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Spironolactone for heart failure with preserved ejection fraction.

BACKGROUNDMineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODSIn this random... Full description

Journal Title: The New England journal of medicine April 10, 2014, Vol.370(15), pp.1383-1392
Main Author: Pitt, Bertram
Other Authors: Pfeffer, Marc A , Assmann, Susan F , Boineau, Robin , Anand, Inder S , Claggett, Brian , Clausell, Nadine , Desai, Akshay S , Diaz, Rafael , Fleg, Jerome L , Gordeev, Ivan , Harty, Brian , Heitner, John F , Kenwood, Christopher T , Lewis, Eldrin F , O'Meara, Eileen , Probstfield, Jeffrey L , Shaburishvili, Tamaz , Shah, Sanjiv J , Solomon, Scott D , Sweitzer, Nancy K , Yang, Song , Mckinlay, Sonja M , Pitt, Bertram
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1533-4406 ; DOI: 10.1056/NEJMoa1313731
Link: http://search.proquest.com/docview/1515646288/?pq-origsite=primo
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title: Spironolactone for heart failure with preserved ejection fraction.
format: Article
creator:
  • Pitt, Bertram
  • Pfeffer, Marc A
  • Assmann, Susan F
  • Boineau, Robin
  • Anand, Inder S
  • Claggett, Brian
  • Clausell, Nadine
  • Desai, Akshay S
  • Diaz, Rafael
  • Fleg, Jerome L
  • Gordeev, Ivan
  • Harty, Brian
  • Heitner, John F
  • Kenwood, Christopher T
  • Lewis, Eldrin F
  • O'Meara, Eileen
  • Probstfield, Jeffrey L
  • Shaburishvili, Tamaz
  • Shah, Sanjiv J
  • Solomon, Scott D
  • Sweitzer, Nancy K
  • Yang, Song
  • Mckinlay, Sonja M
  • Pitt, Bertram
subjects:
  • Aged–Mortality
  • Aged, 80 and Over–Drug Therapy
  • Cardiovascular Diseases–Mortality
  • Double-Blind Method–Physiopathology
  • Female–Statistics & Numerical Data
  • Follow-Up Studies–Adverse Effects
  • Heart Failure–Therapeutic Use
  • Hospitalization–Adverse Effects
  • Humans–Therapeutic Use
  • Incidence–Therapeutic Use
  • Kaplan-Meier Estimate–Therapeutic Use
  • Male–Therapeutic Use
  • Middle Aged–Therapeutic Use
  • Mineralocorticoid Receptor Antagonists–Therapeutic Use
  • Spironolactone–Therapeutic Use
  • Stroke Volume–Therapeutic Use
  • Treatment Failure–Therapeutic Use
  • Abridged
  • Mineralocorticoid Receptor Antagonists
  • Spironolactone
ispartof: The New England journal of medicine, April 10, 2014, Vol.370(15), pp.1383-1392
description: BACKGROUNDMineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODSIn this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. RESULTSWith a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. CONCLUSIONSIn patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).
language: eng
source:
identifier: E-ISSN: 1533-4406 ; DOI: 10.1056/NEJMoa1313731
fulltext: fulltext
issn:
  • 15334406
  • 1533-4406
url: Link


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titleSpironolactone for heart failure with preserved ejection fraction.
creatorPitt, Bertram ; Pfeffer, Marc A ; Assmann, Susan F ; Boineau, Robin ; Anand, Inder S ; Claggett, Brian ; Clausell, Nadine ; Desai, Akshay S ; Diaz, Rafael ; Fleg, Jerome L ; Gordeev, Ivan ; Harty, Brian ; Heitner, John F ; Kenwood, Christopher T ; Lewis, Eldrin F ; O'Meara, Eileen ; Probstfield, Jeffrey L ; Shaburishvili, Tamaz ; Shah, Sanjiv J ; Solomon, Scott D ; Sweitzer, Nancy K ; Yang, Song ; Mckinlay, Sonja M ; Pitt, Bertram
contributorAnand, Inder (correspondence author) ; Assmann, Susan (record owner) ; Boineau, Robin ; Desai, Akshay ; Fleg, Jerome ; Lathrop, David ; Lewis, Eldrin ; Mckinlay, Sonja ; Montrond, Maureen ; Pfeffer, Marc ; Pitt, Bertram ; Solomon, Scott ; Sopko, George ; Sweitzer, Nancy ; Yang, Song ; Anand, Inder ; Boineau, Robin ; Clausell, Nadine ; Fleg, Jerome ; Mckinlay, Sonja ; O'Meara, Eileen ; Pfeffer, Marc ; Pitt, Bertram ; Shah, Sanjiv ; Solomon, Scott ; Sweitzer, Nancy ; Yang, Song ; Massie, Barry ; Packer, Milton ; Pitt, Bertram ; Saksena, Sanjeev ; Shapiro, Edward ; Zile, Michael ; Bristow, Michael ; Gersh, Bernard ; Grady, Christine ; Greenberg, Barry ; Rice, Madeline ; Singh, Steven ; Barkoudah, Ebrahim ; Finn, Peter V ; Joseph, Jacob ; Lewis, Eldrin F ; Odutayo, Kayode ; Pouleur, Anne-Catherine ; Boineau, Robin ; Fleg, Jerome ; Sopko, George ; Keleti, Julianna ; Caccavo, A ; Cartasegna, L ; Cuello, J ; Cuneo, C ; Fernandez, A ; Hasbani, E ; Hominal, M ; Luciardi, H ; Marquez, L ; Sala, J ; Sanchez, A ; Santos, D ; Schygiel, P ; Zaidman, C ; Abdalla Saad, J ; Albuquerque, D ; Almeida, D ; Botelho, R ; Braga, J ; Clausell, N ; Manenti, E ; Moura, L ; Rassi, S ; Reis, G ; Saraiva, J ; Tumelero, R Tadeu ; Amyot, R ; Arnold, M ; Boulianne, M ; Brossoit, R ; Comtois, H ; Deyoung, J ; Diaz, A ; Dion, D ; Giannetti, N ; Gosselin, G ; Haddad, H ; Huynh, T ; Lepage, S ; Mansour, S ; Manyari, D ; Mckelvie, R ; Moe, G ; O'Meara, E ; Proulx, G ; Rajda, M ; Rupka, D ; Sabbah, E ; Saulnier, D ; Sestier, F ; Sheppard, R ; Shibata, M ; Sussex, B ; Syan, G ; Talbot, P ; Vizel, S ; Warnica, J ; Zieroth, S ; Chapidze, G ; Chumburidze, V ; Emukhvari, N ; Kobulia, B ; Lominadze, Z ; Mamatsashvili, M ; Megreladze, I ; Paposhvili, K ; Shaburishvili, T ; Arutyunov, G ; Balluzek, M ; Barbarash, O ; Belenky, D ; Berezin, V ; Bessonova, N ; Bondarev, S ; Butomo, M ; Chumakova, G ; Dembitskaya, A ; Ermoshkina, L ; Esayan, A ; Filippov, A ; Giorgadze, M ; Goloshchekin, B ; Gordeev, I ; Gratsiansky, N ; Khrustalev, O ; Kosmacheva, E ; Kostenko, V ; Markov, V ; Martsevich, S ; Masin, A ; Nedogoda, S ; Orlikova, O ; Panov, A ; Pikalova, N ; Popov, V ; Popova, V ; Shalnev, V ; Shilkina, N ; Shvarts, Y ; Simanenkov, V ; Timofeev, A ; Usova, G ; Vishnevsky, A ; Adamson, P ; Adler, A ; Albert, T ; Alimard, R ; Altschuller, A ; Alvarez, R ; Amidi, M ; Anand, I ; Aranda, J ; Arcement, L ; Ariani, M ; Baliga, R ; Balk, M ; Banerjee, S ; Berk, M ; Bhalodkar, N ; Bilazarian, S ; Birkhead, R ; Bisognano, J ; Blair, J ; Bolukoglu, H ; Bommer, W ; Bonita, R ; Campbell, P ; Cansino, S ; Cappola, T ; Carter, W ; Chambers, C ; Chapel, H ; Chung, E ; Colucci, W ; Corder, C ; Davidson, R ; Deedwania, P ; Desai, V ; Desai, A ; Deswal, A ; Donahue, M ; Drazner, M ; Dunlap, S ; Dunlap, M ; Eckrich, S ; Ellis, J ; Engelmeier, R ; Fang, J ; Fein, F ; Felicetta, J ; Fesniak, H ; Fox, D ; Frandsen, B ; Furiasse, J ; Gillespie, E ; Gitler, B ; Goldschmidt, M ; Gottlieb, S ; Graham, S ; Gredler, F ; Greenberg, M ; Hankins, S ; Hearne, S ; Heitner, J ; Herre, J ; Hummel, S ; Hunter, C ; Hutchins, S ; Iacona, M ; Imburgia, M ; Islam, J ; Jansujwicz, A ; Johnson, F ; Kesselbrenner, M ; Kfoury, A ; Khera, G ; Khoury, W
