Fidaxomicin: Difference between revisions
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==History== | ==History== | ||
Dificid brand of fidaxomicin was approved for Optimer Pharms by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 2011.<ref>{{FDA-Drug_Details|201699}}</ref> | Dificid brand of fidaxomicin was approved for Optimer Pharms by the [[Food and Drug Administration]] in the [[United States of America]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 2011.<ref>{{FDA-Drug_Details|201699}}</ref> | ||
==Usage== | ==Usage== | ||
In a [[randomized controlled trial]], the [[relative risk ratio]] of fidaxomicin, as compared to [[vancomycin]], for recurrence of [[clostridium difficile]] infection was 0.6 and the [[relative risk reduction]] was 40.0%. In populations similar to those in this study which had a rate of risk as measured by the recurrence of C. difficile infection of 25% without treatment, the [[number needed to treat]] is 10. <ref name="pmid21288078">{{cite journal| author=Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y et al.| title=Fidaxomicin versus vancomycin for Clostridium difficile infection. | journal=N Engl J Med | year= 2011 | volume= 364 | issue= 5 | pages= 422-31 | pmid=21288078 | doi=10.1056/NEJMoa0910812 | pmc= | url= }} </ref> | In a [[randomized controlled trial]], the [[relative risk ratio]] of fidaxomicin, as compared to [[vancomycin]], for recurrence of [[clostridium difficile]] infection was 0.6 and the [[relative risk reduction]] was 40.0%. In populations similar to those in this study which had a rate of risk as measured by the recurrence of C. difficile infection of 25% without treatment, the [[number needed to treat]] is 10. <ref name="pmid21288078">{{cite journal| author=Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y et al.| title=Fidaxomicin versus vancomycin for Clostridium difficile infection. | journal=N Engl J Med | year= 2011 | volume= 364 | issue= 5 | pages= 422-31 | pmid=21288078 | doi=10.1056/NEJMoa0910812 | pmc= | url= }} </ref> | ||
A second, unpublished [[randomized controlled trial]] found benefit on rate of recurrence.<ref>{{cite web |url= http://clinicaltrials.gov/ct2/show/results/NCT00468728 |title=PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) - Study Results - ClinicalTrials.gov |first= |last={{err|{{AUTHOR MISSING}}}} |work=clinicaltrials.gov |year=2011 [last update] |accessdate=August 8, 2011}}</ref> | |||
==Pharmacology== | ==Pharmacology== | ||
Latest revision as of 12:18, 2 February 2023
In infectious disease, fidaxomicin is an macrocyclide antibiotic. It may be used to treat diarrhea caused by clostridium difficile infection as well as Pseudomembranous enterocolitis.
History
Dificid brand of fidaxomicin was approved for Optimer Pharms by the Food and Drug Administration in the United States of America with a New Drug Application (NDA) in 2011.[1]
Usage
In a randomized controlled trial, the relative risk ratio of fidaxomicin, as compared to vancomycin, for recurrence of clostridium difficile infection was 0.6 and the relative risk reduction was 40.0%. In populations similar to those in this study which had a rate of risk as measured by the recurrence of C. difficile infection of 25% without treatment, the number needed to treat is 10. [2]
A second, unpublished randomized controlled trial found benefit on rate of recurrence.[3]
Pharmacology
Administration
Distribution
Metabolism
Excretion
Toxicity
Drug toxicity includes
External links
The most up-to-date information about Fidaxomicin and other drugs can be found at the following sites.
- Fidaxomicin - FDA approved drug information (drug label) from DailyMed (U.S. National Library of Medicine).
- Fidaxomicin - Drug information for consumers from MedlinePlus (U.S. National Library of Medicine).
- Fidaxomicin - Detailed information from DrugBank.
References
- ↑ Anonymous. Drugs@FDA for FDA Application No. 201699. U S Food and Drug Administration
- ↑ Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y et al. (2011). "Fidaxomicin versus vancomycin for Clostridium difficile infection.". N Engl J Med 364 (5): 422-31. DOI:10.1056/NEJMoa0910812. PMID 21288078. Research Blogging.
- ↑ Template:Err (2011 [last update]). PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) - Study Results - ClinicalTrials.gov. clinicaltrials.gov. Retrieved on August 8, 2011.