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.
"Today marks another milestone in our longstanding commitment to the fight against neglected tropical diseases, and we are proud to partner with the Global Chagas Disease Coalition and its members to help improve access to diagnosis and reimagine treatment for people with Chagas disease," said Patrice Matchaba, Group Head, Global Health and Corporate Responsibility at Novartis. "It is only by joining forces that we can succeed in bringing our innovation to the people that need it."
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.
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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 the disease, resulting in the majority of morbidity and mortality.
"We are pleased to welcome Novartis as one of our member contributors," said Javier Sancho, Coordinator of the Global Chagas Disease Coalition. "It is only by openly sharing our experience and knowledge and fostering synergies that we can hope to achieve our common goal of controlling and potentially eliminating Chagas disease."
Novartis is a signatory to the London Declaration on Neglected Tropical Diseases, which aims to control, eliminate or eradicate 10 diseases by 2020. Since 1999, Novartis has donated multidrug therapy for the treatment of leprosy through the WHO, reaching more than seven million people worldwide. In addition, since 2005, we have donated Egaten® for the treatment of fascioliasis (liver fluke infestation) to the WHO, helping to treat around 2 million people in more than 30 countries. In 2018, we renewed our agreement with the WHO to extend the drug donation until 2022, expected to reach 300 000 patients per year.
Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi (T. cruzi), which is carried by the triatomine bug, commonly known as "the kissing bug". It is recognized by the World Health Organization as one of the world's 13 most neglected tropical diseases. It is estimated to affect approximately six million people globally and to cause approximately 12 000 deaths annually. The disease is endemic in 21 Latin American countries; however, due to population mobility, in the past decades, it has been increasingly detected in the United States, Canada, and many European and some Western Pacific countries.
Chagas disease presents in an initial acute phase, where a high number of parasites circulate in the blood. In most cases, symptoms are absent or mild and nonspecific. During the chronic phase, the disease mainly affects the heart and digestive muscles, leading to cardiac disorders in up to 30% of patients and digestive, neurological or mixed alterations in up to 10% of patients. The infection can eventually lead to sudden death due to cardiac arrhythmias or progressive heart failure.
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.
Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Other common heart failure medicines, called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.
In Europe, Entresto is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction. In the United States, Entresto is indicated for the treatment of heart failure (New York Heart Association class II-IV) in patients with systolic dysfunction. It has been shown to reduce the rate of cardiovascular death, heart failure hospitalization and 30-day hospital readmission[14] compared to enalapril, to reduce the rate of all-cause mortality compared to enalapril, and to improve aspects of health-related quality of life (including physical and social activities) compared to enalapril. Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB). Approved indications may vary depending upon the individual country.