Do we need more long-term outcome trials for the treatment of hypertension?

• Published in: The Journal of the Royal College of Physicians of Edinburgh 2011-03, Vol.41 (1), p.30-37
• Main Authors: Beevers, D G, McInnes, G T
• Format: Article
• Language: English
• Subjects: Antihypertensive Agents - therapeutic use; Clinical Trials as Topic; Health Services Needs and Demand; Humans; Hypertension - drug therapy
• ISSN: 2042-8189; 2042-8189; 1478-2715
• DOI: 10.4997/JRCPE.2011.109

The epidemiology of arterial hypertension and its treatment has been underlined by a huge research literature. Consistently raised arterial blood pressure in a clinic or home setting is a simple clinical observation that marks a predilection to a variety of fatal and non-fatal vascular disease events. Over the past 50 years tolerable, safe and effective primary and secondary medicines to offset a substantial amount of the associated morbidity and mortality risk of elevated blood pressure have emerged. Due to the nature of the population-relative risk and low absolute risk of this phenomenon it has often taken very large numbers of patients recruited from multiple centres in several countries and huge financial investment to define these profiles. Few national clinical research funds have invested in this process and it has often been left to a relatively small group of investigators to work closely with the commercial producers of new medicines to complete the essential outcome trials on which much of contemporary cardiovascular medical practice is based. Currently there are few, if any, significant new drug entities relevant to raised blood pressure under development. Most of the underlying clinical management principles and associations are clear. Achieved blood pressure, through patient adherence and variable prescriber practice, defines outcomes for individuals. The theoretical likelihood of a major step forward in the understanding of raised arterial blood pressure or a preferred means for population management is low. Moreover, with few new drug entities, investment in major outcome trials is unlikely to be proposed and the target for new trials is perhaps less apparent. While there can be no doubt that few areas in recent medical practice have benefited more from such huge achievements in underlining treatment, is it time to move on from the cardiovascular mega trial in hypertension?