Trajectories of Sacubitril/Valsartan Adherence Among Medicare Beneficiaries With Heart Failure
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SUBMITTER: Huang W
PROVIDER: S-EPMC11312759 | biostudies-literature | 2024 May
REPOSITORIES: biostudies-literature
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| S-EPMC10674925 | biostudies-literature
Project description:Abstract This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess benefits and harms of first‐in‐class angiotensin receptor‐neprilysin inhibitor sacubitril/valsartan (LCZ696) as compared to angiotensin‐converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in chronic heart failure (HF) patients with either reduced, mid‐range, or preserved ejection fraction.
| S-EPMC6984414 | biostudies-literature
Project description:ImportanceThe US Food and Drug Administration expanded labeling of sacubitril-valsartan from the treatment of patients with chronic heart failure (HF) with reduced ejection fraction (EF) to all patients with HF, noting the greatest benefits in those with below-normal EF. However, the upper bound of below normal is not clearly defined, and value determinations across a broader EF range are unknown.ObjectiveTo estimate the cost-effectiveness of sacubitril-valsartan vs renin-angiotensin system inhibitors (RASis) across various upper-level cutoffs of EF.Design, setting, and participantsThis economic evaluation included participant-level data from the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and the PARAGON-HF (Prospective Comparison of ARNi with ARB Global Outcomes in HF With Preserved Ejection Fraction) trials. PARADIGM-HF was conducted between 2009 and 2014, PARAGON-HF was conducted between 2014 and 2019, and this analysis was conducted between 2021 and 2023.Main outcomes and measuresA 5-state Markov model used risk reductions for all-cause mortality and HF hospitalization from PARADIGM-HF and PARAGON-HF. Quality-of-life differences were estimated from EuroQol-5D scores. Hospitalization and medication costs were obtained from published national sources; the wholesale acquisition cost of sacubitril-valsartan was $7092 per year. Risk estimates and treatment effects were generated in consecutive 5% EF increments up to 60% and applied to an EF distribution of US patients with HF from the Get With the Guidelines-Heart Failure registry. The base case included a lifetime horizon from a health care sector perspective. Incremental cost-effectiveness ratios (ICERs) were estimated at EFs of 60% or less (base case) and at various upper-level EF cutoffs.ResultsAmong 13 264 total patients whose data were analyzed, for those with EFs of 60% or less, sacubitril-valsartan was projected to add 0.53 quality-adjusted life-years (QALYs) at an incremental lifetime cost of $40 892 compared with RASi, yielding an ICER of $76 852 per QALY. In a probabilistic sensitivity analysis, 95% of the values of the ICER occurred between $71 516 and $82 970 per QALY. Among patients with chronic HF and an EF of 60% or less, treatment with sacubitril-valsartan vs RASis would be at least of economic intermediate value (ICER <$180 000 per QALY) at a sacubitril-valsartan cost of $10 242 or less per year, of high economic value (ICER <$60 000 per QALY) at a cost of $3673 or less per year, and cost-saving at a cost of $338 or less per year. The ICERs were $67 331 per QALY, $59 614 per QALY, and $56 786 per QALY at EFs of 55% or less, 50% or less, and 45% or less, respectively. Treatment with sacubitril-valsartan in only those with EFs of 45% or greater (up to ≤60%) yielded an ICER of $127 172 per QALY gained; treatment was more cost-effective in those at the lower end of this range (ICER of $100 388 per QALY gained for those with EFs of 45%-55%; ICER of $84 291 per QALY gained for those with EFs of 45%-50%).Conclusions and relevanceCost-effectiveness modeling provided an ICER for treatment with sacubitril-valsartan vs RASis consistent with high economic value for patients with reduced and mildly reduced EFs (≤50%) and at least intermediate value at the current undiscounted wholesale acquisition cost price at an EF of 60% or less. Treatment was more cost-effective at lower EF ranges. These findings may have implications for coverage decisions and value assessments in contemporary clinical practice guidelines.
