"MERCURY PE is the first prospective randomized trial to evaluate emergency department discharge in U.S. patients with lowrisk PE Results suggest opportunity to change hospital protocols for lowrisk PE management Lowrisk PE patients on XARELTO discharged early from the emergency department report it is less burdensome than inpatient standard of care  TITUSVILLE N.J. June   PRNewswire  The Janssen Pharmaceutical Companies of Johnson  Johnson today announced results from the MERCURY PE study which showed that people with lowrisk pulmonary embolism PE treated with XARELTO rivaroxaban and discharged from the emergency department had significantly reduced time in the hospital and a median savings of  in per patient costs compared to standard of care inpatient treatment. Results from MERCURY PE which evaluated the benefits of treating patients with lowrisk PE with XARELTO and discharging them early from the emergency department to complete treatment at home were published in Academic Emergency Medicine httpsonlinelibrary.wiley.comdoiabs.acem.. Click to Tweet httpsctt.acRZka New study shows outpatient use of Janssen bloodthinner results in cost savings and reduces time in hospital for lowrisk PE patients httpsctt.acRZka Every year U.S. health care systems spend more than two billion dollars to manage patients with pulmonary emboli said principal study investigator W. Frank Peacock MD FACEP FACC Associate Chair and Research Director Emergency Medicine Baylor College of Medicine Houston TX. By avoiding hospitalizations that are not clinically necessary and transitioning patients with lowrisk PE to outpatient treatment with XARELTO weve seen significant cost savings which could help alleviate the burden on health care systems.  Venous thromboembolism VTE includes deep vein thrombosis DVT a blood clot in a deep vein and PE a potentially lifethreatening condition that occurs when a blood clot travels to the lung. Of the approximately  Americans who experience a VTE each yeari more than  are diagnosed with PE in the emergency departmentii. Hospitals across the United States have varying protocols for managing PE but standard of care typically requires people to be admitted for treatment which drives up costs and substantially increases hospitalacquired conditions and infectionsiiiiv. While people with more severe PE have higher mortality rates the day mortality rate of lowrisk PE is less than one percentv. Click to Tweet httpsctt.acWcS Patients taking Janssen blood thinner say in a new study that outpatient treatment is less burdensome than the standard of care httpsctt.acWcS MERCURY PE met its primary efficacy endpoint with XARELTO leading to significantly reduced time in the hospital due to VTE or bleeding within  days after randomization compared with the standard of care mean duration of . vs. . hours respectively  CI p.. The mean difference of length of stay between the two groups was . hours. Of note there was no recurrence of VTE or VTErelated death or any significant differences in the bleedingrelated hospitalizations or physician visits within  days from randomization in either group though this outcome should be interpreted with caution as the study was significantly underpowered to detect any such differences. Were proud to have pioneered this groundbreaking research which was the first prospective randomized trial to confirm the benefit of discharging patients with lowrisk PE early from the hospital and completing treatment at home said Paul Burton MD PhD FACC Vice President Janssen Scientific Affairs LLC. We expect that this XARELTO study will prompt physicians to reconsider how patients with lowrisk PE are managed. About MERCURYPE Patients with lowrisk PE were randomly assigned in a  ratio to open label XARELTO or standard of care within  hours of diagnosis. Patients randomized to XARELTO were discharged from the emergency department within  hours and were instructed to take XARELTO  mg twice daily for  days then XARELTO  mg once daily until the study was completed. Patients randomized to standard of care were treated per local hospital protocol which could include hospitalization and any U.S. Food and Drug Administrationapproved anticoagulant strategy including XARELTO. Researchers also made the following observations about XARELTO in this setting   The mean length of initial and subsequent hospitalizations for any reason was shorter for patients who were discharged early on XARELTO within  days from randomization compared to those receiving standard of care p. . hours vs. . hours respectively.   There was no major bleeding in either group within  days from randomization although two patients reported clinically relevant nonmajor bleeding one in each group. There were no deaths due to bleeding in the study.   