Post-Marketing Study Shows Rivaroxaban Safe for Use in Elderly Patients with Atrial Fibrillation


A multi-year study of rivaroxaban in patients with non-valvular atrial fibrillation demonstrated that the drug is about as safe in real-world usage as it was in phase 3 trials.

A multi-year study of rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (AF) demonstrated that the drug is about as safe in real-world usage as it was in phase 3 trials.

Researchers collected the electronic medical records of 31,883 rivaroxaban users aged 19 to 105 from the US Department of Defense and used a validated case-finding algorithm to detect major bleeds. (The algorithm matches diagnosis codes related to bleeding with patient identities.) Further analysis, which was presented at the American Geriatrics Society Annual Meeting, used descriptive statistics to characterize patient demographics, usage of other medications and treatment for bleeding, as well fatality totals.

A total of 622 patients experienced a major bleed, which translated into an incidence rate of 2.85 for every 100 patient years (95% confidence interval [CI], 2.63-3.08). A total of 20 patients suffered fatal outcomes after major bleeding, which translates into an incidence rate of 0.09 for every 100 patient years.

“The data from this ongoing five-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,” said study investigator W. Frank Peacock, MD, FACEP, in a news release from Janssen Pharmaceuticals.

“These real-world results are important as clinicians evaluate treatment options for high-risk non-valvular atrial fibrillation patients who are also at the greatest risk of having a stroke,” said Peacock, who is the Associate Chair and Research Director of the Emergency Medicine department at Baylor College of Medicine in Houston.

Patients who were 75 years or older at baseline were by far the most likely to experience major bleeds. Indeed, 74.1% of all major bleeds occurred in such patients even though only 21% of the study population was even 65 years or older at baseline.

The most common type of bleed, by an even wider margin was gastrointestinal bleeding: 88.3%. Intracranial bleeds, which are considerably more dangerous, accounted for just 7.7% of the major bleeds detected by the algorithm the researchers used, but elderly patients again seemed to face the highest risks.

Intracranial bleeds occurred at a rate of 0.40 per 100 patient years in patients who 85 or older when the study began, while they occurred at a rate of 0.30 per 100 patient years in those who were 75 to 84 at baseline and just 0.10 per 100 patient years in those who where under 65-years-old at baseline. That said, the apparent relationship here could be coincidence; the 95% CI for the oldest group (0.24-0.67) overlapped that of the youngest group (0.03-0.40).

All of the safety figures reported at the conference were generally consistent with those found in the ROCKET-AF trial, which led the US Food and Drug Administration to approve the novel oral anticoagulant. However, the post-marketing safety studies are not complete. Other researchers are performing other reviews, most of them focused on high-risk patients.

“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,” said Paul Burton, MD, PhD, Vice President of Medical Affairs at Janssen, speaking in the same statement.

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