Clinical efficacy and safety of levosimendan in patients with peripartum cardiomyopathy

doi:10.5246/jcps.2023.02.012

Abstract

Abstract:

In the present study, we aimed to explore the efficacy and safety of levosimendan for patients with peripartum cardiomyopathy (PPCM). Overall, 62 cases with PPCM were selected as the research subjects and randomly divided into an experimental group (30 cases) and a control group (32 cases). The groups differed only in terms of the use of levosimendan. Both groups received conventional therapy. Besides, the experimental group was administered 12.5 mg of levosimendan once a week. The levels of high-sensitivity troponin I (cTnI) and B-type brain natriuretic peptide (BNP) and their cardiac structure and function in the two groups were evaluated before and after treatment. Concurrently, the experimental group was observed for adverse reactions, such as hypotension, ventricular arrhythmia, and allergy. After 14 d of treatment, the experimental group, when compared with the control group, showed significantly increased left ventricular ejection fraction and significantly lower left ventricular internal diameter, left atrial anteroposterior diameter, and pulmonary artery pressure (P < 0.05). Serum cTnI and BNP were also significantly decreased (P < 0.01). Transient hypotension occurred in one patient. Through this study, we concluded that levosimendan could significantly improve cardiac function and reverse cardiac remodeling in patients with PPCM, and this approach had good levels of safety and tolerance.

Key words: Levosimendan, Peripartum cardiomyopathy, Cardiac structure, Cardiac function, BNP

Supporting:

Fanfan Xu, Huiping Gong, Zengqiang Liu, Qian Wu. Clinical efficacy and safety of levosimendan in patients with peripartum cardiomyopathy[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(2): 138-144.

Figures/Tables 4

Table 1. Comparisons of the experimental and control groups in terms of baseline data.

Table 2. Comparisons of the experimental and control groups in terms of rates of effectiveness after drug treatment.

Table 3. Comparison of echocardiography before and after drug treatment.

Table 4. Inter-group comparison of changes in BNP and cTnI before and after treatment.

