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

Interactions

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  • grapefruit juice
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