Utilization of Sacubitril/Valsartan in Real-World Settings
- PDF / 535,674 Bytes
- 5 Pages / 595.276 x 790.866 pts Page_size
- 112 Downloads / 145 Views
RESEARCH LETTER
Utilization of Sacubitril/Valsartan in Real‑World Settings Efe Eworuke1 · Talia J. Menzin2 · Emily C. Welch1 · Joy Kolonoski2 · Ting‑Ying Huang2
© Springer Nature Switzerland AG 2020
Sacubitril/valsartan (SV), an angiotensin-receptor-neprilysin inhibitor (ARNI) and angiotensin-receptor blocker (ARB), was approved on 7 July 2015 for the treatment of patients with New York Heart Association (NYHA) class II–IV heart failure (HF) with reduced ejection fraction (HFrEF). The pivotal trial for new drug approval concluded early because of overwhelming benefits and reported a 20% reduction in death from cardiovascular causes or HF hospitalization compared with enalapril [1]. In 2016, the American College of Cardiology/American Heart Association (ACC/AHA) Task Force on clinical practice guidelines recommended that angiotensin-converting enzyme inhibitors (ACEIs) or ARBs be replaced with an ARNI for patients with chronic symptomatic NYHA class II or III HFrEF to further reduce morbidity or mortality [2]. We examined SV use, duration, and patterns of switching from existing treatments to understand its uptake in the real world [3–5]. In the Sentinel Distributed Database, we examined SV utilization in six separate HF cohorts aged ≥ 18 years between 1 January 2015 and 31 July 2019. From new user ACEI and ARB cohorts, defined as patients with no use of an ACEI, ARB, or SV 183 days prior (baseline period), we selected new SV users who switched from an ACEI or ARB during follow-up. The next two SV cohorts were defined as new SV users of an ACEI (ACEI-SV new users) or ARB (ARB-SV new users) in the baseline period. The final two SV cohorts were defined as new users of SV with no ACEI or ARB, separately, during the baseline period and on the index date. Subsequent switching back to an ACEI or ARB was evaluated in all SV cohorts. Patients were followed * Efe Eworuke [email protected] 1
Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
2
until product discontinuation (no new SV dispensing after 14 days), medical or drug insurance disenrollment, death, or end of available data, whichever came first. For each cohort, we obtained the number of users, duration of SV use prior to switching, and patient characteristics 6 months before and on the index date. These analyses were completed using the Sentinel Cohort Identification and Descriptive Analysis Module, version 8.1.1. This study was conducted as part of public health surveillance activities under the auspices of the US FDA and is not under the purview of institutional review boards [6]. We identified 703,848 and 318,588 new ACEI and ARB users compared with 58,141 and 41,351 ACEI-SV and ARBSV new users; 6622 and 3361 SV new users who switched from ACEIs and ARBs, respectively; and 30,557 and 30,54
Data Loading...
