Key result
Aliskiren shows no mortality benefit over standard therapy but increases hyperkalemia in diabetic patients.
Why the study?
Does the addition of aliskiren to standard medical therapy improve mortality and cardiovascular outcomes in patients with diabetes and cardiovascular disease or risk?
Meta-Analysis (n=13,395)
Does the addition of aliskiren to standard medical therapy improve mortality and cardiovascular outcomes in patients with diabetes and cardiovascular disease or risk?
Relative Risk: 1.05 (95% CI 0.9–1.24)
p-value: p=0.53
The addition of aliskiren to standard medical therapy in patients with diabetes and cardiovascular risk does not improve mortality or cardiovascular outcomes and significantly increases the risk of hyperkalemia and renal impairment.
BACKGROUND: Aliskiren was shown to increase adverse events in patients with diabetes and concomitant renin-angiotensin blockade. We aim to investigate the efficacy and safety of aliskiren in patients with diabetes and increased cardiovascular risk or established cardiovascular disease. METHODS: MEDLINE and Embase were searched for prospective studies comparing addition of aliskiren to standard medical therapy in patients with diabetes and cardiovascular disease, or ⩾1 additional cardiovascular risk factor (hypertension, abnormal lipid profile, microalbuminuria/proteinuria, chronic kidney disease). Relative risk for efficacy (all-cause mortality, combined cardiovascular mortality and hospitalisation) and safety (hyperkalaemia, hypotension, renal impairment) outcomes was calculated. RESULTS: Of 2151 studies identified in the search, seven studies enrolling 13,395 patients were included. Aliskiren had no effect on all-cause mortality (relative risk: 1.05, 95% confidence interval: 0.90 to 1.24, p = 0.53), or combined cardiovascular mortality or heart failure hospitalisation (relative risk: 1.07, 95% confidence interval: 0.81 to 1.40, p = 0.64). Patients receiving aliskiren had a greater risk of developing hyperkalaemia (relative risk: 1.32, 95% confidence interval: 1.14 to 1.53, p = 0.0003) and renal impairment (relative risk: 1.15, 95% confidence interval: 1.02 to 1.30, p = 0.03), but not hypotension. CONCLUSION: Patients with diabetes and cardiovascular disease or cardiovascular risk do not benefit from the addition of aliskiren to standard medical therapy. Detrimental safety profile in pooled analysis supports current warnings.
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Zheng et al. (2017) conducted a meta-analysis in diabetes and cardiovascular disease or risk (n=13,395). Aliskiren vs. standard medical therapy was evaluated on all-cause mortality (RR 1.05, 95% CI 0.90-1.24, p=0.53). Addition of aliskiren to standard medical therapy in patients with diabetes and cardiovascular risk had no effect on all-cause mortality (RR 1.05; 95% CI 0.90-1.24; p=0.53) but increased hyperkalaemia.
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