Oxygen Biotherapeutics, Inc., (OXBT) announced that a recently published study in the Journal of Cardiothoracic and Vascular Anesthesia provides evidence that levosimendan provides significant renal benefits to patients undergoing mitral valve surgery. The study was a double blinded, randomized, controlled trial of 128 patients with low ejection fraction (EF<45%) undergoing mitral valve surgery. As the authors reference, patients with low ejection fraction undergoing mitral valve surgery are at risk for adverse outcomes, including a significant risk for acute kidney injury. A link to access "In Press" version of this publication is found here www.jcvaonline.com/article/S1053-0770(13...
The results of the study indicate that low ejection fraction patients, undergoing mitral valve surgery and receiving perioperative treatment with levosimendan in addition to standard inotropic therapy, have improved immediate postoperative renal function. This improvement in renal function was shown by these patients having lower serum creatinine levels and improved glomerular filtration rate (primary endpoints of the study) as compared to patients who did not receive levosimendan. In addition, patients treated with levosimendan also had a statistically significant reduction in renal replacement therapy (dialysis) for patients treated with levosimendan, one of the secondary endpoints of the trial.
John Kelley, CEO of Oxygen Biotherapeutics, Inc. stated "This is the second publication in the last six months of a clinical study showing statistically significant improvement in the renal function of cardiac surgery patients treated with levosimendan (Critical Care Medicine Bragadottir et al. - Oct 2013). While this study is much smaller and not identical in design to our planned Phase 3 trial, it provides insight as to how levosimendan may perform in the low ejection fraction patients undergoing mitral valve surgery who will be included in our Phase 3 trial."
As previously announced, Oxygen Biotherapeutics Inc. expects to begin their Phase 3 trial of levosimendan in low EF (<25%) cardiac surgery patients undergoing coronary artery by-pass and or mitral valve surgery in the third quarter of this calendar year. One of the components of the trial's quadruple composite endpoint is post-operative need for dialysis, which is an important clinical outcome and significant cost driver for cardiac surgery patients.
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