When the Clinical Trials Raise More Questions Than Answers: Blood Pressure Controversy Beyond the TRANSCEND Results

Abstract

Many trials have reported that in high-risk hypertensive patients, blood pressure (BP) control must be effectively achieved as soon as possible, following the motto ‘‘the lower and the sooner, the better.’’ Surprisingly, in the Telmisartan Randomized Assessment Study in ACEIntolerant Subjects With Cardiovascular Disease (TRANSCEND) where all of the patients were high-risk and more than 75% were hypertensive, a marked reduction in BP did not attain the expected results. This study included patients who were treated with an angiotensin receptor blocker and who were intolerant to angiotensinconverting enzyme (ACE) inhibitor therapy. Could this be due to BP-lowering benefits that will depend only on baseline values? Should we accept that BP reduction is just one goal, and not the most relevant, in high-risk hypertensive patients? Could there be a BP threshold beyond which further reduction will not be effective in improving outcomes? After TRANSCEND, the answers are more than ever ‘‘blowing in the wind.’’ It must be kept in mind that most of the population included in trials in which a significant improvement after intensive BP reduction has been demonstrated exhibited higher baseline BPs. These patients markedly benefit from an antihypertensive regimen. On the other hand, it had been assumed that the results of the Heart Outcomes Prevention Evaluation (HOPE) could be directly translated to the TRANSCEND population. However, patients included in these studies were significantly different. In the HOPE study, patients were less rigorously treated, with fewer antiplatelets, statins, and b-blockers used. What results would have been obtained with ramipril as part of a regimen as it was in the HOPE trial if tested on the TRANSCEND study population? It is likely that the benefits would have been less dramatic. Since the management of hypertensive patients has markedly improved in the past decades, the benefits provided by the addition of new drugs to regimens that include other antihypertension agents, statins, or aspirin, will be less promising in terms of morbidity and mortality reduction.