The FDA recently approved apixaban (Eüquis; Bristol-Myers Squibb) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AP).
Apixaban, a factor Xa inhibitor, is the third anticoagulant to receive FDA approval for this indication, adding to an ever-growing number of treatment options.
FDA based its approval on the positive results of the ARISTOTLE and AVERROES trials, after delaying approval in June of 2012 because of a request for further data. No new studies were required, but additional information on data management and verification was requested from the ARISTOTLE trial.
Apixaban will be dispensed with a patient Medication Guide that provides instructions on its use and drug safety information.
Source: FDA approves Eliquis. http://www.drugs.com/newdrugs/fda-approves-elicquis-reduoe-risk-stroke-blood-clots-paamts-n atrial-fibrulation-3618.html. Accessed January 28, 2013.
Study addresses barriers to alteplase use
According to a recently published study, when barriers to use of the tissue plasminogen activator (tPA) alteplase (Activase; Genenetech) in acute ischemic stroke patients were identified and addressed, a modest increase in use followed. The study was conducted in nonspecialty acute-care community hospitals in Michigan.
These findings are important because many trials involve delivery of thrombolytic agents by stroke teams. This study shows that in the community setting, the safety, particularly with respect to symptomatic intracranial hemorrhage, matches historical numbers achieved by specialized stroke teams.
The researchers say they uncovered several key barriers to thrombolytic use in participating hospitals, including delay in patients' presentation, communication with radiology departments, and poor availability of neurologists (many hospitals had only one or two neurologists, who typically worked in private, office -based community practices). Familiarity with treatment guidelines and physician motivation were also barriers. With the exception of presentation delay, all these barriers were addressed by one or more intervention elements.
The primary outcome of the INSTINCT trial was change in alteplase use in patients with stroke in emergency departments between the pre-intervention period (January 2005 to December 2006) and the post -intervention period (January 2008 to January 2010).
In intervention hospitals, the number treated increased from 89 (1.25%) of 7,119 patients in the pre-intervention period to 235 (2.79%) of 8,419 in the post-intervention period. …