J&J and Bayer's Xarelto proves its worth across PAD subgroups in 2 new analyses

14 Nov 2023
www.fiercepharma.com
Clinical ResultPhase 3AHA
J&J and Bayer's Xarelto proves its worth across PAD subgroups in 2 new analyses
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Source: FiercePharma
The new analyses come from a massive 6,564 patient wide phase 3 study.
Johnson & Johnson and Bayer’s wide-spanning VOYAGER PAD study continues to be a gold mine for proving its Xarelto’s worth in several subsets of patients with peripheral artery disease (PAD).
New analyses that J&J presented at this year’s American Heart Association (AHA)’s Scientific Sessions confirm the blood thinner’s benefits in patients classified as “fragile” and those with comorbid coronary artery diseases (CAD).
PAD patients are considered fragile when they weigh less than 50 kg (around 110 lbs), are more than 75 years old or fall in a lower range on kidney health marker eGFR (estimated glomerular filtration rate). These patients are often at a higher risk for major adverse limb events (MALE), which is defined as amputation and acute limb ischemia. Ischemia is a sudden loss of blood flow attributed to an artery blockage.
In fragile patients treated with Xarelto plus standard-of-care aspirin, 6.2% of patients experienced a MALE compared to the 10.3% of solely aspirin-treated patients that also did. Non-fragile patients saw similar stats with 7.9% of patients in the Xarelto group having a MALE while the same could be said of 9.7% of patients on aspirin alone.
The benefits continued over time, with 82.1 events occurring per 100 patients at three years in the Xarelto group and 99.3 in the placebo arm. In non-fragile patients, the analysis tallied 70.4 events per 100 patients over three years in Xarelto patients and 81.6 events in the solo aspirin group.
The second analysis relates to lower extremity revascularization (LER), a common procedure for those with PAD that aims to restore blood flow to blocked arteries in the legs through surgery. The surgery can often trigger acute limb ischemia, which is where Xarelto and aspirin can come into play.
The drug has already proved in a prior analysis that it can reduce the chance of ischemia by 33% versus aspirin alone. But according to the new analysis, Xarelto can also make a difference in MACE outcomes, which are defined as myocardial infection, ischemic stroke or cardiovascular death.
The analysis showed that 14.1% of Xarelto-treated patients with PAD and CAD experienced a MACE, compared to 17.6% in the solo aspirin group. The same goes for 11% of PAD patients who don’t have CAD and are on Xarelto, versus 9.8% of patients on placebo.
In the wider VOYAGER PAD study, which included 6,564 patients, the benefit of adding Xarelto to aspirin was “apparent early, consistent among major subgroups and continued to accrue over time,” the company said. In 2021, the med scored an expanded PAD label to include patients following LER due to PAD.
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