Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1. D-30625 Hannover, Germany.
Department of Cardiology, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Eur Heart J. 2017 Sep 14;38(35):2671-2679. doi: 10.1093/eurheartj/ehx355.
An anti-angiogenic cleaved prolactin fragment is considered causal for peripartum cardiomyopathy (PPCM). Experimental and first clinical observations suggested beneficial effects of the prolactin release inhibitor bromocriptine in PPCM.
In this multicentre trial, 63 PPCM patients with left ventricular ejection fraction (LVEF) ≤35% were randomly assigned to short-term (1W: bromocriptine, 2.5 mg, 7 days) or long-term bromocriptine treatment (8W: 5 mg for 2 weeks followed by 2.5 mg for 6 weeks) in addition to standard heart failure therapy. Primary end point was LVEF change (delta) from baseline to 6 months assessed by magnetic resonance imaging. Bromocriptine was well tolerated. Left ventricular ejection fraction increased from 28 ± 10% to 49 ± 12% with a delta-LVEF of + 21 ± 11% in the 1W-group, and from 27 ± 10% to 51 ± 10% with a delta-LVEF of + 24 ± 11% in the 8W-group (delta-LVEF: P = 0.381). Full-recovery (LVEF ≥ 50%) was present in 52% of the 1W- and in 68% of the 8W-group with no differences in secondary end points between both groups (hospitalizations for heart failure: 1W: 9.7% vs. 8W: 6.5%, P = 0.651). The risk within the 8W-group to fail full-recovery after 6 months tended to be lower. No patient in the study needed heart transplantation, LV assist device or died.
Bromocriptine treatment was associated with high rate of full LV-recovery and low morbidity and mortality in PPCM patients compared with other PPCM cohorts not treated with bromocriptine. No significant differences were observed between 1W and 8W treatment suggesting that 1-week addition of bromocriptine to standard heart failure treatment is already beneficial with a trend for better full-recovery in the 8W group.
ClinicalTrials.gov, study number: NCT00998556.
一种抗血管生成的裂解泌乳素片段被认为与围产期心肌病（PPCM）有关。实验和初步临床观察表明，催乳素释放抑制剂溴隐亭对 PPCM 有有益的影响。
在这项多中心试验中，63 名左心室射血分数（LVEF）≤35%的 PPCM 患者被随机分配到短期（1 周：溴隐亭，2.5mg，7 天）或长期（8 周：2 周 5mg，然后 6 周 2.5mg）溴隐亭治疗，外加标准心力衰竭治疗。主要终点是通过磁共振成像评估从基线到 6 个月时的 LVEF 变化（delta）。溴隐亭耐受性良好。1 周组的 LVEF 从 28±10%增加到 49±12%，delta-LVEF 为+21±11%，8 周组的 LVEF 从 27±10%增加到 51±10%，delta-LVEF 为+24±11%（delta-LVEF：P=0.381）。1 周组有 52%的患者完全恢复（LVEF≥50%），8 周组有 68%的患者完全恢复，两组次要终点无差异（心力衰竭住院：1 周组 9.7%，8 周组 6.5%，P=0.651）。8 周组 6 个月后完全恢复失败的风险较低。研究中没有患者需要进行心脏移植、LV 辅助装置或死亡。
与未接受溴隐亭治疗的其他 PPCM 队列相比，溴隐亭治疗可使 PPCM 患者获得较高的完全左心室恢复率和较低的发病率和死亡率。1 周和 8 周治疗之间没有观察到显著差异，表明在标准心力衰竭治疗中添加 1 周溴隐亭已经有益，8 周组有更好的完全恢复趋势。
ClinicalTrials.gov，研究编号：NCT00998556。
