Initiation of Sacubitril/Valsartan (S/V) in Patients with Heart Failure with Reduced Ejection Fraction (hfref) and Compliance with Guideline-Directed (GD) Concomitant Medical Therapy for Heart Failure

BackgroundThe 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure (HF) Treatment guides healthcare providers on treatment plans and discussions with patients with HFrEF. Data on concomitant GD medical therapy for HF pre and post S/V initiation in the real world is limited.ObjectiveTo assess concomitant GD medical therapy for HF pre and post S/V initiation.MethodsAll adult patients with ≥1 claim for S/V or angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (ACEI/ARB) in 7/7/2015-5/31/2016 were identified from a large administrative claims database. Patients on S/V were assumed to have HFrEF based on its approved indication. Patients on ACEI/ARB had claims-based evidence of HFrEF. The index date was 1st claim for S/V (searched first) or ACEI/ARB. All patients had data for ≥24 months pre-index and ≥6 months post-index, unless inpatient death occurred. The uses of GD beta blockers (BB) and mineralocorticoid receptor antagonists (MRA) were assessed. Daily dose of the last fill of GD BB and MRA within 12-month pre S/V initiation and up to 4 fills post S/V was classified into 4 levels: <25%, 25-50%, 50-75% and >75% of GD target dose. McNemar's tests were conducted on % of patients with GD medications pre- and post-index; Cochran-Armitage tests were for the trend of target dose levels for all patients.ResultsA total of 956 patients had ≥1 claim for S/V (median age 64 years, 71% male) and 55,492 patients had ≥1 claim for ACEI/ARB (median age 70 years, 62% male). Compared to pre S/V initiation, fewer S/V patients had concomitant GD BB (post vs. pre: 84.1% vs 89.3%) or MRA (47.7% vs 52.1%) post S/V; both p<.001. In contrast, the ACEI/ARB cohort had no marked difference in post- vs pre-index use of GD BB (67.1% vs 68.5%) or MRA (21.5% vs 22.1%). In the S/V cohort, 50.8% of patients started S/V at ≤24/26 mg b.i.d., 35.7% at 49/51 mg b.i.d., and 11.5% at 97/103 mg b.i.d. During the median follow-up of 433 days, 36.8% of patients reached target maintenance dose of 97/103 mg b.i.d. Importantly, among patients who remained on GD BB or MRA post S/V, daily doses did not vary post vs pre S/V initiation (all p>0.10). About 34-35% and >70% of patients received >75% of GD target daily dose for BB and MRA, respectively, across all fills (Figure 1).ConclusionsThe majority of patients remained on GD BB or MRA with S/V; most continued at the same dose level of GD BB and MRA. Thus, in real-world practice, S/V is prescribed concomitantly with GD BB and MRA without the need for dose adjustment in the majority of cases. The 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure (HF) Treatment guides healthcare providers on treatment plans and discussions with patients with HFrEF. Data on concomitant GD medical therapy for HF pre and post S/V initiation in the real world is limited. To assess concomitant GD medical therapy for HF pre and post S/V initiation. All adult patients with ≥1 claim for S/V or angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (ACEI/ARB) in 7/7/2015-5/31/2016 were identified from a large administrative claims database. Patients on S/V were assumed to have HFrEF based on its approved indication. Patients on ACEI/ARB had claims-based evidence of HFrEF. The index date was 1st claim for S/V (searched first) or ACEI/ARB. All patients had data for ≥24 months pre-index and ≥6 months post-index, unless inpatient death occurred. The uses of GD beta blockers (BB) and mineralocorticoid receptor antagonists (MRA) were assessed. Daily dose of the last fill of GD BB and MRA within 12-month pre S/V initiation and up to 4 fills post S/V was classified into 4 levels: <25%, 25-50%, 50-75% and >75% of GD target dose. McNemar's tests were conducted on % of patients with GD medications pre- and post-index; Cochran-Armitage tests were for the trend of target dose levels for all patients. A total of 956 patients had ≥1 claim for S/V (median age 64 years, 71% male) and 55,492 patients had ≥1 claim for ACEI/ARB (median age 70 years, 62% male). Compared to pre S/V initiation, fewer S/V patients had concomitant GD BB (post vs. pre: 84.1% vs 89.3%) or MRA (47.7% vs 52.1%) post S/V; both p<.001. In contrast, the ACEI/ARB cohort had no marked difference in post- vs pre-index use of GD BB (67.1% vs 68.5%) or MRA (21.5% vs 22.1%). In the S/V cohort, 50.8% of patients started S/V at ≤24/26 mg b.i.d., 35.7% at 49/51 mg b.i.d., and 11.5% at 97/103 mg b.i.d. During the median follow-up of 433 days, 36.8% of patients reached target maintenance dose of 97/103 mg b.i.d. Importantly, among patients who remained on GD BB or MRA post S/V, daily doses did not vary post vs pre S/V initiation (all p>0.10). About 34-35% and >70% of patients received >75% of GD target daily dose for BB and MRA, respectively, across all fills (Figure 1). The majority of patients remained on GD BB or MRA with S/V; most continued at the same dose level of GD BB and MRA. Thus, in real-world practice, S/V is prescribed concomitantly with GD BB and MRA without the need for dose adjustment in the majority of cases.