The U.S. Food and Drug Administration (FDA) recently approved a combination of quinupristin and dalfopristin (Synercid), the first antibacterial drug to treat infections associated with vancomycin-resistant Enterococccus faecium (VREF) bacteremia when no alternative treatment is available.
According to the FDA, infections related to E. faecium occur in persons who are hospitalized or immunocompromised. E. faecium is resistant to multiple antibiotics. For many years, vancomycin (Vancocin) has been the last resort for treatment of this infection. In 1989, the first case of VREF was reported in the United States; since that time, the incidence of VREF has rapidly increased.
Synercid is the first drug in the streptogramin class of antibiotics to be approved for use in humans in the United States. Because Synercid was able to remove VREF infection from the bloodstream, it was given accelerated approval, a regulatory mechanism that allows early approval for products intended to treat serious or life-threatening conditions when they provide meaningful therapeutic benefit over existing treatments.
In four noncomparative studies, 1,222 patients were given Synercid to treat VREF infections. Based on study criteria, Synercid was found to be 52 percent effective in the patients who were well enough to be evaluated. The sources of infection in these patients included intra-abdominal sites, skin, soft tissue and the urinary tract. Also, 330 of the enrolled VREF patients had bacteremia of unknown origin. Of these patients, 90 percent experienced clearance of VREF in the first 48 to 72 hours of initial therapy.
The most frequently reported side effects of Synercid included muscle and joint pain, nausea, diarrhea, vomiting and rash. When the drug was administered through a peripheral vein, many patients also experienced local reactions to the injection, including pain and inflammation at the site of the injection.
COPYRIGHT 1999 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group
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