Overall early discharge on XARELTO was markedly less expensive than standard of care. The cost associated with the emergency room visit and any subsequent hospitalization at the time of PE diagnosis and the total costs were  p. and  p. less with XARELTO. MERCURY PE builds on prior research including a June  study published in Academic Emergency Medicine httponlinelibrary.wiley.comdoi.acem.abstract showing that  patients with lowrisk PE or DVT when prescribed XARELTO and immediately discharged had no recurrent events while on therapy. Additionally no major or clinically relevant bleeding events were observed. A companion study found patients with lowrisk PE or DVT who were prescribed XARELTO had significantly lower medical costs than those admitted and given standard treatment.  The clinical and economic benefits demonstrated in the MERCURYPE trial have been confirmed in more than  U.S. patients in a realworld study showing that XARELTO resulted in a significant oneday reduction in hospital length of stay and significantly lower total healthcare costs approximately . MERCURY PE Patient Satisfaction Results Patient satisfaction both with outpatient and inpatient care was also analyzed using Likert scales and the AntiClot Treatment Score ACTS. On the Likert scales most patients in both groups indicated they were very satisfied with their care but numerically more patients taking XARELTO preferred to receive outpatient care  percent compared to slightly less than half of patients receiving inpatient standard of care . percent. The ACTS measured the patients perspective on the burden of treatment with more patients taking XARELTO reporting it was not at all burdensome compared to those receiving standard of care . percent vs. . percent. About MERCURY PE MERCURY PE was a randomized open label parallelgroup multicenter trial conducted at  hospitals across the U.S. Adult patients who arrived at the emergency department with confirmed lowrisk PE defined by the absence of any Hestia criteria were eligible for enrollment. Of the  patients randomized  completed the study  in the XARELTO group and  in the standard of care group. Patients who did not complete the study were mainly lost to followup or adverse events. Analyses were conducted by intentiontotreat basis regardless of the anticoagulant used. The primary efficacy outcome was the total amount of time spent in the hospital in hours for VTE or bleeding events in the  days after randomization. Hospital readmissions for reasons unrelated to VTE were excluded. The primary safety outcome was major bleeding within  days. Secondary efficacy endpoints included day rates of newrecurrent VTE VTErelated death unplanned hospital or physician office visits for VTE or bleeding total length of initial or subsequent hospitalizations for any reason patientreported satisfaction and total costs of care. A secondary safety endpoint was clinically relevant nonmajor bleeding based on International Society on Thrombosis and Haemostasis ISTH definitions.  MERCURY PE also had a few limitations including sample size study enrolled  of a planned  patients exclusion bias based on subjective evaluation of hemodynamic stability and ability to adhere to protocol and potential bias due to inability to blind patients to their admission status. About EXPLORER  MERCURY PE is part of the EXPLORER program which is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size scope and ambition. A collaborative effort between Janssen and its development partner Bayer EXPLORER seeks to generate important clinical evidence on the safety and efficacy of XARELTO and its potential role in addressing critical unmet medical needs. A number of the studies in the program are designed to seek additional indications or expand the label for XARELTO to benefit more patients in need of additional therapies for their cardiovascular disease. By the time of its completion more than  patients will have participated in the EXPLORER clinical development program other completed and ongoing clinical trials investigative registries and noninterventional studies.  WHAT IS XARELTO XARELTO rivaroxaban is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke. XARELTO is also a prescription medicine used to treat deep vein thrombosis DVT and pulmonary embolism PE and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least  months. XARELTO is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery. IMPORTANT SAFETY INFORMATION  What is the most important information I should know about XARELTO rivaroxaban   For people taking XARELTO for atrial fibrillation People with atrial fibrillation an irregular heart beat are at an increased risk of forming a blood clot in the heart which can travel to the brain causing a stroke or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke.  