diabetes drugs

JANUVIA ® - Sitagliptin

GALVUS ® a drug based on Vidagliptin

THERAPEUTIC GROUP: Oral hypoglycemic agents - DPP-4 inhibitors

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications GALVUS ® - Vidagliptin

GALVUS ® is a drug useful in the treatment of second-type diabetes mellitus hyperglycemia, in combination with metformin, sulfonylureas and agonists of PPAR gamma, in case of insufficient therapeutic response observed following monotherapy

Mechanism of action GALVUS ® - Vidagliptin

Vidagliptin, the active ingredient of GALVUS ® is a very useful molecule to guarantee the correct glycemic control, thanks to the indirect ability, to improve the glucose response of the beta cell and therefore the subsequent production and secretion of insulin.

More precisely, this active ingredient acts by selectively inhibiting the enzyme DPP-4, involved in the breakdown of incretins (GLP1 and GIP), hormones produced at the level of the gastro-intestinal tract, and useful in sensitizing the beta cell to increased glucose concentrations to guarantee a correct answer in terms of insulin secretion, modulating at the same time the production and secretion of glucagon.

From a metabolic point of view, this complex mechanism of action translates into a reduction in the post-prandial hyperglycemic peak and fasting glycaemia, through a greater availability of insulin and a reduced production of endogenous glucose.

From the pharmacokinetic point of view, on the other hand, GALVUS ® is fully part of oral hypoglycemic agents, from the moment, taken orally, it is absorbed at the intestinal level, reaching the maximum plasma concentration in about 2 hours, to be subsequently eliminated as metabolites mainly inactive via the kidneys.

Studies carried out and clinical efficacy

1. VIDAGLIPTIN AND METFORMIN

Vidagliptin is known to be used concomitantly with metformin in the treatment of diabetic patients who are not responsive to metformin alone. In this study, in fact, the combined therapy, prolonged for 52 weeks, guaranteed a further lowering of glycosylated hemoglobin from 8.7% to 6.5%, significantly reducing cases of hypoglycemia and weight gain.

2. VIDAGLIPTIN AND GLIMEPIRIDE IN THE TREATMENT OF DIABETIC PATIENT

The treatment of the diabetic patient with vidagliptin and glimepiride, guaranteed a significant reduction of glycosylated hemoglobin, and an excellent control of fasting and post-prandial glycaemia, decidedly higher than the monotherapies. The recorded side effects were modest with only two cases of hypoglycemia.

3. VIDAGLIPTIN AND ACUTE PANCREATITIS

Case report that focuses on the possibility of vidagliptin determining the onset of acute pancreatitis. Despite being the first case at present, the severity of this pathology obliges the various international bodies to monitor the possible side effects of incretin-based therapy.

Method of use and dosage

GALVUS ® tablets 50 mg of vidagliptin:

the recommended dosage is two tablets of GALVUS ® a day taken independently of meals.

However, it is always necessary to remember that the correct dosage should be formulated by your doctor based not only on the physio-pathological condition of the patient, but also on the possible presence of therapies combined with other hypoglycemic drugs.

Warnings GALVUS ® - Vidagliptin

It is important that drug therapy for the treatment of type II diabetic patient be accompanied by non-pharmacological measures such as healthy eating and a healthy lifestyle.

The modest clinical trial that characterizes this type of drug has not allowed to better characterize the activity of GALVUS ® in patients suffering from cardiac and hepatic diseases, therefore, in these cases medical supervision would be ideal.

Monitoring of blood glucose and transaminases as well as renal function is therefore useful for the therapy to maintain the correct balance, reducing the risk of potential side effects.

GALVUS ® contains lactose, therefore administration in patients with lactase enzyme deficiency, lactose intolerance or glucose / galactose absorption deficiency could be accompanied by the concomitant presence of side effects concentrated mainly on the gastro-intestinal level.

The risk of hypoglycaemia could make the use of machinery and driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

The contraindication to the use of GALVUS ® during the period of pregnancy and lactation essentially derives from the absence of studies that test the safety profile of the drug on fetal health when taken during pregnancy, and from the availability of other well-characterized drugs on the market, useful for the management of gestational diabetes.

Interactions

The various experiments and the various pharmacokinetic tests have demonstrated the low degree of interaction between vidagliptin and other active ingredients, probably also justified by the poor hepatic metabolism to which this active principle meets.

However, it is necessary to remember that the concomitant intake of other oral hypoglycemic drugs, could enhance the therapeutic effects of GALVUS ® thus increasing the risk of hypoglycemia.

Contraindications GALVUS ® - Vidagliptin

GALVUS ® is contraindicated in patients who are hypersensitive to the active substance or to one of its excipients, in patients suffering from type I diabetes, diabetic ketoacidosis, liver and kidney failure and during the period of pregnancy and lactation.

Undesirable effects - Side effects

The various clinical trials carried out have described, after taking vidagliptin, modest and transient side effects that do not require suspension of therapy.

Among the side effects, the most observed were angioedema, nausea, weight gain, headache and asthenia, whereas reactions to the liver and cutaneous district were more rare but clinically significant following hypersensitivity to the active ingredient.

However, it is important to remember that some of these effects have been observed in combination therapies.

Note

GALVUS ® can only be sold under strict medical prescription