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Juvisync (Sitagliptin Phosphate / Simvastatin) - Summary

 
 



JUVISYNC SUMMARY

JUVISYNC Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme, and simvastatin, a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus.

JUVISYNC™ (sitagliptin and simvastatin) is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate.

Sitagliptin

Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies.]

Simvastatin

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.

Reductions in Risk of CHD Mortality and Cardiovascular Events

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin is indicated to:

  • Reduce the risk of total mortality by reducing CHD deaths.
  • Reduce the risk of non-fatal myocardial infarction and stroke.
  • Reduce the need for coronary and non-coronary revascularization procedures.

Hyperlipidemia

Simvastatin is indicated to:

  • Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
  • Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
  • Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type lll hyperlipidemia).
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Important Limitations of Use

JUVISYNC should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

JUVISYNC has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JUVISYNC. [See Warnings and Precautions.]

JUVISYNC has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

Because doses of JUVISYNC appropriate for patients with severe renal impairment (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or end-stage renal disease (ESRD) are not available in this combination product, JUVISYNC is not recommended in patients with severe renal impairment or ESRD.


See all Juvisync indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Juvisync (Sitagliptin / Simvastatin)

Sitagliptin: a novel agent for the management of type 2 diabetes mellitus. [2008]
CONCLUSION: Sitagliptin, a DPP4 inhibitor, offers a novel treatment option for

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Clinical Trials Related to Juvisync (Sitagliptin / Simvastatin)

A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266) [Terminated]
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

Glucagon-like Peptide (GLP) Utilization and Safety [Completed]
This study will assess the utilization patterns (adherence, source of the index antidiabetic agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors, separately, in comparison to other ADAs. The proposed study will help in understanding the treatment utilization patterns and the incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists. This study differs from previous observational studies by including both exenatide and

liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).

This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters) commercial health insurance database from 2005-2011.

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Page last updated: 2013-02-10

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