Cytokinetics Presents Additional Data From SEQUOIA-HCM At The HCMS Scientific Sessions; Says "Overall, 83.8% Of Patients Treated With Aficamten Experienced Favorable Effects In At Least One Of The Five Domains, Compared To 39.3% Of Patients On Placebo"
Cytokinetics Presents Additional Data From SEQUOIA-HCM At The HCMS Scientific Sessions; Says "Overall, 83.8% Of Patients Treated With Aficamten Experienced Favorable Effects In At Least One Of The Five Domains, Compared To 39.3% Of Patients On Placebo"
Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions by Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease and Assistant Professor of Medicine at the University of Pennsylvania.
納斯達克上市公司Cytokinetics今天宣佈，在患有症狀性梗阻性肥厚型心肌病（HCM）的患者中，來自SEQUOIA-HCm（Aficamten在HCM中的安全性、有效性和梗阻影響的定量理解）關鍵3期臨床試驗的額外數據已由賓夕法尼亞大學遺傳性心臟病中心的董事兼醫學助理教授Anjali t. Owens萬博士在肥厚性心肌病醫學會（HCMS）科學會議上發佈。
A new analysis from SEQUOIA-HCM showed that treatment with aficamten was associated with beneficial changes in five indices reflecting structural, electrophysiologic and biomarker changes in patients from SEQUOIA-HCM. This analysis was performed in patients treated with aficamten and compared to placebo, at 24 weeks as follows:
來自SEQUOIA-HCm的新分析顯示，用aficamten治療與患者結構、電生理和生物標誌物變化相關的五個指數有益變化。此分析是在接受aficamten治療，與安慰劑相比的患者進行的，在24周內如下：
- Improvement in maximal wall thickness by ≥1.5 mm (n = 282; 47.9% vs 30.7%; p=0.003)
- Improvement in left atrial volume index (LAVI) category in those with mild, moderate, or severe enlargement at baseline (n = 185; 46.8% vs. 18.7%; p<0.001)
- Resolution of ECG changes consistent with left ventricular hypertrophy (n = 282; 19.0% vs. 4.3%; p<0.001)
- Normalization of hyperdynamic left ventricular ejection fraction (defined as ≥72%) into the normal range (n = 282; 35.2% vs 20.7%; p<0.007)
- Reduction in NT-proBNP by ≥50% from baseline (n = 282; 81.7% vs. 7.1%; p<0.001).
- 最大壁厚度改善≥1.5毫米（n = 282; 47.9% vs 30.7%; p=0.003）
- 在基線輕度、中度或重度擴大者中改善左心房容積指數（LAVI）類別（n = 185; 46.8% vs. 18.7%; p
- 解決與左室肥厚一致的心電圖變化（n = 282; 19.0% vs. 4.3%; p
- 將超動力左室射血分數（定義爲≥72%）歸爲正常範圍的正常化（n = 282; 35.2% vs 20.7%; p
- 從基線減少Nt-proBNP≥50%（n = 282; 81.7% vs. 7.1%; p
Overall, 83.8% of patients treated with aficamten experienced favorable effects in at least one of the five domains, compared to 39.3% of patients on placebo (p<0.001, NNT = 2.2).
總體而言，83.8%接受aficamten治療的患者在五個領域中至少有一個有利影響，而安慰劑組中僅有39.3%的患者（p
