Galvus Review Article |
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 Galvus, sold as tablets, contains the vidagliptin active ingredient which is a DPP-4 inhibitor and it is used to treat people with type II diabetes, whose blood sugar is not sufficiently controlled by other medicines. It works by increasing the amount of glucagon-like peptide-1 and glucose-dependent insulinotropic peptide which are normally produced naturally by the body in response to food intake. You should not take this drug if you have a type I diabetes, diabetic ketoacidosis or decreased liver function, if you are pregnant or breastfeeding, or if you have severe heart failure.
Diabetes mellitus
Diabetes mellitus is a group of common metabolic disorders characterized by abnormally high sugar/glucose levels in the blood – a state known as hyperglycemia. It is a disease caused by an interaction of genetics and lifestyle (e.g. high intake of sweets). Continue reading...
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Diabetes mellitus may either be due to:
1) reduced insulin secretion (insulin is the enzyme that metabolizes sugar),
2) decreased glucose utilization or
3) increased glucose production.
The three cardinal signs of diabetes are polyuria (excessive urination), polyphagia (excessive eating) and polydipsia (excessive thirst). Diabetes is also characterized by glucosuria, wherein glucose is excreted via the urine. Actually, the word diabetes means “passing through” or “siphoning” while “mellitus” derives from “mel”, which means “honey”. Other symptoms of diabetes include dry mouth, blurred vision, fatigue, drowsiness, weight loss and coma.
Diagnosis of diabetes is done through Blood Glucose tests and Urinalysis. As mentioned, an individual with sugar in the urine or glucosuria is a possible diabetic patient. As for blood glucose testing, Table 1 summarizes the possible conditions associated with the blood glucose levels obtained through the different tests involved.
Table 1. Blood Glucose Levels According to Test and Physiological State Tests | Normoglycemia | Impaired Glucose Metabolism | Diabetes Mellitus |
|---|
Fasting Plasma Glucose | <110 mg/dL | >110 & <126 mg/dL | >126 mg/dL | 2 Hour Postload Glucose | <140 mg/dL | >140 & <200 mg/dL | >200 mg/dL | Random Plasma Glucose | - | - | >200 mg/dL | Hemoglobin A1c | - | - | 6.5z% |
There are several complications caused by diabetes, due to the damage to nerves and blood vessels by this disease. Complications include peripheral neuropathy (which can lead to limb amputation), retinopathy (which can lead to blindness), nephropathy (kidney failure) and cardiovascular diseases (such as stroke and heart attack). The World Health Organization (WHO) has stated that diabetes is a major risk factor for cardiovascular diseases, which account for almost 50% of mortality among diabetic patients.
According to newer references, diabetes may be classified into four types: Type 1 or insulin dependent diabetes mellitus (IDDM), wherein the body does not produce enough insulin; Type 2 or non-insulin dependent diabetes mellitus (NIDDM) where the body produces insulin but is not utilized by cells because of resistance to it; Gestational Diabetes where there is hyperglycemia in pregnant women; and Diabetes secondary to other conditions which may be due to hormonal abnormalities and pancreatic diseases.
Type 2 Diabetes Mellitus
Type 2 Diabetes or Non Insulin Dependent Diabetes Mellitus is a type of diabetes in which there are insufficient insulin levels in the body combined with insulin resistance (a situation where cells do not respond properly to insulin – they become resistant - hence glucose does not enter the cells). Though there is insulin in the body, it is not enough to overcome the resistance of cells, resulting in increased levels of sugar in the blood. It is the most common type of diabetes, with around 90% of diabetics belonging in this type. It is also referred to as Adult Onset Diabetes, due to its late onset in patients – patients are usually 30 years old when this disease sets in.
The WHO has stated several risk factors for this disease, which include family history, race or ethnicity, obesity, age of greater than forty five, hypertension, hyperlipidemia (HDL >35 mg/dL or Triglyceride level 250 mg/dL), past diagnosis of impaired fasting glucose, history of gestational diabetes, as well as lack of physical activity and excessive food intake.
Sadly, there is no cure for diabetes. Pharmacologic and non pharmacologic therapies are aimed at maintaining the quality of life of patients. Specifically, the treatment goals of diabetes therapy include maintenance of normal blood glucose levels, amelioration of signs and symptoms, and reduction or prevention of the incidence of complications, morbidity and mortality. Non pharmacologic therapy primarily consists of lifestyle modifications, which include exercise and diet, as well as education. Pharmacologic therapy includes the use of oral hypoglycemic agents. There are several drugs available to treat diabetes, such as sulfonylureas, meglitinides, biguanides and thiazolidinediones. A relatively new class of drugs has been developed – the Dipeptidyl Peptidase – 4 (DPP) Inhibitors, which include Vildagliptin or Galvus.
Galvus
 Galvus, or Vildagliptin, is an oral hypoglycemic agent belonging to the novel class of drugs called Dipeptidyl Peptidase-4 Inhibitors. It has been approved by the European Medicines Agency in 2008 for European use for the treatment of Type 2 Diabetes Mellitus. Its molecular formula is C17H25N3O2.
