An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction

Antol, Dana Drzayich; Casebeer, Adrianne Waldman; DeClue, Richard W; Stemkowski, Stephen; Russo, Patrícia A.

doi:10.1007/s12325-018-0710-4

Cited by 31 publications

(29 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…As observed from the PARADIGM sub-analysis by Jhund PS et al, when the authors assessed the efficacy and safety of sacubitril-valsartan by age, they found that the superiority of sacubitril-valsartan over enalapril persisted across all age groups including the elderly, though the same efficacy gap decreased slightly in the older population. 34 The clinical importance of these data is that they reinforce the positive observations from the clinical trial data, 1,33,35 and the emerging real world data, 14,15,17 and indicate that the majority of the cohort of community patients can tolerate the agent and benefit from the compound, in terms of either a reduction in NT-proBNP or an improvement in LVEF. More importantly, these data support the importance of achieving maximum dose and link this to a reduction in diuretic use, establishing clinical volume assessment as a critical feature in using this agent.…”

Section: Discussionmentioning

confidence: 61%

“…Real world data to complement this impressive clinical trial information are of importance to assess whether response is similar in a community population, who are invariably older and with more comorbidities . To date, the limited published real world data indicate a similar positive experience . Notably however, achievement of TD of sacubitril‐valsartan appears to be more of a challenge in the community.…”

Section: Discussionmentioning

confidence: 99%

“…11,28 To date, the limited published real world data indicate a similar positive experience. [10][11][12]14 Notably however, achievement of TD of sacubitril-valsartan appears to be more of a challenge in the community. Some studies have reported rates as low as 17%, and the majority of studies achieved the maximum dose in less than 50% of individuals.…”

Section: Discussionmentioning

confidence: 99%

“…In the main, observations have been in line with what has been reported in the clinical trial data. [10][11][12][13] However, there has been a lower rate of achievement of the target dose (TD), with the majority of studies reaching TD in less than 50% the patients, 14,15 including a large cohort in Germany. 16 To our knowledge, only one study to date had reported success in titration to TD in greater than 50% of the cases.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Sacubitril‐Valsartan in a routine community population: attention to volume status critical to achieving target dose

et al. 2020

View full text Add to dashboard Cite

Aims In the PARADIGM‐heart failure trial, sacubitril‐valsartan demonstrated a reduction in heart failure admissions and reduced all‐cause mortality in patients with heart failure with reduced ejection fraction. Although real world data have shown similar benefits regarding efficacy and safety, there has been difficulty in achieving the target dose (TD). The factors preventing the achievement of TD remains unclear. This study assesses the tolerability, ability to achieve, and factors linked to attaining TD in a routine clinical population. Methods and results This is a retrospective single‐centre review of patients switched from angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers to sacubitril‐valsartan between May 2016 and August 2018. Baseline and follow‐up clinical characteristics and biomarker profiles were collected. Univariate and multivariate analyses were used to analyse predictors of achieving TD. Clinical response to sacubitril‐valsartan was defined as a reduction in N terminal pro BNP of ≥30%, or an increase in left ventricular ejection fraction of ≥5% compared with baseline values. To date, a total of 322 patients (75% male patients) have been switched to sacubitril‐valsartan. Those still in the titration phase were excluded (n = 25). Sacubitril‐valsartan was not tolerated in 40 patients (12.4%). Those intolerant were older (73.4 years [68.3, 80.6] vs. 69.1 years [61.2, 76]; P = 0.003) and had worse renal function with estimated glomerular filtration rate (53.5 mL/min/1.72 m2 [36.8, 60.2] vs 60 mL/min/1.72 m2 [47, 77]; P ≤ 0.001). Of the remaining 257 patients, TD (97/103 mg BD) was achieved in 194 patients (75.5%), while 37 patients (11.4%) were maintained on 49/51 mg BD and 26 patients (8.1%) remained on 24/26 mg BD. Symptomatic hypotension (74.6%) was the main impediment to attaining TD, followed by renal deterioration (12.7%), and to a lesser extent hyperkalaemia and gastrointestinal symptoms (4.8% each). Diuretic dose decrease was achieved in 37.2% of patients, and this was the strongest independent predictor of achieving TD (odds ratio = 2.1; 95% confidence interval [1.16, 3.8]; P = 0.014). Responder status by N terminal pro BNP criterion was observed in 99 of 214 patients (46.3%) while 70 of 142 (49.3%) attained the left ventricular ejection fraction response status. Achieving this response was independently linked to achieving TD. Conclusions Sacubitril‐valsartan was well tolerated. Achievement of TD was possible in the majority of the cohort and was linked to response metrics. Reduction in diuretic was required in a large percentage of the population and was the strongest predictor of attaining TD. Therefore, careful clinical attention to volume status assessment is essential to maximising the benefits of sacubitril‐valsartan.

