Key result
Olmesartan did not significantly lower the risk of death, nonfatal stroke, nonfatal MI, or coronary revascularization compared to control (HR 1.00; 95% CI 0.71-1.40; P=0.99).
Why the study?
Does olmesartan reduce cardiovascular events or death in patients with chronic haemodialysis and elevated blood pressure?
RCT (n=469)
open-label, blinded-endpoint
randomized
Yes
Does olmesartan reduce cardiovascular events or death in patients with chronic haemodialysis and elevated blood pressure?
Hazard Ratio: 1 (95% CI 0.71–1.4)
Absolute Event Rate: 28.9% vs 28.6%
p-value: p=0.99
In patients on chronic hemodialysis with hypertension, treatment with olmesartan did not reduce the risk of major cardiovascular events or death compared to non-RAS inhibitor therapy.
Olmesartan confers no cardiovascular benefit in hypertensive hemodialysis patients; challenges routine RAS inhibitor preference over other antihypertensives in this setting.
BACKGROUND: Hypertension is a major risk factor for death and cardiovascular disease (CVD) in patients undergoing chronic haemodialysis (HD), but there is uncertainty surrounding the effects of blood pressure (BP) lowering on this high-risk patient group. METHODS: In a multicenter, prospective, randomized, open-label, blinded-endpoint trial, 469 patients with chronic HD and elevated BP (140-199/90-99 mmHg) were assigned to receive the angiotensin receptor blockade (ARB) olmesartan (at a dose of 10-40 mg daily; n = 235) or another treatment that does not include angiotensin receptor blockers and angiotensin-converting enzyme (ACE) inhibitors (n = 234). The primary outcomes were the following: (i) composite of death, nonfatal stroke, nonfatal myocardial infarction and coronary revascularization and (ii) all-cause death. RESULTS: During a mean follow-up of 3.5 years, the mean BP was 0.9/0.0 mmHg lower in the olmesartan group than in the control group (not significant). A total of 68 patients (28.9%) in the olmesartan group and 67 patients (28.6%) in the control group had subsequent primary composite endpoints [hazard ratio (HR) in the olmesartan group 1.00, 95% confidence interval (CI) 0.71-1.40, P = 0.99]. All-cause deaths occurred in 38 patients (16.2%) in the olmesartan group and 39 (16.7%) in the control group (HR, 0.97; 95% CI, 0.62-1.52, P = 0.91). Olmesartan did not alter the risks of serious adverse events. CONCLUSIONS: BP-lowering treatment with an ARB did not significantly lower the risks of major cardiovascular events or death among patients with hypertension on chronic HD. (Cochrane Renal Group Prospective Trial Register number CRG010600030).
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Iseki et al. (2013) conducted an RCT in chronic haemodialysis and elevated blood pressure (n=469). olmesartan vs. treatment without angiotensin receptor blockers or ACE inhibitors was evaluated on composite of death, nonfatal stroke, nonfatal myocardial infarction and coronary revascularization (HR 1.00, 95% CI 0.71-1.40, p=0.99). Olmesartan did not significantly lower the risk of death, nonfatal stroke, nonfatal MI, or coronary revascularization compared to control (HR 1.00; 95% CI 0.71-1.40; P=0.99).
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