A secondary prevention component of the Helsinki Heart Study enrolled middle-aged men excluded from the primary prevention study because of known or suspected coronary heart disease. Subjects received gemfibrozil or placebo for 5 years.
Although cardiac deaths trended higher in the gemfibrozil group, this was not statistically significant hazard ratio 2. The rate of gallbladder surgery was not statistically significant between study groups, but did trend higher in the gemfibrozil group, 1. Skeletal Muscle Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis.
The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal insufficiency, or hypothyroidism. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Data from observational studies indicate that the risk for rhabdomyolysis is increased when fibrates, in particular gemfibrozil, are co-administered with an HMG-CoA reductase inhibitor statin.
When transaminase determinations were followed either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed. The incidence of increases in transaminases related to fenofibrate therapy appear to be dose related. Hepatocellular, chronic active and cholestatic hepatitis associated with fenofibrate therapy have been reported after exposures of weeks to several years.
In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis. Serum Creatinine Elevations in serum creatinine have been reported in patients on fenofibrate.
These elevations tend to return to baseline following discontinuation of fenofibrate. The clinical significance of these observations is unknown. Renal monitoring should also be considered for patients taking TRICOR at risk for renal insufficiency such as the elderly and patients with diabetes.
Cholelithiasis Fenofibrate, like clofibrate and gemfibrozil, may increase cholesterol excretion into the bile , leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Pancreatitis Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate. This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
Hematologic Changes Mild to moderate hemoglobin , hematocrit , and white blood cell decreases have been observed in patients following initiation of fenofibrate therapy. However, these levels stabilize during long-term administration. Thrombocytopenia and agranulocytosis have been reported in individuals treated with fenofibrate. Periodic monitoring of red and white blood cell counts are recommended during the first 12 months of TRICOR administration.
Hypersensitivity Reactions Acute hypersensitivity reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis requiring patient hospitalization and treatment with steroids have been reported in individuals treated with fenofibrates. Urticaria was seen in 1. Of 9, patients enrolled in FIELD, there were 4, in the placebo group and 4, in the fenofibrate group. In the Coronary Drug Project, a higher proportion of the clofibrate group experienced definite or suspected fatal or nonfatal pulmonary embolism or thrombophlebitis than the placebo group 5.
This decrease has been reported to occur within 2 weeks to years after initiation of fibrate therapy. The HDL-C levels remain depressed until fibrate therapy has been withdrawn; the response to withdrawal of fibrate therapy is rapid and sustained. The clinical significance of this decrease in HDL-C is unknown. It is recommended that HDL-C levels be checked within the first few months after initiation of fibrate therapy.
If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated. When cholesterol and fats accumulate along the walls of your arteries, it decreases blood flow therefore preventing the oxygen supply to your heart, brain, and other parts of your body. Lowering "bad" cholesterol and triglycerides and increasing "good" cholesterol lowers the risk of heart disease and helps prevent strokes and heart attacks.
Do not switch between different forms unless directed by your doctor. It is important to take this medication correctly so that the drug has the greatest benefit. Take this medication regularly with food in order to obtain optimal results. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Follow your doctor's instructions very closely. While using TriCor, you may need frequent blood tests.
Your liver and gallbladder function may also need to be checked. Store at room temperature away from moisture, heat, and light. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Dosage Information in more detail What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.
Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at What should I avoid? If you also take cholestyramine, colesevelam, or colestipol: Wait 4 to 6 hours after taking any of these other medicines before you take TriCor.
Avoid taking fenofibrate within 1 hour before taking the other medicine. It can raise triglyceride levels, and may also damage your liver while you are taking TriCor.
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