Ezetimibe
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Ezetimibe Elevated creatine kinase and aminotransferase levels: case report A 45-year-old man experienced elevations in his creatine kinase (CK) and aminotransferase levels during a drug trial evaluating the addition of ezetimibe to a regimen including a statin and protease inhibitor. The man, whose history included HIV, hepatitis C, endstage renal disease following renal transplant, diabetes mellitus, hyperlipidaemia, hypertension, HIV wasting, and cocaine abuse, was receiving a ciclosporin and sirolimusbased immunosuppressive regimen, lopinavir/ritonavir-based antiretroviral therapy, and pravastatin for hyperlipidaemia. Baseline laboratory evaluations were as follows: alkaline phosphatase (ALP) 159 U/L (reference range 20–125), AST 73 U/L (2–50), ALT 88 U/L (2–60), and CK 328 U/L (0–200). His respective baseline sirolimus and ciclosporin concentrations were 38 ng/mL (reference range 5–20) and 140 ng/mL (100–400). Because he had not reached his goal LDLcholesterol level, he started ezetimibe 10 mg/day. After 6 weeks, his liver function tests (LFTs) had increased (ALP 186 U/L, AST 126 U/L, ALT 173 U/L); his CK level was 731 U/L. Two weeks later, his high liver enzyme levels persisted; his CK level had decreased to 224 U/L. A potential interaction was noted between ciclosporin and ezetimibe 6 weeks later, but he reported no side effects. At the time, his liver enzyme levels were stable, but his CK level was markedly elevated (1021 U/L). Ezetimibe and pravastatin were stopped, and the man reported cocaine abuse before and during the study. Two months after he withdrew from the study, elevation of his liver enzyme levels persisted (ALP 182 U/L, AST 202 U/L, ALT 238 U/L), but his CK level had decreased (420 U/L). His respective sirolimus and ciclosporin concentrations were 44 and 109 ng/mL. Four months after study withdrawal, his CK level remained high (454 U/L), but his liver enzyme levels had improved (ALP 123 U/L, AST 112 U/L, ALT 136 U/L). His drug urine screen was positive for cocaine metabolites. [Patient outcome not stated.] Author comment: Several factors may have contributed to the elevations in LFTs and CK. "One possible explanation is a drug-drug interaction between [cyclosprin] and ezetimibe. . . Additive toxicity of ezetimibe and pravastatin is another potential reason . . .coinfection with hepatitis C and baseline liver disease may have contributed . . .the relationship between cocaine use or initiation of ezetimibe and laboratory abnormalities was identified as ’possible’ by the application of the Naranjo probability scale." Klibanov OM, et al. Elevations in creatine kinase and hepatic transaminases in an HIV-positive patient. Infectious Diseases in Clinical Practice 14: 181-184, No. 3, 801067515 May 2006 - USA
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Reactions 8 Jul 2006 No. 1109
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