Ticagrelor Not Linked to Sleep Apnea

April 28, 2020

Use of the antiplatelet drug ticagrelor (Brilenta, AstraZeneca) is not associated with an increased risk for sleep apnea, according to a new analysis of randomized controlled trial data.

The suggestion that ticagrelor may cause sleep apnea came about after a report in 2018 described four anecdotal cases of this adverse effect that were linked to the initiation of ticagrelor. In one patient, the effect disappeared after switching to clopidogrel (Plavix, Sanofi).

This prompted a French group to search in the World Health Organization's global individual case safety reports database, VigiBase, for sleep apnea as a possible adverse effect of ticagrelor. The investigators found 28 reports of sleep apnea among ticagrelor users. They characterized the finding as a "weak disproportionality signal" for ticagrelor vs comparator.

But now a team of researchers involved in the major clinical trials of ticagrelor have analyzed data from these trials and have found no increased risk for sleep apnea in patients randomly assigned to receive ticagrelor compared to those who received control treatment.

In a research letter published online in the April 27 issue of JACC Cardiovascular Interventions, a group led by Marc Sabatine, MD, Brigham and Women's Hospital, Boston, report the pooling of individual patient data from six large phase 3 trials of ticagrelor: PLATO, PHILO, PEGASUS-TIMI 54, SOCRATES, EUCLID, and THEMIS.

These trials included 86,195 patients. The median follow-up period was 1.1 years, and more than 16,000 patients were followed for at least 3 years, Sabatine colleagues note.

The investigators found that 158 patients reported sleep apnea adverse events, but the cumulative incidence curves for patients on ticagrelor vs control patients showed no excess with ticagrelor, they say.

The hazard ratio for sleep apnea with ticagrelor was 0.82 (95% confidence interval: 0.60 – 1.12).

"Our findings highlight the importance of data from randomized, controlled studies and the risk of overinterpretation of nonrandomized data," they conclude.

The study was funded by AstraZeneca. Sabatine and several coauthors have received research grants and have been consultants for AstraZeneca.

JACC Cardiovascular Interv. 2020 Apr 27;13:1012-1014. Abstract

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