The FDA Has Approved a New Indication for Zetia®
Updated June 08, 2015.
The FDA has approved a new use for ezetimibe in patients that have mixed hyperlidemia. Individuals that have been diagnosed with mixed hyperlipidemia have low HDL levels ("good" cholesterol), high LDL levels (?bad? cholesterol), and high triglyceride levels. The new indication calls for the use of ezetimibe with fenofibrate, a cholesterol-lowering drug from the fibrate drug class, when diet and exercise alone are not enough to lower cholesterol levels.
Until this new indication, ezetimibe was used in combination with statins or by itself in lowering cholesterol levels.
In the most recent clinical trial involving 625 patients, co-administration of 10 mg of ezetimibe and 160 mg of fenofibrate reduced LDL cholesterol levels by 20.4%, and triglyceride levels by 44% over a 12-week period. This drug combination revealed a marked improvement in cholesterol levels compared to only a 6% reduction in LDL cholesterol levels when taking 160 mg of fenofibrate alone or by only 13% when taking 10 mg of ezetimibe alone. Approximately 576 of these patients continued to take the ezetimibe/fenofibrate combination, ezetimibe or fenofibrate over the next 48 weeks. The resulting cholesterol levels from continued use of each of the drugs are consistent with the results from the 12-week time period. This trial was published in the Journal of the American College of Cardiology in April 2006. Other results, such as one published in the European Heart Journal last year revealed that the ezetimibe/fenofibrate combination reduced LDL cholesterol levels by 20.4% and triglyceride levels by 44%,, and raised HDL cholesterol levels by 19% over a 12-week period.
The researchers who performed this study felt that the ezetimibe/fenofibrate combination was generally well tolerated among the participants of this study. However, gallbladder removal appeared to be more frequent among those taking the ezetimibe/fenofibrate combination (1.7%) in comparison to those taking fenofibrate alone (0.6%). Therefore, it is suggested that if gallstones are suspected in a patient, alternative lipid-lowering therapies should be used. Additionally, the use of ezetimibe with other fibrates in lowering cholesterol levels has not been investigated and such a combination should not be used until further studies are performed.
Currently, ezetimibe is marketed under the trade name Zetia®. Ezetimibe is unique from the other currently available cholesterol-lowering drugs in that it works in the small intestine by preventing the absorption of cholesterol into the blood stream and is usually used alone or in combination with a statin. Fenofibrate is the generic name for Tricor® or Lofibra®. This drug is classified as a fibrate, which is thought to increase the synthesis of the enzyme lipoprotein lipase, which breaks down VLDL. As more individuals use the ezetimibe/fenofibrate combination over time, the efficacy and side effects of such a combination will become clearer.
The FDA has approved a new use for ezetimibe in patients that have mixed hyperlidemia. Individuals that have been diagnosed with mixed hyperlipidemia have low HDL levels ("good" cholesterol), high LDL levels (?bad? cholesterol), and high triglyceride levels. The new indication calls for the use of ezetimibe with fenofibrate, a cholesterol-lowering drug from the fibrate drug class, when diet and exercise alone are not enough to lower cholesterol levels.
Until this new indication, ezetimibe was used in combination with statins or by itself in lowering cholesterol levels.
In the most recent clinical trial involving 625 patients, co-administration of 10 mg of ezetimibe and 160 mg of fenofibrate reduced LDL cholesterol levels by 20.4%, and triglyceride levels by 44% over a 12-week period. This drug combination revealed a marked improvement in cholesterol levels compared to only a 6% reduction in LDL cholesterol levels when taking 160 mg of fenofibrate alone or by only 13% when taking 10 mg of ezetimibe alone. Approximately 576 of these patients continued to take the ezetimibe/fenofibrate combination, ezetimibe or fenofibrate over the next 48 weeks. The resulting cholesterol levels from continued use of each of the drugs are consistent with the results from the 12-week time period. This trial was published in the Journal of the American College of Cardiology in April 2006. Other results, such as one published in the European Heart Journal last year revealed that the ezetimibe/fenofibrate combination reduced LDL cholesterol levels by 20.4% and triglyceride levels by 44%,, and raised HDL cholesterol levels by 19% over a 12-week period.
The researchers who performed this study felt that the ezetimibe/fenofibrate combination was generally well tolerated among the participants of this study. However, gallbladder removal appeared to be more frequent among those taking the ezetimibe/fenofibrate combination (1.7%) in comparison to those taking fenofibrate alone (0.6%). Therefore, it is suggested that if gallstones are suspected in a patient, alternative lipid-lowering therapies should be used. Additionally, the use of ezetimibe with other fibrates in lowering cholesterol levels has not been investigated and such a combination should not be used until further studies are performed.
Currently, ezetimibe is marketed under the trade name Zetia®. Ezetimibe is unique from the other currently available cholesterol-lowering drugs in that it works in the small intestine by preventing the absorption of cholesterol into the blood stream and is usually used alone or in combination with a statin. Fenofibrate is the generic name for Tricor® or Lofibra®. This drug is classified as a fibrate, which is thought to increase the synthesis of the enzyme lipoprotein lipase, which breaks down VLDL. As more individuals use the ezetimibe/fenofibrate combination over time, the efficacy and side effects of such a combination will become clearer.
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