World Hypertension Day: 17 May 2013
The European Medicines Agency supports World Hypertension Day, which is taking place on Friday 17 May 2013.
World Hypertension Day was initiated by the World Hypertension League and is held every year on 17 May to highlight the preventable symptoms and diseases caused by high blood pressure and to communicate information on prevention, detection and treatment to the public.
Long-term untreated high blood pressure can damage the arteries and vital organs throughout the body, leading to heart disease, stroke, kidney disease and serious vision disorders. Globally, around 9.4 million people die every year because of high blood pressure, making it the biggest single risk factor for death worldwide.
While a number of medicines for the treatment of high blood pressure have been authorised at European Union level on the recommendation of the Agency's Committee for Medicinal Products for Human Use (CHMP), many others have been approved at national level. These include medicines acting as vasodilators, which cause the blood vessels to dilate, and diuretics, which increase urine production. Due to the complexity of blood-pressure control mechanisms, combination therapies are often needed to reach satisfactory blood pressure.
The Agency publishes guidelines describing how studies of medicines for the treatment of high blood pressure should be designed and carried out. Such guidelines are intended to help pharmaceutical industry and public institutions carry out clinical research in this field.
The latest such guideline, the guideline on clinical investigation of medicinal products in the treatment of hypertension, was published in December 2010.
The CHMP’s Cardiovascular Working Party is currently revising this guideline to include information on the need for long-term safety and outcome studies at the time of marketing-authorisation application, in line with the guidelines on the development of medicines for the treatment of diabetes and of lipid disorders. It is also developing a paediatric addendum to this guideline to highlight the specific aspects of hypertension in children and adolescents, and to provide specific regulatory guidance on the clinical development of medicines against high blood pressure in this population.
The revised guideline and addendum are expected to be published for public consultation later this year.