Eligibility did not depend on lipid levels. Patients were followed for a median of 4. At the mid-point of the study 2. Patients no longer taking study medication were included in all lipid measurements. The primary endpoint for the study was time to first major vascular event, defined as the composite of non-fatal heart attack or cardiac death, stroke or revascularization procedure in the two groups assigned to VYTORIN or placebo at study initiation.
This analysis did not include patients initially randomized to simvastatin alone for the first year. In the primary intent-to-treat analysis, The SHARP study design precluded drawing conclusions about the independent contribution of either ezetimibe or simvastatin to the observed effect on major vascular events.
Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred.
The risk of myopathy, including rhabdomyolysis, is dose related. The risk of myopathy, including rhabdomyolysis, is greater in patients taking simvastatin 80 mg compared with other statin therapies with similar or greater LDL cholesterol lowering efficacy, and with lower doses of simvastatin.
Please read Warnings and Precautions in the Prescribing Information for additional information. In such patients, higher doses should be used with caution and close monitoring. See Dosage and Administration in the Prescribing Information for additional information. Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be used when prescribing VYTORIN with colchicine.
Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate or severe hepatic impairment, VYTORIN is not recommended in these patients. Persistent elevations in hepatic transaminase can occur. Liver function tests should be performed at treatment initiation and thereafter when clinically indicated. Increases in HbA1c and fasting serum glucose levels have been reported with statins, including simvastatin.
In clinical trials, the most commonly reported side effects, regardless of cause, included headache 5. That label states that, because renal impairment is a risk factor for statin-associated myopathy, doses of simvastatin exceeding 20 mg should be used with caution and close monitoring when administered concomitantly with ZETIA in patients with moderate to severe renal impairment.
ZETIA, administered alone or in combination with a statin, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, and non-HDL cholesterol in patients with primary heterozygous familial and nonfamilial hyperlipidemia when diet alone is not enough.
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. FDA intends to update this sheet when additional information or analyses become available. In August , FDA issued an Early Communication describing a possible association between the use of Vytorin--a combination of simvastatin Zocor and ezetimibe Zetia --and an increased risk of cancer and cancer-related death compared to placebo.
Ezetimibe Zetia is a drug that lowers LDL cholesterol by decreasing its absorption in the intestine. Atorvastatin Lipitor is one of the world's best selling statins. The generic version, which is used in Liptruzet, has been available since November
0コメント