cohort Study Evaluating the Incidence of Stroke in the Absence of Anticoagulation in Atrial Fibrillation (AF)
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Ridha et al. /
Poster
Aug. 28,
14:00
Poster Area
Differences in the Characteristics of Patients with Non-Valvular Atrial Fibrillation Who Are Newly Prescribed Apixaban, Rivaroxaban, Dabigatran and VKA in General Practice in the UK
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Stynes et al. /
Poster
Aug. 28,
14:00
Poster Area
Risk of Bleeding with Non-Vitamin K Antagonists and Phenprocoumon in Routine Care Patients with Non-Valvular Atrial Fibrillation
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Hohnloser et al. /
Poster
Aug. 28,
14:00
Poster Area
Are Your Atrial Fibrillation (AF) Patients Protected from Ischaemic Stroke? Clinical Characteristics of AF Patients Eligible for Stroke Prevention but Remaining Untreated in UK Clinical Practice
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Ridha et al. /
Poster
Aug. 28,
14:00
Poster Area
Bleeding Risk for Non-Valvular AF Patients Prescribed Warfarin, or Standard Doses of Apixaban 5mg BID, Dabigatran 150mg BID or Rivaroxaban 20mg QD in Real-World Practice: Findings from EHR
Session: Are You Still Afraid about Bleeding Risk of Antithrombotic Therapy in Atrial Fibrillation?
Lip et al. /
Oral, Advances in Science
Aug. 28,
14:18
Minsk – Village 4
Demographic and Clinical Characteristics Associated with Initiation of Individual Oral Anticoagulants among Patients with Newly Diagnosed Venous Thromboembolism
Session: Poster Session 4: Thrombosis and Coagulation
Li et al. /
Poster
Aug. 29,
08:30
Poster Area
A Nationwide Register Study to Compare Bleeding Rates in Patients with Non-Valvular Atrial Fibrillation Prescribed Oral Anticoagulants
Session: Registries Atrial Fibrillation
Halvorsen et al. /
Late-Breaker
Aug. 29,
08:45
Raphael – The Hub
Costs of Major Adverse Outcomes in Patients with Incident Venous Thromboembolism in Clinical Practice in the United Kingdom
Session: Advances in Pulmonary Embolism
Cohen et al. /
Poster
Aug. 29,
16:03
Moderated Poster Station – Poster Area
Potential Impact of Apixaban on Hospital Resource Use in Patients with Venous Thromboembolism
Session: Antithrombotics in Daily Clinical Practice
Li et al. /
Oral, Rapid Fire
Aug 30,
17:24
Galileo – The Hub
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from seven Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.
ELIQUIS Indications and Important Safety Information
Indications
ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy.
ELIQUIS Important Safety Information
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS 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 nonsteroidal 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 ELIQUIS 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 anticoagulated or to be anticoagulated.
CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available.
Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis.
The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours.
Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.
Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONS
The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
DRUG INTERACTIONS
Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp.
Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban and increase the risk of stroke and other thromboembolic events.
Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.
PREGNANCY CATEGORY B
There are no adequate and well-controlled studies of ELIQUIS in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. ELIQUIS should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, available atwww.bms.com (link is external).
About ACROPOLIS
ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.
Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.
About ARISTOTLE
ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.