Niacin and Simvastatin Brand Name– Simcor
What is Niacin and Simvastatin
Niacin and simvastatin is an oral combination product containing simvastatin, a hydroxymethylglutaryl CoA (HMG-CoA) reductase inhibitor, and extended-release niacin.
Niacin and simvastatin reduces total cholesterol, LDL cholesterol, non-HDL cholesterol, apolipoprotein B, triglycerides, and increases HDL cholesterol in patients with primary type II hyperlipidemia, mixed dyslipidemia, or hypertriglyceridemia when monotherapy with niacin extended-release or simvastatin is inadequate.
In clinical trials, niacin and simvastatin was found to not be superior to simvastatin alone in lowering LDL cholesterol but was superior to simvastatin in lowering triglycerides and increasing HDL.
No incremental benefit has been established for niacin; simvastatin on cardiovascular morbidity and mortality above that seen with monotherapy with simvastatin and niacin.
In addition, the combination of niacin (1500—2000 mg/day PO) and simvastatin did not result in a greater reduction in the incidence of cardiovascular events than simvastatin alone in the AIM-HIGH trial, which randomized patients with stable cardiovascular disease and mean baseline LDL-C levels of 74 mg/dL.
Simcor was approved by the FDA on February 18, 2008.
Indications
- hypercholesterolemia
- hyperlipoproteinemia
For the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, non-HDL cholesterol, or triglyceride concentrations, and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa or IIb hyperlipoproteinemia); or to treat Fredrickson Type IV (hypertriglyceridemia, increased VLDL)
NOTE: Because of the risk of hepatotoxicity related with sustained-release or time-release niacin preparations or immediate-release (crystalline) niacin, the combination product niacin; simvastatin should only be substituted for equivalent doses of niacin extended release (Niaspan).
Side Effects
- abdominal pain
- alopecia
- amnesia
- anaphylactoid reactions
- angina
- angioedema
- arthralgia
- asthenia
- back pain
- blurred vision
- bullous rash
- cataracts
- chills
- cholestasis
- cirrhosis
- Co-Enzyme Q-10 deficiency
- confusion
- constipation
- depression
- diabetes mellitus
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dysarthria
- dyspepsia
- dysphagia
- dyspnea
- edema
- elevated hepatic enzymes
- eosinophilia
- erythema multiforme
- fatigue
- fever
- flatulence
- flushing
- headache
- hemolytic anemia
- hepatic failure
- hepatic necrosis
- hepatitis
- hyperbilirubinemia
- hyperglycemia
- hyperuricemia
- hypophosphatemia
- hypotension
- immune-mediated necrotizing myopathy
- impotence (erectile dysfunction)
- infection
- insomnia
- interstitial lung disease
- jaundice
- laryngeal edema
- leukopenia
- lupus-like symptoms
- maculopapular rash
- malaise
- muscle cramps
- muscle paralysis
- musculoskeletal pain
- myalgia
- myasthenia
- myoglobinuria
- myopathy
- nausea
- orthostatic hypotension
- palpitations
- pancreatitis
- paresthesias
- peptic ulcer
- peripheral edema
- peripheral neuropathy
- peripheral vasodilation
- photosensitivity
- pruritus
- purpura
- rash
- renal tubular obstruction
- rhabdomyolysis
- rhinitis
- sinus tachycardia
- skin discoloration
- Stevens-Johnson syndrome
- syncope
- thrombocytopenia
- toxic epidermal necrolysis
- urticaria
- vasculitis
- vesicular rash
- vomiting
Monitoring Parameters
- blood glucose
- creatine phosphokinase (CPK)
- LFTs
- serum cholesterol profile
- serum uric acid
Contraindications
- alcoholism
- anticoagulant therapy
- Asian patients
- bleeding
- breast-feeding
- children
- cholestasis
- coagulopathy
- contraception requirements
- diabetes mellitus
- electrolyte imbalance
- endocrine disease
- females
- geriatric
- gout
- hepatic disease
- hepatic encephalopathy
- hepatitis
- hypophosphatemia
- hypotension
- hypothyroidism
- infants
- infection
- jaundice
- myopathy
- peptic ulcer disease
- pregnancy
