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Predicting adverse events during angiotensin receptor blocker treatment in heart failure: results from the HEAAL trial
Author(s) -
Kiernan Michael S.,
Wentworth Deborah,
Francis Gary,
Martinez Felipe A.,
Dickstein Kenneth,
Komajda Michel,
Zannad Faiez,
Neaton James D.,
Konstam Marvin A.
Publication year - 2012
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hfs145
Subject(s) - medicine , heart failure , hazard ratio , cardiology , ejection fraction , valsartan , angiotensin receptor , blood pressure , hyperkalemia , adverse effect , proportional hazards model , losartan , creatinine , confidence interval , renin–angiotensin system
Aims In patients with heart failure and reduced left ventricular ejection fraction (HFrEF), renin–angiotensin–aldosterone system blockade reduces morbidity and mortality, but comes at an increased risk of adverse events (AEs). We utilized the HEAAL trial data to identify predictors of the most frequent investigator‐reported AEs. Methods and results The HEAAL trial investigated the relationship between losartan dose and outcomes in patients with HFrEF. Cox proportional hazards modelling was used to investigate predictors of AEs and their association with subsequent outcomes. In multivariate analyses, kidney impairment, hyperkalaemia, and hypotension were more likely to occur in older patients ( P < 0.01 for each), and those taking aldosterone blockers ( P < 0.01 for each). Entry levels of creatinine, potassium, and systolic blood pressure were associated with their respective AEs ( P < 0.001 for each). Diabetes, baseline haemoglobin, and diuretic use were predictors ( P < 0.05) of kidney impairment and hyperkalaemia. Following AEs due to kidney impairment [hazard ratio (HR) 2.19, 95% confidence interval (CI) 1.91–2.50], hyperkalaemia (HR 1.53, 95% CI 1.27–1.85), and hypotension (HR 1.93, 95% CI 1.62–2.29), the risk of death increased compared with patients who did not experience these AEs. Conclusion While the risk of severe AEs is low, patients with HFrEF can be identified who are at increased risk during treatment with an angiotensin receptor blocker. AEs are associated with excess mortality, and at‐risk patients should be monitored closely.