Research Finds U.S. Cardiogenic Shock Patients Have High Hospital Inpatient Mortality and Long Length of Stay - Adding to Previously Reported Need for New Pharmacologic Innovation
WARRINGTON, Pa., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced the results of U.S. hospital claims data analysis showing hospital inpatient mortality and length of hospital stay for cardiogenic shock patients.
Cardiogenic shock is a serious condition that occurs when the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Cardiogenic shock is a medical emergency and needs to be treated immediately.1 There is a lack of satisfactory pharmacological intervention to reverse the conditions as available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit their usefulness and position them as “rescue medicines” for severe cases.
U.S. hospital claims data reveals that inpatient mortality for cardiogenic shock patients was 30% in 2020.2 To help explain the relative severity of cardiogenic shock, the acute myocardial infarction (e.g. “heart attack”) mortality rate in the U.S. was 5% in 2020.3 The analysis, along with previously reported primary market research with 100 U.S. cardiologists noting a high need for new therapies and their high likelihood of using an agent with istaroxime’s observed clinical profile further reveals the need for improved pharmacologic innovation for cardiogenic shock patients.
Additionally, U.S. hospital claims data was assessed to determine length of stay in the hospital for cardiogenic shock patients. The average length of stay for patients with cardiogenic shock was 19.6 days with a median of 10 days in 2020.4 According to the Agency for Healthcare Research and Quality (AHRQ), the U.S. national average for a hospital stay of any disease was 4.6 days in 2020.5
“We are working to complete our early cardiogenic shock study with istaroxime with the ultimate goal of developing a therapy that can be used earlier to rapidly improve blood pressure and cardiac function without unwanted side effects of many existing, older agents,” said Craig Fraser, CEO and President of Windtree Therapeutics. “In the next few months, we should be in a position to assess the results of this initial early cardiogenic shock study and if positive, will meet with regulatory agencies to discuss the development program and approval requirements and the potential for applying for supportive pathways that could accelerate development timelines.”
The istaroxime phase 2 study in early cardiogenic shock is an international, randomized, double blind, placebo- controlled study. It will include approximately 60 SCAI class B early cardiogenic shock patients with severe heart failure and systolic blood pressures (SBP) between 75-90 mmHg – all will receive standard of care with 30 assigned to istaroxime and 30 assigned to placebo. The patients will receive study drug infusion for 24 hours. The primary endpoint is the difference in SBP area under the curve over six hours after initiating the infusion. Secondary endpoints will include characterization of blood pressure changes over 24 hours, the number of patients requiring rescue therapy (vasopressors, inotropes or mechanical devices), assessment of renal function and measures associated with safety and tolerability. Windtree is targeting topline data results from the study in Q1, 2022.
2 Windtree market research, hospital claims data, October 2021
3 AHRQ Quality Indicators, Inpatient Quality Indicators, v2020, July 2020
4 Windtree market research, hospital claims data, October 2021
5 AHRQ, Healthcare cost and utilization project, March 2021
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