- renal disease
- renal failure
- renal impairment
- rhabdomyolysis
- seizure disorder
- surgery
- thrombocytopenia
- trauma
Interactions
- Acarbose
- Acetohexamide
- Albiglutide
- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Alogliptin
- Alogliptin; Metformin
- Alogliptin; Pioglitazone
- Alpha-blockers
- Alpha-glucosidase Inhibitors
- 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
- Angiotensin II receptor antagonists
- Angiotensin-converting enzyme inhibitors
- Aprepitant, Fosaprepitant
- Aspirin, ASA; Pravastatin
- Atazanavir
- Atazanavir; Cobicistat
- Atorvastatin
- Atorvastatin; Ezetimibe
- Barbiturates
- Bempedoic Acid
- Bempedoic Acid; Ezetimibe
- Beta-blockers
- Bile acid sequestrants
- Boceprevir
- Bortezomib
- Bosentan
- Calcium-channel blockers
- Canagliflozin
- Canagliflozin; Metformin
- Carbamazepine
- Central-acting adrenergic agents
- Ceritinib
- Cerivastatin
- Chlorpropamide
- Chlorzoxazone
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Colchicine
- Colchicine; Probenecid
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabigatran
- Dabrafenib
- Daclatasvir
- Danazol
- Dapagliflozin
- Dapagliflozin; Metformin
- Dapagliflozin; Saxagliptin
- Daptomycin
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Deferasirox
- Delavirdine
- Digoxin
- Diltiazem
- Dronedarone
- Dulaglutide
- Duvelisib
- 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
- Empagliflozin
- Empagliflozin; Linagliptin
- Empagliflozin; Linagliptin; Metformin
- Empagliflozin; Metformin
- Encorafenib
- Eplerenone
- Epoprostenol
- Ertugliflozin; Metformin
- Ertugliflozin; Sitagliptin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Eslicarbazepine
- Ethanol
- Etravirine
- Everolimus
- Exenatide
- Fedratinib
- Fenofibrate
- Fenofibric Acid
- Flibanserin
- Fluconazole
- Fluvastatin
- Fluvoxamine
- Fosamprenavir
- Fostamatinib
- Fostemsavir
- Gemfibrozil
- Glecaprevir; Pibrentasvir
- Glimepiride
- Glimepiride; Pioglitazone
- Glimepiride; Rosiglitazone
- Glipizide
- Glipizide; Metformin
- Glyburide
- Glyburide; Metformin
- grapefruit juice
- Hydantoins
- Hydrochlorothiazide, HCTZ; Propranolol
- Idelalisib
- Iloprost
- Imatinib
- Incretin Mimetics
- Indinavir
- Insulin Degludec; Liraglutide
- Insulin Glargine; Lixisenatide
- Insulins
- Isavuconazonium
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ivacaftor
- Ivosidenib
- Ketoconazole
- Lanthanum Carbonate
- Lefamulin
- Leflunomide
- Letermovir
- Linagliptin
- Linagliptin; Metformin
- Liraglutide
- Lixisenatide
- Lomitapide
- Loop diuretics
- Lopinavir; Ritonavir
- Lovastatin
- Lovastatin; Niacin
- Lumacaftor; Ivacaftor
- Lumacaftor; Ivacaftor
- Mecamylamine
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Mifepristone
- Miglitol
- Mitotane
- Nateglinide
- Nefazodone
- Nelfinavir
- Netupitant, Fosnetupitant; Palonosetron
- Nevirapine
- Niacin, Niacinamide
- Nicardipine
- Obeticholic Acid
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Oxcarbazepine
- Pazopanib
- Perindopril; Amlodipine
- Pexidartinib
- Pitavastatin
- Posaconazole
- Potassium-sparing diuretics
- Pramlintide
- Pravastatin
- Propranolol
- Protease inhibitors
- Quinine
- Raltegravir
- Ranolazine
- Red Yeast Rice
- Repaglinide
- Reserpine
- Ribociclib
- Ribociclib; Letrozole
- Rifabutin
- Rifampin
- Rifapentine
- Riluzole
- Ritonavir
- Rosuvastatin
- Saquinavir
- Sarilumab
- Saxagliptin
- Semaglutide
- Siltuximab
- Simeprevir
- Simvastatin; Sitagliptin
- Sirolimus
- Sitagliptin
- Sofosbuvir; Velpatasvir
- Sofosbuvir; Velpatasvir; Voxilaprevir
- St. John’s Wort, Hypericum perforatum
- Sulfonylureas
- Tacrolimus
- Telaprevir
- Telbivudine
- Telithromycin
- Teriflunomide
- Tesamorelin
- Tezacaftor; Ivacaftor
- Thiazide diuretics
- Thiazolidinediones
- Ticagrelor
- Tipranavir
- Tocilizumab
- Tolazamide
- Tolbutamide
- Tolvaptan
- Trandolapril; Verapamil
- Treprostinil
- Tucatinib
- Vasodilators
- Verapamil
- Voriconazole
- Warfarin
- Zafirlukast
