Abstract
Objectives This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. Background Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. Methods Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). Results Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. Conclusions Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)
| Original language | English (US) |
|---|---|
| Pages (from-to) | 816-822 |
| Number of pages | 7 |
| Journal | JACC: Heart Failure |
| Volume | 4 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2016 |
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Keywords
- heart failure
- neprilysin inhibition
- renin angiotensin system
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation : The PARADIGM-HF Trial. / Solomon, Scott D.; Claggett, Brian; Packer, Milton; Desai, Akshay; Zile, Michael R.; Swedberg, Karl; Rouleau, Jean; Shi, Victor; Lefkowitz, Martin; McMurray, John J V.
In: JACC: Heart Failure, Vol. 4, No. 10, 01.10.2016, p. 816-822.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation
T2 - The PARADIGM-HF Trial
AU - Solomon, Scott D.
AU - Claggett, Brian
AU - Packer, Milton
AU - Desai, Akshay
AU - Zile, Michael R.
AU - Swedberg, Karl
AU - Rouleau, Jean
AU - Shi, Victor
AU - Lefkowitz, Martin
AU - McMurray, John J V
PY - 2016/10/1
Y1 - 2016/10/1
N2 - Objectives This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. Background Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. Methods Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). Results Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. Conclusions Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)
AB - Objectives This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. Background Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. Methods Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). Results Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. Conclusions Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)
KW - heart failure
KW - neprilysin inhibition
KW - renin angiotensin system
UR - http://www.scopus.com/inward/record.url?scp=84991633745&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84991633745&partnerID=8YFLogxK
U2 - 10.1016/j.jchf.2016.05.002
DO - 10.1016/j.jchf.2016.05.002
M3 - Article
C2 - 27395349
AN - SCOPUS:84991633745
VL - 4
SP - 816
EP - 822
JO - JACC: Heart Failure
JF - JACC: Heart Failure
SN - 2213-1779
IS - 10
ER -