This article is more than 5 years old. Information may no longer be current.
ROCKET AF: High number of medications affects bleeding risk, not stroke risk
Click Here to Manage Email Alerts
In patients with nonvalvular atrial fibrillation from the ROCKET AF trial, higher number of medications was associated with increased risk for bleeding, but not increased risk for stroke, researchers found.
Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS, and colleagues compared adjusted outcomes between those assigned rivaroxaban (Xarelto, Janssen Pharmaceuticals) and those assigned warfarin in ROCKET AF by number of medications at baseline, as well as the presence of combined cytochrome P450 3A4 and P-glycoprotein inhibitors, which are currently contraindicated for use with rivaroxaban.
Jonathan P. Piccini
Patients were stratified by number of baseline medications: 5,101 (36%) were assigned zero to four, 7,298 (51%) were assigned five to nine and 1,865 (13%) were assigned 10 or more.
Piccini, from Duke Clinical Research Institute and Duke Heart Center, Duke University School of Medicine, and colleagues found that number of medications was not associated with elevated risk for stroke or noncentral nervous system embolism (adjusted HR for 10 vs. 4 medications = 1.02; 95% CI, 0.76-1.38).
However, they found that compared with the lowest medication group, the highest medication group had increased risk for the composite endpoint of stroke, noncentral nervous system embolism, vascular death or MI (adjusted HR = 1.41; 95% CI, 1.18-1.68), as well as the endpoint of nonmajor clinically relevant or major bleeding (adjusted HR = 1.47; 95% CI, 1.31-1.65).
Number of medications did not affect the primary efficacy (adjusted P for interaction = .99) and primary safety (adjusted P for interaction = .87) outcomes from ROCKET AF by treatment group, the researchers reported.
Among those assigned rivaroxaban, patients taking zero to four medications were at reduced risk for major bleeding (adjusted HR = 0.71; 95% CI, 0.52-0.95), they wrote.
They found no evidence that taking at least one combined cytochrome P450 3A4 and P-glycoprotein inhibitors affected outcomes. “This should be reassuring for clinicians who care for patients on rivaroxaban and combined inhibitors,” Piccini and colleagues wrote. – by Erik Swain
Disclosure: The ROCKET AF study was supported by Johnson & Johnson Pharmaceutical Research & Development and Bayer HealthCare. Piccini reports receiving clinical research grants from Arca Biopharma, Boston Scientific, Gilead, Janssen Pharmaceuticals, ResMed and St. Jude Medical and consulting for GlaxoSmithKline, Janssen Pharmaceuticals, Laguna Pharmaceuticals, Medtronic and Spectranetics. Please see the full study for a list of the other researchers’ relevant financial disclosures.
Click Here to Manage Email Alerts