Bristol-Myers Squibb and Pfizer Announce Global Real-World Data Program and Present New Analyses of Eliquis (apixaban) at the American College of Cardiology’s 65th Annual Scientific Session
Seventeen abstracts to be presented, including new analyses from the Phase 3 ARISTOTLE and AMPLIFY clinical studies and from real-world databases
Wednesday, March 30, 2016 7:45 am EDT
"Retrospective analyses of real-world data add an important component to our knowledge of Eliquis and may help to inform healthcare practitioners in their treatment decisions"
PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced today that 17 abstracts will be presented at the American College of Cardiology’s 65th Annual Scientific Session (ACC.16), to be held April 2-4 in Chicago, IL. The new analyses contribute to the Bristol-Myers Squibb and Pfizer Alliance’s body of evidence on the use of Eliquis to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of patients with venous thromboembolism (VTE). Abstracts include new analyses from Phase 3 ARISTOTLE and AMPLIFY clinical studies, as well as a number of retrospective analyses of real-world data. “The Alliance is pleased to present new analyses from both Phase 3 clinical trials and real-world databases at this important cardiology conference,” said Douglas Manion, M.D., head of specialty development, Bristol-Myers Squibb. “Clinical trial data help to evaluate the safety and efficacy of Eliquis under well-controlled circumstances, while real-world data can offer additional insight into the use of Eliquis for its approved indications in routine clinical practice.”
The real-world data to be presented at ACC.16 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 Eliquis in routine clinical practice. “Retrospective analyses of real-world data add an important component to our knowledge of Eliquis and may help to inform healthcare practitioners in their treatment decisions,” said Rory O’Connor, M.D., senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc.
A list of Alliance presentations is included below. Complete abstracts can be accessed via the ACC.16 program planner: http://www.abstractsonline.com/pp8/#!/3874
| Title |
Lead Author
/ Type
| Date / Time
CST
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Location /
Session –
Chicago
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| Phase 4 Clinical Trial Analysis | |||||||||
| Current Treatment Options in Afib and PCI: Review of Completed and Ongoing Trials With Novel Anticoagulants. Apixaban- The AUGUSTUS Study: Rationale, Design, Status Update | Lopes,
Oral
| April 3,
3:05-3:10 p.m.
| Room S103ab | ||||||
| Phase 3 Clinical Trial Subanalyses | |||||||||
| Apixaban Versus Warfarin for Patients With Recent Onset Atrial Fibrillation: Insights From the ARISTOTLE Trial | Guimaraes et al., Moderated Poster | April 2
1:30-1:40 p.m.
| Arrhythmias and Clinical EP Moderated Poster Theater, South Hall A1 | ||||||
| Hospitalizations, Recurrent Venous Thromboembolism or Venous Thromboembolism-Related Death, and Major Bleeding, by Index Event From the AMPLIFY Trial | Lee et al.,
Moderated Poster
| April 3
4:00-4:10 p.m.
| Vascular Medicine Moderated Poster Theater, South Hall A1 | ||||||
| External Validation of the Biomarker-Based ABC-Bleeding Risk Score for Atrial Fibrillation | Hijazi et al.,
Poster
| April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| External Validation of the Biomarker-Based ABC-Stroke Risk Score for Atrial Fibrillation | Oldgren et al., Poster | April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| Real-World Data Analyses | |||||||||
| Real-World Comparison of Inpatient Bleeding Risk, Bleeding-Related Hospitalization Rates and Costs Among Non-Valvular Atrial Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban: Cohorts Comprising New Initiators and/or Switchers From Warfarin | Tepper et al., Moderated Poster | April 2
10:00-10:10 a.m.
| Arrhythmias and Clinical EP Moderated Poster Theater, South Hall A1 | ||||||
| Treatment and Discharge Patterns Among Patients Hospitalized With Non-Valvular Atrial Fibrillation Who Transition From the Inpatient to Outpatient Setting | Henk et al.,
Poster
| April 2
10:00-10:45 a.m.
| Poster Area, South Hall A1 | ||||||
| Real-World Comparison of Major Bleeding Risk Among Untreated Non-Valvular Atrial Fibrillation Patients and Those Initiating Apixaban, Dabigatran, Rivaroxaban, or Warfarin | Amin et al., Moderated Poster | April 2
11:30-11:40 a.m.
| Arrhythmias and Clinical EP Moderated Poster Theater, South Hall A1 | ||||||
| Changes Over Time in Treatment Persistence of Oral Anticoagulants in Patients With Non-Valvular Atrial Fibrillation | Lefevre et al., Poster | April 2
3:45-4:30 p.m.
| Poster Area, South Hall A1 | ||||||
| Comparison of Treatment Persistence in Real-World Use of Novel Oral Anticoagulants Among Patients With Non-Valvular Atrial Fibrillation | Lefevre et al., Poster | April 3
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| Hospital Readmissions Among Patients With Nonvalvular Atrial Fibrillation Treated With the New Oral Anticoagulants, Apixaban, Dabigatran, and Rivaroxaban | Deitelzweig et al,
Poster
| April 3
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| An Evaluation of the Abandonment of Electronically Transmitted Prescriptions for Warfarin and New Oral Anticoagulant Agents | Gupta et al., Poster | April 3
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| What Do Real World Data say About Safety and Resource Use of Oral Antagonists? Early Analysis of Newly Anticoagulated Non-Valvular Atrial Fibrillation Patients Using Either Apixaban, Dabigatran, Rivaroxaban or Warfarin | Pan et al.,
Poster
| April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| Compare Major Bleeding Risk and Associated Costs Among NVAF Patients With CHA2DS2-VASc Score ≥ 3 Newly Anticoagulated With Apixaban Versus Warfarin | Deitelzweig et al,
Poster
| April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| Real-World Comparison of Major Bleeding Risk Among Non-Valvular Atrial Fibrillation Patients Newly Initiated on Apixaban, Warfarin, Dabigatran or Rivaroxaban: A 1:1 Propensity-Score Matched Analysis | Lip et al.,
Poster
| April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| Comparison of Bleeding and Treatment Persistence Among New Users of Novel Oral Anticoagulants and Warfarin in Patients With Non-Valvular Atrial Fibrillation | Lamberts et al,
Poster
| April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 | ||||||
| Anticoagulation Control in Patients With Non-Valvular Atrial Fibrillation Treated With Vitamin K Antagonist Therapy for 12 months or More in Primary Care in the UK | Ridha et al.,
Poster
| April 4
9:45-10:30 a.m.
| Poster Area, South Hall A1 |
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases 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 Important Safety Information and Indications
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: |
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| 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 at www.bms.com.
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.
About ACROPOLIS™
ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is theEliquis (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 AMPLIFY
The AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) trial was a double-blind, randomized, multicenter study that compared the efficacy and safety of Eliquis (at a dose of 10 mg orally twice daily for seven days, followed by 5 mg orally twice daily for six months) with those of conventional therapy in 5,395 patients with symptomatic proximal DVT or symptomatic PE with or without DVT. The primary efficacy outcome was the incidence of the adjudicated composite of recurrent symptomatic VTE or death related to VTE that occurred by the end of the treatment period. The primary safety outcome was adjudicated major bleeding that occurred by the end of the treatment period. 1
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.
About Bristol-Myers Squibb
Bristol-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 onLinkedIn, Twitter, and YouTube.
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 March 30, 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; 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 atwww.sec.gov and www.pfizer.com.
1 Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. New England Journal of Medicine. 2013;369:799-808.
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