| Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver-transplant recipients. The Oral Ganciclovir International Transplantation Study Group [corrected] | |
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MedLine Citation:
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PMID: 9413463 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Cytomegalovirus (CMV) disease is a frequent cause of serious morbidity after solid-organ transplantation. The prophylactic regimens used to prevent CMV infection and disease have shown limited benefit in seronegative recipients. We studied the safety and efficacy of oral ganciclovir in the prevention of CMV disease following orthotopic liver transplantation. METHODS: Between December, 1993, and April, 1995, 304 liver-transplant recipients were randomised to receive oral ganciclovir 1000 mg or matching placebo three times a day. Seronegative recipients of seronegative livers were excluded. Study drug was administered as soon as the patient was able to take medication by mouth (no later than day 10) until the 98th day after transplantation. Patients were assessed at specified times throughout the first 6 months after surgery for evidence of CMV infection, CMV disease, rejection, opportunistic infections, and possible drug toxicity. FINDINGS: The Kaplan-Meier estimate of the 6-month incidence of CMV disease was 29 (18.9%) of 154 in the placebo group, compared with seven (4.8%) of 150 in the ganciclovir group (p < 0.001). In the high-risk group of seronegative recipients (R-) of seropositive livers (D+), incidence of CMV disease was 11 (44.0%) of 25 in the placebo group, three (14.8%) of 21 in the ganciclovir group (p = 0.02). Significant benefit was also observed in those receiving antibodies to lymphocytes, where the incidence of CMV disease was 12 (32.9%) of 37 in the placebo group and two (4.6%) of 44 in the ganciclovir group (p = 0.002). Oral ganciclovir reduced the incidence of CMV infection (placebo 79 [51.5%] of 154; ganciclovir 37 [24.5%] of 150; p < 0.001) and also reduced symptomatic herpes-simplex infections (Kaplan-Meier estimates: placebo 36 [23.5%] of 154; ganciclovir five [3.5%] of 150; p < 0.001). INTERPRETATION: Oral ganciclovir is a safe and effective method for the prevention of CMV disease after orthotopic liver transplantation. |
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Authors:
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E Gane; F Saliba; G J Valdecasas; J O'Grady; M D Pescovitz; S Lyman; C A Robinson |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Lancet Volume: 350 ISSN: 0140-6736 ISO Abbreviation: Lancet Publication Date: 1997 Dec |
Date Detail:
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Created Date: 1998-01-22 Completed Date: 1998-01-22 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: ENGLAND |
Other Details:
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Languages: eng Pagination: 1729-33 Citation Subset: AIM; IM |
Affiliation:
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Institute of Liver Studies, Kings College School of Medicine, London, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Adult Antiviral Agents / administration & dosage, adverse effects, therapeutic use* Cytomegalovirus Infections / prevention & control* Disease-Free Survival Double-Blind Method Female Ganciclovir / administration & dosage, adverse effects, therapeutic use* Humans Liver Transplantation* Male Middle Aged Postoperative Period |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 82410-32-0/Ganciclovir |
| Comments/Corrections | |
Comment In:
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Lancet. 1997 Dec 13;350(9093):1718-9
[PMID:
9413457
]
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Erratum In:
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Lancet 1998 Feb 7;351(9100):454 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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