{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T09:11:27Z","timestamp":1784193087875,"version":"3.55.0"},"reference-count":53,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2012,2,1]],"date-time":"2012-02-01T00:00:00Z","timestamp":1328054400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate the pharmacology, microbiology, safety, and efficacy of fidaxomicin for treatment of Clostridium difficile infections (CDI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>Literature was identified through Ovid MEDLINE (1940-December 2011) and International Pharmaceutical Abstracts (1970-December 2011) using the search terms fidaxomicin, OPT-80, PAR-101, OP-118, difimicin, tiacumicin, lipiarmycin, Clostridium difficile, Clostridium difficile infection, Clostridium difficile-associated diarrhea, and cost. Drug monographs were retrieved from manufacturers\u2019 Web pages, and the Red Book component of Micromedex was used for cost Information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction:<\/jats:title>\n                    <jats:p>All pertinent Phase 1,2, and 3 studies published in English were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Fidaxomicin is a macrocyclic compound bactericidal against C. difficile and inhibits toxin and spore production. It has poor oral absorption with high fecal concentrations. Available Phase 2 and 3 data with fidaxomicin 200 mg orally every 12 hours demonstrate similar effectiveness in treating CDI compared to oral vancomycin. Fidaxomicin was shown to have less frequency of recurrent infections. Adverse effects are uncommon and occur at similar rates as with oral vancomycin. The most frequently reported adverse effects are gastrointestinal, hematologic, and electrolyte disorders. Available data are lacking in several areas, including the efficacy and safety of fidaxomicin compared to established regimens for mild-to-moderate, life-threatening, and recurrent CDIs. The cost of a 10-day course of fidaxomicin is significantly more than that of metronidazole and vancomycin for treatment of mild-to-moderate CDI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Fidaxomicin appears to be an effective and safe alternative to oral vancomycin for treatment of mild-to-moderate and severe CDI. Data on its use compared to guideline-recommended therapies for mild-to-moderate and life-threatening CDI are needed. Further data assessing the cost-effectiveness of fidaxomicin are needed. Currently, it cannot be recommended over vancomycin for treatment of CDI. However, it may be considered for treatment of recurrent infections.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1345\/aph.1q481","type":"journal-article","created":{"date-parts":[[2012,2,8]],"date-time":"2012-02-08T02:58:08Z","timestamp":1328669888000},"page":"219-228","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":21,"title":["Fidaxomicin for the Treatment of Clostridium diff\u00eccile Infections"],"prefix":"10.1177","volume":"46","author":[{"given":"Craig B","family":"Whitman","sequence":"first","affiliation":[{"name":"Clinical Pharmacy, Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quinn A","family":"Czosnowski","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy, Philadelphia College of Pharmacy, University of the Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2012,2,7]]},"reference":[{"key":"e_1_2_2_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/651706"},{"key":"e_1_2_2_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/QCO.0b013e32833229ce"},{"key":"e_1_2_2_4_2","doi-asserted-by":"publisher","DOI":"10.1086\/592981"},{"key":"e_1_2_2_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cir301"},{"key":"e_1_2_2_6_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid1309.061116"},{"key":"e_1_2_2_7_2","doi-asserted-by":"publisher","DOI":"10.1086\/649213"},{"key":"e_1_2_2_8_2","unstructured":"Product information. Vancocin (vancomycin HCl). Exton PA: ViroPharma Inc. October 2005. www.vancocin.com\/Vancocin_PI_2011.pdf (accessed 2011 Jul 18)."},{"key":"e_1_2_2_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/MCG.0b013e31814a4e97"},{"key":"e_1_2_2_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/1756283X10372985"},{"key":"e_1_2_2_11_2","doi-asserted-by":"publisher","DOI":"10.1086\/596552"},{"key":"e_1_2_2_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD004611.pub2"},{"key":"e_1_2_2_13_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1Q080"},{"key":"e_1_2_2_14_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-010-1411-2"},{"key":"e_1_2_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2011.04.012"},{"key":"e_1_2_2_16_2","unstructured":"ClinicalTrials.gov. Study of CB-183315 in patients with Clostridium difficile infection. http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01085591?term=cb-183&rank=1 (accessed 2011 Aug 2)."