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Fluvastatin Brand Names- Lescol | Lescol XL
What is Fluvastatin
Fluvastatin is an oral antilipemic agent indicated for the treatment of primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb).
Fluvastatin doses of 20—40 mg once daily result in mean LDL reductions ranging from 22—25%; whereas, the extended-release formulation (Lescol XL 80 mg) reduces LDL by about 36%.
Fluvastatin is a HMG-CoA reductase inhibitor and was the first to be synthetically prepared. It has some similarities to lovastatin, simvastatin, and pravastatin, but it is structurally distinct, resulting in unique biopharmaceutic properties.
Purported advantages of fluvastatin over the other HMG-CoA reductase inhibitors include short half-life with no active metabolites, extensive protein binding, and minimal CSF penetration.
These criteria suggest fluvastatin may be less likely to cause systemic adverse reactions than the other agents in this class.
Fluvastatin is primarily used as an adjunct to diet to lower cholesterol and triglyceride levels associated with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb).
Based on results from the Lipoprotein and Coronary Atherosclerosis Study,
the FDA approved fluvastatin for slowing of progression of coronary atherosclerosis in patients with coronary artery disease.
The FDA also approved Lescol and Lescol XL for secondary prevention of coronary events in patients with coronary heart disease based on the findings of the LIPS trial.
The LIPS trial demonstrated that initiation of fluvastatin 80 mg/day within days following PCI significantly reduces the risk of major cardiac events (cardiac death, nonfatal MI, coronary revascularization).
Additionally, a large retrospective study demonstrated that continuation of statin therapy provides an ongoing reduction in all-cause mortality in patients with and without known coronary heart disease (CHD), with the greatest risk reduction among patients with a baseline LDL-C >= 190 mg/dL and patients initiated on higher efficacy statins (i.e., simvastatin, pravastatin, or lovastatin 80 mg/day; atorvastatin >= 20 mg/day; rosuvastatin >= 10 mg/day).
Among patients with a proportion of days covered (PDC) of >= 90%, determined by the number of statin prescriptions dispensed during the time between the first statin prescription and the end of follow up, there was a 45% and 51% lower mortality risk in the primary (patients without known CHD) and secondary (patients with known CHD) prevention groups, respectively, compared to patients with a PDC <= 10%.
The mean length of follow up was 4 and 5 years in the primary and secondary prevention groups, respectively, with a maximum length of follow up of 9.5 years.
Fluvastatin (Lescol) was approved by the FDA in December 1993.
An extended-release product (Lescol XL) was approved by the FDA in October 2000.
Indications
- hypercholesterolemia
- hyperlipoproteinemia
- hypertriglyceridemia
- myocardial infarction prophylaxis
- stroke prophylaxis
For the treatment of hypercholesterolemia, including hyperlipidemia, hyperlipoproteinemia, or hypertriglyceridemia, as an adjunct to dietary controll, for the purpose of reducing the risk of cardiovascular events (e.g., myocardial infarction prophylaxis, stroke prophylaxis)
Side Effects
- abdominal pain
- alopecia
- amnesia
- anaphylactoid reactions
- angioedema
- anorexia
- anxiety
- arthralgia
- arthropathy
- atrial fibrillation
- chills
- cholestasis
- cirrhosis
- Co-Enzyme Q-10 deficiency
- confusion
- constipation
- cranial nerve palsies
- depression
- diabetes mellitus
- diarrhea
- dizziness
- drowsiness
- dysarthria
- dysesthesia
- dysgeusia
- dyspepsia
- dysphagia
- dyspnea
- elevated hepatic enzymes
- eosinophilia
- erythema multiforme
- fatigue
- fever
- flatulence
- flushing
- gynecomastia
- headache
- hemolytic anemia
- hepatic failure
- hepatic necrosis
- hepatitis
- hyperglycemia
- hypertension
- hypoesthesia
- immune-mediated necrotizing myopathy
- impotence (erectile dysfunction)
- infection
- influenza
- insomnia
- jaundice
- leukopenia
- libido decrease
- lupus-like symptoms
- malaise
- memory impairment
- muscle cramps
- muscle paralysis
- myalgia
- myasthenia
- myoglobinuria
- myopathy
- nausea
- pancreatitis
- paresthesias
- peripheral edema
- peripheral neuropathy
- pharyngitis
- photosensitivity
- pruritus
- purpura
- rash
- rhabdomyolysis
- sinusitis
- Stevens-Johnson syndrome
- syncope
- thrombocytopenia
- toxic epidermal necrolysis
- tremor
- urticaria
- vasculitis
- vertigo
- vomiting
- weakness
Monitoring Parameters
- creatine phosphokinase (CPK)
- LFTs
- serum cholesterol profile
Contraindications
- alcoholism
- breast-feeding
- children
- cholestasis
- contraception requirements
- diabetes mellitus
- electrolyte imbalance
- endocrine disease
- females
- geriatric
- hepatic disease
- hepatic encephalopathy
- hepatitis
- hypotension
- hypothyroidism
- infants
- infection
- jaundice
- myopathy
- organ transplant
- pregnancy
- renal disease
- renal failure
- renal impairment
- rhabdomyolysis
- seizure disorder
- surgery
- trauma
Interactions
- Amiodarone
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amprenavir
- Aprepitant, Fosaprepitant
- Aspirin, ASA; Omeprazole
- Atazanavir
- Atazanavir; Cobicistat
- Bortezomib
- Cholestyramine
- Cimetidine
- Clarithromycin
- Cobicistat
- Colchicine
- Colchicine; Probenecid
- Cyclosporine
- Daclatasvir
- Daptomycin
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Deferasirox
- Delavirdine
- Diclofenac
- Diclofenac; Misoprostol
- Digoxin
- Dronabinol
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elbasvir; Grazoprevir
- Elexacaftor; tezacaftor; ivacaftor
- Eltrombopag
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Erythromycin
- Erythromycin; Sulfisoxazole
- Esomeprazole
- Esomeprazole; Naproxen
- Ethanol
- Etravirine
- Everolimus
- Fenofibrate
- Fenofibric Acid
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluvoxamine
- food
- Fosamprenavir
- Fosphenytoin
- Fostemsavir
- Gemfibrozil
- Glecaprevir; Pibrentasvir
- Glimepiride
- Glimepiride; Pioglitazone
- Glimepiride; Rosiglitazone
- Glyburide
- Glyburide; Metformin
- Imatinib
- Indinavir
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Ivacaftor
- Lanthanum Carbonate
- Leflunomide
- Lesinurad
- Lesinurad; Allopurinol
- Letermovir
- Lopinavir; Ritonavir
- Lovastatin; Niacin
- Lumacaftor; Ivacaftor
- Meloxicam
- Mifepristone
- Nelfinavir
- Niacin, Niacinamide
- Niacin; Simvastatin
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Oritavancin
- Phenytoin
- Raltegravir
- Ranitidine
- Red Yeast Rice
- Regorafenib
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Rucaparib
- Saquinavir
- Simeprevir
- Sirolimus
- Sofosbuvir; Velpatasvir; Voxilaprevir
- Sulfinpyrazone
- Sulfonamides
- Tacrolimus
- Telaprevir
- Telbivudine
- Telithromycin
- Terbinafine
- Teriflunomide
- Tezacaftor; Ivacaftor
- Tipranavir
- Tolvaptan
- Vemurafenib
- Voriconazole
- Warfarin
- Zafirlukast
