Rivaroxaban shows continued safety data in nonvalvular AF, consistent with phase 3 trials

Data from an ongoing study evaluating the safety of rivaroxaban in patients with nonvalvular atrial fibrillation showed rates of major bleeding and fatalities similar to findings reported in phase 3 clinical trials, with incidence increasing along with age, according to results presented at the American Geriatrics Society Annual Meeting.

“The data from this ongoing 5-year observational study reaffirm the safety profile of Xarelto, including in elderly patients who are at a particularly increased risk for adverse events like bleeding,” W. Frank Peacock, MD, FACEP, associate chair and research director of emergency medicine at Baylor College of Medicine in Houston, said in a news release. “These real-world results are important as clinicians evaluate treatment options for high-risk, nonvalvular atrial fibrillation patients who are also at the greatest risk of having a stroke.”

Peacock and researchers from several U.S. institutions examined data on 31,883 rivaroxaban (Xarelto, Janssen) users aged 19 to 105 years with nonvalvular AF collected through the U.S. Department of Defense electronic medical records database. Patients aged 65 years and older comprised 21% of the study population vs. 13% in the general population.

The investigators identified major bleeding events through a validated, case-finding algorithm requiring at least one of a series of bleeding-related diagnosis codes within the primary diagnosis field on an inpatient hospital record.

The team used descriptive statistics to evaluate demographics, concomitant drugs, bleed locations and management, and fatal outcomes. Major bleeding and fatal bleeding (death during hospitalization) were reported per 100 person-years. Overall, 622 patients experienced a major bleed, for an incidence rate of 2.85 (95% CI, 2.63-3.08).

Gastrointestinal bleeding occurred most frequently (88.3%), followed by intracranial bleeding (7.7%). Patients aged 75 years and older were most likely to experience major bleeding (74.1%). Fatal outcomes occurred in 20 patients with major bleeding, at a mean age of 82.1 years.

The major bleeding incidence rate for the intracranial locale was highest among patients aged 85 years and older (0.40; 95% CI, 0.24-0.67), followed by those aged 75 years and older (0.30; 95% CI, 0.22-0.41) and those aged below 65 years (0.10; 95% CI; 0.03-0.40).

Although the present study was not conducted to form direct comparisons, the rates and patterns of major bleeding events were generally consistent with findings from an earlier randomized FDA registration trial, according to researchers.

Janssen is currently conducting post-marketing safety research in diverse patients, particularly those at high-risk.

“The program will include more than 74,000 patients and will continue to provide important real-world data across a variety of comorbidities that help doctors optimize care for people taking Xarelto,” Paul Burton, MD, PhD, vice president of medical affairs, Janssen, said in the release. – by Julia Ernst, MS

Reference: S Tamayo, et al. Presented at: The American Geriatrics Society Annual Meeting; May 14-17, 2015; National Harbor.

Disclosure: Peacock reports receiving research grants from Abbott, Alere, Banyan, Cardiorentis, Portola, Roche, and The Medicines Company; consulting for Alere, BG Medicine, Beckman, Boehringer-Ingelheim, Cardiorentis, Instrument Labs, Janssen, Prevencio, The Medicines Company, and ZS Pharma; and having ownership interests in Comprehensive Research Associates, LLC, and Emergencies in Medicine, LLC. Please see the abstract for a list of all other authors’ relevant financial disclosures.