AMSTERDAM, Sept 3 (Reuters) - Use of AstraZeneca’s new heart drug Brilinta is frequently discontinued in a real world setting, according to a small clinical study presented on Tuesday.
The finding may raise questions about the uptake of Brilinta, a key new product for AstraZeneca as it seeks to replace older drugs losing patent protection, although the drugmaker played down the significance of the research.
The 367-patient study presented as a poster at the European Society of Cardiology showed that around 14 percent of patients prematurely stopped taking the blood-thinning drug or switched to an alternative, most frequently due to experiencing breathlessness.
Brilinta is used to prevent recurrent heart attacks or strokes.
Dr. Thomas Bergmeijer of the St. Antonius Hospital Nieuwegein in the Netherlands and colleagues, who carried out the study between December 2011 and December 2012, said the discontinuation rate due to dyspnea, or shortness of breath, was higher than expected.
An AstraZeneca spokeswoman said that while the discontinuation rate was higher than in the original 18,000-patient study, dubbed PLATO, that led to Brilinta’s approval, the rate was similar to that seen with Sanofi’s rival product Plavix in the real world.
Dyspnea was already observed in the PLATO trial and was therefore not a new adverse event, she added. In the PLATO study, overall about one in 100 patients taking Brilinta discontinued therapy due to dyspnea.