Cardiovascular disease is a major health threat in Europe. Every year, cardiovascular disease accounts for 23% of Europe's
disease burden and is responsible for nearly half of all deaths (48%) in the region (1). Major risk factors include diet,
obesity, diet, smoking, physical inactivity, alcohol consumption, high blood pressure and high cholesterol.
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.