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1 21st November 02:50
ironjustice
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Default New Antibiotic Effective for Diabetic Foot Infections (diabetes vancomycin cellulitis antibiotic osteomyelitis)



Study Finds New Antibiotic Effective for Diabetic Foot Infections
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VETERANS AFFAIRS DIABETES INFECTIONS LINEZOLID ANTIBIOTICS AMPUTATION FOOT
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Description

A clinical trial involving 371 patients in eight countries shows that
linezolid, a new antibiotic, is at least as effective as two older therapies
for treating diabetic foot infections. The drug may be an important new agent
for doctors treating infections that are increasingly caused by bacteria
resistant to standard antibiotics.

Newswise — A clinical trial involving 371 patients in eight countries shows
that linezolid, a new antibiotic, is at least as effective as two older
therapies for treating diabetic foot infections. The drug may be an important
new agent for doctors treating infections that are increasingly caused by
bacteria resistant to standard antibiotics, and that in severe cases may
require amputation. The study, led by a Department of Veterans Affairs (VA)
physician and conducted at 30 U.S. and 15 European sites, appears in the
current issue of Clinical Infectious Diseases.

Foot infections are among the most serious complications of diabetes, and a
leading cause of diabetes-related hospitalizations. The infections typically
occur when pathogens—usually gram-positive bacteria—infect foot ulcers.
These sores develop because of diabetes-related nerve damage and loss of
feeling in the feet. Amputation may be needed when infections fail to respond
to therapy. People with diabetes account for about two-thirds of the 134,000
lower-limb amputations performed each year in the United States.

“The complication of diabetes that patients fear most is leg amputation, and
infection is often the final pathway that leads to this tragic, if often
preventable, outcome,” said lead author Benjamin A. Lipsky, director of the
General Internal Medicine and Antibiotic Research clinics at the VA Puget Sound
Health Care System and professor of medicine at the University of Washington
School of Medicine in Seattle.

Linezolid, sold as Zyvox (Pfizer, Inc.), was approved by the Food and Drug
Administration (FDA) in 2000 to treat a variety of infections, including some
caused by bacteria resistant to the drug methicillin. Methicillin-resistant
Staphylococcus aureus (MRSA) has become a major cause of infections—including
diabetic foot infections—both in hospitals and communities. For years the
antibiotic vancomycin had been a last line of defense against infections caused
by MRSA and other antibiotic-resistant “superbugs,” but now
vancomycin-resistant infections have been reported.

Because of the growing problem of MRSA and vancomycin-resistant enterococci
(VRE), new agents have been developed. Linezolid is among the first new
treatments for MRSA infections since vancomycin was introduced in the 1950s.
Based on the results of the new trial, the FDA has now specifically extended
the drug’s use to most diabetic foot infections.

Unlike other newer antibiotics for MRSA and VRE, linezolid can be given orally,
as well as intravenously, making it suitable for outpatient use.

“The approval of this drug for appropriately selected diabetic foot
infections is important because it may reduce the need to hospitalize patients
and the risk of IV-related complications,” said Lipsky.

In the study, patients with diabetic foot infections were randomly assigned to
receive either linezolid or one of two standard combination treatments,
consisting of an aminopenicillin and a betalactamase inhibitor, a drug that
blocks an enzyme that inactivates penicillin. Vancomycin could be added to the
regimen for patients in the non-linezolid group if their infection was caused
by MRSA.

Linezolid produced a clinical cure for 81 percent of patients, while the
comparator combination was effective for 71 percent of patients. Statistically,
the overall results for the two groups were about equal. However, linezolid
outperformed the aminopenicillin treatments in the largest subgroup: patients
with an infected ulcer, as opposed to cellulitis, osteomyelitis, or other less
common types of diabetic foot infections.

Lipsky’s results were presented in part at the Oct. 2002 annual meeting of
the Infectious Diseases Society of America. The study was supported by VA and
Pharmacia, now part of Pfizer, the maker of linezolid. Lipsky has served as a
consultant and speaker for Pharmacia and Pfizer.


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