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New Study Demonstrates the Clinical and Economic Challenges of Staphylococcus Aureus Infections

Posted on: Wednesday, 10 November 2004, 15:00 CST

ROCKVILLE, Md., Nov. 10 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced results from a study presented at the 2004 annual meeting of the American Heart Association that showed that Staphylococcus aureus bacteremia (Staphylococcus aureus bloodstream infections) in patients with cardiovascular devices significantly increased the incidence of medical complications, treatment costs and death.

The study evaluated heart disease patients with cardiovascular devices such as prosthetic valves, pacemakers and defibrillators, ventricular assist devices, intra-aortic balloon pumps and non-hemodialysis intravascular stents/grafts who developed S. aureus bacteremia (SAB). Among the 122 patients evaluated, 44 percent experienced serious complications as a result of their infection and 35 percent died within 12 weeks. One group consisted of patients with a cardiovascular device who had S. aureus infection when they were admitted to the hospital. The other group consisted of patients with a cardiovascular device who developed SAB during the hospitalization. The study also demonstrated that SAB was associated with substantial medical costs with individual patients incurring a mean cost of $82,300 for a hospital-acquired infection and $47,390 when the patient was admitted to the hospital with the infection.

This study was sponsored by Nabi Biopharmaceuticals and executed by investigators from Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina and Health Economics Consulting, Annapolis, Maryland.

S. aureus Infections Have Significant Clinical Impact

The study included patients that were identified prospectively with both SAB and a cardiovascular device and found that health complications and death occurred frequently in these patients. Patients with prosthetic valves experienced the highest rates of complications and deaths with 25 patients experiencing serious health complications (60%) and 19 patients dying (45%) within 12 weeks. The second highest number of complications and deaths occurred among patients with pacemaker and/or defibrillator devices with 13 patients experiencing complications (38%) and 11 patients dying (33%) within 12 weeks. Finally, among patients with other cardiovascular devices, such as ventricular assist devices, intra-aortic balloon pumps and non-hemodialysis intravascular stents/grafts, 16 patients experienced serious complications (35%) and 13 patients died (28%) within 12 weeks.

S. aureus Infections Have Significant Economic Impact

The study also demonstrated that SAB was associated with substantial medical costs. Patients with prosthetic valves incurred a mean cost of $45,506 among those who were admitted to the hospital with SAB and a mean cost of $126,925 among those who developed a hospital-acquired infection. Patients with pacemaker and/or defibrillator devices incurred mean costs of $46,183 for those admitted with SAB and $55,007 for those with hospital-acquired SAB. (Costs for inpatients were calculated from the day of admission for patients admitted with suspected SAB and from the day of the first positive blood culture for patients with hospital-acquired SAB. Costs include re- hospitalization due to infection and infection-related outpatient costs.) Finally, patients with other cardiovascular devices, such as ventricular assist devices, intra-aortic balloon pumps and intravascular stents/grafts incurred mean costs of $55,779 for those admitted with SAB and $74,375 for those who acquired SAB during their hospital stay

"This study adds to the significant growing body of evidence that underscores the need for better prevention and treatment options for the patients most at risk of acquiring S. aureus infections," said Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals. "Nabi is committed to the continued development of StaphVAX, our conjugate vaccine in a confirmatory Phase III study, as a potential new option to help prevent the deadly and costly consequences of S. aureus infections in patients at risk for developing these infections, such as heart disease patients with cardiovascular devices."

About Staphylococcus aureus Infections

S. aureus is the most common cause of serious hospital-acquired bloodstream infections. Staphylococcal infections are difficult to treat because the bacteria that cause them are highly virulent and, in many cases, resistant to currently available antibiotics. This rise of antibiotic resistance has markedly curtailed options for treating S. aureus infections. According to the current estimates by the U.S. Centers for Disease Control and Prevention (CDC), more than two million patients in the U.S. each year contract an infection as a result of exposure to a pathogen while receiving care in a hospital. S. aureus can spread from the blood (bacteremia), to the bones (osteomyelitis), or the inner lining of the heart and its valves (endocarditis), or cause abscesses in internal organs such as the lungs, liver and kidneys. People most at-risk for these infections are surgical patients, trauma or burn victims, newborns whose immune systems are not yet developed, and patients with chronic illnesses such as diabetes, cancer, or lung or kidney diseases. People whose immune systems are suppressed due to disease, chemotherapy, or radiation therapy are generally more susceptible to these bacterial infections.

About Cardiac Device Related Infections

Infections associated with implanted devices are associated with significant and costly consequences and death. Mortality attributable to such infections is highest among patients that receive cardiovascular implant devices, particularly prosthetic heart valves and aortic grafts. Each year in the U.S. alone, there are nearly 800,000 cardiovascular devices implanted in patients. The devices that are implanted include vascular grafts, pacemakers, mechanical heart valves and ventricular assist devices. The rates of infection in patients receiving these devices range from 4% on average for vascular grafts, pacemakers and mechanical heart valves to 40% for ventricular assist devices (Dariouche, R.O., N Engl J Med 2004;350:1422-9).

About Nabi Biopharmaceuticals

Nabi Biopharmaceuticals applies its knowledge of the human immune system to commercialize and develop products that address serious, unmet medical needs. The company's focus is in the areas of infectious, autoimmune and addictive diseases. In addition to four marketed products (PhosLo(R), Nabi- HB(R), WinRho SDF(R), Aloprim(TM)), the company has several products in various stages of preclinical and clinical testing. Nabi Biopharmaceuticals has advanced StaphVAX(R) to Phase III clinical development. StaphVAX is designed to prevent the most dangerous and prevalent strains of Staphylococcus aureus bacterial infections. S. aureus bacteria are a major cause of hospital- acquired infections and are becoming increasingly resistant to antibiotics. The company's other products in development include Altastaph(TM), an antibody for prevention and treatment of S. aureus infections, currently in Phase II testing, NicVAX(TM), a vaccine to treat nicotine addiction, and Civacir(TM), an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our Website at: http://www.nabi.com/ .

This press release contains forward-looking statements that reflect the company's current expectations regarding future events. Any such forward- looking statements are not guarantees of future performance and involve significant risks and uncertainties. Actual results may differ significantly from those in the forward-looking statements as a result of any number of factors, including, but not limited to, risks relating to the possibility that our confirmatory Phase III clinical trial for StaphVAX or our plans to commercialize StaphVAX in the EU may not be successful; the possibility that we may not realize the value of our acquisition of PhosLo; the company's dependence upon third parties to manufacture its products; the company's ability to utilize the full capacity of its manufacturing facility; the impact on sales of Nabi-HB from patient treatment protocols and the number of liver transplants performed in HBV-positive patients; reliance on a small number of customers; the future sales growth prospects for the company's biopharmaceutical products; and the company's ability to obtain regulatory approval for its products in the U.S. or abroad or to successfully develop, manufacture and market its products. These factors are more fully discussed in the company's Annual Report on Form 10-K for the fiscal year ended December 27, 2003 filed with the Securities and Exchange Commission.

Nabi Biopharmaceuticals

CONTACT: Mark Soufleris, Vice President, Investor & Public Relations,Nabi Biopharmaceuticals, +1-561-989-5800

Web site: http://www.nabi.com/

Source: PRNewswire-FirstCall

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