Comparision of Blood Pressure Variability Between Amlodipine and Losartan
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
Blood pressure (BP) is believed to be a major determinant of vascular disease, and BP
lowering is the most important goal in hypertension treatment. Thus, clinical guidelines for
hypertension are mainly focused on lowering mean BP. However, despite an increasing incidence
of stroke with age, the association between systolic BP (SBP) and the risk of stroke
decreases with age. This disparity highlights a gap in the link between BP and
vascular-related diseases (i.e., stroke). In clinical practice, visit-to-visit fluctuations
in BP have been largely ignored and are thought to be an unreliable finding, even though this
phenomenon is frequently observed. Rothwell et al. demonstrated that the visit-to-visit
variability in SBP was a more powerful independent predictor of stroke than mean SBP, and
that an increased residual variability in SBP in treated hypertensive patients was also a
strong predictor of stroke and coronary events.
Recently updated (2011) hypertension guidelines from the National Institute for Health and
Clinical Excellence (NICE) recommend an angiotensin converting enzyme inhibitor (ACEi) [or
angiotensin II receptor blocker (ARB)] and calcium-channel blocker (CCB) as a first line
drug. Although the significance of BP variability (BPV) has been illustrated, the main focus
of the current guidelines is to reduce systolic and diastolic BP, not BPV.
In the X-CELLENT study, a CCB (amlodipine) and thiazide-like diuretic drug (indapamide
sustained-release) led to a significant reduction in BPV, compared to an ARB (candesartan).
In addition, the CCB showed the most effective reduction in systolic BPV among the
antihypertensive drug class in a meta-analysis. However, there are no direct comparison
studies of a CCB and ARB on BPV. Thus, we aim to compare the systolic BPV effects of a CCB
versus an ARB in essential hypertensive patients. The primary hypothesis is that an ARB is
not inferior to a CCB in the reduction of the systolic BPV standard deviation (SD) in
essential hypertensive patients.