著者
Hiroyuki Tsutsui Shin-ichi Momomura Yoshihiko Saito Hiroshi Ito Kazuhiro Yamamoto Yasushi Sakata Akshay Suvas Desai Tomomi Ohishi Takayuki Iimori Toshihito Kitamura Weinong Guo on behalf of the PARALLEL-HF Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-20-0854, (Released:2021-03-16)
参考文献数
21
被引用文献数
37

Background:In the Prospective Comparison of angiotensin receptor neprilysin inhibitor (ARNI) With ACEi to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study, treatment with sacubitril/valsartan reduced the primary outcome of cardiovascular (CV) death and heart failure (HF) hospitalization compared with enalapril in patients with chronic HF and reduced ejection fraction (HFrEF). A prospective randomized trial was conducted to assess the efficacy and safety of sacubitril/valsartan in Japanese HFrEF patients.Methods and Results:In the Prospective comparison of ARNI with ACEi to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients (PARALLEL-HF) study, 225 Japanese HFrEF patients (New York Heart Association [NYHA] class II–IV, left ventricular ejection fraction [LVEF] ≤35%) were randomized (1 : 1) to receive sacubitril/valsartan 200 mg bid or enalapril 10 mg bid. Over a median follow up of 33.9 months, no significant between-group difference was observed for the primary composite outcome of CV death and HF hospitalization (HR 1.09; 95% CI 0.65–1.82; P=0.6260). Early and sustained reductions in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline were observed with sacubitril/valsartan compared with enalapril (between-group difference: Week 2: 25.7%, P<0.01; Month 6: 18.9%, P=0.01, favoring sacubitril/valsartan). There was no significant difference in the changes in NYHA class and Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score at Week 8 and Month 6. Sacubitril/valsartan was well tolerated with fewer study drug discontinuations due to adverse events, although the sacubitril/valsartan group had a higher proportion of patients with hypotension.Conclusions:In Japanese patients with HFrEF, there was no difference in reduction in the risk of CV death or HF hospitalization between sacubitril/valsartan and enalapril, and sacubitril/valsartan was safe and well tolerated.

言及状況

外部データベース (DOI)

Twitter (7 users, 8 posts, 29 favorites)

PARALLEL-HF試験 NYHA 2~4度、LVEF≦35、NT-proBNP≧600pg/mL、既にレニンアンジオテンシン系阻害薬およびβ遮断薬が投与されているなどの条件を満たした日本人慢性心不全患者に対して、ARNI投与群はACE阻害薬と比較して心血管死と心不全による初回入院に有意差を認めなかった https://t.co/JUS4v8pCXC
Results From the PARALLEL-HF Study ― https://t.co/Ih4vS8OCcP
ARNIの国内第三相PARALLEL-HF study, 結果見れました(今更?) 非劣性はそうだけど、70%以上がtarget doseまで用量あげれてたことに感動!!日本人でも、症例選べば、いけるんじゃーーーーん!!! https://t.co/Ih4vS8OCcP https://t.co/0CCVaUn5s2
PARALLEL HF 日本人HF患者ではARNIはenalaprilと比べて有意なrisk reductionを認めなかった。必要sample sizeの見積もりはこれでよかったのだろうか。NTpro-は早期に差がついているので薬理作用は発揮されているようです。日本では入院のハードルが低いからかも。 https://t.co/XwpEDJXsnL
エントリーからフォロー、書類仕事も含めて施設の責任者として参加したので、思い入れのある治験です。 Efficacy and Safety of Sacubitril/Valsartan in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction -Results From the PARALLEL-HF Study- https://t.co/Cd1MHsbr26
当初見込みでは、エントレスト群で相対的に20%の減少。 https://t.co/XMJPWx6syD

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