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Risk of acute myocardial infarction, stroke, or death in patients initiating olmesartan or other angiotensin receptor blockers — a cohort study using the Clinical Practice Research Datalink
Author(s) -
Zhou Esther H.,
Gelperin Kate,
Levenson Mark S.,
Rose Martin,
Hsueh YaHui,
Graham David J.
Publication year - 2014
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3549
Subject(s) - medicine , olmesartan , hazard ratio , propensity score matching , myocardial infarction , stroke (engine) , placebo , cohort , proportional hazards model , cohort study , cardiology , confidence interval , blood pressure , mechanical engineering , alternative medicine , pathology , engineering
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.