The news release is about a study that explores if patients with pulmonary embolism, a blood clot in the lungs, who are at low risk for complications can be sent home from the emergency department early rather than be admitted to hospital. The patients were divided into two groups: One group of patients were sent home early while taking rivaroxaban (Xarelto), a type of blood thinner, whereas the “usual care” group could get any blood thinner of their physician’s choosing, including rivaroxaban, and hospitalization.
The study findings suggest that early discharge of low-risk patients was safe and feasible and also resulted in cost savings because of less time spent in hospital. Unfortunately, the news release seemed to suggest that it was the use of rivaroxaban that resulted in cost savings–rather than the strategy of sending low risk patients home early. The news release failed to state was that over half the patients in the comparison group who got usual care also received rivaroxaban.
In other words, the news release implies that rivaroxaban was being compared to other anti-coagulants when what was actually being compared was an early vs. late discharge strategy.
Janssen’s misleading news release could result in news stories trumpeting rivaroxaban as a superior blood thinner, when that is not what this study looked at.
The news release acknowledged that there would be a cost savings associated with the early discharge group. But, adding in the cost of the drugs used in the study would have been useful.
It’s worth noting that the modest case savings reported here might be considerably larger if a generic blood thinner is used.
Both primary and secondary efficacy outcomes are listed:
Primary: patients who received Xarelto spent less time in the hospital due to blot clots — either in deep veins (DVT) or the lungs (PE) — when compared to the standard of care (SOC) within the first 30 days of treatment (4.8 vs. 33.6 hours, respectively).
Secondary: No recurrence of venous thromboembolism (VTE), or VTE-related deaths … or any significant differences in the bleeding-related hospitalizations … or physician visits … within the first 90 days.
It requires a close reading of this news release, and the study, to realize that this should have been framed as early discharge while on a blood thinner did not result in harmful outcomes compared to patients who were admitted and had longer hospital stays. We’ll address this issue under quality of evidence, below. However, the release did provide quantification of benefits so it squeaks by on this one.
This news release does provide a section on the side effects and drug interactions of Xarelto. It also could have mentioned some of the risks of early release from the hospital.
While this news release describes the study with reasonable accuracy, one glaring omission is the fact that they neglected to mention that most of the usual care group also got rivaroxaban. In effect, attempting to spin this study to suggest that rivaroxaban was better than its competitors in treating pulmonary embolism is a rather significant mischaracterization of what the study attempted to demonstrate, which was the safety of an early discharge strategy compared to keeping patients in the hospital.
No disease mongering. Pulmonary embolism is a relatively common disorder with a very wide range of severity and mortality.
It’s made somewhat clear that both the news release and the study are sourced from Janssen Pharmaceutical Company (who’s developing rivaroxaban with Bayer).
However, the principal investigator quoted in the release has financial ties to the company, which should have been disclosed.
There are other blood thinners used in patients with PE, but the release doesn’t name any of them.
The news release states that the current research adds to previous studies dating back to 2015, and that rivaroxaban is currently being used to reduce the risk of blood clots in people with atrial fibrillation and deep vein thrombosis (or, DVT).
The vice president of scientific affairs for Janssen Pharmaceuticals is quoted in the news release as saying the research is “the first prospective randomized trial” to investigate discharging emergency room patients with low-risk pulmonary embolism” (LRPE). It also gives some background on an earlier study to establish that this isn’t a brand new idea.
The headline of this release crosses the line into unjustified language. It credits rivaroxaban with reducing the time patients spent in the hospital, when the early discharge strategy was actually the main difference between the groups — not the use of rivaroxaban.