References 12

[1]	Robbins, K.S.; Krause, M.; Nguyen, A.P.; Almehlisi, A.; Meier, A.; Schmidt, U. Peripartum cardiomyopathy: current options for treatment and cardiovascular support. J. Cardiothorac. Vasc. Anesth. 2019, 33, 2814–2825.
[2]	Isogai, T.; Kamiya, C.A. Worldwide incidence of peripartum cardiomyopathy and overall maternal mortality. Int. Heart J. 2019, 60, 503–511.
[3]	Sliwa, K.; Hilfiker-Kleiner, D.; Mebazaa, A.; Petrie, M.C.; Maggioni, A.P.; Regitz-Zagrosek, V.; Schaufelberger, M.; Tavazzi, L.; van Veldhuisen, D.J.; Roos-Hesslink, J.W.; Shah, A.J.; Seferovic, P.M.; Elkayam, U.; van Spaendonck-Zwarts, K.; Bachelier-Walenta, K.; Mouquet, F.; Kraigher-Krainer, E.; Hall, R.; Ponikowski, P.; McMurray, J.J.V.; Pieske, B. EURObservational Research Programme: a worldwide registry on peripartum cardiomyopathy (PPCM) in conjunction with the Heart Failure Association of the European Society of Cardiology Working Group on PPCM. Eur. J. Heart Fail. 2014, 16, 583–591.
[4]	Irizarry, O.C.; Levine, L.D.; Lewey, J.; Boyer, T.; Riis, V.; Elovitz, M.A.; Arany, Z. Comparison of clinical characteristics and outcomes of peripartum cardiomyopathy between African American and non-African American women. JAMA Cardiol. 2017, 2, 1256–1260.
[5]	Sliwa, K.; Petrie, M.C.; Hilfiker-Kleiner, D.; Mebazaa, A.; Jackson, A.; Johnson, M.R.; van der Meer, P.; Mbakwem, A.; Bauersachs, J. Long-term prognosis, subsequent pregnancy, contraception and overall management of peripartum cardiomyopathy: practical guidance paper from the Heart Failure Association of the European Society of Cardiology Study Group on Peripartum Cardiomyopathy. Eur. J. Heart Fail. 2018, 20, 951–962.
[6]	Davis, M.B.; Arany, Z.; McNamara, D.M.; Goland, S.; Elkayam, U. Peripartum cardiomyopathy. J. Am. Coll. Cardiol. 2020, 75, 207–221.
[7]	Bauersachs, J.; König, T.; van der Meer, P.; Petrie, M.C.; Hilfiker-Kleiner, D.; Mbakwem, A.; Hamdan, R.; Jackson, A.M.; Forsyth, P.; de Boer, R.A.; Mueller, C.; Lyon, A.R.; Lund, L.H.; Piepoli, M.F.; Heymans, S.; Chioncel, O.; Anker, S.D.; Ponikowski, P.; Seferovic, P.M.; Johnson, M.R.; Mebazaa, A.; Sliwa, K. Pathophysiology, diagnosis and management of peripartum cardiomyopathy: a position statement from the Heart Failure Association of the European Society of Cardiology Study Group on peripartum cardiomyopathy. Eur. J. Heart Fail. 2019, 21, 827–843.
[8]	Lin, Y.K.; Chen, Y.C.; Chen, Y.A.; Huang, J.H.; Chen, S.A.; Chen, Y.J. Levosimendan differentially modulates electrophysiological activities of sinoatrial nodes, pulmonary veins, and the left and right atria. J. Cardiovasc. Electrophysiol. 2018, 29, 1150–1158.
[9]	Papp, Z.; Agostoni, P.; Alvarez, J.; Bettex, D.; Bouchez, S.; Brito, D.; Černý, V.; Comin-Colet, J.; Crespo-Leiro, M.G.; Delgado, J.F.; Édes, I.; Eremenko, A.A.; Farmakis, D.; Fedele, F.; Fonseca, C.; Fruhwald, S.; Girardis, M.; Guarracino, F.; Harjola, V.P.; Heringlake, M.; Herpain, A.; Heunks, L.M.; Husebye, T.; Ivancan, V.; Karason, K.; Kaul, S.; Kivikko, M.; Kubica, J.; Masip, J.; Matskeplishvili, S.; Mebazaa, A.; Nieminen, M.S.; Oliva, F.; Papp, J.G.; Parissis, J.; Parkhomenko, A.; Põder, P.; Pölzl, G.; Reinecke, A.; Ricksten, S.E.; Riha, H.; Rudiger, A.; Sarapohja, T.; Schwinger, R.H.; Toller, W.; Tritapepe, L.; Tschöpe, C.; Wikström, G.; von Lewinski, D.; Vrtovec, B.; Pollesello, P. Levosimendan efficacy and safety: 20 years of SIMDAX in clinical use. Card. Fail. Rev. 2020, 6, e19.
[10]	Michaels, A.D.; McKeown, B.; Kostal, M.; Vakharia, K.T.; Jordan, M.V.; Gerber, I.L.; Foster, E.; Chatterjee, K. Effects of intravenous levosimendan on human coronary vasomotor regulation, left ventricular wall stress, and myocardial oxygen uptake. Circulation. 2005, 111, 1504–1509.
[11]	Bouchez, S.; Fedele, F.; Giannakoulas, G.; Gustafsson, F.; Harjola, V.; Karason, K.; Kivikko, M.; von Lewinski, D.; Oliva, F.; Papp, Z.; Parissis, J.; Pollesello, P.; Pölzl, G.; Tschöpe, C. Levosimendan in acute and advanced heart failure: an expert perspective on posology and therapeutic application. Cardiovasc. Drugs Ther. 2018, 32, 617–624.
[12]	Farmakis, D.; Alvarez, J.; Gal, T.B.; Brito, D.; Fedele, F.; Fonseca, C.; Gordon, A.C.; Gotsman, I.; Grossini, E.; Guarracino, F.; Harjola, V.P.; Hellman, Y.; Heunks, L.; Ivancan, V.; Karavidas, A.; Kivikko, M.; Lomivorotov, V.; Longrois, D.; Parissis, J. Levosimendan beyond inotropy and acute heart failure: evidence of pleiotropic effects on the heart and other organs: an expert panel position paper. Int. J. Cardiol. 2016, 222, 303–312.