ispartofThe New England journal of medicine, April 10, 2014, Vol.370(15), pp.1383-1392
identifierE-ISSN: 1533-4406 ; DOI: 10.1056/NEJMoa1313731
subjectAged–Mortality ; Aged, 80 and Over–Drug Therapy ; Cardiovascular Diseases–Mortality ; Double-Blind Method–Physiopathology ; Female–Statistics & Numerical Data ; Follow-Up Studies–Adverse Effects ; Heart Failure–Therapeutic Use ; Hospitalization–Adverse Effects ; Humans–Therapeutic Use ; Incidence–Therapeutic Use ; Kaplan-Meier Estimate–Therapeutic Use ; Male–Therapeutic Use ; Middle Aged–Therapeutic Use ; Mineralocorticoid Receptor Antagonists–Therapeutic Use ; Spironolactone–Therapeutic Use ; Stroke Volume–Therapeutic Use ; Treatment Failure–Therapeutic Use ; Abridged ; Mineralocorticoid Receptor Antagonists ; Spironolactone
descriptionBACKGROUNDMineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODSIn this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. RESULTSWith a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. CONCLUSIONSIn patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).
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0Pitt, Bertram
1Pfeffer, Marc A
2Assmann, Susan F
3Boineau, Robin
4Anand, Inder S
5Claggett, Brian
6Clausell, Nadine
7Desai, Akshay S
8Diaz, Rafael
9Fleg, Jerome L
10Gordeev, Ivan
11Harty, Brian
12Heitner, John F
13Kenwood, Christopher T
14Lewis, Eldrin F
15O'Meara, Eileen
16Probstfield, Jeffrey L
17Shaburishvili, Tamaz
18Shah, Sanjiv J
19Solomon, Scott D
20Sweitzer, Nancy K
21Yang, Song
22Mckinlay, Sonja M
titleSpironolactone for heart failure with preserved ejection fraction.
descriptionBACKGROUNDMineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODSIn this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. RESULTSWith a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. CONCLUSIONSIn patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).
subject
0Aged–Mortality
1Aged, 80 and Over–Drug Therapy
2Cardiovascular Diseases–Mortality
3Double-Blind Method–Physiopathology
4Female–Statistics & Numerical Data
5Follow-Up Studies–Adverse Effects
6Heart Failure–Therapeutic Use
7Hospitalization–Adverse Effects
8Humans–Therapeutic Use
9Incidence–Therapeutic Use
10Kaplan-Meier Estimate–Therapeutic Use
11Male–Therapeutic Use
12Middle Aged–Therapeutic Use
13Mineralocorticoid Receptor Antagonists–Therapeutic Use
14Spironolactone–Therapeutic Use
15Stroke Volume–Therapeutic Use
16Treatment Failure–Therapeutic Use
17Abridged
18Mineralocorticoid Receptor Antagonists
19Spironolactone
20NCT00094302
21ClinicalTrials.gov
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1Assmann, Susan
2Boineau, Robin
3Desai, Akshay
4Fleg, Jerome
5Lathrop, David
6Lewis, Eldrin
7Mckinlay, Sonja
8Montrond, Maureen
9Pfeffer, Marc
10Pitt, Bertram
11Solomon, Scott
12Sopko, George
13Sweitzer, Nancy
14Yang, Song
15Clausell, Nadine
16O'Meara, Eileen
17Shah, Sanjiv
18Massie, Barry
19Packer, Milton
20Saksena, Sanjeev
21Shapiro, Edward
22Zile, Michael
23Bristow, Michael
24Gersh, Bernard
