- Comparisons of All-Cause, Stroke- and Major Bleeding-Related Medical Costs Among Non-Valvular Atrial Fibrillation Patients Who Initiated Oral Anticoagulation Therapies in the U.S. Department of Defense Military Health System - November 12, from 3:15 p.m. to 4:30 p.m. PST
- Risk of Stroke and Major Bleeding for Dabigatran, Rivaroxaban, and Warfarin Compared to Apixaban Among Non-Valvular Atrial Fibrillation Patients in the United States Medicare Population - November 13, from 3:00 p.m. to 4:15 p.m. PST
- Effectiveness and Safety of Apixaban versus Other Oral Anticoagulants in Older Adults With Non-Valvular Atrial Fibrillation and Concomitant Coronary Artery Disease or Peripheral Arterial Disease - November 14, from 10:30 a.m. to 11:45 a.m. PST
Below is a complete list of BMS-Pfizer Alliance presentations during the AHA Conference. Abstracts can be accessed through the AHA Scientific Sessions 2017 Online Program Planner.
|Title||Presenting Author/Type||Date/Time (PST)||Location/Session|
|Multimorbidity is Associated With Greater Risk of Thromboembolism and Bleeding in Patients With Atrial Fibrillation but a Constant Benefit of Apixaban: Results From ARISTOTLE Sessions: Atrial Fibrillation-Related Stroke Prevention: How To Do It Right||Alexander KP, et al./Poster||Nov. 12, 3:15-4:30 p.m.||Clinical Science Section, Science and Technology Hall|
|Patients With Good Adherence to Study Medication Have Better Outcomes: Insights From the ARISTOTLE Trial Sessions: Atrial Fibrillation-Related Stroke Prevention: How To Do It Right||Xavier D, et al./ Poster||Nov. 12, 3:15-4:30 p.m.||Clinical Science Section, Science and Technology Hall|
|Variation in Patient Characteristics Does Not Explain Regional Differences in Outcomes: Findings From ARISTOTLE Sessions: Atrial Fibrillation-Related Stroke Prevention: How To Do It Right||Bahit MC, et al./ Poster||Nov. 12, 3:15-4:30 p.m.||Clinical Science Section, Science and Technology Hall|
|Obesity Paradox on Outcome in Atrial Fibrillation Maintained Even Considering the Prognostic Influence of Biomarkers: Insights From the ARISTOTLE Trial Session: Obesity in CVD Risk and Prevention||Sandhu RK, et al./Poster||Nov. 14, 12:00-1:15 p.m.||Population Science Section, Science and Technology Hall|
|Strokes Prevented: Biosurveillance of NVAF Patient Cohorts CHA2DS2-VASc and HAS-BLED Scores Using Natural Language Processing and SNOMED CT Session: Stroke||Elkin PL, et al./ Poster||Nov. 12, 11:30-12:45 p.m.||Clinical III Section, Science and Technology Hall|
|Comparisons of All-cause, Stroke- and Major Bleeding-related Medical Costs Among Non-valvular Atrial Fibrillation Patients Who Initiated Oral Anticoagulation Therapies in the US Department of Defense Military Health System Session: Contemporary Investigations in Outcomes Research||Gupta K, et al./Poster||Nov.12, 3:15-4:30 p.m.||Population Science Section, Science and Technology Hall|
|Effectiveness and Safety of Apixaban Compared to Other Oral Anticoagulants Among Non-Valvular Atrial Fibrillation Patients with Coronary Artery Disease or Peripheral Arterial Disease: A Propensity Score Matched Analysis of Four Large Databases Session: Quality Assessments in Big Data||Lip GY, et al./Poster||Nov. 12, 3:15-4:30 p.m.||Population Science Section, Science and Technology Hall|
|Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Among Non-Valvular Atrial Fibrillation Patients: A Propensity Score Matched Analysis of Four Large Databases Session: Quality of Care||Deitelzweig S, et al./Poster||Nov. 13, 3:00-4:15 p.m.||Population Science Section, Science and Technology Hall|
|Risk of Stroke and Major Bleeding for Dabigatran, Rivaroxaban, and Warfarin Compared to Apixaban Among Non-Valvular Atrial Fibrillation Patients in the United States Medicare Population Session: Quality of Care, Outcomes Research and Health Policy||Amin A, et al./Poster||Nov. 13, 3:00-4:15 p.m.||Population Science Section, Science and Technology Hall|
|Effectiveness and Safety of Apixaban versus Other Oral Anticoagulants in Older Adults With Non-Valvular Atrial Fibrillation and Concomitant Coronary Artery Disease or Peripheral Arterial Disease Session: Risk Prediction and Modification||Lopes R, et al./Poster||Nov. 14, 10:30-11:45 a.m.||Population Science Section, Science and Technology Hall|
|Routine Cardiac Implantable Electronic Device Interrogation at the Point Of Care— Implications for Stroke Prevention and Management Session: Stroke Risk Stratification and Prevention in Atrial Fibrillation||Pugh M, et al./Poster||Nov. 14, 10:30-11:45 a.m.||Clinical Science Section, Science and Technology Hall|
|Eliminate Thromboembolism: Improving Anticoagulation in Non-Valvular Atrial Fibrillation Patients' (ELITE) Registry - Insights From the Baseline Results Session: EP in a Heartbeat: Rapid Abstracts||Sharma A, et al./ Oral||Nov. 14, 10:50-10:55 a.m.||Clinical Science Section, Science and Technology Hall|
|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, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and 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, 2016, 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, 2017. 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, 2016 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 U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com . i Centers for Medicare & Medicaid Services. CMS press toolkit (webpage). Accessed on October 12, 2017. https://www.cms.gov/Newsroom/PressToolkit.html ii Bjerring Olesen, J., Gislason, G. H., Torp-Pedersen, C. and Lip, G. Y. H. (2012), Atrial Fibrillation and Vascular Disease—A Bad Combination. Clin Cardiol, 35: S15-S20. doi:10.1002/clc.20955 iii Bjerring Olesen, J., Gislason, G. H., Torp-Pedersen, C. and Lip, G. Y. H. (2012), Atrial Fibrillation and Vascular Disease—A Bad Combination. Clin Cardiol, 35: S15-S20. doi:10.1002/clc.20955