},{"key":"e_1_2_2_17_2","unstructured":"American Society of Health-System Pharmacists. Fidaxomicin approved for C. difficile infections. http:\/\/www.ashp.org\/menu\/News\/PharmacyNews\/NewsArticle.aspx?id=3549 (accessed 2011 Jul 18)."},{"key":"e_1_2_2_18_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1M351"},{"key":"e_1_2_2_19_2","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2010.485614"},{"key":"e_1_2_2_20_2","unstructured":"Product information. Dificid (fidaxomicin). San Diego CA: Optimer Pharmaceuticals May 2011."},{"key":"e_1_2_2_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.35.6.1108"},{"key":"e_1_2_2_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.50.1.401-402.2006"},{"key":"e_1_2_2_23_2","doi-asserted-by":"crossref","unstructured":"OsburneMS SonensheinAL. Inhibition by lipiarmycin of bacteriophage growth in Bacillus subtilis. J Virol 1980;33:945\u201353. www.dificid.com\/upload\/dificid.pdf (accessed 2011 Jul 18).","DOI":"10.1128\/jvi.33.3.945-953.1980"},{"key":"e_1_2_2_24_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.11.4430-4434.2004"},{"key":"e_1_2_2_25_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.12.4898-4902.2004"},{"key":"e_1_2_2_26_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01443-07"},{"key":"e_1_2_2_27_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00090-10"},{"key":"e_1_2_2_28_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.6.2280-2282.2004"},{"key":"e_1_2_2_29_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00476-08"},{"key":"e_1_2_2_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.anaerobe.2009.09.005"},{"key":"e_1_2_2_31_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0910812"},{"key":"e_1_2_2_32_2","article-title":"RNA polymerase target modification in Clostridium difficile with reduced susceptibility to fidaxomicin","author":"Seddon J","year":"2011","unstructured":"SeddonJ, BabakhaniF, GomezA, ArtsimovitchI, SearsP. RNA polymerase target modification in Clostridium difficile with reduced susceptibility to fidaxomicin. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_33_2","unstructured":"BabakhaniF ShangleS RobertN SearsP ShueYK. Resistance development cross-resistance and synergy studies of OPT-80 (poster Eo-2047). Presented at: 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington DC October 30-November 2 2004."},{"key":"e_1_2_2_34_2","article-title":"Fidaxomicin inhibits spore production in Clostridium difficile","author":"Gomez A","year":"2011","unstructured":"GomezA, SearsP, NguyenL, BabakhaniF. Fidaxomicin inhibits spore production in Clostridium difficile. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_35_2","article-title":"Fidaxomicin inhibits Clostridium difficile toxin synthesis and sporulation","author":"Bouillant L","year":"2011","unstructured":"BouillantL, BabakhaniF, SonensheinAL. Fidaxomicin inhibits Clostridium difficile toxin synthesis and sporulation. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_36_2","article-title":"Fidaxomicin inhibits production of toxin A and toxin B in Clostridium difficile","author":"Sims C","year":"2011","unstructured":"SimsC, GomezA, SearsP, BabakhaniF. Fidaxomicin inhibits production of toxin A and toxin B in Clostridium difficile. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_37_2","article-title":"Antimicrobial activity and post-antibiotic effect (PAE) of OPT-80, a new makrocytic compound against Clostridium difficile (abstract E-2048)","author":"Babakhani F","year":"2004","unstructured":"BabakhaniF, RobertN, ShangleS. Antimicrobial activity and post-antibiotic effect (PAE) of OPT-80, a new makrocytic compound against Clostridium difficile (abstract E-2048). Presented at: 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, October 30-November 2, 2004.","journal-title":"Presented at: 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_38_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01442-07"},{"key":"e_1_2_2_39_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01045-07"},{"key":"e_1_2_2_40_2","article-title":"High fecal and low plasma levels of fidaxomicin and metabolite OP-118 in patients with Clostridium difficile infection: combined results of two phase 3 trials","author":"Sears PS","year":"2011","unstructured":"SearsPS, CrookDW, LouieTJ, MillerM, WeissK. High fecal and low plasma levels of fidaxomicin and metabolite OP-118 in patients with Clostridium difficile infection: combined results of two phase 3 trials. Presented at: Digestive Disease Week, Chicago, IL, May 7-10, 2011.","journal-title":"Presented at: Digestive Disease Week"},{"key":"e_1_2_2_41_2","article-title":"Minimal impact of food on the pharmacokinetics of oral fidaxomicin","author":"Lewis W","year":"2011","unstructured":"LewisW, SearsPS. Minimal impact of food on the pharmacokinetics of oral fidaxomicin. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_42_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1102685"},{"key":"e_1_2_2_43_2","article-title":"Randomized clinical trial in Clostridium difficile infection confirms equivalent cure rate and lower recurrence rate of fidaxomicin vs vancomycin (abstract LB 2401)","author":"Crook D","year":"2010","unstructured":"CrookD, WeissK, MillerOACM, EspositoR, GorbachS. Randomized clinical trial in Clostridium difficile infection confirms equivalent cure rate and lower recurrence rate of fidaxomicin vs vancomycin (abstract LB 2401). Presented at: 2010 European Congress of Clinical Microbiology and Infectious Diseases 2010; Vienna, Austria.","journal-title":"Presented at: 2010 European Congress of Clinical Microbiology and Infectious Diseases"},{"key":"e_1_2_2_44_2","article-title":"Multivariate analysis of Clostridium difficile infection (CDI) outcomes in epidemic BI-associated cases treated with fidaxomicin or vancomycin","author":"Patrella LA","year":"2011","unstructured":"PatrellaLA, SambolSP, NagaroK. Multivariate analysis of Clostridium difficile infection (CDI) outcomes in epidemic BI-associated cases treated with fidaxomicin or vancomycin. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_45_2","article-title":"Risk of recurrence and time to recurrence following treatment of Clostridium difficile infection: patient characteristics and the differential effect of fidaxomicin vs vancomycin","author":"Golan Y","year":"2011","unstructured":"GolanY, LouieTJ, MillerM. Risk of recurrence and time to recurrence following treatment of Clostridium difficile infection: patient characteristics and the differential effect of fidaxomicin vs vancomycin. Presented at: Digestive Disease Week, Chicago, IL, May 7-10, 2011.","journal-title":"Presented at: Digestive Disease Week"},{"key":"e_1_2_2_46_2","article-title":"Effect of cyclosporine on the pharmacokinetics of fidaxomicin","author":"Lewis W","year":"2011","unstructured":"LewisW, SearsPS. Effect of cyclosporine on the pharmacokinetics of fidaxomicin. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_47_2","article-title":"Minimal effect of fidaxomicin on digoxin pharmacokinetics","author":"Lewis W","year":"2011","unstructured":"LewisW, TangM, SearsPS. Minimal effect of fidaxomicin on digoxin pharmacokinetics. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_48_2","article-title":"Coadministration of fidaxomicin does not impact the pharmacokinetics of CYP substrates omeprazole, warfarin, or midazolam","author":"Lewis W","year":"2011","unstructured":"LewisW, SearsPS. Coadministration of fidaxomicin does not impact the pharmacokinetics of CYP substrates omeprazole, warfarin, or midazolam. Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2011.","journal-title":"Presented at: 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy"},{"key":"e_1_2_2_49_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01842-09"},{"key":"e_1_2_2_50_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD004610.pub4"},{"key":"e_1_2_2_51_2","unstructured":"Dificid. Red book online. Thomson Reuters Healthcare Inc. Greenwood Village CO. www.thomsonhc\/micromedex.com (accessed 27 July 2011)."},{"key":"e_1_2_2_52_2","unstructured":"Metronidazole. Red book online. Thomson Reuters Healthcare Inc. Greenwood Village CO. www.thomsonhc\/micromedex.com (accessed 27 July 2011)."},{"key":"e_1_2_2_53_2","unstructured":"Vancomycin. Red book online. Thomson Reuters Healthcare Inc. Greenwood Village CO. www.thomsonhc\/micromedex.com (accessed 27 July 2011)."},{"key":"e_1_2_2_54_2","first-page":"172","article-title":"Economic healthcare costs of Clostridium difficile infection: a systematic review","volume":"77","author":"Ghantoji SS","year":"2010","unstructured":"GhantojiSS, SailK, LairsonDR, DuPontHL, GareyKW. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect 2010;77:172\u20133.","journal-title":"J Hosp Infect"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1345\/aph.1Q481","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1345\/aph.1Q481","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:11:28Z","timestamp":1777374688000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1345\/aph.1Q481"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,2]]},"references-count":53,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2012,2]]}},"alternative-id":["10.1345\/aph.1Q481"],"URL":"https:\/\/doi.org\/10.1345\/aph.1q481","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,2]]}}}