Fewer mega-trials and more clinically oriented studies in hypertension research? The case of blocking the renin-angiotensin-aldosterone system.
In recent years, medical practice has been influenced substantially by several factors, including the overwhelming development of evidence-based medicine, which is a consequence of the impressive, growing number of large clinical trials, the so-called "mega-trials." These clinical studies are designed mostly to investigate the effects of drugs or treatments on hard end points that cannot be tested by individual physicians in their daily clinical practice. The growing role of this epidemiologic approach to medicine, which is based mostly on the assessment of the average response or behavior of large populations rather than of individuals, is systematically replacing the former knowledge and reference points of the physician, as a substitute rather than as an aid. Taking into account the case of hypertension and particularly the renin-angiotensin system-blocking agents, this article reviews the issues and limitations of transferring evidence from mega-trials to clinical practice and suggests new strategies to make trials more effective and transferable to the case of individual patients.
Division of Cardiology, II Faculty of Medicine, University of Rome La Sapienza, Sant'Andrea Hospital, Via di Grottarossa 1035-9, 00189 Rome, Italy. volpema@uniroma1.it
Massimo
M
Volpe
Giuliano
G
Tocci
Erika
E
Pagannone
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000494:pharmacology; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000628:therapy; D002986:Clinical Trials as Topic; D006801:Humans; D006973:Hypertension / Q000453:epidemiology / Q000473:pathology / Q000532:radiotherapy*; D012084:Renin-Angiotensin System; D012107:Research Design
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents