Empagliflozin, irrespective of blood pressure, improves outcomes in heart failure with preserved ejection fraction: the EMPEROR-Preserved trial

被引:22
|
作者
Boehm, Michael [1 ]
Anker, Stefan [2 ,3 ,4 ]
Mahfoud, Felix [1 ]
Lauder, Lucas [1 ]
Filippatos, Gerasimos [5 ]
Ferreira, Joao Pedro [6 ,7 ]
Pocock, Stuart J. [8 ]
Brueckmann, Martina [9 ,10 ]
Saloustros, Ilias [11 ]
Schueler, Elke [12 ]
Wanner, Christoph [13 ]
Zannad, Faiez [6 ,7 ]
Packer, Milton [14 ,15 ]
Butler, Javed [14 ,16 ]
机构
[1] Saarland Univ, Univ Klinikum Saarlandes, Klin Innere Med 3, Kirrberger Str 1, D-66421 Homburg, Germany
[2] Dept Cardiol CVK, Augustenburger Pl 1, D-13353 Berlin, Germany
[3] Berlin Inst Hlth Ctr Regenerat Therapies BCRT, Augustenburger Pl 1, D-13353 Berlin, Germany
[4] Charite Univ Med Berlin, Ctr Cardiovasc Res DZHK Partner Site Berlin, Augustenburger Pl 1, D-13353 Berlin, Germany
[5] Natl & Kapodistrian Univ Athens, Athens Univ Hosp Attikon, Sch Med, 1Rimini St, Athens 12462, Greece
[6] Univ Lorraine, Ctr Invest Clin Plurithemat Inserm CIC P 1433, F-54500 Vandoeuvre Les Nancy, France
[7] CHRU Nancy Brabois, F CRIN INI CRCT Cardiovasc & Renal Clin Trialists, Inserm U1116, F-54500 Vandoeuvre Les Nancy, France
[8] London Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1 7HT, England
[9] Boehringer Ingelheim Int, Binger Str 173, D-55218 Ingelheim, Rheinland Pfalz, Germany
[10] Heidelberg Univ, Fac Med Mannheim, Dept Med 1, Grabengasse 1, D-69117 Heidelberg, Baden Wurttembe, Germany
[11] Boehringer Ingelheim TA Cardiometab Resp Med, Med Dept, Ringstr 173, D-55218 Ingelheim, Germany
[12] Mainanalyt GmbH, Otto Volger Str 3c, D-65843 Sulzbach am Taunus, Hessen, Germany
[13] Univ Klinikum Wurzburg, Schwerpunkt Nephrol, Med Klin & Poliklin, Oberdurrbacher Str 6, D-97080 Wurzburg Bayern, Germany
[14] Baylor Univ, Baylor Heart & Vasc Inst, Med Ctr, 3500 Gaston Ave, Dallas, TX 75246 USA
[15] Imperial Coll, Exhibit Rd, London SW7 2AZ, England
[16] Univ Mississippi, Dept Med, Dept Med L650, 2500 N State St, Jackson, MS 39216 USA
关键词
Empagliflozin; Systolic blood pressure; Heart failure; Preserved ejection fraction; Cardiovascular outcomes; Kidney outcomes; CARDIOVASCULAR OUTCOMES; EFFICACY; HYPERTENSION; SAFETY; LEVEL;
D O I
10.1093/eurheartj/ehac693
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims Empagliflozin reduces the risk of cardiovascular death or heart failure (HF) hospitalization in patients with HF and preserved ejection fraction. This study aims to evaluate if systolic blood pressure (SBP) moderates these effects. Methods and results The association of SBP and the treatment effects of empagliflozin in EMPEROR-Preserved (empagliflozin outcome trial in patients with chronic heart failure with preserved ejection fraction) was evaluated. Randomized patients (n = 5988) were grouped according to SBP at baseline (< 110 mmHg, n = 455; 110-130 mmHg, n = 2415; > 130 mmHg, n = 3118). The effect of empagliflozin on blood pressure, cardiovascular death or HF hospitalization (primary outcome), total HF hospitalizations, and rate of decline in estimated glomerular filtration rate was studied. Over a median of 26.2 months, the placebo-corrected decline was small and not significantly different across baseline SBP. On placebo, the risk of cardiovascular death or hospitalization for HF was 8.58 at > 130 mmHg, 8.26 at 110-130 mmHg, and 11.59 events per 100 patient-years at < 110 mmHg (P = 0.12 vs. > 130 mmHg, P = 0.08 vs. 110-130 mmHg). There was no evidence for baseline SBP moderating the effect of empagliflozin on risk of HF events (primary endpoint interaction P = 0.69, recurrent HF hospitalizations interaction P = 0.55). When comparing empagliflozin with placebo, SBP did not meaningfully associate with adverse events such as hypotension, volume depletion, and acute renal failure. Conclusion In EMPEROR-Preserved, empagliflozin was effective and safe without SBP meaningfully moderating empagliflozin's treatment effects. This analysis of EMPEROR-Preserved shows that empagliflozin can be used safely and effectively without blood pressure being a meaningful moderator of the drug benefit.
引用
收藏
页码:396 / 407
页数:12
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