| S-EPMC10534998 | biostudies-literature
Project description:AimsLarge-scale clinical trials have demonstrated clinical benefits of sacubitril-valsartan in symptomatic heart failure with reduced ejection fraction patients (PARADIGM-HF), with potential benefits in patients hospitalized for acute decompensated heart failure (ADHF) (PIONEER-HF) and fewer benefits in patients with heart failure with preserved ejection fraction (PARAGON-HF). The aim of this study was to evaluate eligibility for sacubitril-valsartan using criteria described in PIONNER-HF in non-selected patients hospitalized for ADHF.Methods and resultsBetween November 2014 and May 2019, 799 patients were recruited in a prospective registry of acute heart failure at the University Hospitals of Geneva (ClinicalTrials.gov: NCT02444416). The cohort consists of consecutive patients admitted to the Department of Medicine with ADHF. Eligibility for sacubitril-valsartan was determined using criteria described in PIONEER-HF, including left ventricular ejection fraction, clinical parameters, and co-morbidities. Of 799 patients, 123 (15.39%) were eligible for sacubitril-valsartan treatment. Clinical outcomes including all-cause mortality and readmission were similar in eligible and non-eligible groups, hazard ratio 1.02 (95% confidence interval 0.81-1.29, P = 083).ConclusionsUsing current criteria from randomized controlled trials, only 15% of non-selected patients admitted for ADHF are theoretically eligible for sacubitril-valsartan. Eligibility for sacubitril-valsartan using published criteria is not associated with worse outcome, suggesting that further evaluation of benefits of sacubitril-valsartan in heart failure patients based on parameters other than left ventricular ejection fraction may be of interest.
| S-EPMC7261587 | biostudies-literature
Project description:Despite significant therapeutic advances, patients with chronic heart failure (HF) remain at high risk for HF progression and death. Sacubitril/valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP) inhibitor (sacubitril) and an angiotensin II (Ang-II) receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang-II. In consequence, its inhibition increases mainly the levels of both, natriuretic peptides (promoting diuresis, natriuresis and vasodilatation) and Ang-II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release). Results from the 8442 patient PARADIGM-HF study showed in patients with New York Heart Association (NYHA) class II-IV and reduced ejection fraction treated with LCZ696 (versus enalapril), the following benefits: reduction of the risk of death from cardiovascular causes by 20%; reduction of HF hospitalizations by 21%; reduction of the risk of all-cause mortality by 16%. Overall there was a 20% risk reduction on the primary endpoint, composite measure of cardiovascular (CV) death or time to first HF hospitalization. PARADIGM-HF was stopped early after a median follow up of 27 months. Post hoc analyses of PARADIGM-HF as well as the place in therapy of sacubitril/valsartan, including future directions, are included in the present review.
| S-EPMC5076745 | biostudies-literature
Project description:Sacubitril/valsartan is a combined neprilysin inhibitor/angiotensin II receptor blocker designed for treatment of heart failure (HF). Nonetheless, its renal protective effect remained an issue of debate. This retrospective cohort study investigated the renal protective effect of sacubitril/valsartan in HF patients. HF patients on sacubitril/valsartan or valsartan for > 30 days were matched for gender, age, estimated glomerular filtration rate (eGFR), and left ventricular ejection fraction (LVEF) to be enrolled into analysis. The follow-up period was 18 months. The outcomes included end eGFR, renal function decline defined as 20% reduction of eGFR, mortality, and HF-related hospitalization. Each group had 137 patients after matching. The mean age was 72.7 years and 65.7% were male. Mean eGFR was 70.9 mL/min/1.73 m2 and LVEF was 54.0% at baseline. Overall, the eGFR of sacubitril/valsartan groups was significantly higher than valsartan group at the end (P < 0.01). Subgroup analysis showed that the difference in eGFR was significant in subgroups with LVEF ≥ 40% or eGFR ≥ 60 mL/min/1.73 m2. Multivariate Cox regression model showed that sacubitril/valsartan group had significantly reduced risk for renal function decline (hazard ratio: 0.5, 95% confidence interval: 0.3-0.9). Kaplan-Meier curve showed no difference in the risk for cardiovascular mortality, all-cause mortality or HF-related hospitalization. We showed renal protective effect of neprilysin inhibition in HF patients and specified that subgroups with LVEF ≥ 40% or eGFR ≥ 60 mL/min/1.73 m2 were sensitive to this effect, suggesting an optimal subgroup of this treatment.
