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Do we need more long-term outcome trials for the treatment of hypertension?
1Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK. gareth.beevers@swbh.nhs.uk
Insights
Arterial hypertension management has seen significant advances with effective medications, but large trials are costly. With few new drug developments, it may be time to reconsider the focus on cardiovascular mega trials in hypertension research.
Area of Science:
- Cardiovascular Medicine
- Clinical Pharmacology
- Epidemiology
Background:
- Arterial hypertension is a major risk factor for vascular disease events.
- Effective medications have significantly reduced associated morbidity and mortality.
- Defining treatment profiles requires large, multi-center, and costly outcome trials.
Purpose of the Study:
- To review the evolution of hypertension treatment and research funding.
- To assess the current landscape of hypertension drug development.
- To question the future necessity of large-scale cardiovascular trials in hypertension.
Main Methods:
- Literature review of hypertension research and drug development.
- Analysis of the investment and outcomes of large clinical trials.
- Discussion of current trends in hypertension management and research.
Main Results:
- Decades of research have yielded effective hypertension treatments.
- Few novel drug entities for hypertension are currently under development.
- The cost-effectiveness of mega trials is increasingly questioned given the current research climate.
Conclusions:
- Hypertension management has greatly benefited from past research achievements.
- Individual patient outcomes are primarily determined by achieved blood pressure and adherence.
- The focus may need to shift from cardiovascular mega trials to other research avenues in hypertension.
Abstract:
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?
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