25Grady, Christine
26Greenberg, Barry
27Rice, Madeline
28Singh, Steven
29Barkoudah, Ebrahim
30Finn, Peter V
31Joseph, Jacob
32Lewis, Eldrin F
33Odutayo, Kayode
34Pouleur, Anne-Catherine
35Keleti, Julianna
36Caccavo, A
37Cartasegna, L
38Cuello, J
39Cuneo, C
40Fernandez, A
41Hasbani, E
42Hominal, M
43Luciardi, H
44Marquez, L
45Sala, J
46Sanchez, A
47Santos, D
48Schygiel, P
49Zaidman, C
50Abdalla Saad, J
51Albuquerque, D
52Almeida, D
53Botelho, R
54Braga, J
55Clausell, N
56Manenti, E
57Moura, L
58Rassi, S
59Reis, G
60Saraiva, J
61Tumelero, R Tadeu
62Amyot, R
63Arnold, M
64Boulianne, M
65Brossoit, R
66Comtois, H
67Deyoung, J
68Diaz, A
69Dion, D
70Giannetti, N
71Gosselin, G
72Haddad, H
73Huynh, T
74Lepage, S
75Mansour, S
76Manyari, D
77Mckelvie, R
78Moe, G
79O'Meara, E
80Proulx, G
81Rajda, M
82Rupka, D
83Sabbah, E
84Saulnier, D
85Sestier, F
86Sheppard, R
87Shibata, M
88Sussex, B
89Syan, G
90Talbot, P
91Vizel, S
92Warnica, J
93Zieroth, S
94Chapidze, G
95Chumburidze, V
96Emukhvari, N
97Kobulia, B
98Lominadze, Z
99Mamatsashvili, M
100...
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titleSpironolactone for heart failure with preserved ejection fraction.
authorPitt, Bertram ; Pfeffer, Marc A ; Assmann, Susan F ; Boineau, Robin ; Anand, Inder S ; Claggett, Brian ; Clausell, Nadine ; Desai, Akshay S ; Diaz, Rafael ; Fleg, Jerome L ; Gordeev, Ivan ; Harty, Brian ; Heitner, John F ; Kenwood, Christopher T ; Lewis, Eldrin F ; O'Meara, Eileen ; Probstfield, Jeffrey L ; Shaburishvili, Tamaz ; Shah, Sanjiv J ; Solomon, Scott D ; Sweitzer, Nancy K ; Yang, Song ; Mckinlay, Sonja M ; Pitt, Bertram
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2Cardiovascular Diseases–Mortality
3Double-Blind Method–Physiopathology
4Female–Statistics & Numerical Data
5Follow-Up Studies–Adverse Effects
6Heart Failure–Therapeutic Use
7Hospitalization–Adverse Effects
8Humans–Therapeutic Use
9Incidence–Therapeutic Use
10Kaplan-Meier Estimate–Therapeutic Use
11Male–Therapeutic Use
12Middle Aged–Therapeutic Use
13Mineralocorticoid Receptor Antagonists–Therapeutic Use
14Spironolactone–Therapeutic Use
15Stroke Volume–Therapeutic Use
16Treatment Failure–Therapeutic Use
17Abridged
18Mineralocorticoid Receptor Antagonists
19Spironolactone
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49Joseph, Jacob
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55Cuello, J
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58Hasbani, E
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60Luciardi, H
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66Zaidman, C
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30Finn, Peter V
31Joseph, Jacob
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atitleSpironolactone for heart failure with preserved ejection fraction.
jtitleThe New England journal of medicine
risdate20140410
volume370
issue15
spage1383
epage1392
pages1383-1392
eissn1533-4406
formatjournal
genrearticle
ristypeJOUR
abstractBACKGROUNDMineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODSIn this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. RESULTSWith a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. CONCLUSIONSIn patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).
doi10.1056/NEJMoa1313731
urlhttp://search.proquest.com/docview/1515646288/
issn00284793
date2014-04-10