An EU-funded project is carrying out the first clinical trial among elderly cardiac patients of a novel multi-medication pill to prevent recurrent heart attacks, improve the efficacy of care and save lives.
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The Trinomia polypill a single, fixed-dose capsule that contains aspirin, atorvastatin and ramipril promises to replace a cocktail of drugs traditionally given to people after they have suffered a heart attack or stroke.
This standard combination treatment has proven highly effective in improving post-heart attack care but many patients become tired of taking so much medication separately or simply forget to keep up with their regimen, putting their recovery at risk.
Cardiovascular disease is responsible for half of all deaths in Europe, where an ageing population and improving survival rates of heart attack patients are rapidly increasing the number of older adults eligible for secondary prevention. The use of polypills could simplify healthcare delivery, improve the cost-effectiveness of treatment and support the comprehensive prescription of heart-protective drugs.
The new trial, currently being conducted by the EU-funded SECURE project, aims to determine whether prescribing the polypill as an alternative, simpler therapy improves the health and medication adherence among people over 65 who have already suffered a cardiovascular incident.
The most important factors responsible for a lack of adherence to treatment are the complexity of treatment and the daily number of prescribed pills, say Valentin Fuster and José María Castellano, SECUREs principal investigators at the Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III in Spain. Patients taking the polypill are therefore expected to show improved adherence to treatment regimes and, in turn, improved risk factor control, which we believe will translate into fewer recurrent heart attacks, fewer strokes and fewer deaths.
Trials across seven countries
The trial is being conducted across seven EU countries Spain, Italy, France, Germany, Hungary, Poland and the Czech Republic where more than 3 200 patients will be monitored to determine rates of adherence and the efficacy of treatment.
The SECURE consortium, which includes Trinomia developer Ferrer Internacional, will also measure and compare the effects of standard versus polypill treatment strategies on healthcare resource use and costs. The aim is to design more efficient regimes tailored to meet the specific challenges in different European countries of so-called secondary prevention, which focuses on stopping or slowing the progression of a disease.
Although the concept of combining drugs together into a single pill may seem simple, considerable research has gone into developing this first-in-class cardiovascular polypill, Fuster says. It supports public health strategies to improve cardiovascular health via more efficient delivery of medications through better accessibility and adherence.
Results with global reach
The results of SECURE will be instrumental for patients, healthcare professionals and policymakers, he adds.
The findings will contribute to clinical guidelines and recommendations that will serve as a reference framework for all stakeholders involved in tackling major challenges related to secondary prevention and treatment of chronic diseases in the elderly population.
The SECURE study will also contribute to addressing the critical issue of secondary prevention of cardiovascular disease in developing countries, where inadequate health policies, poor drug availability and lack of affordable medication limit the effectiveness of standard treatment approaches.
Epidemiological changes worldwide, including ageing populations and rising obesity, call for simple, effective, scalable public health strategies, Castellano says. The SECURE study will contribute to effectively tackling the cardiovascular disease epidemic that is occurring worldwide.