The puzzle over nonfatal events
A puzzling key study finding was that except for cardiovascular death, the other components of the primary composite endpoint – that is, nonfatal MI, nonfatal stroke, and urgent revascularization due to unstable angina – were all either neutral or numerically favored febuxostat.
“That’s been the biggest challenge in the trial: The nonfatal events didn’t go in the same direction as the fatal events. And we don’t have a real mechanism to explain why,” Dr. White told a panel of discussants.
“I scanned the medical literature over the last 4 decades, and I did not see another prospective, randomized, double-blind trial in which mortality was increased when none of the nonfatal events were increased. The finding is unique. Statistically there is only a 4% chance that the mortality finding is wrong,” the cardiologist said.
The CARES leadership included rheumatologists and nephrologists as well as cardiologists. Dr. White said he and the others were at a loss to come up with an explanation for the findings.