PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced findings from a global real-world evidence study that the risk of mortality increases with worse New York Heart Association functional class (NYHA class) for patients with obstructive hypertrophic cardiomyopathy (obstructive HCM). While other studies have documented this association in HCM, this study represents one of the largest, multi-centered studies that specifically focuses on the obstructive HCM patient population.
“These data demonstrate the importance of assessing NYHA functional class in obstructive HCM patients,” said Neal Lakdawala, MD, cardiovascular medicine specialist at Brigham and Women's Hospital and lead author on the study. “We should determine the impact of therapies for obstructive HCM on patients' overall prognosis.”
Over a median follow-up of 3.9 years, the data show a 5% mortality rate in obstructive HCM patients initially classified as NYHA class I, 9% in class II, and 13% in class III/IV. Risks of all-cause mortality and the composite outcome of death or heart transplant increased with worse NYHA class at baseline (p<0.001). The study was conducted in partnership with the Sarcomeric Human Cardiomyopathy Registry (SHaRe) and presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting taking place from September 10 to 13, 2021.
The full data presentation will be available starting September 10, 2021, 6:15 p.m. - 7:15 p.m. MT on the HFSA website for registered attendees.
“As approximately half a million people are affected by obstructive HCM worldwide, these data on the association between mortality and NYHA class in obstructive HCM patients are critical globally,” said Mitch Higashi, vice president of U.S. Health Economics and Outcomes Research, Bristol Myers Squibb. “The insight provided by these real-world data in identifying at-risk patients supports improved patient outcomes as well as healthcare efficiencies overall.”
About the Study
The study analyzed 2,495 obstructive HCM patients with a mean age of 47.6 years at diagnosis, 42% of whom were female. Patient characteristics varied across NYHA class. The Sarcomeric Human Cardiomyopathy Registry (SHaRe) enrolled patients from 10 HCM specialty centers worldwide. The study used data through March 2019, analyzing patients ≥18 years old with obstructive HCM (left ventricular outflow tract (LVOT) peak gradient >30 mmHg or septal reduction therapy) and documentation of NYHA class. Patients were followed from the date of index NYHA class assessment (first documentation of NYHA class I, II, III or IV) to last SHaRe visit or death. The risks of all-cause mortality and a composite endpoint of death and heart transplant were compared across index NYHA classes using log-rank tests.
About Obstructive Hypertrophic Cardiomyopathy
Obstructive hypertrophic cardiomyopathy (obstructive HCM), the most common type of HCM, is a chronic, progressive disease in which the heart muscle becomes abnormally enlarged or thick causing the left ventricular outflow tract (LVOT) where blood leaves the heart to become obstructed by the enlarged heart muscle. As a result, obstructive HCM can lead to debilitating symptoms for patients and has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death.
The most frequent cause of obstructive HCM is mutations in the heart muscle proteins of the sarcomere and as many as 50% of patients have a hereditary predisposition to the disease. Obstructive HCM is estimated to affect 400,000-600,000 people worldwide, however many patients remain undiagnosed and/or asymptomatic.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
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