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Fenofibric Acid Brand Names- Fibricor | Trilipix
What is Fenofibric Acid
Fenofibric acid is an oral antilipemic agent and is the active metabolite of fenofibrate.
It is a fibric acid derivative; other members of this drug class include clofibrate and gemfibrozil.
Like the other ‘fibrates’, fenofibric acid is most effective in treating lipid disorders associated with very high elevations of serum triglycerides and VLDL (e.g., type IV and V hyperlipoproteinemias).
Concomitant administration of fenofibric acid with both low-dose and moderate-dose statins has shown statistically significant increases in HDL-C and decreases in triglycerides that were greater than those seen with statin monotherapy and statistically significant reductions in LDL-C that were greater than seen with fenofibric acid monotherapy.
However, no incremental benefit of fenofibrate on coronary heart disease morbidity and mortality over and above that demonstrated for statin monotherapy has been established. In both the ACCORD and FIELD trials, fenofibrate, at a dose equivalent to 135 mg fenofibric acid, did not reduce coronary heart disease morbidity or mortality in patients with type 2 diabetes mellitus.
ACCORD was a randomized, placebo-controlled trial with a mean follow-up of 4.7 years that evaluated the use of fenofibrate in 5518 patients with type 2 diabetes mellitus who were on background statin therapy.
Fenofibrate demonstrated a non-significant 8% relative reduction in the primary outcome of major adverse cardiovascular events (HR 0.92 [0.79—1.08], p=0.32). In subgroup analysis, men seemed to benefit from fenofibrate therapy (HR 0.82 [0.69—0.99]); whereas, there was a trend toward harm among women (HR 1.38 [0.98-1.94], p=0.01 for interaction).
In the FIELD trial, fenofibrate, at a dose equivalent to 135 mg fenofibric acid, did not reduce coronary heart disease morbidity or mortality in patients with type 2 diabetes mellitus. FIELD was a 5-year randomized, placebo-controlled trial that evaluated the use of fenofibrate in 9,795 patients with type 2 diabetes mellitus.
Fenofibrate demonstrated a non-significant 11% relative reduction in the primary outcome of coronary heart disease events and a significant 11% reduction in the secondary outcome of total cardiovascular disease events (HR 0.89 [0.89—0.99], p=0.04).
Further results indicate a non-significant 11% and 19% increase in total and coronary heart disease mortality, respectively, associated with the use of fenofibrate as compared to placebo.
Fenofibric acid delayed-release capsules (TriLipix) were approved by the FDA in December 2008; fenofibric acid tablets (Fibricor) were approved by the FDA in August 2009.
Indications
- hyperlipoproteinemia
- hypertriglyceridemia
For use as an adjunct to diet in the treatment of hyperlipoproteinemia or hypertriglyceridemia
Side Effects
- abdominal pain
- agranulocytosis
- anemia
- arthralgia
- asthenia
- back pain
- blurred vision
- cholecystitis
- cholelithiasis
- cirrhosis
- constipation
- decreased HDL cholesterol (HDL-C) concentration
- depression
- diarrhea
- dizziness
- drowsiness
- dyspepsia
- elevated hepatic enzymes
- fatigue
- headache
- hepatitis
- hypertension
- impotence (erectile dysfunction)
- infection
- insomnia
- interstitial lung disease
- jaundice
- leukopenia
- libido decrease
- maculopapular rash
- muscle cramps
- musculoskeletal pain
- myalgia
- myasthenia
- myopathy
- nausea
- pancreatitis
- pharyngitis
- photosensitivity
- pruritus
- pulmonary embolism
- rash
- renal failure (unspecified)
- rhabdomyolysis
- rhinitis
- sinusitis
- Stevens-Johnson syndrome
- thrombocytopenia
- thrombosis
- toxic epidermal necrolysis
- urticaria
- visual impairment
