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Basic Drug Info
Drug Name:Triglide
Manufacturer:Sciele Pharma, Inc.
Other Info:



Clinical Trials:


Indications and Usage
TRIGLIDE is indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.  Markedly elevated levels of serum triglycerides (e.g., >2,000 mg/dL) may increase the risk of developing pancreatitis.  The effect of TRIGLIDE therapy on reducing this risk has not been studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low-density lipoprotein (VLDL).  Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia (Nikkila, 1983). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality.  Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy.  Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated.  Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods.  If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.  (See WARNINGS and PRECAUTIONS.) Fredrickson Classification of Hyperlipoproteinemias  TypeLipoprotein ElevatedLipid ElevationMajor                            Minor I (rare)ChylomicronsTG??C IIaLDLC- IIbLDL, VLDLCTG III (rare)IDLC, TG- IVVLDLTG??C V (rare)Chylomicrons, VLDLTG??  C = cholesterol; IDL - intermediate density lipoprotein; LDL = low-density lipoprotein; TG - triglycerides; VLDL = very low-density lipoprotein NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories Risk CategoryLDL Goal (mg/dL)LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL) CHD† or CHD risk equivalents (10-year risk >20%)<100?100?130 (100-129 drug optional) †† 2+ risk factors (10-year risk ?20%)<130?13010-year risk 10%-20% ?13010-year risk < 10% ?160 0-1 risk factor†††<160?160?190(160-189: LDL-lowering drug optional) † CHD = coronary heart disease††  Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes.  Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate.  Clinical judgment also may call for deferring drug therapy in this category.†††  Almost all people with 0-1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary.
Contraindications
TRIGLIDE administration is contraindicated in the following conditions:Hypersensitivity to fenofibrate or any of the formulation componentsSevere renal dysfunctionHepatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormalityPre-existing gallbladder disease(See WARNINGS.)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Primary biliary cirrhosis -- a form of biliary cirrhosis in which small intrahepatic ducts are destroyed while the major intra and extra hepatic ducts remain patent; most patients are middle aged females and have circulating antimitochondrial antibodies.

Gall Bladder Diseases -- Diseases of the GALLBLADDER. They generally involve the impairment of BILE flow, GALLSTONES in the BILIARY TRACT, infections, neoplasms, or other diseases.

Warnings

The Helsinki Heart Study was a large (n = 4,081) study of middle-aged men without a history of coronary artery disease.  Subjects received either placebo or gemfibrozil for 5 years, with a 3.5 year open extension afterward.  Total mortality was numerically higher in the gemfibrozil randomization group but did not achieve statistical significance (p=0.19, 95% confidence interval for relative risk G:P = 0.91- 1.64).  Although cancer deaths trended higher in the gemfibrozil group (p=0.11), cancers (excluding basal cell carcinoma) were diagnosed with equal frequency in both study groups.  Due to the limited size of the study, the relative risk of death from any cause was not shown to be different than that seen in the 9 year follow-up data from World Health Organization study (RR = 1.29).  Similarly, the numerical excess of gallbladder surgeries in the gemfibrozil group did not differ statistically from that observed in the WHO study.  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 2.2, 95% confidence interval: 0.94-5.05).  The rate of gallbladder surgery was not statistically significant between study groups, but did trend higher in the gemfibrozil group, (1.9% vs.

0.3%, p=0.07).  There was a statistically significant difference in the number of appendectomies in the gemfibrozil group (6/311 vs.

0/317, p=0.029).

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