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A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease.
Agarwal, Rajiv; Pitt, Bertram; Palmer, Biff F; Kovesdy, Csaba P; Burgess, Ellen; Filippatos, Gerasimos; Malyszko, Jolanta; Ruilope, Luis M; Rossignol, Patrick; Rossing, Peter; Pecoits-Filho, Roberto; Anker, Stefan D; Joseph, Amer; Lawatscheck, Robert; Wilson, Daniel; Gebel, Martin; Bakris, George L.
Affiliation
  • Agarwal R; Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN, USA.
  • Pitt B; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.
  • Palmer BF; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.
  • Kovesdy CP; Division of Nephrology, Department of Medicine, University of Tennessee, Health Science Center Memphis, TN, USA.
  • Burgess E; Nephrology Section, Memphis VA Medical Center, Memphis, TN, USA.
  • Filippatos G; Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
  • Malyszko J; National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece.
  • Ruilope LM; Department of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.
  • Rossignol P; Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.
  • Rossing P; CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Pecoits-Filho R; Faculty of Sport Sciences, European University of Madrid, Madrid, Spain.
  • Anker SD; Université de Lorraine, Inserm, Centre d'Investigations Cliniques - Plurithématique 14-33, and Inserm U1116, CHRU Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
  • Joseph A; Steno Diabetes Center Copenhagen, Herlev, Denmark.
  • Lawatscheck R; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
  • Wilson D; Arbor Research Collaborative for Health, Ann Arbor, MI, USA.
  • Gebel M; School of Medicine, Pontificia Universidade Católica do Paraná, Curitiba, Brazil.
  • Bakris GL; Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.
Clin Kidney J ; 16(2): 293-302, 2023 Feb.
Article in En | MEDLINE | ID: mdl-36864892
Background: Mineralocorticoid receptor antagonists (MRAs) reduce systolic blood pressure (SBP) and increase serum potassium concentration ([K+]). This indirect comparison investigated any differences in SBP-lowering and hyperkalemia risk between finerenone, a nonsteroidal MRA, and the steroidal MRA spironolactone ± a potassium binder. Methods: In FIDELITY (a pooled analysis of FIDELIO-DKD and FIGARO-DKD), a subgroup of patients with treatment-resistant hypertension (TRH) and chronic kidney disease meeting eligibility criteria of the AMBER trial were identified (FIDELITY-TRH). The main outcomes were mean change in SBP, incidence of serum [K+] ≥5.5 mmol/L and hyperkalemia-associated treatment discontinuation. Results at ∼17 weeks were compared with 12 weeks from AMBER. Results: In 624 FIDELITY-TRH patients and 295 AMBER patients, the least squares mean change in SBP (mmHg) from baseline was -7.1 for finerenone and -1.3 for placebo {between-group difference -5.74 [95% confidence interval (CI) -7.99 to -3.49], P < .0001} versus -11.7 for spironolactone + patiromer and -10.8 for spironolactone + placebo [between-group difference -1.0 (95% CI -4.4-2.4), P = .58]. The incidence of serum [K+] ≥5.5 mmol/L was 12% for finerenone and 3% for placebo versus 35% with spironolactone + patiromer and 64% with spironolactone + placebo. Treatment discontinuation due to hyperkalemia was 0.3% for finerenone and 0% for placebo versus 7% for spironolactone + patiromer and 23% for spironolactone + placebo. Conclusions: In patients with TRH and chronic kidney disease compared with spironolactone with or without patiromer, finerenone was associated with a lower SBP reduction and lower risk of hyperkalemia and treatment discontinuation.Trial Registration: AMBER (NCT03071263), FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049).
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Prognostic_studies Language: En Journal: Clin Kidney J Year: 2023 Document type: Article Affiliation country: United States Country of publication: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Prognostic_studies Language: En Journal: Clin Kidney J Year: 2023 Document type: Article Affiliation country: United States Country of publication: United kingdom