the Anglo-Scandinavian Cardiac Outcomes Trial - Blood Pressure Lowering Arm (ASCOT-BPLA) results were published in September 2005 (1)
ASCOT-BPLA was a randomised controlled trial that included 19,257 patients aged 40-79 years with hypertension and with at least three additional risk factors for cardiovascular (CV) disease (e.g. age >55 years, male, smoker, microalbuminuria or proteinuria, type 2 diabetes)
patients with prior myocardial infarction (MI), recent stroke, or treated angina were excluded
management of hypertension was based on stepped regimens of a beta-blocker (atenolol) and a thiazide diuretic, or a calcium channel blocker (CCB) (amlodipine) and an angiotensin-converting enzyme (ACE) inhibitor, with further addition of doxazosin, if necessary, to achieve blood pressure (BP)
on termination of the study 78% of patients were taking at least two drugs
ASCOT-BPLA was stopped early by the data safety monitoring board after a median of 5.5 years when interim analysis showed higher mortality for patients in the atenolol group
Results (1):
primary endpoint (nonfatal MI plus fatal coronary heart disease CHD) - the trial did not reveal a statistical significance between treatment groups:
amlodipine group 4.5%; atenolol group 4.9% (HR 0.90; 95% CI 0.79-1.02)
there were significant differences in favour of the amlodipine group found in most secondary endpoints including CV mortality, strokes, and CV events plus procedures
fewer patients developed new-onset diabetes in the amlodipine group than in the atenolol group: 5.9% vs. 8.3% (HR 0.70; 95% CI 0.63 - 0.78)
25% of patients in both groups stopped therapy early because of adverse events (AEs)
fewer did so because of serious AEs in the amlodipine group compared with the atenolol group (1.7% vs. 2.6%, P<0.0001)
it has however been stated in a Lancet editorial that the differences in outcomes between groups may be explained by the difference in BP-lowering effects between the two regimens, which averaged 2.7/1.9mmHg during the study (P<0.0001) (2)
Notes:
ASCOT-BPLA strengthens the case for a more cautious use of beta-blockers (or at least atenolol) as first-line therapy for hypertension, but there may be occasions when this is appropriate, e.g. a patient has CHD (3)
ASCOT-BPLA confirms that a treatment strategy based on a beta-blocker and diuretic can increase the risk of new-onset diabetes
ASCOT-BPLA does not diminish the position of thiazide diuretics a highly appropriate first line therapy for many patients with hypertension (4)
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