Data from Pharmawand - Curated by EPG Health - Date added 15 March 2019
At the Annual Meeting of the Global Chagas Disease Coalition in Barcelona, Spain, Novartis announced that it is joining the Coalition as a member contributor. In addition, the company announced its commitment to launch a multinational, prospective, randomized study with heart failure drug, Entresto (sacubitril / valsartan), in people with chronic Chagas cardiomyopathy, one form of heart failure with reduced ejection fraction.
This is the first definitive morbidity and mortality study to assess a potential therapy for cardiac disease in this underserved patient population.
The clinical trial will assess the efficacy and safety of Entresto vs. enalapril and is expected to start within 2019, with the aim of recruiting approximately 900 patients with confirmed Chagas disease in Latin America. The primary endpoint is time to occurrence of a composite of cardiovascular events, including cardiovascular death or first hospitalization due to heart failure. This definitive study follows an exploratory post hoc analysis from the PARADIGM-HF trial, which suggested that Entresto may have beneficial effects in people with chronic Chagas cardiomyopathy and heart failure with reduced ejection fraction. At the same time, Novartis is working with stakeholders in endemic countries to co-develop tailored access-to-medicine programs and health system strengthening strategies to help ensure lower-income patients suffering from chronic Chagas cardiomyopathy can benefit from the best available treatment.
Chagas disease also known as American trypanosomiasis, is a potentially life-threatening neglected tropical disease estimated to affect approximately six million people globally and is responsible for approximately 12 000 deaths annually. The disease is endemic in 21 Latin American countries, where it is the second leading cause for developing chronic heart failure. Due to population mobility, in the past decades, Chagas disease has been increasingly detected in the United States, Canada, and many European and some Western Pacific countries.
Chagas cardiomyopathy is the most important clinical manifestation of Chagas disease, resulting in the majority of morbidity and mortality.The patients, despite being younger, tend to have a worse quality of life and higher hospitalization and mortality rates compared with other etiologies..