Bromocriptine for the treatment of peripartum cardiomyopathy: a multicentre randomized study.

Bromocriptine for the treatment of peripartum cardiomyopathy: a multicentre randomized study.
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DOI:
10.1093/eurheartj/ehx355
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发表时间:
2017-09-14
影响因子:
39.3
通讯作者:
Bauersachs J
Bauersachs J
中科院分区:
医学1区
文献类型:
--
作者:
Hilfiker-Kleiner D;Haghikia A;Berliner D;Vogel-Claussen J;Schwab J;Franke A;Schwarzkopf M;Ehlermann P;Pfister R;Michels G;Westenfeld R;Stangl V;Kindermann I;Kühl U;Angermann CE;Schlitt A;Fischer D;Podewski E;Böhm M;Sliwa K;Bauersachs J

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抗血管生成切割催乳素片段被认为是围产期心肌病(PPCM)的病因。实验和第一次临床观察表明,PPCM的催乳素释放抑制剂溴隐亭的有益效果。在这项多中心试验中,63例左心室射血分数(LVEF)≤35%的PPCM患者被随机分配到短期(1W:溴隐亭,2.5 mg,7天)或长期溴隐亭治疗(8W:5 mg持续2周,随后2.5 mg持续6周),以及标准心力衰竭治疗。主要终点是通过磁共振成像评估的LVEF从基线到6个月的变化(delta)。溴隐亭耐受良好。1W组左心室射血分数从28 ± 10%增加到49 ± 12%,Δ LVEF为+ 21 ± 11%,8W组从27 ± 10%增加到51 ± 10%,Δ LVEF为+ 24 ± 11%(Δ LVEF:P = 0.381)。完全恢复(LVEF ≥ 50%)在1W组中为52%,在8W组中为68%,两组之间的次要终点无差异(因心力衰竭住院:1W:9.7% vs. 8W:6.5%,P = 0.651)。8 W组在6个月后未能完全恢复的风险往往较低。研究中无患者需要心脏移植、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,溴隐亭治疗与PPCM患者的高LV完全恢复率和低发病率和死亡率相关。在1W和8W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溴隐亭1周已经是有益的,在8W组中有更好的完全恢复的趋势。ClinicalTrials.gov,研究编号:NCT 00998556。
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.
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