Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study

被引：307

作者：

Wachter, Rolf ^{[1
,2
,3
]}

Senni, Michele ^{[4
]}

Belohlavek, Jan ^{[5
]}

Straburzynska-Migaj, Ewa ^{[6
]}

Witte, Klaus K. ^{[7
]}

Kobalava, Zhanna ^{[8
]}

Fonseca, Candida ^{[9
]}

Goncalvesova, Eva ^{[10
]}

Cavusoglu, Yuksel ^{[11
]}

Fernandez, Alberto ^{[12
]}

Chaabann, Said ^{[13
]}

Bohmer, Ellen ^{[14
]}

Pouleur, Anne-Catherine ^{[15
]}

Mueller, Christian ^{[16
]}

Tribouilloy, Christophe ^{[17
]}

Lonn, Eva ^{[18
]}

Buraiki, Jehad A. L. ^{[19
]}

Gniot, Jacek ^{[20
]}

Mozheiko, Maria ^{[21
]}

Lelonek, Malgorzata ^{[22
]}

Noe, Adele ^{[23
]}

Schwende, Heike ^{[23
]}

Bao, Weibin ^{[24
]}

Butylin, Dmytro ^{[23
]}

Pascual-Figal, Domingo ^{[25
]}

机构：

[1] Univ Hosp Leipzig, Clin & Policlin Cardiol, Liebigstr 20, D-04103 Leipzig, Germany

[2] Univ Med Gottingen, Clin Cardiol, Gottingen, Germany

[3] German Cardiovasc Res Ctr, Partner Site, Gottingen, Germany

[4] Papa Giovanni XXIII Hosp, Cardiovasc Dept, Cardiol Div, Bergamo, Italy

[5] Charles Univ Prague, Gen Teaching Hosp, Prague, Czech Republic

[6] Univ Med Sci, Dept Cardiol 1, Poznan, Poland

[7] Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, W Yorkshire, England

[8] RUDN Univ, Peoples Friendship Univ Russia, Moscow, Russia

[9] Univ Nova Lisboa, Heart Failure Unit, Hosp Sao Francisco Xavier, Internal Med Dept,CHLO,NOVA Med Sch,Fac Ciencias, Lisbon, Portugal

[10] Odd Srdcovehozlyhavania & Transplantacie, Bratislava, Slovakia

[11] Eskisehir Osmangazi Univ, Med Fac, Eskisehir, Turkey

[12] Sanatorio Modelo Quilmes, Buenos Aires, DF, Argentina

[13] Hammoud Hosp Univ, Med Ctr, Saida, Lebanon

[14] Innlandet Hosp Trust, Lillehammer, Norway

[15] Clin Univ St Luc, Cardiol Div, Brussels, Belgium

[16] Univ Basel, Univ Hosp Basel, Basel, Switzerland

[17] Amiens Univ Hosp, Dept Cardiol, Amiens, France

[18] McMaster Univ & Hamilton Hlth Sci, Hamilton, ON, Canada

[19] King Faisal Specialist Hosp & Res Ctr, Riyadh, Saudi Arabia

[20] SP ZOZ Szpital Specjalisty, Pulawy, Poland

[21] Yaroslavl Reg Hosp Vet Wars, Yaroslavl, Russia

[22] Med Univ Lodz, Dept Noninvas Cardiol, Lodz, Poland

[23] Novartis Pharma AG, Basel, Switzerland

[24] Novartis Pharmaceut, E Hanover, NJ USA

[25] Univ Murcia, Hosp Univ Virgen de la Arrixaca, Cardiol Dept, Murcia, Spain

来源：

EUROPEAN JOURNAL OF HEART FAILURE | 2019年 / 21卷 / 08期

关键词：

Acute decompensated heart failure; Angiotensin receptor-neprilysin inhibitor; Heart failure; Hospitalisation; Sacubitril; valsartan; NEPRILYSIN INHIBITION; UPTITRATION; GUIDELINES; ENALAPRIL; THERAPY;

D O I：

10.1002/ejhf.1498

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims To assess tolerability and optimal time point for initiation of sacubitril/valsartan in patients stabilised after acute heart failure (AHF). Methods and results TRANSITION was a randomised, multicentre, open-label study comparing two treatment initiation modalities of sacubitril/valsartan. Patients aged >= 18 years, hospitalised for AHF were stratified according to pre-admission use of renin-angiotensin-aldosterone system inhibitors and randomised (n = 1002) after stabilisation to initiate sacubitril/valsartan either >= 12-h pre-discharge or between Days 1-14 post-discharge. Starting dose (as per label) was 24/26 mg or 49/51 mg bid with up- or down-titration based on tolerability. The primary endpoint was the proportion of patients attaining 97/103 mg bid target dose after 10 weeks. Median time of first dose of sacubitril/valsartan from the day of discharge was Day -1 and Day +1 in the pre-discharge group and the post-discharge group, respectively. Comparable proportions of patients in the pre- and post-discharge initiation groups met the primary endpoint [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.79-1.02]. The proportion of patients who achieved and maintained for >= 2 weeks leading to Week 10, either 49/51 or 97/103 mg bid was 62.1% vs. 68.5% (RR 0.91; 95% CI 0.83-0.99); or any dose was 86.0% vs. 89.6% (RR 0.96; 95% CI 0.92-1.01). Discontinuation due to adverse events occurred in 7.3% vs. 4.9% of patients (RR 1.49; 95% CI 0.90-2.46). Conclusions Initiation of sacubitril/valsartan in a wide range of heart failure with reduced ejection fraction patients stabilised after an AHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks. Clinical Trial Registration: ID: NCT02661217

引用

页码：998 / 1007

页数：10