Recent health statistics have renewed concerns that the situation is worsening (1). For example, obesity and physical inactivity have often been linked to adult lifestyles, but these risk factors are now routinely being observed among children. According to the European Heart Network, almost 20% of children in Europe are overweight or obese (2). Similarly, although public perception of heart disease mainly focuses on men, women are also increasingly affected; indeed, cardiovascular disease is the main cause of death in women in all European countries (1). One contributory factor is that a previously seen decline in smoking across Europe appears to have slowed and that women now smoke nearly as much as men.
Not surprisingly, cardiovascular disease has a huge economic impact in Europe. The cost to the EU economy has been estimated at €192 billion a year, with around 57% of this related directly to healthcare costs, 21% to productivity losses and 22% to the informal care of people with cardiovascular disease (1).Multiparty interest and initiatives
European policymakers, regulators, the medical community and patient groups alike are alarmed at the impact cardiovascular disease has had in the region and in recent years there has been increasing cooperation between countries to lessen the threat. Part of this cooperation has involved raising the profile of World Heart Day. Created in 2000 by the World Heart Federation, World Heart Day is an annual event held on 29 September to inform people that heart disease and stroke are the world's leading cause of death. In Europe, this year's event was backed by the EMA, which worked together with other organisations representing patients. A number of pharmaceutical companies, including AstraZeneca, Pfizer, Sanofi, Bayer and Boehringer Ingelheim, also supported the 2011 event.
This year's event centred on individuals to drive home the importance of healthy lifestyles (3). People were encouraged to visit their doctor and have their blood pressure, cholesterol and glucose levels, waist-to-hip ratio and body mass index assessed. The campaign also featured a "know your numbers" theme to make people more aware of their risk of developing cardiovascular disease and the need to develop a personal action plan. The World Heart Federation also encouraged companies to become involved by educating their employees in the workplace. The organisers emphasised economic arguments and highlighted the financial benefits for companies of having a healthier workforce.
The EMA plays an important role in the authorisation of medicines to treat heart disease and stroke and has used this position to become more directly involved in initiatives, such as World Heart Day, as a means to lessen the healthcare burden of cardiovascular disease. It also has an important role in providing guidance to the pharmaceutical industry and to users of its cardiovascular products, and organises regular events and meetings for stakeholders. In late 2010, for example, the EMA set up an expert group meeting on paediatric heart failure. The group's objectives include the optimal design of studies on drug development in paediatric heart failure, developing a priority list of pipeline drugs in this field and establishing a wider paediatric cardiology network. In terms of high-profile cardiovascular guidance projects, in September 2011, the EMA began finalising its benefit–risk review of Sanofi's anti-arrhythmic medicine Multaq (dronedarone) after two patients taking the medicine experienced liver damage in January 2011. In the US, Sanofi took note of this development and sent a letter to healthcare professionals to suggest considering periodic liver-function tests in patients taking Multaq (4). The FDA reacted by issuing its own safety announcement while the EMA began to independently review the data. By July 2011, the scope of the EMA review had been extended to look at emerging data related to the effects of the medicine on the heart, blood vessels and lungs. Due to the seriousness of the situation, the EMA held additional meetings outside of its normal schedule.