|Title||Presenting Author/Type||Date/Time (CST)||Location/Session|
|Phase 3 Clinical Trial Sub-Analyses|
|Use of the Novel Biomarker-based ABC Bleeding Risk Score Over Time in Atrial Fibrillation: Insights from the ARISTOTLE Trial Session: Arrhythmia: Clinical Electrophysiology, Diagnosis and Risk Stratification VII||Hijazi et al./ Oral||Nov. 14, 2:00-3:15 PM||Science and Technology Hall, Clinical Science II Section|
|Percutaneous Coronary Intervention and Antiplatelet Therapy on Apixaban or Warfarin: Insights from the ARISTOTLE Trial Session: Antiplatelet Therapy for PCI and ACS: Insights from Large Trials and Registries||Kopin et al./ Poster||Nov. 13,3:45 PM||Science and Technology Hall, Clinical Science Section|
|Adherence and Persistence to Apixaban Treatment in Patients with Non-Valvular Atrial Fibrillation is High and Similar with Standard-of-care Patient Education or with an Additional Educational Program: The Randomized AEGEAN study Session: Cardiovascular Stroke||Montalescot et al./ Oral||Nov. 13, 5:45-5:55 PM||Room 348-349|
|A History of GI Bleeding is associated with Increased Risk of Subsequent Bleeding, but not Stroke: Insights from the ARISTOTLE Trial Session: Treatment of Arrhythmias: Pharmacologic II||Lopes et al./ Poster||Nov. 15,1:30 PM||Science and Technology Hall, Clinical Science Section|
|Risk Factors for Cause-Specific Mortality in Patients Anticoagulated for Atrial Fibrillation: Insights From the ARISTOTLE trial Session: Clinical Risk Factors and Novel Biomarkers: Diagnostic, Prognostic, and Therapeutic Implications||Sharma et al./ Rapid-Fire||Nov. 15,2:25 PM||Science and Technology Hall, Population Science Theater|
|Biomarkers Predict Cause of Death More Accurately than Clinical Variables in Patients with Atrial Fibrillation on Oral Anticoagulation - Results from the ARISTOTLE trial Session: Chronic and Acute Ischemic Heart Disease||Hijazi et al./ Rapid-Fire||Nov. 15,6:30-6:40 PM||Room 228-230|
|Real-World Data and Other Analyses|
|Outcomes Associated with Warfarin Time in Therapeutic Range among Veterans with Non-Valvular Atrial Fibrillation in the US, 2005-2015 Session: Issues in Atrial Fibrillation and Anticoagulation||Liu et al./ Rapid-Fire||Nov. 14,12:10 PM||Science and Technology Hall, Population Science Theater|
|Real World Bleeding Risks in Non-Valvular Atrial Fibrillation Patients with Heart Failure: Contemporary EHR Results Among Prescribed Apixaban, Dabigatran, Rivaroxaban and Warfarin Session: Issues in Atrial Fibrillation and Anticoagulation||Masseria, C. et al./ Rapid-Fire||Nov. 14,12:20 PM||Science and Technology Hall, Population Science Theater|
|Real-World Comparisons of Major Bleeding Risk for Commercially Insured Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban, or Warfarin Session: Patient Centered Outcomes Research in Atrial Fibrillation and Anticoagulation||Amin et al./ Poster||Nov. 14,2:00 PM||Science and Technology Hall, Population Science Section|
|Real World Comparisons of Major Bleeding Risk Stratified by CHA 2DS 2-VASc Scores among Non-Valvular Atrial Fibrillation Patients Initiating Apixaban or Warfarin Session: Patient Centered Outcomes Research in Atrial Fibrillation and Anticoagulation||Lip et al./ Poster||Nov. 14,2:00 PM||Science and Technology Hall, Population Science Section|
|Performance of the Novel Biomarker-Based ABC-Stroke Risk Score over Time in Patients with Atrial Fibrillation Session: Arrhythmia: Clinical Electrophysiology, Diagnosis and Risk Stratification V||Hijazi et al./ Oral||Nov. 14,2:00 PM||Science and Technology Hall, Clinical Science II Section|
|Real-world Evaluation of Healthcare Resource Use and Costs of Elderly Patients with Non-Valvular Atrial Fibrillation Treated with Apixaban vs. Warfarin in the US Session: Resource Intensity, Costs, and Cost-Effectiveness in CVD||Deitelzweig et al./ Poster||Nov. 15,1:30 PM||Science and Technology Hall, Population Science Section|
|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:|
|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.|
- Active pathological bleeding
- Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
- 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.
- The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.
- 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.
- 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.
- 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.
About Bristol-Myers SquibbBristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook. About Pfizer Inc.: Working together for a healthier world ® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2015, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Pfizer Disclosure Notice The information contained in this release is as of November 10, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Eliquis (apixaban), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Eliquis; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com .