23 Sep 2014

Galvus (Vildagliptin) - United Kingdom

ATC: A10BH
ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
DIPEPTIDYL PEPTIDASE 4 (DPP-4) INHIBITORS
Galvus

Generic Matches for Vildagliptin (4)
Jalra
Xiliarx
Icandra-
Galvus 50 mg Tablets

Last Updated on 23 Sep 2014 by EPG Health Media Staff.
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Galvus Indication

Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:

As monotherapy
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

As dual oral therapy in combination with
- metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin,
- a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
- a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.

As triple oral therapy in combination with
- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

 

Galvus Generic Name

Vildagliptin

Type

POM

Summary Product Caracteristics (SPCs) Links
SPC - Galvus (external site)

Free Medical Education Resources

Selected content related to Galvus (Vildagliptin)

Clinical Trials

Journals

  • Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment Persistence and Safety from the 2-Year Real-Life VILDA Study.1
    Simon D, Detournay B, Eschwege E, Bouée S, Bringer J, Attali C, Dejager S.
    Diabetes Ther. 2014 Jun;5(1):207-24. doi: 10.1007/s13300-014-0064-0. Epub 2014 Apr 12.

    Introduction: There is an increasing interest for real-life data on drug use in many countries. Reimbursement authorities more and more request observational studies to assess the conditions of use of the products but also to improve knowledge about efficacy and safety in the real world and on a longer term than in clinical trials.
    Aim: To evaluate the effectiveness, treatment persistence and tolerability of vildagliptin in clinical practice.
    Conclusions: In everyday conditions of care, vildagliptin efficacy was in line with existing data from randomized clinical trials, sustained over 2 years, with low discontinuation rate and low hypoglycemia risk.
    Read full Article
     
  • Managing diabetic patients with moderate or severe renal impairment using DPP-4 inhibitors: focus on vildagliptin.2
    Russo E, Penno G, Del Prato S.
    Diabetes Metab Syndr Obes. 2013 Apr 24;6:161-70. doi: 10.2147/DMSO.S28951. Print 2013.

    Background: Dipeptidyl peptidase-4 (DPP-4) inhibitors are novel classified oral anti-diabetic drugs for the treatment of type 2 diabetes mellitus (T2DM) that provide important reduction in glycated hemoglobin, with a low risk for hypoglycemia and no weight gain. In T2DM patients with reduced renal function, adequate glycemic control is essential to delay the progress of kidney dysfunction, but they are at a greater risk of experiencing hypoglycemic events, especially with longer-acting sulfonylureas and meglitinides.
    Objective: To evaluate vildagliptin as an option to achieve glycemic control in T2DM patients with moderate or severe chronic kidney disease (CKD).
    Conclusion: Vildagliptin can be safely used in T2DM patients with varying degrees of renal impairment. Dose adjustments for renal impairment are required. Potential long-term renal benefit of vildagliptin needs to be further explored.
    Read full Article
     
  • Effects of vildagliptin (Galvus®) therapy in patients with type 2 diabetes mellitus after heart transplantation.3
    Gueler I, Mueller S, Helmschrott M, Oeing CU, Erbel C, Frankenstein L, Gleißner C, Ruhparwar A, Ehlermann P, Dengler TJ, Katus HA, Doesch AO.
    Drug Des Devel Ther. 2013 Apr 8;7:297-303. doi: 10.2147/DDDT.S43092. Print 2013.

    Background: Type 2 Diabetes mellitus (T2DM) is a common comorbidity in patients after heart transplantation (HTx) and is associated with adverse long-term outcomes.
    Conclusion: Vildagliptin therapy significantly reduced HbA1c and mean blood glucose levels in post-HTx patients in this study with T2DM and did not have any negative effects on lipid profile or body weight. Thus, vildagliptin therapy presented an interesting therapeutic approach for this selected patient cohort.
    Read full Article
     
  • Clinical evidence and mechanistic basis for vildagliptin's effect in combination with insulin.4
    Schweizer A, Foley JE, Kothny W, Ahrén B.
    Vasc Health Risk Manag. 2013;9:57-64. doi: 10.2147/VHRM.S40972. Epub 2013 Feb 15.

