A phase III clinical trial, called GALILEO, comparing the blood thinner Xarelto to the antiplatelet Plavix with aspirin in patients who have undergone transcatheter aortic valve replacement, was stopped early after a preliminary analysis showed excesses in key adverse events in patients treated with Xarelto.
Among patients in the Xarelto group, 11.4 percent suffered thromboembolic events compared to 8.8 percent of patients in the Plavix/aspirin group; and 4.2 percent of Xarelto patients experienced bleeding compared to 2.4 percent of patients in the Plavix/aspirin group. There was also a 6.8 all-cause mortality risk in Xarelto patients compared to 3.3 percent among Plavix/aspirin users.
“We do not consider these preliminary data transferable to patients covered by Xarelto’s approved indications,” Johnson & Johnson subsidiary Janssen Pharmaceuticals said in a statement. Janssen manufactures and markets Xarelto in partnership with Bayer. Janssen and Bayer were collaborators on the GALILEO trial of Xarelto.
Xarelto was approved by the Food and Drug Administration (FDA) and is used to prevent strokes in patients with atrial fibrillation, to treat and prevent deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery.
The GALILEO trial was conducted at 143 sites in 15 countries, including the United States, and its primary efficacy endpoint was to investigate how effective the medication was at preventing the combination of all-cause death, stroke, systemic embolism, heart attack, pulmonary embolism, deep vein thrombosis, and symptomatic valve thrombosis. The drug’s safety goal was the combined life-threatening disabling and major bleeds.
The study’s data safety monitoring board recommended in August that the trial be halted. However, it was not stopped until Oct. 2.
Source: MedPage Today