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Incidence and risk factors of hypotension-related adverse events among Japanese patients with heart failure receiving sacubitril/valsartan or enalapril: Results from the PARALLEL-HF study.
Tsutsui, Hiroyuki; Momomura, Shin-Ichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Sakata, Yasushi; Ohishi, Tomomi; Iimori, Takayuki; Kitamura, Toshihito.
Afiliación
  • Tsutsui H; School of Medicine and Graduate School, International University of Health and Welfare, Okawa, Japan. Electronic address: tsutsui.hiroyuki.691@m.kyushu-u.ac.jp.
  • Momomura SI; Saitama Citizens Medical Center, Saitama, Japan.
  • Saito Y; Nara Prefecture Seiwa Medical Center, Sango, Japan.
  • Ito H; Department of General Internal Medicine 3, Kawasaki Medical School, Kurashiki, Japan.
  • Yamamoto K; Department of Cardiovascular Medicine and Endocrinology and Metabolism, Tottori University, Yonago, Japan.
  • Sakata Y; Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
  • Ohishi T; Novartis Pharma K.K., Tokyo, Japan.
  • Iimori T; Novartis Pharma K.K., Tokyo, Japan.
  • Kitamura T; Novartis Pharma K.K., Tokyo, Japan.
J Cardiol ; 2024 Sep 14.
Article en En | MEDLINE | ID: mdl-39284545
ABSTRACT

BACKGROUND:

The PARALLEL-HF trial showed that treatment with sacubitril/valsartan resulted in more symptomatic hypotension versus enalapril in Japanese patients with heart failure (HF) and reduced ejection fraction, similar to PARADIGM-HF. Use of sacubitril/valsartan in these patients may be limited by concerns regarding hypotension.

METHODS:

This post-hoc analysis characterized hypotension-related adverse events (AEs) and their effects on efficacy using data from PARALLEL-HF, in which patients received sacubitril/valsartan 200 mg twice daily or enalapril 10 mg twice daily.

RESULTS:

Of 223 patients, 28.2 % experienced hypotension-related AEs and incidence was higher with sacubitril/valsartan versus enalapril (hazard ratio, 2.2; 95 % CI, 1.3-3.8; p = 0.0027). However, reduction in mean systolic blood pressure from baseline to study end did not significantly differ (sacubitril/valsartan -2.2 mmHg vs enalapril -1.3 mmHg; p = 0.6895). Patients who experienced hypotension-related AEs had lower mean body mass index, higher median N-terminal pro-brain natriuretic peptide at randomization, and more frequent history of stroke. Hypotension-related AEs leading to treatment discontinuation were not significantly different for sacubitril/valsartan versus enalapril (3.4 % vs 6.9 %, p = 0.5957). Reduction in risk of cardiovascular death or HF hospitalization was similar with sacubitril/valsartan versus enalapril in patients with or without hypotension-related AEs.

CONCLUSIONS:

Incidence of hypotension-related AEs was higher in the sacubitril/valsartan versus enalapril group but did not affect risk of cardiovascular death or HF hospitalization, which was similar between treatment groups.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Cardiol Asunto de la revista: CARDIOLOGIA Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Cardiol Asunto de la revista: CARDIOLOGIA Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos