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Vildagliptin is a substance used to treat diabetes mellitus type 2, more commonly known as type 2 diabetes. It is used for patients who cannot control their blood sugar, or glucose in their blood, with other anti-diabetic medicines. Swiss-based multinational pharmaceutical company Novartis International AG markets the drug under the trade name Galvus.
The medical condition that vildagliptin fights against is the most common form of diabetes. It is sometimes called adult onset diabetes to set it apart from type 1 diabetes, or juvenile diabetes. Either way, the presence of diabetes indicates the lack of the insulin hormone, which leads to an increase of blood sugar. Vildagliptin is introduced to increase the amount of two hormones named glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), which contribute to the control of the body's glucose level. The anti-diabetic drug does this by inhibiting dipeptidyl peptidase 4 (DPP4), a protein that inactivates GLP-1 and GIP.
Vildagliptin can also be combined with other antidiabetic drugs. Perhaps the most common combination is Eucreas, another trade name from Novaris, which is a combination of vildagliptin and metformin. The latter is actually a first-line drug for type 2 diabetes treatment and is one of the most widely used anti-diabetic drugs in the world.
Another popular candidate for combination, sulphonylurea, works by increasing the insulin from the pancreas organ's beta cells. Other anti-diabetic drugs that are commonly joined with vildagliptin include rosiglitazone, brand name Avandia; and pioglitazone, brand name Actos. Both belong to a class of five-membered heterocyclic ring-possessing medications called thiazolidinediones.
Side effects of vildagliptin include constipation, dizziness, fatigue, headaches, nausea, swelling of legs and ankles, tremors, weakness and weight gain. Most of these side effects are caused when the drug is combined with metformin, sulphonylurea or glitazone. Physicians can withhold vildagliptin if the patient is over 75 years of age, has mild heart failure, or is taking angiotensin-converting enzyme (ACE) inhibitors, which are drugs used to treat the aforementioned condition, as well as hypertension.
On 26 September 2007, the European Medicines Agency (EMA) authorized vildagliptin. The European Commission, the executive body of the European Union (EU), then approved the drug on 1 February 2008 for launch in its member nations. Twenty-four days later, the same body approved Eucreas.
Since then, vildagliptin has launched in 37 countries and has been approved in 70 countries. Novaris, however, has not submitted the drug to the United States Food and Drug Administration (FDA). This has placed a halt of the medication's approval in the U.S., since the FDA has called for additional clinical data in light of skin lesions and kidney problems that have appeared in animal studies.