2006NLA他汀肝臟安全性評估共識
《2006NLA他汀肝臟安全性評估共識》內(nèi)容簡介：
This has been consistently dem-onstrated in clinical trials performed during statin phase 2and 3 development programs and in long-term, end pointtrials.1The prescribing ***rmation for each statin citesthese associations. Aminotransferase elevations 3 timesthe upper limit of normal generally occur in 1% of pa-tients across the dose range for marketed statins; the excep-tions are aminotransferase elevations of this magnitude thatoccur in 2%–3% of patients receiving atorvastatin 80 mg/day or the combination of ezetimibe and a statin.
《2006NLA他汀肝臟安全性評估共識》內(nèi)容預覽：
Are statin-associated elevations in aminotransferase
levels indicative of liver damage or dysfunction?
● Response: No
● Confidence/level of evidence: 2C
RATIONALE. Isolated elevations of aminotransferases in theabsence of increased bilirubin levels have not been linkedclinically or histologically with evidence of acute or chronicliver injury.6 - 8Other mechanisms have been proposed thatcould explain commonly observed aminotransferase elevationsin individuals treated with statins, including a transient phar-macologic effect secondary to cholesterol reduction in hepato-cytes, comorbid conditions such as diabetes mellitus and obe-sity, and the consumption of alcohol or nonstatin medications.6Are statin-associated elevations in aminotransferasesa class effect?
● Response: Yes
● Confidence/level of evidence: 1A
RATIONALE. The Liver Expert Panel affirms that eleva-tions in aminotransferase levels have been reported with alldoses of all marketed statins and that no particular statinappears to cause these elevations more frequently than oth-ers. This observation is supported by the official productlabeling for each marketed statin2,3,9 -13and by long-termrandomized end point trials.1A recent meta-**ysis of 13of these clinical trials, involving 49,275 patients, supportsthis assertion.14Whereas fluvastatin demonstrated statisti-cally significant higher aminotransferase elevations at cer-tain doses in this meta-**ysis, the Panel was not persuadedthat this difference is clinically significant.
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