- vitamin B12 deficiency
- vomiting
- weakness
Monitoring Parameters
- CBC with differential
- creatine phosphokinase (CPK)
- LFTs
- serum bilirubin (total and direct)
- serum cholesterol profile
- serum triglycerides
Contraindications
- anticoagulant therapy
- biliary cirrhosis
- breast-feeding
- cardiac disease
- cholelithiasis
- diabetes mellitus
- dialysis
- gallbladder disease
- geriatric
- hepatic disease
- hypothyroidism
- pancreatitis
- pregnancy
- renal disease
- renal failure
- renal impairment
- thromboembolic disease
Interactions
- Acarbose
- Acetaminophen; Diphenhydramine
- Acetohexamide
- Albiglutide
- Aliskiren; Valsartan
- Alogliptin; Metformin
- Alogliptin; Pioglitazone
- Alpha-glucosidase Inhibitors
- Amlodipine; Atorvastatin
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Valsartan
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amprenavir
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Omeprazole
- Aspirin, ASA; Pravastatin
- Atorvastatin
- Atorvastatin; Ezetimibe
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Bempedoic Acid; Ezetimibe
- Bortezomib
- Bosentan
- Canagliflozin
- Canagliflozin; Metformin
- Candesartan
- Candesartan; Hydrochlorothiazide, HCTZ
- Carbetapentane; Diphenhydramine; Phenylephrine
- Carisoprodol
- Celecoxib
- Chenodiol
- Chlorpropamide
- Cholestyramine
- Citalopram
- Clomipramine
- Clopidogrel
- Colchicine
- Colchicine; Probenecid
- Colestipol
- Dapagliflozin
- Dapagliflozin; Metformin
- Dapagliflozin; Saxagliptin
- Dextromethorphan; Diphenhydramine; Phenylephrine
- Diazepam
- Diclofenac
- Diclofenac; Misoprostol
- Dipeptidyl Peptidase-4 Inhibitors
- Diphenhydramine
- Diphenhydramine; Hydrocodone; Phenylephrine
- Diphenhydramine; Ibuprofen
- Diphenhydramine; Naproxen
- Diphenhydramine; Phenylephrine
- Dronabinol
- Dulaglutide
- Empagliflozin
- Empagliflozin; Linagliptin
- Empagliflozin; Linagliptin; Metformin
- Empagliflozin; Metformin
- Ertugliflozin
- Ertugliflozin; Metformin
- Ertugliflozin; Sitagliptin
- Escitalopram
- Esomeprazole; Naproxen
- Etravirine
- Exenatide
- Ezetimibe
- Ezetimibe; Simvastatin
- Famotidine; Ibuprofen
- Fluoxetine
- Fluoxetine; Olanzapine
- Flurbiprofen
- Fluvastatin
- Fosamprenavir
- Fosphenytoin
- Glimepiride
- Glimepiride; Pioglitazone
- Glimepiride; Rosiglitazone
- Glipizide
- Glipizide; Metformin
- Glyburide
- Glyburide; Metformin
- Hydrochlorothiazide, HCTZ; Losartan
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrochlorothiazide, HCTZ; Valsartan
- Hydrocodone; Ibuprofen
- Ibuprofen
- Ibuprofen; Oxycodone
- Ibuprofen; Pseudoephedrine
- Imipramine
- Incretin Mimetics
- Indomethacin
- Insulin Degludec; Liraglutide
- Insulin Glargine; Lixisenatide
- Insulins
- Lacosamide
- Lansoprazole
- Lansoprazole; Naproxen
- Linagliptin; Metformin
- Liraglutide
- Lixisenatide
- Loperamide
- Loperamide; Simethicone
- Losartan
- Lovastatin
- Lovastatin; Niacin
- Meloxicam
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Methadone
- Miglitol
- Naproxen
- Naproxen; Pseudoephedrine
- Naproxen; Sumatriptan
- Nateglinide
- Nebivolol; Valsartan
- Nelfinavir
- Niacin; Simvastatin
- Olanzapine
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Paclitaxel
- Phenobarbital
- Phenytoin
- Pioglitazone
- Piroxicam
- Pitavastatin
- Pramlintide
- Pravastatin
- Primidone
- Propranolol
- Quinine
- Rabeprazole
- Raltegravir
- Ramelteon
- Red Yeast Rice
- Repaglinide
- Rosiglitazone
- Rosuvastatin
- Sacubitril; Valsartan
- Semaglutide
- Sertraline
- SGLT2 Inhibitors
- Sildenafil
- Simvastatin
- Simvastatin; Sitagliptin
- Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
- Sulfonylureas
- Telbivudine
- Thalidomide
- Tolazamide
- Tolbutamide
- Torsemide
- Ursodeoxycholic Acid, Ursodiol
- Valdecoxib
- Valsartan
- Voriconazole
- Warfarin
