Recent Clinical Trials of Hypertension Management

Abstract

The scene for clinical trials of hypertension management is in transition. The era of mega trials may not be over but is certainly in decline, and in the past 2 years there have been no studies reporting primary outcome data the scale of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET), Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), and other major studies that marked clinical trial activity and informed guideline committees during the past 2 to 3 decades. This reflects in part the view that the present benchmark pharmacological agents for treating hypertension are difficult to improve, some systemic issues affecting the pharmaceutical industry influencing the ability to make the large investment required to perform mega trials and the quality of the antihypertensive drug pipeline. Together these considerations have tended to drive interest toward equivalence rather than efficacy studies (ie, trials designed to show an investigational agent is as good as, not better than, existing treatment), surrogate end points, including new blood pressure (BP) variables, and studies of combinations and algorithms rather than single interventions. Population studies around the world, however, continue to show that large numbers of people have hypertension that is not treated satisfactorily and are not achieving the goals set by the major national guidelines. These guidelines themselves are under continual scrutiny on the basis of recent data casting doubt on the validity of present BP goals. Guideline committees also face the issue that evidence based on expensive large-scale clinical trials is more often funded by the pharmaceutical or device industries than by government, leaving large evidence gaps in areas of public importance but no direct interest to industry funders. The purpose of the present article is to briefly review clinical trials of …