Tuesday, July 3, 2012

Trajenta, (Linagliptin-film-coated tablet) A new drug for type-2 diabetes was launched.

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A new drug for type-2 diabetes was launched. The drug was introduced in metros like Mumbai and Delhi earlier this month. Launched by Boehringer Ingelheim India (BI) and Eli Lilly and Company, the 5mg film-coated tablet Linagliptin is sold under the brand name Trajenta.
Type-2 diabetes is a progressive disease and often, over a period of time, people are unable to maintain their sugar levels, requiring therapies to prevent diabetes-induced complications. New drugs are constantly being tested and introduced in the hope of finding a solution to maintain the blood glucose levels at acceptable levels. 

 Regular use of the drug showed improvement in the cell function that controls blood sugar levels

Chennai-based diabetologist V. Mohan said that the new tablet is an improvement on the other three products in the same class as a person has to take it only once a day. “The earlier tablets like sitagliptine, vildagliptine and sexagliptine have proved to be effective. This group of drugs are quite effective with very mild hypoglycaemia-inducing property. Linagliptin can be given even if (a person has) renal or liver failure.”
According to him, the tablet has been marketed by the company after conducting a five-year study for its effect on the human cardiovascular system. “Normally when such drugs come into the market, the Food and Drug Administration in the US calls for a five-year study. Other drugs underwent the study after being launched but in this case the study was done before launch and was found to be safe,” he said.
Regular use of the drug showed improvement in pancreatic beta cells function, an important component in controlling blood sugar levels. The tablet has been found to maintain the levels for a 24-hour period, he said.
He however cautioned that these drugs have been around only for six to eight years and hence there is no knowing what the side effects could be when it is used for a long term. Another factor would be the cost of the tablets itself. Dr. Mohan said if the price is reduced then more patients would benefit.
The drugs in this category are quite pricey. A person who is prescribed sitagliptin tablet, which is one dose per day, spends around Rs. 40 on each dose while vidagliptin costs around Rs. 20. According to a company spokesperson, per day therapy of linagliptin costs Rs. 42.70. 

linagliptin, Tradjenta

GENERIC NAME: linagliptin

BRAND NAME: Tradjenta

DRUG CLASS AND MECHANISM: Linagliptin is an oral drug that reduces blood sugar (glucose) levels in patients with type 2 diabetes. Linagliptin is a member of a class of drugs that inhibit the enzyme, dipeptidyl peptidase-4 (DPP-4). Other members of this class include sitagliptin (Januvia), and saxagliptin (Onglyza). Following a meal, incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released from the intestine, and their levels increase in the blood. GLP-1 and GIP reduce blood glucose by increasing the production and release of insulin from the pancreas. GLP-1 also reduces blood glucose by reducing the secretion by the pancreas of the hormone, glucagon, a hormone that increases the production of glucose by the liver and raises the blood level of glucose. The net effect of increased release of GLP-1 and GIP is to reduce blood glucose levels. Linagliptin inhibits the enzyme, DPP-4, that destroys GLP-1 and GIP and thereby increases the levels and activity of both hormones. As a result, levels of GLP-1 and GIP in the blood remain higher, and blood glucose levels fall. In summary, linagliptin reduces blood glucose levels by inhibiting DPP-4 and increasing the levels of GLP-1 and GIP. Linagliptin was approved by the FDA in May 2011.
GENERIC AVAILABLE: No
PRESCRIPTION: Yes
PREPARATIONS: Tablets: 5 mg
STORAGE: Tablets should be stored at room temperature, 15-30 C (59-86 F)
PRESCRIBED FOR: Linagliptin is combined with diet and exercise to improve blood glucose levels in patients with type 2 diabetes.
DOSING: Linagliptin may be taken with or without food. The recommended dose is 5 mg once daily.
DRUG INTERACTIONS: Rifampin decreases the blood concentration of linagliptin by stimulating break down of linagliptin by CYP3A4 liver enzymes. Other drugs that increase activity CYP3A4 may also reduce the blood concentration of linagliptin.
PREGNANCY: There are no adequate studies of linagliptin in pregnant women.
NURSING MOTHERS: It is unknown whether linagliptin is secreted in human breast milk.
SIDE EFFECTS AND PRECAUTIONS: The most common side effects of linagliptin are stuffy or runny nose and sore throat. Hypoglycemia may occur when linagliptin is combined with insulin or a sulfonylurea-type drug. Allergic reactions and muscle pain also may occur. Pancreatitis also has been reported.

REFERENCE: FDA prescribing information.

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