| S-EPMC7907094 | biostudies-literature
Project description:ObjectiveThis study was undertaken to characterize trajectories of antiseizure medication (ASM) adherence in adults with newly treated epilepsy and to determine predictors of trajectories.MethodsThis was a retrospective cohort study using Medicare. We included beneficiaries with newly treated epilepsy (one or more ASM and none in the preceding 2 years, plus International Classification of Diseases codes) in 2010-2013. We calculated the proportion of days covered (proportion of total days with any ASM pill supply) for 8 quarters or until death. Group-based trajectory models characterized and determined predictors of trajectories.ResultsWe included 24 923 beneficiaries. Models identified four groups: early adherent (60%), early nonadherent (18%), late adherent (11%), and late nonadherent (11%). Numerous predictors were associated with being in the early nonadherent versus early adherent group: non-White race (e.g., Black, odds ratio [OR] = 1.7, 95% confidence interval [CI] = 1.5-1.8), region (e.g., South vs. Northeast: OR = 1.2, 95% CI = 1.1-1.4), and once daily initial medication (OR = 1.1, 95% CI = 1.0-1.3). Predictors associated with decreased odds of being in the early nonadherent group included older age (OR = .9 per decade, 95% CI = .9-.9), female sex (OR = .9, 95% CI = .8-1.0), full Medicaid eligibility (OR = .6, 95% CI = .4-.8), neurologist visit (OR = .6, 95% CI = .6-.7), and initial older generation ASM (OR = .6, 95% CI = .6-.7).SignificanceWe identified four ASM adherence trajectories in individuals with newly treated epilepsy. Whereas risk factors for early nonadherence such as race or geographic region are nonmodifiable, our work highlighted a modifiable risk factor for early nonadherence: lacking a neurologist. These data may guide future interventions aimed at improving ASM adherence, in terms of both timing and target populations.
| S-EPMC8563423 | biostudies-literature
Project description:Heart failure is a global problem with elevated prevalence, and it is associated with substantial cardiovascular morbidity and mortality. Treating heart-failure patients has been a very challenging task. This review highlights the main pharmacological developments in the field of heart failure with reduced ejection fraction, giving emphasis to a drug that has a dual-acting inhibition of the neprilysin and renin-angiotensin-aldosterone system. Neprilysin is an enzyme that participates in the breakdown of biologically active natriuretic peptides and several other vasoactive compounds. The inhibition of neprilysin has been a therapeutic target for several drugs tested in cardiovascular disease, mainly for heart failure and/or hypertension. However, side effects and a lack of efficacy led to discontinuation of their development. LCZ696 is a first-in-class neprilysin- and angiotensin-receptor inhibitor that has been developed for use in heart failure. This drug is composed of two molecular moieties in a single crystalline complex: a neprilysin-inhibitor prodrug (sacubitril) and the angiotensin-receptor blocker (valsartan). The PARADIGM-HF trial demonstrated that this drug was superior to an angiotensin-converting enzyme inhibitor (enalapril) in reducing mortality in patients with heart failure with reduced ejection fraction. The ability to block the angiotensin receptor and augment the endogenous natriuretic peptide system provides a distinctive mechanism of action in cardiovascular disease.
| S-EPMC4869613 | biostudies-other
Project description:Disease management programs that target patients with the highest risk of subsequent costs may help payers and providers control health care costs, but identifying these patients prospectively is challenging. We hypothesized that medical history and clinical data from a heart failure registry could be used to prospectively identify patients with heart failure most likely to incur high costs. We linked Medicare inpatient claims to clinical registry data for patients with heart failure and calculated total Medicare costs during the year after the index heart failure hospitalization. We defined patients as having high costs if they were in the upper 5% (>$76,500) of the distribution. We used logistic regression models to identify patient and clinical characteristics associated with high costs. Costs for 40,317 patients in the study varied widely. Patients in the upper 5% of the cost distribution incurred mean costs of $117,193 ± 55,550 during 1 year of follow-up compared to $17,086 ± 17,792 for the lower-cost group. Demographic and clinical characteristics associated with high costs included younger age and black race; history of anemia, chronic obstructive pulmonary disease, ischemic heart disease, diabetes mellitus, or peripheral vascular disease; serum creatinine level; and systolic blood pressure at admission. Mean 1-year Medicare costs for patients whom the model predicted would exceed the high-cost threshold were >2 times the costs for patients below the threshold. In conclusion, a model based on variables from clinical registries can identify a group of patients with heart failure who on average will incur higher costs in the first year after hospitalization.
| S-EPMC3288564 | biostudies-literature
Project description:We tested it in an animal model of myocardial infarction to ensure whether early initiation of dapagliflozin (DAPA), or different orders of combination with sacubitril-valsartan would result in a greater improvement of heart function than sacubitril-valsartan alone in post-myocardial infarction heart failure.
2023-04-13 | GSE229147 | GEO