Department of Pharmacy, University of North Carolina Medical Center, Chapel Hill, North Carolina.
Department of Pharmacy, Massachusetts General Hospital, Boston, Massachusetts.
Clin Transplant. 2019 Jan;33(1):e13454. doi: 10.1111/ctr.13454. Epub 2018 Dec 18.
Following heart transplantation (HT), HMG CoA reductase inhibitors (statins) have been shown to reduce total and low-density lipoprotein (LDL) cholesterol, development of cardiac allograft vasculopathy (CAV), and mortality. Studies in HT patients have demonstrated the safety of low/moderate intensity statins; however, little data exist using high-intensity (HI) statins. The study aim was to evaluate the safety and efficacy of HI statins in HT recipients receiving tacrolimus.
This single-center, retrospective analysis included adult HT recipients from January 1, 2005, to December 31, 2015, who received HI statin therapy during posttransplant follow-up. The primary outcome, tolerability, was defined as the absence of myalgias, hepatotoxicity, rhabdomyolysis, or HI statin dose reduction/discontinuation. The secondary end point was the mean reduction in total and LDL cholesterol.
Among the 24 patients included, one experienced myalgias and therapy discontinuation (4%; P > 0.99). No other HI statin dose reduction/discontinuation occurred, and no instances of rhabdomyolysis or hepatotoxicity were observed. The average reduction in total and LDL cholesterol after conversion to HI statin was 35 mg/dL (P = 0.02) and 19 mg/dL (P = 0.10), respectively.
High-intensity statin therapy appears safe and efficacious in HT recipients receiving tacrolimus and is a reasonable option for the treatment of refractory hyperlipidemia.
心脏移植(HT)后,HMG CoA 还原酶抑制剂(他汀类药物)已被证明可降低总胆固醇和低密度脂蛋白(LDL)胆固醇、心脏移植血管病(CAV)的发展和死亡率。HT 患者的研究表明低/中强度他汀类药物的安全性;然而,使用高强度(HI)他汀类药物的数据很少。本研究旨在评估 HT 受者接受他克莫司后 HI 他汀类药物的安全性和疗效。
这项单中心、回顾性分析包括 2005 年 1 月 1 日至 2015 年 12 月 31 日期间接受 HT 的成年受者,他们在移植后随访期间接受 HI 他汀类药物治疗。主要结局为耐受性,定义为无肌肉疼痛、肝毒性、横纹肌溶解症或 HI 他汀类药物剂量减少/停药。次要终点是总胆固醇和 LDL 胆固醇的平均降低。
在纳入的 24 例患者中,1 例患者出现肌肉疼痛和停药(4%;P>0.99)。没有其他 HI 他汀类药物剂量减少/停药,也没有横纹肌溶解症或肝毒性的发生。转换为 HI 他汀类药物后,总胆固醇和 LDL 胆固醇的平均降低分别为 35mg/dL(P=0.02)和 19mg/dL(P=0.10)。
高强度他汀类药物治疗在接受他克莫司治疗的 HT 受者中似乎是安全有效的,是治疗难治性高脂血症的合理选择。