Study will give statin drug to H1N1 patients in respiratory failure
SAN ANTONIO (Dec. 15, 2009) — H1N1 influenza has sickened an estimated 22 million Americans, put 98,000 in the hospital and resulted in 3,900 deaths since the outbreak began last April, according to the U.S. Centers for Disease Control and Prevention (CDC).
Some of the deaths occurred in a small subset of H1N1 patients who developed “white lungs” — a sign of life-threatening breathing failure called acute respiratory distress syndrome (ARDS).
Lung/critical care specialists at The University of Texas Health Science Center at San Antonio are launching a study to treat ARDS patients with a statin medication. The study will enroll patients in critical care at University Hospital and the South Texas Veterans Health Care System, Audie Murphy Division.
Statin drugs are approved for lowering cholesterol but are not currently used for ARDS. There is scientific evidence, however, that they can decrease the severe respiratory swelling seen in patients with the disease.
Unlike seasonal flu, which has greater prevalence in older people and the very young, 90 percent of H1N1 infections are occurring in young people and adults under 65. (See estimates by age group: http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm)
“We are studying patients with H1N1 who are in their 20s and 30s and become severely sick, even to the point of having lungs that are white with inflammation,” said lead investigator Antonio Anzueto, M.D., a pulmonologist and professor in the Health Science Center School of Medicine. “Susceptible individuals include women in the last trimester of pregnancy, and men and women with underlying conditions such as asthma, obesity, diabetes and heart disease.”
ARDS usually is associated with other disease states. Because of severe respiratory failure, ARDS patients invariably end up on breathing machines. No other therapies exist to treat it, Dr. Anzueto said. “This is a very lethal disease and patients require very aggressive therapy,” he said. “Statin therapy is something we can do above and beyond what we are doing now.”
In September and October 2009, eight H1N1 patients with ARDS needed breathing machines at University Hospital and the VA hospital, Dr. Anzueto said.
Although confirmed H1N1 cases declined in recent weeks, the CDC projects that the percentage of visits to health care providers for influenza-like illness — including the dominant influenza virus this year, H1N1 — will spike upward starting in late December and will remain high through February. (See Figure 2 in http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5844a4.htm.) The Health Science Center continues to take preventive measures, such as inoculating health care personnel and training them about precautions, and obtaining supplies of intranasal and injected vaccine, said Jan Patterson, M.D., professor and leader of the influenza response team in the School of Medicine.
The Health Science Center is the only center in Texas conducting the statin study, which is supported by a Clinical and Translational Science Award (CTSA) from the National Center for Research Resources, part of the National Institutes of Health (NIH). The Health Science Center and nine consortium partners make up the South Texas CTSA Consortium.
The study, which is in 30 centers with CTSAs nationwide, is coordinated by the Vanderbilt University Medical Center.
Recovered ARDS patients will return for follow-up visits with Dr. Anzueto at the Medical Arts and Research Center (MARC) in the South Texas Medical Center. The MARC is the clinical home of UT Medicine San Antonio, the multispecialty practice of School of Medicine physicians.
The Health Science Center belongs to a clinical research network of NIH called ARDS Net, which studies potential therapies for the disease.
The University of Texas Health Science Center at San Antonio is the leading research institution in South Texas and one of the major health sciences universities in the world. With an operating budget of $668 million, the Health Science Center is the chief catalyst for the $16.3 billion biosciences and health care sector in San Antonio’s economy. The Health Science Center has had an estimated $36 billion impact on the region since inception and has expanded to six campuses in San Antonio, Laredo, Harlingen and Edinburg. More than 25,600 graduates (physicians, dentists, nurses, scientists and other health professionals) serve in their fields, including many in Texas. Health Science Center faculty are international leaders in cancer, cardiovascular disease, diabetes, aging, stroke prevention, kidney disease, orthopaedics, research imaging, transplant surgery, psychiatry and clinical neurosciences, pain management, genetics, nursing, dentistry and many other fields. For more information, visit www.uthscsa.edu.