show abstract

Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Sacubitril‐Valsartan in a routine community population: attention to volume status critical to achieving target dose

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Biorąc pod uwagę rzeczywiste dane w zakresie kosztów terapii w warunkach rzeczywistej praktyki klinicznej wśród 200 chorych z HFrEF w Stanach Zjednoczonych [20], wykazano, że stosowanie Entresto TM obniżyło koszty opieki zdrowotnej u pacjentów z HF. Stosowanie sakubitrilu/walsartanu wiązało się z poprawą stanu zdrowia i zmniejszeniem liczby hospitalizacji w ciągu 4 miesięcy od rozpoczęcia leczenia tym lekiem.…”

Section: Kontynuacja Leczenia I Jego Monitorowanieunclassified

Sakubitril/walsartan w praktyce klinicznej

Lelonek¹,

Rubiś

Gierczyński

et al. 2019

Folia Cardiologica

View full text Add to dashboard Cite

Heart failure signs and symptoms, hospital referrals, and prescription patterns in patients receiving sacubitril/valsartan in primary care and cardiologist settings in Germany

et al. 2020

View full text Add to dashboard Cite

Aims The aim of this paper was to analyse heart failure (HF) signs and symptoms, hospital referrals, and prescription patterns in patients receiving sacubitril/valsartan (sac/val) in primary care and cardiology settings in Germany. Methods and results A retrospective cohort study of electronic medical records identified 1263 adults (aged ≥18 years) in the German IMS® Disease Analyzer database who were prescribed sac/val during 2016 and had at least 6 months of data following sac/val initiation. Clinical characteristics were collected during the 12 months before the first recorded sac/val prescription (index date) and 6 months post-index. Details of sac/val dose and prescription patterns were also recorded in the 6 months post-index. HF signs, symptoms, and all-cause hospital referrals were evaluated for 90 days pre-index and 30-120 days post-index. Most patients (62%) were prescribed the lowest sac/val dose of 24/26 mg twice daily (b.i.d.) at index; only 14% of patients initiated on 24/26 mg or 49/51 mg b.i.d. were up-titrated to the 97/103 mg b.i.d. target dose during the 6 months post-index, while 6% of patients initiated on either 49/51 mg or 97/103 mg b.i.d. were stably down-titrated. Evaluation of prescription patterns in relation to clinical characteristics did not clearly explain the reluctance to up-titrate in the majority of patients. More patients experienced HF signs or symptoms or all-cause referrals to hospital during the 90 days pre-index than during the 30-120 days post-index. Conclusions The majority of patients receiving sac/val are not up-titrated, contrary to recommendations of the EU summary of product characteristics; this is not fully explained by patients' clinical characteristics. Further research is required to understand the reasons for clinician inertia.

show abstract

An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction

Abstract: Novartis Pharmaceuticals Corporation.

Cited by 31 publications

References 13 publications

Sacubitril‐Valsartan in a routine community population: attention to volume status critical to achieving target dose

Sacubitril‐Valsartan in a routine community population: attention to volume status critical to achieving target dose

Sakubitril/walsartan w praktyce klinicznej

Heart failure signs and symptoms, hospital referrals, and prescription patterns in patients receiving sacubitril/valsartan in primary care and cardiologist settings in Germany

Contact Info

Product

Resources

About