Galvus, as the drug class name implies, inhibits dihydropeptidyl dipeptidase-4. In normal physiological states, blood glucose levels are controlled by two enzymes – insulin and glucagon. Insulin is responsible for the breakdown of glucose, lowering its levels in the blood, while glucagon is responsible for synthesizing glucose from stored fats in the body, raising its levels in the blood. These two enzymes are regulated by a group of hormones called incretin hormones. Specifically, glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) stimulate insulin release and inhibit glucagon release. Finally, incretin hormones are regulated by the enzyme dihydropeptidyl peptidase-4 (DPP-4), which inactivates incretin and results to decreased insulin release and increased glucagon release, ultimately leading to increased blood glucose levels. Therefore, inhibiting DPP-4 is a rational approach in decreasing glucose levels (Holst and Deacon, 1998).
Aside from its glucose-lowering effects (Prigeon, et al., 2003), increasing incretin hormone levels have other beneficial effects such as delaying gastric emptying (Naslund, et al., 1999) and induction of a feeling of fullness or satiety (Ahren, 1998; Holst, 2002), enhancement of glucose disposal (D’Alessio, Prigeon and Enswick, 1995), reduction of food intake (Gutzwiller, 1999) and weight loss (Zander, et al., 2002).
Clinical trials
Galvus has been shown to effectively control glucose levels both in animal and human clinical studies. In one study, patients with a starting HbA1c value of 8% (indicated to be diabetic) were decreased to a desirable 7% after a 24 week trial with Galvus. In another study made by Ristic and colleagues (2005), they found that after 12 weeks, significant reductions in HbA1c were observed. In a study by Ahren and colleagues (2004), they found that DPP-4 inhibitors like Galvus not only improve glucose tolerance, they also sustain insulin levels and reduce glucagon levels. Finally, in another study made by Mari and colleagues (2005), they concluded that Galvus is an effective antidiabetic drug that improves β-cell function (secretes insulin) by increasing insulin secretion.
In a recent study study called the The Galvus in Addition to Metformin versus Tzd/Metformin in Lowering HbA1c (GALIANT), several findings about the drugs were made. In this study, they found that Galvus have a better safety profile than other antidiabetic agents, in that it has no weight gain, hypoglycemia and a lower risk for cardiovascular and cerebrovascular adverse events.
Combination with other Antidiabetic drugs
Currently, Galvus is recommended for use in combination with other antidiabetic agents such as thiazolidinediones, biguanides, and sulfonylurea (as a substitute when metformin cannot be used). In the GALIANT study, it was found that Galvus in addition to metformin or a thiazolidinedione is not inferior to thiazolidinedione therapy.
References
AHREN, B., LANDIN-OLSSON, M., JANSSON, P.-A., ET AL. 2004. Inhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels and reduces glucagon levels in type 2 diabetes. J Clin Endocrinol Metab 89:2078–2084
RISTIC, S., BYIERS, S., FOLEY, J., & HOLMES, D. 2005. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose response. Retrieved from
http://onlinelibrary.wiley.com/doi/10.1111/j.1463-1326.2005.00539.x/abstract
AHREN, B. 1998. Glucagon-like peptide 1 (GLP-1)-a gut hormone of potential interest in the treatment of diabetes. Bioessays 20:642-651
D’ALESSIO, D.A., PRIGEON, R.L. & ENSWICK, J.W. 1995. Enteral enhancement of glucose disposition by both insulin-dependent and insulin-independent processes. A physiological role of glucagon-like peptide I. Diabetes 44:1433-1437
GUTZWILLER, J.P., DREWE, J., GOKE, B., ET AL. 1999. Glucagon-like peptide-1 promotes satiety and reduces food intake in patients with diabetes mellitus type 2. Am J Physiol 276:R1541-1544
HOLST, J.J. & DEACON, C.F. 1998. Inhibition of dipeptidyl-peptidase IV as a treatment for type 2 diabetes. Diabetes 47:1663-1670
HOLST, J.J. 2002. Therapy of type 2 diabetes mellitus based on the actions of glucagon-like peptide-1. Diabet Metab Res Rev 18:430-431
MARI, A., SALLAS, W.M., HE, Y.L., ET AL. 2005. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed β-cell function in patients with type 2 diabetes. Retrieved from
http://jcem.endojournals.org/content/90/8/4888.full.pdf+html
NASLUND, E., BOGEFORS, J., SKOGER, S., ET AL. 1999. GLP-1 slows solid gastric emptying and inhibits insulin, glucagon, and PYY release in humans. Am J Physiol 277:R910-R916
OTTERBECK, P.E., BANERJI, M.A. 2011. The efficacy and safety of vildagliptin in the GALIANT trial: chronic kidney disease and other applications. Expert Review of Endocrinology and Metabolism, 6(2): 143-151(9)
PRIGEON, R.L., QUDDUSI, S., PATY, B. & D’ALESSIO, D.A. 2003. Suppression of glucose production by GLP-1 independent of islet hormones: a novel extrapancreatic effect. Am J Physiol 285:E701-E707
ZANDER, M., MADSBAD, S., MADSEN, J.L., & HOLST, J.J. 2002. Effect of 6-week course of glucagon-like peptide 1 on glycemic control, insulin sensitivity and B-cell function in type 2 diabetes: a parallel-group study. Lancet 359:824-830
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