Safety Analysis of Fidaxomicin in Comparison With Oral Vancomycin for Clostridium difficile Infections

被引:26
作者
Weiss, Karl [1 ]
Allgren, Robin L. [2 ]
Sellers, Sarah [3 ]
机构
[1] Univ Montreal, Hop Maison Neuve Rosemont, Fac Med, Dept Infect Dis & Microbiol, Montreal, PQ H1T 2M4, Canada
[2] Breakthrough Bio Dev LLC, San Diego, CA USA
[3] Q Vigilance LLC, Barrington, IL USA
关键词
METRONIDAZOLE; DIARRHEA; COLITIS; NEUROPATHY; MORTALITY; OUTBREAK;
D O I
10.1093/cid/cis390
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Fidaxomicin is a novel macrocyclic antibiotic recently approved by the US Food and Drug Administration for the treatment of Clostridium difficile-associated diarrhea in adults. We reviewed safety data from nonclinical studies and clinical trials (phases 1, 2A, and 3) with fidaxomicin. In nonclinical studies, fidaxomicin was administered orally at approximately 1 g/kg/d to dogs for up to 3 months with no significant target-organ toxicities observed. A total of 728 adults have received oral fidaxomicin in clinical trials to date: 116 healthy volunteers and 612 patients with C. difficile infection. In phase 3 clinical trials, fidaxomicin was well tolerated, with a safety profile comparable with oral vancomycin. There were no differences in the incidence of death or serious adverse events between the 2 drugs. Fidaxomicin appears to be well tolerated. Continued monitoring of adverse events in the postmarketing setting will provide additional information about the full safety profile of fidaxomicin.
引用
收藏
页码:S110 / S115
页数:6
相关论文
共 23 条
  • [1] Anti-Infective Drugs Advisory Committee, DIF FID TABL TREATM
  • [2] Significant absorption of oral vancomycin in a patient with Clostfidium difficile colitis and normal renal function
    Aradhyula, Sangita
    Manian, Farrin A.
    Hafidh, Saad A. S.
    Bhutto, Saqib S.
    Alpert, Martin A.
    [J]. SOUTHERN MEDICAL JOURNAL, 2006, 99 (05) : 518 - 520
  • [3] ANTIBIOTIC-ASSOCIATED PSEUDOMEMBRANOUS COLITIS DUE TO TOXIN-PRODUCING CLOSTRIDIA
    BARTLETT, JG
    CHANG, TW
    GURWITH, M
    GORBACH, SL
    ONDERDONK, AB
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1978, 298 (10) : 531 - 534
  • [4] The case for vancomycin as the preferred drug for treatment of Clostridium difficile infection
    Bartlett, John G.
    [J]. CLINICAL INFECTIOUS DISEASES, 2008, 46 (10) : 1489 - 1492
  • [5] BROWNE RA, 1977, JOHNS HOPKINS MED J, V141, P183
  • [6] PERIPHERAL NEUROPATHY IN CROHNS-DISEASE PATIENTS TREATED WITH METRONIDAZOLE
    DUFFY, LF
    DAUM, F
    FISHER, SE
    SELMAN, J
    VISHNUBHAKAT, SM
    AIGES, HW
    MARKOWITZ, JF
    SILVERBERG, M
    [J]. GASTROENTEROLOGY, 1985, 88 (03) : 681 - 684
  • [7] Is there a relationship between vancomycin-resistant enterococcal infection and Clostridium difficile infection?
    Gerding, DN
    [J]. CLINICAL INFECTIOUS DISEASES, 1997, 25 : S206 - S210
  • [8] Gorbach S, 2009, 49 ANN INT C ANT AG
  • [9] Health care costs and mortality associated with nosocomial diarrhea due to Clostridium difficile
    Kyne, L
    Hamel, MB
    Polavaram, R
    Kelly, CNP
    [J]. CLINICAL INFECTIOUS DISEASES, 2002, 34 (03) : 346 - 353
  • [10] A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality
    Loo, VG
    Poirier, L
    Miller, MA
    Oughton, M
    Libman, MD
    Michaud, S
    Bourgault, AM
    Nguyen, T
    Frenette, C
    Kelly, M
    Vibien, A
    Brassard, P
    Fenn, S
    Dewar, K
    Hudson, TJ
    Horn, R
    René, P
    Monczak, Y
    Dascal, A
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2005, 353 (23) : 2442 - 2449