Top News from American College of Cardiology’s 67th Annual Scientific Session & Expo in Orlando, Florida – ACC 2018
New Analyses Show Payer Utilization Management Criteria Deny Access to PCSK9 Inhibitors for Patients at The Highest Risk for Subsequent Cardiovascular Events
March 9, 2018
Amgen has announced data from two new studies exploring barriers to access for PCSK9 inhibitors and the potential consequences of denying coverage for high-risk patients. The first study, “Cardiovascular Risk in Patients Denied Access to PCSK9i Therapy,” found only 35 percent of 3,472 commercially insured and Medicare patients requesting access to a PSCK9 inhibitor were approved by their health plan in 2016. Another study presented, “Predicting Cardiovascular Risk Using Common Utilization Management Criteria for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Commercially Insured Patients with Atherosclerotic Cardiovascular Disease,” showed commercial payer utilization management criteria fail to prioritize patients at the highest risk for CV events.
Praluent® (alirocumab) Injection significantly reduced risk of cardiovascular events in high-risk patients, and was associated with lower death rate
March 10, 2018
Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent® (alirocumab) Injection significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack.
New Late-Breaking Study Finds Wearable Electrocardiogram (ECG) Monitoring Patch Can Detect Atrial Fibrillation Earlier and More Efficiently than Routine Care
March 10, 2018
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced late-breaking results of a new home-based clinical trial showing that a wearable continuous electrocardiogram (ECG) monitoring patch can identify people with asymptomatic atrial fibrillation (AFib) earlier and more efficiently than routine care. One-year findings from the investigator-initiated study, mSToPS (mHealth Screening to Prevent Strokes), done in collaboration with Scripps Translational Science Institute (STSI), Aetna and iRhythm Technologies, Inc., were presented during a Featured Clinical Research Session at the ACC.18.
Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants
March 11, 2018
Bristol-Myers Squibb Company and Pfizer Inc. have presented findings from a real-world data (RWD) analysis titled ‘Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients Treated in US Clinical Practice’. This is the largest RWD analysis reporting outcomes among different direct oral anticoagulants (DOACs), including Eliquis® (apixaban), rivaroxaban and dabigatran, to date. In this analysis, apixaban use was associated with significantly lower rates of both stroke/systemic embolism (S/SE) (hazard ratio [HR]:0.83, 95% confidence interval [CI]: 0.73 to 0.94, p=0.004) and major bleeding (MB) (HR:0.54, 95% CI: 0.50 to 0.58, p=<0.001) when compared to rivaroxaban; and significantly lower rates of both S/SE (HR:0.69, 95% CI: 0.56 to 0.84, p=<0.001) and MB (HR:0.77, 95% CI: 0.68 to 0.88, p=<0.001) when compared to dabigatran.
INVOKANA® (canagliflozin) Significantly Reduces the Risk of Heart Failure- Related Outcomes in Type 2 Diabetes Patients at Risk for or With a History of Cardiovascular Disease
March 11, 2018
Janssen has announced results of a new analysis showing that INVOKANA® (canagliflozin) significantly reduced the risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with type 2 diabetes (T2D) at high CV risk. This exploratory analysis from the CANVAS Program was featured as a late-breaking oral presentation at ACC.18
Portola Pharmaceuticals Announces New Interim Results from Ongoing ANNEXA-4 Study of Factor Xa Inhibitor Reversal Agent AndexXa® (Andexanet Alfa) in Patients with Life-Threatening Bleeding
March 12, 2018
Portola Pharmaceuticals, Inc. has announced new interim results from ANNEXA-4, the Company’s ongoing Phase 3b/4 trial of its investigational universal Factor Xa inhibitor antidote AndexXa® (andexanet alfa) among patients experiencing acute major bleeding while taking a Factor Xa inhibitor. Interim data from 228 patients (of which 132 were adjudicated for efficacy) showed that AndexXa rapidly and significantly reversed anti-Factor Xa activity (the anticoagulant mechanism of these drugs) when administered as a bolus and sustained this reversal when followed by a 120-minute infusion. In addition, 83 percent of these patients achieved excellent or good hemostasis (stoppage of bleeding) over a 12-hour period following treatment with AndexXa. Thrombotic events (11 percent) and death rates (12 percent) were consistent with previous ANNEXA-4 trial results and with the high background thrombotic risk of the enrolled patient population.
New data from landmark CVD-REAL study of patients with type-2 diabetes confirms CV benefits associated with SGLT-2 Inhibitors
March 12, 2018
AstraZeneca has announced results from a new analysis of its landmark CVD-REAL study, the first large real-world evidence study of its kind evaluating the risk of all-cause death (ACD), hospitalization for heart failure (hHF), heart attack (myocardial infarction or MI) and stroke in patients with type-2 diabetes (T2D) receiving treatment with SGLT-2 inhibitors (SGLT-2i), including Farxiga (dapagliflozin) versus other glucose-lowering medicines.
Lantheus Presents New Data on Novel Cardiac PET Imaging Agent LMI 1195 in Development for the Diagnostic Assessment of Ischemic Heart Failure Patients at Risk for Sudden Cardiac Death
March 12, 2018
Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the development, manufacturing and commercialization of innovative diagnostic imaging agents, has announced positive new data from a Phase 2 study of LMI 1195, a fluorine-18 (F18) labeled tracer for use in cardiac positron emission tomography (PET) to assess myocardial presynaptic sympathetic nerve function. Altered sympathetic nervous system (SNS) function has been implicated in a broad range of clinical conditions including heart failure and sudden death.Top News from American College of Cardiology’s 67th Annual Meeting – ACC.18 last edit: 2018-03-13T18:34:04+00:00 da