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| __NOTOC__
| | #REDIRECT [[Gemfibrozil#Nonclinical Toxicology]] |
| {{Gemfibrozil}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Nonclinical Toxicology==
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| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
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| Long-term studies have been conducted in rats at 0.2 and 1.3 times the human exposure (based on AUC). The incidence of benign liver nodules and [[liver carcinoma]]s was significantly increased in high dose male rats. The incidence of liver carcinomas increased also in low dose males, but this increase was not statistically significant (p=0.1). Male rats had a dose-related and statistically significant increase of benign Leydig cell tumors. The higher dose female rats had a significant increase in the combined incidence of benign and malignant [[liver neoplasms]].
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| Long-term studies have been conducted in mice at 0.1 and 0.7 times the human exposure (based on AUC). There were no statistically significant differences from controls in the incidence of liver tumors, but the doses tested were lower than those shown to be carcinogenic with other fibrates.
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| Electron microscopy studies have demonstrated a florid hepatic peroxisome proliferation following LOPID administration to the male rat. An adequate study to test for peroxisome proliferation has not been done in humans but changes in peroxisome morphology have been observed. Peroxisome proliferation has been shown to occur in humans with either of two other drugs of the fibrate class when liver biopsies were compared before and after treatment in the same individual.
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| Administration of approximately 2 times the human dose (based on surface area) to male rats for 10 weeks resulted in a dose-related decrease of fertility. Subsequent studies demonstrated that this effect was reversed after a drug-free period of about eight weeks, and it was not transmitted to the offspring.<ref>{{Cite web | last = | first = | title = DailyMed: Search | url = http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=+Lopid&x=11&y=10 | publisher = | date = | accessdate = 13 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| | [[Category: Cardiovascular Drugs]] |
| | [[Category: Drug]] |
| [[Category:Fibrates]] | | [[Category:Fibrates]] |
| [[Category:Phenol ethers]]
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| [[Category:Cardiovascular Drug]]
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| [[Category:Drug]]
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