LOFIBRA SUMMARY
LOFIBRA® [Fenofibrate capsules (micronized)]
LOFIBRA® [Fenofibrate capsules (micronized)] is a lipid regulating agent available as capsules for oral administration.
Fenofibrate capsules (micronized) are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).
Treatment of Hypertriglyceridemia
Fenofibrate capsules (micronized) are also 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 fenofibrate therapy on reducing this risk has not been adequately 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 hyperlipoproteinemia2.
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic 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).
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NEWS HIGHLIGHTS
Published Studies Related to Lofibra (Fenofibrate)
Correlation of non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol with apolipoprotein B during simvastatin + fenofibrate therapy in patients with combined hyperlipidemia (a subanalysis of the SAFARI trial). [2009.08.15]
Guidelines have recommended non-high-density lipoprotein (non-HDL) cholesterol as a secondary target for therapy after the low-density lipoprotein (LDL) cholesterol goals have been met in patients with hypertriglyceridemia; non-HDL cholesterol is viewed as a surrogate for apolipoprotein (Apo)B, an alternate end point of treatment.
Relationships of HDL cholesterol, ApoA-I, and ApoA-II with homocysteine and creatinine in patients with type 2 diabetes treated with fenofibrate. [2009.06]
CONCLUSIONS: PPAR alpha agonists that have a more robust effect on HDL-C and apoA-I would be desirable.
Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomised controlled trial. [2009.05.23]
BACKGROUND: Amputations in people with type 2 diabetes mellitus substantially impair their quality of life and impose high costs on health-care systems. Our aim was to assess the effect of fenofibrate on amputation events in a large cohort of patients with type 2 diabetes... INTERPRETATION: Classic markers of macrovascular and microvascular risk were associated with lower extremity amputations in patients with type 2 diabetes. Treatment with fenofibrate was associated with a lower risk of amputations, particularly minor amputations without known large-vessel disease, probably through non-lipid mechanisms. These findings could lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations. FUNDING: Laboratoires Fournier SA (now part of Solvay Pharmaceuticals) and National Health and Medical Research Council of Australia.
Effect of fenofibrate on adiponectin and inflammatory biomarkers in metabolic syndrome patients. [2009.03]
Adiponectin is an adipose-secreted hormone with anti-inflammatory properties mediated by inhibition of nuclear factor-kappaB (NF-kappaB) signaling. This study investigates whether fenofibrate alters adiponectin levels in patients with hypertriglyceridemia and the metabolic syndrome, and examines the association of adiponectin with circulating inflammatory markers and whole blood cytokine production.
Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. [2009]
BACKGROUND: Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduces TG and, more moderately, LDL-C, increases HDL-C and produces a shift from small to large LDL particle size; the main effect of ezetimibe is a reduction in LDL-C levels. Combined treatment with fenofibrate and ezetimibe may correct all the abnormalities of type IIb dyslipidemia. OBJECTIVE: To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal(R)) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome compared with administration of fenofibrate and ezetimibe alone (ClinicalTrials.gov Identifier: NCT00349284; Study ID: CLF178P 04 01)... CONCLUSION: In patients with type IIb dyslipidemia and features of the metabolic syndrome, coadministration of fenofibrate 145 mg and ezetimibe 10 mg daily was more effective than either monotherapy in reducing LDL-C, non-HDL-C, apolipoprotein B, and cardiovascular risk ratios, and was as effective as fenofibrate 145 mg alone in reducing TG and in increasing HDL-C in patients with low baseline HDL-C levels.
Clinical Trials Related to Lofibra (Fenofibrate)
A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia [Active, not recruiting]
This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study
with a 52-week open-label follow-up to evaluate the safety and efficacy of daily
administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of
both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia.
There will be an open-label, 8-week, Selection Phase prior to randomization in which all
patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if
the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm,
double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg
or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg).
The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which
all patients will receive Pravafen.
After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria
will be randomized on a 1: 1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen
(the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the
completion of the 12-week double-blind phase of the study, all patients that haven't had
changes in their well being, will be allowed to roll-over into the 52-week, open-label,
follow-up portion of the study. During the 52 week, open label, Safety Phase of the study,
all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160
mg).
Patients will be evaluated at baseline and every three weeks thereafter throughout the
initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week,
open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks.
Participation in the study can be up to 72 weeks.
Evaluation of Efficacy and Safety of Omacor (Omega-3-Acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by 2 Extensions [Completed]
To evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to
Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.
The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study [Active, not recruiting]
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl
or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate;
or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target
dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C,
insulin resistance, and markers of inflammation.
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin [Active, not recruiting]
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both
hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary
mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall
objective of the study is to compare the efficacy and safety of combining fenofibrate and
simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of
cardiovascular diseases.
Zolip 0501: Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy [Active, not recruiting]
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both
hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary
mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall
objective of the study is to evaluate the efficacy and safety of combining fenofibrate and
simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
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Page last updated: 2009-10-20
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