Key result
Initiating olmesartan was not associated with an overall increased risk of acute myocardial infarction (HR 1.04; 95% CI 0.75-1.42) or death (HR 1.16; 95% CI 0.95-1.42) compared to other ARBs.
Why the study?
Does olmesartan increase the risk of acute myocardial infarction or death compared to other ARBs in patients initiating therapy?
Cohort (n=58,617)
Does olmesartan increase the risk of acute myocardial infarction or death compared to other ARBs in patients initiating therapy?
Effect estimate: HR 1.04 for AMI; HR 1.16 for death (95% CI 0.75-1.42 for AMI; 0.95-1.42 for death)
In a large UK cohort, overall use of olmesartan was not associated with increased risk of AMI or death compared to other ARBs, though a potential risk signal was noted for high-dose olmesartan.
Reassures on olmesartan cardiovascular safety versus other ARBs; leaves open high-dose signals for prospective confirmation.
PURPOSE: Results of two randomized trials (ROADMAP and ORIENT) suggest that high-dose (40 mg/day) olmesartan (Olm) is associated with increased cardiovascular mortality compared to placebo in diabetic patients. We evaluated the risks of acute myocardial infarction (AMI) and death in patients initiating Olm compared with an active comparator group, other angiotensin receptor blockers (ARBs), with a focus on high-dose and diabetic subgroups. METHODS: We conducted a cohort study with patients who initiated Olm or another ARB between 2003 and 2011, using the UK Clinical Practice Research Datalink GOLD. We included patients who had no prior ARB or angiotensin converting enzyme inhibitor exposure during the preceding 6 months. Hazard ratios (HRs) were estimated using Cox regression models with both multivariable adjustment and propensity score matching. RESULTS: There were 3964 Olm and 54 653 other-ARB initiators, respectively. Adjusted HRs comparing Olm and other-ARBs were 1.04 (95% CI: 0.75-1.42) for AMI and 1.16 (0.95-1.42) for death, using multivariable adjustment. Comparing patients initiated with a high-dose Olm and a high-dose other-ARB, HRs were 3.09 (0.94-10.13) for AMI and 2.03 (0.74-5.61) for death, using multivariable adjustment; and 4.38 (0.97-19.66) and 1.99 (0.63-6.32) for AMI and death, using propensity score matching. CONCLUSIONS: Overall, no differences in risk were observed in the main cohort analyses comparing Olm initiators with patients initiating therapy with other ARBs; however, HRs were marginally increased for all study endpoints which compared high-dose subgroups, suggesting potential increased risk may be associated with high-dose Olm. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.
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Zhou et al. (2013) conducted a cohort in Patients initiating angiotensin receptor blockers (n=58,617). Olmesartan vs. Other angiotensin receptor blockers (ARBs) was evaluated on Acute myocardial infarction (AMI) and death (HR 1.04 for AMI; HR 1.16 for death, 95% CI 0.75-1.42 for AMI; 0.95-1.42 for death). Initiating olmesartan was not associated with an overall increased risk of acute myocardial infarction (HR 1.04; 95% CI 0.75-1.42) or death (HR 1.16; 95% CI 0.95-1.42) compared to other ARBs.
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