Key result
Olmesartan is not linked to increased sudden cardiac death or mortality vs other RAAS inhibitors.
Why the study?
Clinical trials of olmesartan showed renal protection but an unexpected imbalance in cardiac deaths, prompting a large cohort study to assess cardiac mortality risks.
Does olmesartan increase the risk of sudden cardiac death or all-cause mortality compared to other ARBs or ACE inhibitors?
Cohort
Does olmesartan increase the risk of sudden cardiac death or all-cause mortality compared to other ARBs or ACE inhibitors?
In a large retrospective cohort, olmesartan did not increase the risk of sudden cardiac death or all-cause mortality compared to other ARBs or ACE inhibitors, alleviating prior safety concerns.
Answers are grounded in this paper and cite their sources.
Olmesartan shows no excess SCD or mortality risk versus comparators; leaves open causal confirmation by randomized trials.
PURPOSE: Clinical trials of olmesartan for prevention of progression of renal disease in patients with diabetes showed renal protection but an unexpected imbalance in cardiac deaths. The US Food and Drug Administration requested from the manufacturer a cohort study of olmesartan, other angiotensin-receptor blockers (ARBs), and angiotensin-converting enzyme (ACE) inhibitors in a large population. METHODS: A retrospective cohort study was conducted with the cooperation of a US health insurer. Subject entry and follow-up ran from 2002 through 2009. In propensity-matched cohorts, the primary analysis considered continuous current users. Endpoints were sudden cardiac death (SCD) and all-cause mortality, identified through the US National Death Index, supplemented by insurance and hospital discharge data. Statistical estimation was based on proportional hazards analyses with 95% confidence intervals. Power calculations had shown that 25,000 olmesartan initiators would be required to detect relative risks (RRs) of SCD of twofold or greater. RESULTS: A total of 57,123 initiators of olmesartan were matched 1:2 to initiators of other ARBs and 41,801 to initiators of ACE inhibitors. Average follow-up time ranged from 8 to 9 months. Olmesartan initiators and comparators experienced similar patterns of both outcomes, with RRs ≤1.0 and upper confidence bounds ≤1.6. Among persons with prior use of hypoglycemic agents, in comparison with other ARBs, the RR of SCD for olmesartan users was 0.8, with an upper confidence bound of 2.2. CONCLUSION: The results of this well-powered study do not raise concerns for the risk of SCD or death from all causes among olmesartan users in comparison with users of other ARBs or ACE inhibitors.
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Walker et al. (2013) reported a cohort. Olmesartan vs. Other ARBs and ACE inhibitors was evaluated on Sudden cardiac death (SCD) and all-cause mortality (RR ≤1.0, 95% CI upper bound ≤1.6). Olmesartan use was not associated with an increased risk of sudden cardiac death or all-cause mortality compared to other ARBs or ACE inhibitors (RRs ≤1.0, upper confidence bounds ≤1.6).
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