Shiga Tsuyoshi, Ikeda Takanori, Shimizu Wataru, Kinugawa Koichiro, Sakamoto Atsuhiro, Nagai Ryozo, Daimon Takashi, Oki Kaori, Okamoto Haruka, Yamashita Takeshi
Department of Clinical Pharmacology and Therapeutics, The Jikei University School of Medicine Tokyo Japan.
Department of Cardiovascular Medicine, Toho University Faculty of Medicine Tokyo Japan.
Circ Rep. 2020 Jun 20;2(8):440-445. doi: 10.1253/circrep.CR-20-0017.
Post hoc analysis was used to investigate the effects of renal function on the efficacy and safety of landiolol using data from the J-Land II study, which evaluated landiolol in patients with hemodynamically unstable ventricular tachycardia (VT) or ventricular fibrillation (VF) who were refractory to Class III antiarrhythmic drugs. Patient data from the J-Land II study (n=29) were stratified by renal function (estimated glomerular filtration rate [eGFR] <45 and ≥45 mL/min/1.73 m) and analyzed. Continuous landiolol infusion (1 μg/kg/min, i.v.) was initiated after VT/VF was suppressed with electrical defibrillation; subsequent dose adjustments were made (1-40 μg/kg/min). The primary efficacy endpoint was the proportion of patients free from recurrent VT/VF during the assessment period. Safety endpoints were also assessed. In the eGFR <45 and ≥45 mL/min/1.73 m groups, the median doses of landiolol during the assessment period were 9.44 and 8.97 μg/kg/min, the proportions of patients free from recurrent VT/VF were 69.2% and 81.8%, and adverse events occurred in 9 and 10 of 13 patients in each group, respectively. There were no apparent differences in the efficacy or safety of landiolol between the 2 groups. The data suggest that renal function may not affect the efficacy and safety of landiolol for hemodynamically unstable VT or VF.
采用事后分析，利用J-Land II研究的数据，调查肾功能对兰地洛尔疗效和安全性的影响。J-Land II研究评估了兰地洛尔在对III类抗心律失常药物难治的血流动力学不稳定的室性心动过速（VT）或室性颤动（VF）患者中的应用。将J-Land II研究的患者数据（n = 29）按肾功能（估计肾小球滤过率[eGFR]<45和≥45 mL/min/1.73 m²）进行分层并分析。在通过电除颤抑制VT/VF后，开始持续静脉输注兰地洛尔（1μg/kg/min）；随后进行剂量调整（1 - 40μg/kg/min）。主要疗效终点是评估期内无复发性VT/VF的患者比例。还评估了安全性终点。在eGFR<45和≥45 mL/min/1.73 m²组中，评估期内兰地洛尔的中位剂量分别为9.44和8.97μg/kg/min，无复发性VT/VF的患者比例分别为69.2%和81.8%，每组13例患者中分别有9例和10例发生不良事件。两组之间兰地洛尔的疗效或安全性无明显差异。数据表明，肾功能可能不影响兰地洛尔对血流动力学不稳定的VT或VF的疗效和安全性。
