Department of Oncology, Jagiellonian University Medical College, Kraków, Poland
Human Nutrition Department,Faculty of Health Science, Jagiellonian University Medical College, Kraków, Poland
Kardiol Pol. 2020 Feb 25;78(2):131-137. doi: 10.33963/KP.15163. Epub 2020 Jan 29.
Anthracycline‑induced cardiotoxicity (AIC) remains the main long‑term irreversible side effect in malignancy survivors. Cardiotoxicity prevention is one of the most reasonable approaches.
In this prospective randomized open‑label study, we aimed to verify whether ramipril protects from early‑onset AIC in women with breast cancer (BC).
We analyzed data from 96 women (median age, 47 years) with BC after breast surgery, without significant cardiovascular diseases, who were eligible for adjuvant anthracyclines. They were randomized to a ramipril or control arm. Cardiotoxicity was estimated with repeat echocardiography and themeasurement of troponin I and N‑terminal fragment of the prohormone brain natriuretic peptide (NT‑proBNP) levels over 1‑year follow‑up. Anthracycline‑induced cardiotoxicity was defined as a decrease in left ventricular ejection fraction (LVEF), elevated biomarker levels, and/or occurrence of heart failure (HF) or cardiac death.
A decrease in LVEF above 10‑percent points occurred in 6.3% of ramipril patients and 18.5% ofcontrols (P = 0.15). No cases of HF, cardiac death, or LVEF decline below 50% were reported. The percentage of patients with elevated NT‑proBNP levels increased with time in controls (P = 0.003) and remained unchanged in the ramipril arm. At the end of follow‑up, an increase in NT‑proBNP levels was more common and decline was less common in the control than ramipril arm (P = 0.01). No significant differences in troponin levels were found between the study arms. Ramipril was well tolerated in normotensive women.
In relatively young women with BC without serious comorbidities, who received anthracyclines, 1‑year treatment with ramipril exerts potentially protective effects on cardiotoxicity assessed with NT‑proBNP levels.
蒽环类药物诱导的心脏毒性（AIC）仍然是恶性肿瘤幸存者的主要长期不可逆的副作用。心脏毒性预防是最合理的方法之一。
在这项前瞻性随机开放标签研究中，我们旨在验证雷米普利是否能预防乳腺癌（BC）女性的早期 AIC。
我们分析了 96 名接受过乳房手术后、无明显心血管疾病且有资格接受辅助蒽环类药物治疗的 BC 女性患者的数据。她们被随机分配到雷米普利或对照组。通过重复超声心动图和测量肌钙蛋白 I 和脑钠肽前体 N 末端片段（NT-proBNP）水平，在 1 年的随访中评估心脏毒性。蒽环类药物诱导的心脏毒性定义为左心室射血分数（LVEF）下降、生物标志物水平升高以及/或心力衰竭（HF）或心脏性死亡的发生。
雷米普利组有 6.3%的患者 LVEF 下降超过 10%，对照组有 18.5%（P=0.15）。未报告 HF、心脏性死亡或 LVEF 下降至 50%以下的病例。对照组 NT-proBNP 水平随时间增加（P=0.003），而雷米普利组则保持不变。随访结束时，对照组 NT-proBNP 水平升高更为常见，下降更为少见（P=0.01）。两组患者肌钙蛋白水平无显著差异。雷米普利在血压正常的女性中耐受性良好。
在接受蒽环类药物治疗的相对年轻的 BC 女性中，无严重合并症，雷米普利治疗 1 年对 NT-proBNP 水平评估的心脏毒性具有潜在的保护作用。