    Due to the progressive nature of type 2 diabetes, many patients need insulin as add-on to oral antidiabetic drugs (OADs) in order to maintain adequate glycemic control. Insulin therapy primarily targets elevated fasting glycemia but is less effective to reduce postprandial hyperglycemia. In addition, the risk of hypoglycemia limits its effectiveness and there is a concern of weight gain. These drawbacks may be overcome by combining insulin with incretin-based therapies as these increase glucose sensitivity of both the α- and β-cells, resulting in improved postprandial glycemia without the hypoglycemia and weight gain associated with increasing the dose of insulin. The dipeptidyl peptidase-IV (DPP-4) inhibitor vildagliptin has also been shown to protect from hypoglycemia by enhancing glucagon counterregulation. The effectiveness of combining vildagliptin with insulin was demonstrated in three different studies in which vildagliptin decreased A1C levels when added to insulin therapy without increasing hypoglycemia. This was established with and without concomitant metformin therapy. Furthermore, the effectiveness of vildagliptin appears to be greater when insulin is used as a basal regimen as opposed to being used to reduce postprandial hyperglycemia, since improvement in insulin secretion likely plays a minor role when relatively high doses of insulin are administered before meals. This article reviews the clinical experience with the combination of vildagliptin and insulin and discusses the mechanistic basis for the beneficial effects of the combination. The data support the use of vildagliptin in combination with insulin in general and, in line with emerging clinical practice, suggest that treating patients with vildagliptin, metformin, and basal insulin could be an attractive therapeutic option.
    Read full Article
     
  • Profile of vildagliptin in type 2 diabetes: efficacy, safety, and patient acceptability.5
    Pan C, Wang X.
    Ther Clin Risk Manag. 2013;9:247-57. doi: 10.2147/TCRM.S30071. Epub 2013 May 24.

    Vildagliptin is a selective and potent dipeptidyl peptidase-4 inhibitor that improves glycemic control by inhibiting the degradation of both endogenous glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. This article is a comprehensive review of the safety and efficacy of vildagliptin in patients with type 2 diabetes. Clinical evidence has proven that it effectively decreases hemoglobin A1c with a low risk of hypoglycemia and is weight neutral. The addition of vildagliptin to metformin improves glucose control and significantly reduces gastrointestinal adverse events, particularly in patients inadequately controlled with metformin monotherapy. Its long-term advantages include preservation of β-cell function, reduction in total cholesterol, decrease in fasting lipolysis in adipose tissue, and triglyceride storage in non-fat tissues. Vildagliptin is well tolerated with a low incidence of AEs, and it does not increase the risk of cardiovascular/cerebrovascular (CCV) events. It can be taken before or after meals, and has little drug interaction, thus it will be well accepted.
    Read full Article

News

  • Galvus (Novartis) fails German G-BA review for Diabetes - 09-Oct-2013
    Galvus (vildagliptin) from Novartis offers no extra benefit over generic sulfonylureas, according to the G-BA, the body in charge of Germany's pricing and reimbursement process, following a recommendation by IQWiG. The decision, part of first ever retrospective assessment could lead to a big price cut for Galvus to the level of generic sulfonylureas, or withdrawal from the market.
    Read full Article
     
  • CHMP recommends Galvus plus insulin and Eucras triple therapy for Type 2 Diabetes - 24-Sep-2012
    Novartis announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions for new indications for the use of Galvus (vildagliptin) and Eucras (vildagliptin and metformin) in combination with other treatments for Type 2 Diabetes patients.
    Read full Article
     
  • Read other news related to Galvus

Guidelines

References

  1. Simon D, Detournay B, Eschwege E, Bouée S, Bringer J, Attali C, Dejager S. Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment Persistence and Safety from the 2-Year Real-Life VILDA Study. Diabetes Ther. 2014 Jun;5(1):207-24. doi: 10.1007/s13300-014-0064-0. Epub 2014 Apr 12.
  2. Russo E, Penno G, Del Prato S. Managing diabetic patients with moderate or severe renal impairment using DPP-4 inhibitors: focus on vildagliptin. Diabetes Metab Syndr Obes. 2013 Apr 24;6:161-70. doi: 10.2147/DMSO.S28951. Print 2013.
  3. Gueler I, Mueller S, Helmschrott M, Oeing CU, Erbel C, Frankenstein L, Gleißner C, Ruhparwar A, Ehlermann P, Dengler TJ, Katus HA, Doesch AO. Effects of vildagliptin (Galvus®) therapy in patients with type 2 diabetes mellitus after heart transplantation. Drug Des Devel Ther. 2013 Apr 8;7:297-303. doi: 10.2147/DDDT.S43092. Print 2013.
  4. Schweizer A, Foley JE, Kothny W, Ahrén B. Clinical evidence and mechanistic basis for vildagliptin's effect in combination with insulin. Vasc Health Risk Manag. 2013;9:57-64. doi: 10.2147/VHRM.S40972. Epub 2013 Feb 15.
  5. Pan C, Wang X. Profile of vildagliptin in type 2 diabetes: efficacy, safety, and patient acceptability. Ther Clin Risk Manag. 2013;9:247-57. doi: 10.2147/TCRM.S30071. Epub 2013 May 24.

Galvus Marketing Information

Galvus Generic Name
Vildagliptin
Marketing Company
Novartis Europharm Limited
Drug Type
POM
Date of Issue, Marketing Authority 26/09/2007

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