If you have to stop taking XARELTO your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.  XARELTO can cause bleeding which can be serious and rarely may lead to death. This is because XARELTO is a blood thinner medicine anticoagulant that reduces blood clotting. While you take XARELTO you are likely to bruise more easily and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding including o Aspirin or aspirincontaining products  o Nonsteroidal antiinflammatory drugs NSAIDs  o Warfarin sodium Coumadin Jantoven  o Any medicine that contains heparin  o Clopidogrel Plavix  o Selective serotonin reuptake inhibitors SSRIs or serotonin norepinephrine reuptake inhibitors SNRIs  o Other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding  Unexpected bleeding or bleeding that lasts a long time such as  o Nosebleeds that happen often  o Unusual bleeding from gums  o Menstrual bleeding that is heavier than normal or vaginal bleeding  Bleeding that is severe or you cannot control   Red pink or brown urine   Bright red or black stools looks like tar   Cough up blood or blood clots   Vomit blood or your vomit looks like coffee grounds   Headaches feeling dizzy or weak   Pain swelling or new drainage at wound sites   Spinal or epidural blood clots hematoma People who take a blood thinner medicine like XARELTO and have medicine injected into their spinal and epidural area or have a spinal puncture have a risk of forming a blood clot that can cause longterm or permanent loss of the ability to move paralysis. Your risk of developing a spinal or epidural blood clot is higher if  o A thin tube called an epidural catheter is placed in your back to give you certain medicine  o You take NSAIDs or a medicine to prevent blood from clotting  o You have a history of difficult or repeated epidural or spinal punctures  o You have a history of problems with your spine or have had surgery on your spine If you take XARELTO and receive spinal anesthesia or have a spinal puncture your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain tingling numbness muscle weakness especially in your legs and feet or loss of control of the bowels or bladder incontinence.  XARELTO is not for people with artificial heart valves.  Do not take XARELTO if you  Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding.   Are allergic to rivaroxaban or any of the ingredients of XARELTO. Before taking XARELTO tell your doctor about all your medical conditions including if you  Have ever had bleeding problems   Have liver or kidney problems   Are pregnant or plan to become pregnant. It is not known if XARELTO will harm your unborn baby.  o Tell your doctor right away if you become pregnant during treatment with XARELTO. Taking XARELTO while you are pregnant may increase the risk of bleeding in you or in your unborn baby.  o If you take XARELTO during pregnancy tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See What is the most important information I should know about XARELTO for signs and symptoms of bleeding.  Are breastfeeding or plan to breastfeed. XARELTO may pass into your breast milk. You and your doctor should decide if you will take XARELTO or breastfeed. Tell all of your doctors and dentists that you are taking XARELTO. They should talk to the doctor who prescribed XARELTO for you before you have any surgery medical or dental procedure. Tell your doctor about all the medicines you take including prescription and overthecounter medicines vitamins and herbal supplements. Some of your other medicines may affect the way XARELTO works. Certain medicines may increase your risk of bleeding. See What is the most important information I should know about XARELTO How should I take XARELTO   Take XARELTO exactly as prescribed by your doctor.   Do not change your dose or stop taking XARELTO unless your doctor tells you to.   Your doctor may change your dose if needed.   If you take XARELTO for  o Atrial Fibrillation   Take XARELTO  time a day with your evening meal.   If you miss a dose of XARELTO take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. o Blood clots in the veins of your legs or lungs   Take XARELTO  or  times a day as prescribed by your doctor.   For the mg and mg doses XARELTO should be taken with food.   For the mg dose XARELTO may be taken with or without food.   Take your XARELTO doses at the same time each day.   If you miss a dose   If you take the mg dose of XARELTO  times a day a total of  mg of XARELTO in  day Take XARELTO as soon as you remember on the same day. You may take  doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.   If you take XARELTO  time a day Take XARELTO as soon as you remember on the same day. Take your next dose at your regularly scheduled time. o Hip or knee replacement surgery   Take XARELTO  time a day with or without food.   