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Ezetimibe
General information
Ezetimibe is a selective potent inhibitor of the intestinal absorption of dietary and biliary cholesterol. A total of 432 patients were included in a pooled analysis of two phase-II studies, both lasting for 12 weeks; ezetimibe was well tolerated, with an adverse events profile similar to that of placebo [ ]. In 668 patients who took ezetimibe with simvastatin, the adverse reactions were similar to those with simvastatin alone [ ].
Drug studies
Placebo-controlled studies
Several studies of the use of ezetimibe, reported by the Ezetimibe Study Group, funded by the manufacturers Schering–Plough, have shown few differences in the rates of adverse events in patients taking ezetimibe or placebo [ , ], as have later studies [ , ], including trials of ezetimibe monotherapy [ ].
Systematic reviews
In a systematic review of 18 randomized controlled trials of combinations of ezetimibe with a statin in 14 471 patients, there were no increased risks of myalgia, increased creatine kinase, rhabdomyolysis, increased aminotransferases, gastrointestinal adverse events, or withdrawal because of an adverse event compared with statin monotherapy [ ].
In a systematic review of 18 randomized, controlled studies of lipid-lowering therapy in people with chronic kidney disease, two of which examined statins + ezetimibe, the rates of adverse events were similar between the intervention and comparator groups [ ].
Organs and systems
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