番茄社区

Signals of breathing problems may arise when people go on the antiplatelet drug ticagrelor (Brilinta), researchers gathered from safety reports around the world.

A search of World Health Organization global Individual Case Safety Reports on the VigiBase database yielded 13,636 adverse drug reactions tied to ticagrelor, which included cases of dyspnea (n=2,665) and sleep apnea (n=28), according to the study published as a letter in the .

Compared with other drugs in the database, this particular P2Y12 receptor antagonist was associated with a disproportionate number of cases of sleep apnea, with a reporting odds ratio (ROR) of 4.16 (95% CI 2.87-6.03), Jean-Louis Pépin, MD, PhD, of Grenoble Alpes University Hospital in France, and colleagues found.

An excess number of dyspnea cases were also found in association with ticagrelor (ROR 8.26, 95% CI 7.92-8.62).

"Our result must be understood as a safety signal, confirming previous observations of dyspnea and providing new insights regarding sleep apnea," the researchers wrote. "This signal emerged before the case series publications, avoiding a notoriety bias, and a de-duplicated dataset was used to minimize information bias."

The issue is that central sleep apnea may contribute to increased sympathetic activity, which is known to be harmful in patients with cardiac disease, the team explained.

No other antiplatelet was found to have a tie to breathing difficulties, with the results showing the following (relative to other drugs in the WHO dataset):

• Clopidogrel: apnea ROR 0.55, 95% CI 0.33-0.93 (n=14); dyspnea ROR 0.67, 95% CI 0.63-0.71 (n=988)
• Prasugrel: apnea ROR 1.08, 95% CI 0.41-2.89 (n=4); dyspnea ROR 1.12, 95% CI 0.99-1.28 (n=239)
• Aspirin apnea ROR 0.57, 95% CI 0.41-0.80 (n=35); dyspnea ROR 0.96, 95% CI 0.92-0.99 (n=3,374)

The researchers cautioned that although VigiBase contains more than 16 million safety reports collected from 127 countries, it is vulnerable to selective reporting and the lack of the right data for better adjustment of potential confounders.

"Even if data are under-reported, sleep apnea adverse drug reactions appeared to be rare in VigiBase," the researchers said. "Our results do not challenge the overall demonstrated effect of ticagrelor in reducing cardiovascular events. However, further studies should investigate the exact incidence, the sustainability, and the potential consequences of ticagrelor-induced central sleep apnea."

Comment