If you miss a dose of XARELTO take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.  If you have difficulty swallowing the XARELTO tablet whole talk to your doctor about other ways to take XARELTO.   Your doctor will decide how long you should take XARELTO.   Your doctor may stop XARELTO for a short time before any surgery medical or dental procedure.   Your doctor will tell you when to start taking XARELTO again after your surgery or procedure.   Do not run out of XARELTO. Refill your prescription for XARELTO before you run out. When leaving the hospital following a hip or knee replacement be sure that you have XARELTO available to avoid missing any doses.   If you take too much XARELTO go to the nearest hospital emergency room or call your doctor right away. WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO  See What is the most important information I should know about XARELTO Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA visit http or call FDA. You may also report side effects to Janssen Pharmaceuticals Inc. at JANSSEN . Please click here https for full Prescribing Information including Boxed Warnings and Medication Guide. Trademarks are those of their respective owners.  Janssen and Bayer together are developing rivaroxaban.  For more information about XARELTO visit  http  About the Janssen Pharmaceutical Companies At the Janssen Pharmaceutical Companies of Johnson  Johnson we are working to create a world without disease. Transforming lives by finding new and better ways to prevent intercept treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at  http Follow us on Twitter at JanssenUS httpstwitter.comjanssenus. Janssen Pharmaceuticals Inc. and Janssen Scientific Affairs LLC are part of the Janssen Pharmaceutical Companies of Johnson  Johnson. Cautions Concerning ForwardLooking Statements This press release contains forwardlooking statements as defined in the Private Securities Litigation Reform Act of  regarding product development and the presentation of new data and analyses regarding XARELTO rivaroxaban. The reader is cautioned not to rely on these forwardlooking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize actual results could vary materially from the expectations and projections of any of the Janssen Pharmaceutical Companies andor Johnson  Johnson. Risks and uncertainties include but are not limited to challenges and uncertainties inherent in product research and development including the uncertainty of clinical success and of obtaining regulatory approvals uncertainty of commercial success manufacturing difficulties and delays competition including technological advances new products and patents attained by competitors challenges to patents product efficacy or safety concerns resulting in product recalls or regulatory action changes in behavior and spending patterns of purchasers of health care products and services changes to applicable laws and regulations including global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks uncertainties and other factors can be found in Johnson  Johnsons Annual Report on Form K for the fiscal year ended December   including in the sections captioned Item A. Risk Factors and Cautionary Note Regarding ForwardLooking Statements and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at  http  http or on request from Johnson  Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson  Johnson undertakes to update any forwardlooking statement as a result of new information or future events or developments. i Centers for Disease Control and Prevention. Venous thromboembolism blood clots Data and statistics. . Available at http ii Schissler AJ Rozenshtein A Schluger NW Einstein AJ. National trends in emergency room diagnosis of pulmonary embolism  a crosssectional study. Respiratory Research . iii Kandilov A. Analysis report estimating the incremental costs of hospitalacquired conditions HACs. Centers for Medicare and Medicaid Services website. Available at https  Last accessed  May   iv Wang L Baser O Wells P Peacock WF Coleman CI Ferman GJ Schein J Crivera C.  Benefit of early discharge among patients with lowrisk pulmonary embolism. PLOS  ONE  e. httpsdoi.org.journal.pone. httpjournals.plos.orgplosonearticleid.journal.pone.  v Kahler ZP Beam DM Kline JA. Cost of Treating Venous Thromboembolism With Heparin and Warfarin Versus Home Treatment With Rivaroxaban. Acad Emerg Med . Media contacts Sarah Freeman Mobile   sfreemits.jnj.com mailtosfreemits.jnj.com  Christina Chan Office   Mobile   cchanits.jnj.com mailtocchanits.jnj.com  Investor contacts Johnson  Johnson Joseph J. Wolk Office   Lesley Fishman Office   SOURCE Janssen Pharmaceutical Companies of Johnson  Johnson Related Links http"