IDSA: Novel Drug Lowers C. Diff Relapse Rate
VANCOUVER — An investigational antibiotic reduced the rate of relapse for patients with Clostridium difficile-associated diarrhea better than standard therapy, a researcher reported here. Fidaxomicin, the first of a new class of antibiotics, was significantly better than vancomycin (Vancocin) at so-called “global cure” — treating the disease without a relapse, according to Derrick Crook, MD, of John Radcliffe Hospital in Oxford, England. The finding comes from two randomized controlled trials with the same design. The primary endpoint of both was noninferiority in clinical cure, defined as no disease two days after the end of treatment, Crook told attendees at the annual meeting of the Infectious Diseases Society of America.Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- Explain that an investigational antibiotic, fidaxomicin, achieved an equal initial cure rate as vancomycin in C. difficile diarrhea, but significantly fewer patients relapsed following treatment for a superior global cure rate.
- Note that a 20% to 30% relapse rate with vancomycin is a significant problem in the successful treatment of C. difficile-associated diarrhea.
In fact, he said, the drug met that endpoint in both trials and regardless of how the study population was analyzed.
“Gratifyingly,” he told MedPage Today, the drug also reduced relapse rates by about half.
Fidaxomicin is a so-called macrocyclic antibiotic, which has a narrow spectrum and is active against C. difficile, but not against some of the normal gut bacteria, such as Bacteroides, Crook said.
In the two trials, researchers enrolled 1,164 patients and randomly assigned them to 10 days of either 125 mg of vancomycin four times a day or 200 mg of fidaxomicin twice a day.
In the intention-to-treat population (those who had confirmed C. difficile toxin and got at least one dose of the drugs) the clinical cure rates were 88% for fidaxomicin and 86% for vancomycin — not significantly different, Crook said.
The same pattern was seen for the per-protocol population, he said.
On the other hand, Crook said, relapse within 40 days of the end of treatment was more frequent for vancomycin-treated patients — 24%, compared with 13% for those getting fidaxomicin.
That led to a marked difference in the global cure rate — 75% for fidaxomicin and 63% for vancomycin — that was significant at P<0.00001, Crook said.
Subgroup analyses showed similar results, regardless of such characteristics as sex, age, prior antibiotics, and severity of disease.
Adverse events were not different, with 68.3% of fidaxomicin patients reporting at least one, compared with 65.5% of those taking vancomycin, and the same was true of serious adverse events, with rates of 25.7% and 23.2%, respectively.
A request for approval for the drug has been submitted to European authorities, Crook told MedPage Today, and a similar request should go to the FDA next month.
“The relapse rate is the key,” said Paul Auwaerter, MD, of Johns Hopkins University in Baltimore, program chair for the society’s 2009 meeting.
“Vancomycin is a drug that works extremely well,” he said, “but one of the problems that has bedeviled patients and physicians has been relapse rates of anywhere from 20% to 30%.”
There’s some evidence that fidaxomicin may disturb the bowel flora less than vancomycin, he said, so that if it is approved, it will form an important part of the armamentarium against C. difficile disease.
The study was sponsored by Optimer Pharmaceuticals of San Diego, which is developing fidaxomicin.
Crook reported financial links with the company. Some other authors are employed by the company.
Auwaerter reported financial links with Johnson & Johnson, Life Cell, Schering-Plough, and Wyeth.
<a href="http://www.medpagetoday.com/MeetingCoverage/IDSAMeeting/22966tag:news.google.com,2005:cluster=http://www.medpagetoday.com/MeetingCoverage/IDSAMeeting/22966Mon, 25 Oct 2010 18:43:16 GMT 00:00″>IDSA: Novel Drug Lowers C. Diff Relapse Rate
Tags: peer reviewed journal, john radcliffe hospital, Infectious Diseases Society, study population, clostridium difficile associated diarrhea
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