- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
BMS and Pfizer announce new data for Eliquis (apixaban)
11 December 2015 • Author: Victoria White
The subanalysis demonstrated Eliquis was comparable to conventional therapy in recurrent venous thromboembolism (VTE) and VTE-related death with significantly less major bleeding during the first 7, 21 and 90 days after starting treatment.
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.
“For the millions of patients worldwide who experience VTE, the risks of recurrence and major bleeding are highest during the first few weeks of anticoagulant therapy,” said Giancarlo Agnelli, M.D., Professor of Internal Medicine at the University of Perugia, Italy, Director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit at the University Hospital in Perugia. “These findings indicate that the favorable benefit-to-risk profile of Eliquis was demonstrated early during treatment for VTE, including the use of a higher Eliquis dose of 10 mg twice daily for the initial seven days.”
Eliquis non-inferior to conventional therapy at each time point analysed
The results of the subanalyses at each pre-specified time interval were consistent with the overall results of the AMPLIFY trial at 6 months, which demonstrated non-inferiority of Eliquis versus conventional therapy in the primary efficacy endpoint of recurrent VTE and VTE-related death, and superiority in the primary safety endpoint by showing significantly fewer major bleeding events, with a 69% relative risk reduction (RRR) compared to conventional therapy.
In this post-hoc early time course subanalysis, recurrent VTE and VTE-related death at 7, 21, and 90 days after starting treatment occurred in 18 (0.7%), 29 (1.1%), and 46 (1.8%), patients who were given Eliquis, respectively, and in 23 (0.9%), 35 (1.3%), and 58 (2.2%) patients given conventional therapy, respectively. Outcomes at each time point were similar in patients by index event (deep vein thrombosis (DVT) alone or pulmonary embolism (PE) with or without DVT) and were consistent with the results for the entire study period. Major bleeding at the corresponding time points occurred in 3 (0.1%), 5 (0.2%), and 11 (0.4%) patients, who received Eliquis, respectively, and in 16 (0.6%), 26 (1.0%), and 38 (1.4%) patients given conventional therapy, respectively. Eliquis was non-inferior to conventional therapy in recurrent VTE and VTE-related death at each time point analysed, with no excess of early recurrences; and patients treated with Eliquis were less likely to have major bleeding early in the course of treatment than those treated with conventional therapy.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics