Document Detail


Adverse events associated with the use of cyclosporine in patients with inflammatory bowel disease.
MedLine Citation:
PMID:  18177449     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Intravenous cyclosporine (i.v. CsA) is an effective therapy for patients with inflammatory bowel disease (IBD). However, data regarding its adverse events in these patients are limited. METHODS: A retrospective chart review of the initial 111 consecutive patients with IBD treated with i.v. CsA followed by a predetermined duration of oral therapy. RESULTS: One hundred eleven patients (64 UC, 47 CD; mean age 33 yr, range 16-68) received i.v. CsA at 4 mg/kg/day, then oral CsA at 8 mg/kg/day, with dose adjustment based on serum creatinine. The mean treatment duration was 9.3 months (range 1 wk to 34 months). Major adverse events occurred in 17 (15.3%) patients. Nephrotoxicity (serum creatinine > or = 1.4 mg/dL [123 micromol/L] or a rise by at least 33% over baseline not responding to dose adjustment) sufficiently severe to warrant discontinuation of therapy occurred in 6 (5.4%) patients. Serious infection occurred in 7 (6.3%) patients, seizures in 4 (3.6%) patients, anaphylaxis in 1 (0.9%) patient, and death in 2 (1.8%) patients. Minor adverse events (transient effects with complete resolution either spontaneously or with dose adjustment) comprised: paresthesias (51%), hypomagnesemia (42%), hypertension (39%), hypertrichosis (27%), headache (23%), minor nephrotoxicity (defined as above but with restoration of normal serum creatinine with dose adjustment; 19% of patients), abnormal liver function tests (19%), minor infections (15%), hyperkalemia (13%), and gingival swelling (4%). CONCLUSIONS: In our initial experience, limited duration CsA therapy was frequently associated with adverse events although the majority of these were minor and responded to dose adjustment. Although not all severe adverse events can be clearly attributed to CsA use alone, its high incidence suggests that vigorous monitoring by experienced clinicians at tertiary care centers may be required.
Authors:
Michael B Sternthal; Seamus J Murphy; James George; Asher Kornbluth; Simon Lichtiger; Daniel H Present
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Publication Detail:
Type:  Journal Article     Date:  2008-01-02
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  103     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-04-09     Completed Date:  2008-06-03     Revised Date:  2008-10-28    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  937-43     Citation Subset:  IM    
Affiliation:
The Dr. Henry D. Janowitz Division of Gastroenterology, Department of Medicine, Mount Sinai Medical Center, New York, New York 10028, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Aged
Cyclosporine / administration & dosage,  adverse effects*
Female
Humans
Immunosuppressive Agents / administration & dosage,  adverse effects*
Inflammatory Bowel Diseases / drug therapy*
Infusions, Intravenous
Male
Middle Aged
Retrospective Studies
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 59865-13-3/Cyclosporine
Comments/Corrections
Comment In:
Am J Gastroenterol. 2008 Oct;103(10):2654-5; author reply 2655   [PMID:  18855861 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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