Abstract

Purpose: Renin angiotensin system (RAS) inhibitors are recommended in patients with myocardial infarction (MI) complicated by left ventricular systolic dysfunction (LVSD) and/or heart failure (HF). However, their use can be followed by hypotension (HYPO) and/or renal dysfunction (RD) which are known to have a negative impact on patient outcome. The aim of this analysis was to identify the independent predictors of early HYPO or RD in the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial in which all enrolled patients received a RAS inhibitor. Methods: VALIANT enrolled 14,703 patients with HF, LVSD, or both 0.5 to 10 days after MI (median 4.9 days). Patients were randomized to receive valsartan (V), captopril (C), or combination (V+C). For the purpose of this analysis, we considered only the HYPO/RD events occurring within 30 days from the beginning of study treatment and leading to study drug discontinuation. Uni- and multivariable analyses were performed to identify the independent predictors of HYPO/RD. Results: HYPO occurred in 107/14206 (0.8%) patients (C 0.5%, V 0.7%, V+C 1.1%), while RD in 61/14206 (0.4%) (C 0.4%, V 0.3%, V+C 0.7%). See Table 1 for variables. Conclusions: The occurrence of HYPO/RD leading to study drug discontinuation within 30 days from randomization in the VALIANT study was low. Combination treatment (C+V) was independently associated with a higher rate of occurrence of these events. Age, low systolic blood pressure (SBP) and treatment with potassium sparing diuretics before randomization were independently associated with the occurrence of both events. Careful dose up-titration in these patients should be performed to minimize the occurrence and severity of these events.χ2HRP valueHypoSBP (10 mm Hg)25.180.66<0.0001Age (10 years)18.361.51<0.0001Weight (10 kg if <60 kg)14.540.300.0001C+V13.882.110.0002Potassium sparing diuretics at random12.582.410.0004Heart rate (10 BPM)11.571.290.0007RDCreatinine (10 mg/dL)124.101.36<0.0001Pulse press23.892.52<0.0001Potassium sparing diuretics at random13.212.970.0003

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