a cohort study to compare the hospitalization between naive sacubitril/valsartan and naive acei/arbs heart failure patients with reduced ejection fraction using secondary us electronic health records data

Conditions: Heart Failure

Summary: a non-interventional retrospective cohort study conducted to compare the naive sacubitril/valsartan heart failure with reduced ejection fraction (hfref) patient population to a matched naive acei/arb hfref patient population.

this was a non-interventional retrospective cohort study using the us secondary ehr dataset, optum ehr, to compare the naive sacubitril/valsartan hfref patient population (aged ≥ 18 years) to a matched naive acei/arb hfref patient population. the study comprised of the following periods: identification period: 01-jul-2015 to 31-mar-2019 study period * 01-jul-2014 to 31-mar-2020 for primary objective and secondary objective 2 to 6. * 01-jul-2008 to 30-sep-2020 for secondary objective 1. follow-up period: patients were followed up until 31-mar-2020, death or patient transfer out. baseline period: 365 days prior to index

Eligibility criteria:
inclusion criteria: sacubitril/valsartan incident cohort included patients * prescribed sacubitril/valsartan within the identification period (01-july-2015 to 31-mar-2019), that had non-missing gender and year of birth data. * with at least one icd-9-cm or icd-10-cm code for diagnosis of hf within one-year prior to date of first prescription of sacubitril/valsartan (index date), and are treated as part of the integrated delivery network. * with first month active 365 days prior to index and last date active was greater than or equal to (≥) index, and the month of provider source data was greater than the final date of patient follow-up. * that were ≥18 years old at index date. * with a valid lvef value ≤40%, prior to index (index date included). angiotensin-converting enzyme inhibitors (acei) and angiotensin ii receptor antagonist (arb) incident cohort included patient: * prescribed acei or arbs within the identification period (01-jul-2015 to 31-mar-2019), that had non-missing gender and year of birth data. * with at least one icd-9-cm or icd-10-cm code for diagnosis of hf within one-year prior to date of first prescription of acei or arb (index date), and were treated as part of the integrated delivery network. * with first month active 365 days prior to index and last date active was ≥ index, and the month of provider source data is greater than the final date of patient follow-up. * that were ≥ 18 years old at index date. * with a valid lvef value ≤ 40%, prior to index (index date included). exclusion criteria: sacubitril/valsartan incident cohort excluded patients for the primary objective and secondary objective 2 to 6: * patients who were prescribed sacubitril/valsartan within one-year prior to index date. * patients who were prescribed acei or arbs, within one-year prior to index date (index date included). exclude patients for secondary objective 1: * patients who were prescribed sacubitril/valsartan prior to index date. * patients who were prescribed acei or arbs prior to index date (index date included). angiotensin-converting enzyme inhibitors (acei) and angiotensin ii receptor antagonist (arb) incident cohort exclude patients for the primary objective and secondary objective 2 to 6: * patients who were prescribed acei or arbs within one-year prior to index date. * patients who were prescribed sacubitril/valsartan within one-year prior to index date (index date included). * which had a valid sacubitril/valsartan prescription that enables inclusion in the sacubitril/valsartan cohort. * exclude patients for secondary objective 1: * patients who were prescribed acei or arbs prior to index date. * patients who were prescribed sacubitril/valsartan prior to index date (index date included). * which had a valid sacubitril/valsartan prescription that enables inclusion in the sacubitril/valsartan cohort

Keywords: heart failure hospitalizations, sacubitril/valsartan, angiotensin ii receptor antagonist, united states, electronic health record