Lovastatin Brand Names- Altoprev | Mevacor
What is Lovastatin
Lovastatin is an oral antilipemic agent produced by fermentation of Aspergillus terreus.
Lovastatin represents the first HMG-CoA reductase inhibitor to be introduced.
Lovastatin was developed as a prodrug to concentrate active drug in the liver during first-pass circulation.
Simvastatin is also a prodrug, but pravastatin and fluvastatin are not.
Lovastatin (Mevacor) doses of 10—80 mg/day, given in 1—2 divided doses, result in mean LDL reductions ranging from 21—42%.
Lovastatin (Mevacor) was approved by the FDA for the treatment of hypercholesterolemia in August 1987.
Since that time, its indications have been expanded to include slowing the progression of coronary atherosclerosis, primary prevention (myocardial infarction prophylaxis), and stroke prophylaxis.
In the AFCAPS/TexCAPS primary prevention study, lovastatin reduced the risk for the first acute major coronary event in adult men and women with average total and LDL cholesterol levels and below average HDL cholesterol levels.
After an average of 5.2 years, lovastatin reduced the incidence of first acute major coronary event by 37%, fatal or nonfatal myocardial infarction by 40%, unstable angina by 32%, and coronary revascularization procedures by 33%, respectively.
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.
Several generic equivalents for Mevacor were approved in December, 2001. Advicor (see separate monograph), a combination product for lovastatin and niacin, was approved by the FDA in December, 2001.
The FDA approved an extended-release formulation of lovastatin, Altocor, on June 26, 2002. The proprietary name for Altocor lovastatin extended-release tablets was changed to Aloprev by the FDA on July 21, 2004. An FDA advisory committee voted 20 to 3 against marketing lovastatin 20 mg as an OTC product during January 2005.
Although favorable results were reported by the manufacturer-sponsored CUSTOM study in regard to OTC lovastatin use, the FDA advisory committee raised concerns of inappropriate self-selection (self-diagnosis) by the study participants.
In December 2007, an FDA advisory panel again voted 10 to 2 against the OTC marketing of lovastatin citing concern that patients would not be able to properly follow instructions to safely use lovastatin without a prescription.
Indications
- atherosclerosis
- hypercholesterolemia
- hyperlipoproteinemia
- hypertriglyceridemia
- myocardial infarction prophylaxis
- stroke prophylaxis
For the treatment of hypercholesterolemia, including hyperlipidemia, hyperlipoproteinemia, or hypertriglyceridemia, as an adjunct to dietary control
Side Effects
- abdominal pain
- alopecia
- amnesia
- anaphylactoid reactions
- angioedema
- anxiety
- arthralgia
- asthenia
- back pain
- blurred vision
- cataracts
- chest pain (unspecified)
- chills
- cholestasis
- cirrhosis
- Co-Enzyme Q-10 deficiency
- confusion
- constipation
- depression
- diabetes mellitus
- diarrhea
- dizziness
- drowsiness
- dysgeusia
- dyspepsia
- dyspnea
- elevated hepatic enzymes
- eosinophilia
- erythema multiforme
- fatigue
- fever
- flatulence
- flushing
- gastroesophageal reflux
- gynecomastia
- headache
- hemolytic anemia
- hepatic failure
- hepatic necrosis
- hepatitis
- hepatoma
- hyperglycemia
- immune-mediated necrotizing myopathy
- impotence (erectile dysfunction)
- infection
- influenza
- insomnia
- jaundice
- leukopenia
- libido decrease
- lupus-like symptoms
- malaise
- memory impairment
- muscle cramps
- myalgia
- myasthenia
- myoglobinuria
- myopathy
- nausea
- ocular irritation
- pancreatitis
- paresthesias
- peripheral neuropathy
- photosensitivity
- pruritus
- purpura
- rash
- renal failure (unspecified)
- renal tubular obstruction
- rhabdomyolysis
- sinusitis
- Stevens-Johnson syndrome
- thrombocytopenia
- toxic epidermal necrolysis
- tremor
- urticaria
- vasculitis
- vertigo
- vomiting
- weakness
- xerostomia
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
- pregnancy
- renal disease
- renal failure
- renal impairment
- rhabdomyolysis
- seizure disorder
- surgery
- trauma
Interactions
- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Amiodarone
- Amlodipine
- Amlodipine; Atorvastatin
- Amlodipine; Benazepril
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amprenavir
- Aprepitant, Fosaprepitant
- Atazanavir
- Atazanavir; Cobicistat
- Barbiturates
- Boceprevir
- Bortezomib
- Bosentan
- Carbamazepine
- Ceritinib
- Cilostazol
- Cimetidine
- Clarithromycin
- Cobicistat
- Colchicine
- Colchicine; Probenecid
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabigatran
- Dabrafenib
- Daclatasvir
- Danazol
- Daptomycin
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Delavirdine
- Diltiazem
- Dronedarone
- Duvelisib
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elbasvir; Grazoprevir
- Elexacaftor; tezacaftor; ivacaftor
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Encorafenib
- Erythromycin
- Erythromycin; Sulfisoxazole
- Eslicarbazepine
- Ethanol
- Etravirine
- Everolimus
- Fedratinib
- Fenofibrate
- Fenofibric Acid
- Fluconazole
- Fosamprenavir
- Fosphenytoin
- Fostemsavir
- Gemfibrozil
- Glecaprevir; Pibrentasvir
- grapefruit juice
- Idelalisib
- Imatinib
- Indinavir
- Isavuconazonium
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Isradipine
- Itraconazole
- Ivacaftor
- Ivosidenib
- Ketoconazole
- Lanthanum Carbonate
- Lefamulin
- Leflunomide
- Letermovir
- Lomitapide
- Lopinavir; Ritonavir
- Lovastatin; Niacin
- Lumacaftor; Ivacaftor
- Lumacaftor; Ivacaftor
- Mefenamic Acid
- Mifepristone
- Mitotane
- Nefazodone
- Nelfinavir
- Nevirapine
- Niacin, Niacinamide
- Niacin; Simvastatin
- Nicardipine
- Nilotinib
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Oritavancin
- Oxcarbazepine
- Pazopanib
- Perindopril; Amlodipine
- Phenytoin
- Posaconazole
- Protease inhibitors
- Quetiapine
- Quinine
- Raltegravir
- Ranolazine
- Red Yeast Rice
- Ribociclib
- Ribociclib; Letrozole
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Saquinavir
- Sarilumab
- Siltuximab
- Simeprevir
- Sirolimus
- St. John’s Wort, Hypericum perforatum
- Tacrolimus
- Telaprevir
- Telbivudine
- Telithromycin
- Teriflunomide
- Tezacaftor; Ivacaftor
- Ticagrelor
- Tipranavir
- Tocilizumab
- Tolvaptan
- Trandolapril; Verapamil
- Tucatinib
- Verapamil
- Voriconazole
- Warfarin
- Zafirlukast
- Zileuton
