Simvastatin and Sitagliptin

What is Simvastatin and Sitagliptin combination medicine

Simvastatin; sitagliptin (Juvisync) is FDA-approved for treating patients in whom treatment with both simvastatin and sitagliptin is appropriate.

Simvastatin is an HMG-CoA reductase inhibitor indicated as adjunctive therapy to diet to reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides and increase HDL-cholesterol in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated triglycerides in patients with hypertriglyceridemia and reduce triglycerides and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-cholesterol and LDL-cholesterol in adult patients with homozygous familial hypercholesterolemia.

Sitagliptin is an oral hypoglycemic agent in the dipeptidyl peptidase-4 (DPP-4) inhibitor class; it is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Simvastatin; sitagliptin was approved by the FDA in October 2011.

NOTE: In September 2013, Merck announced their decision to voluntarily discontinue the manufacture and distribution of simvastatin; sitagliptin in the United States.

Brand Name

Juvisync

Indications & Dosage

• hypercholesterolemia
• hyperlipoproteinemia
• hypertriglyceridemia
• myocardial infarction prophylaxis
• stroke prophylaxis
• type 2 diabetes mellitus

For the combined treatment of type 2 diabetes mellitus and hypercholesterolemia, hyperlipoproteinemia, and/or hypertriglyceridemia and for myocardial infarction prophylaxis, and/or stroke prophylaxis in patients for whom treatment with both sitagliptin and simvastatin is appropriate

NOTE: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

NOTE: Simvastatin is indicated as an adjunctive therapy to diet to reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. In patients with homozygous familial hypercholesterolemia, simvastatin is an adjunct to other lipid-lowering treatments (e.g., LDL-apheresis) or is used if such treatments are not available.

NOTE: This combination has not been studied in patients with hyperlipidemia of Fredrickson types I and V.

Side Effects

• abdominal pain
• alopecia
• amnesia
• anaphylactoid reactions
• angioedema
• arthralgia
• asthenia
• atopic dermatitis
• atrial fibrillation
• back pain
• chills
• cholestasis
• cirrhosis
• Co-Enzyme Q-10 deficiency
• confusion
• constipation
• depression
• diabetes mellitus
• diarrhea
• dizziness
• drowsiness
• dyspepsia
• dyspnea
• elevated hepatic enzymes
• eosinophilia
• erythema multiforme
• exfoliative dermatitis
• fatigue
• fever
• flatulence
• flushing
• gastritis
• headache
• heart failure
• hemolytic anemia
• hepatic failure
• hepatic necrosis
• hepatitis
• hyperbilirubinemia
• hyperglycemia
• hypoglycemia
• immune-mediated necrotizing myopathy
• impotence (erectile dysfunction)
• infection
• insomnia
• interstitial lung disease
• jaundice
• leukopenia
• lupus-like symptoms
• malaise
• memory impairment
• muscle cramps
• musculoskeletal pain
• myalgia
• myasthenia
• myoglobinuria
• myopathy
• nausea
• pancreatitis
• paresthesias
• peripheral edema
• peripheral neuropathy
• pharyngitis
• photosensitivity
• purpura
• rash
• renal failure (unspecified)
• rhabdomyolysis
• sinusitis
• skin discoloration
• Stevens-Johnson syndrome
• thrombocytopenia
• toxic epidermal necrolysis
• urticaria
• vasculitis
• vertigo
• vomiting
• weakness
• xerosis

Monitoring Parameters

• blood glucose
• creatine phosphokinase (CPK)
• glycosylated hemoglobin A1c (HbA1c)
• LFTs
• serum amylase
• serum calcium
• serum cholesterol profile
• serum creatinine/BUN
• serum electrolytes
• serum lipase

Contraindications

• alcoholism
• arthralgia
• Asian patients
• breast-feeding
• children
• cholestasis
• contraception requirements
• diabetic ketoacidosis
• electrolyte imbalance
• endocrine disease
• females
• geriatric
• heart failure
• hepatic disease
• hepatic encephalopathy
• hepatitis
• history of angioedema
• hypotension
• hypothyroidism
• infection
• jaundice
• myopathy
• organ transplant
• pancreatitis
• pregnancy
• renal disease
• renal failure
• renal impairment
• rhabdomyolysis
• seizure disorder
• serious rash
• surgery
• trauma
• type 1 diabetes mellitus

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