Alogliptin
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Alogliptin, sold under the brand names Nesina and Vipidia,[1][2] is an oral anti-diabetic drug in the DPP-4 inhibitor (gliptin) class.[3] Like other members of the gliptin class, it causes little or no weight gain, exhibits relatively little risk of hypoglycemia, and has relatively modest glucose-lowering activity.[4] Alogliptin and other gliptins are commonly used in combination with metformin in people whose diabetes cannot adequately be controlled with metformin alone.[4]
In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure.[5] It was developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005.[6] In 2020, it was the 295th most commonly prescribed medication in the United States, with more than 1Script error: No such module "String".million prescriptions.[7][8]
Medical uses
Alogliptin is a dipeptidyl peptidase-4 inhibitor (DDP-4) that decreases blood sugar levels similar to other DPP-4 inhibitors.[9]
Side effects
Adverse events include hypoglycemia,[10][11][12] pruritis (itching),[2] nasopharyngitis, headache, and upper respiratory tract infection.[13] It may also cause joint pain that can be severe and disabling.[14] Like other DDP-4 inhibitors, alogliptin is weight-neutral.[4]
A 2014 letter to the editor claimed alogliptin is not associated with increased risk of cardiovascular events.[15]Template:Better source needed In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure.[5]
Market access
In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Administration (FDA),[16] after positive results from Phase III clinical trials.[1] In September 2008, the company also filed for approval in Japan,[17] winning approval in April 2010.[16] The company also filed a Marketing Authorization Application elsewhere outside the United States, which was withdrawn in June 2009 needing more data.[17] The first NDA failed to gain approval and was followed by a pair of NDAs (one for alogliptin and a second for a combination of alogliptin and pioglitazone) in July 2011.[16] In 2012, Takeda received a negative response from the FDA on both of these NDAs, citing a need for additional data.[16]
In 2013, the FDA approved the drug in three formulations: as a stand-alone with the brand-name Nesina,[13] combined with metformin using the name Kazano,[18] and when combined with pioglitazone as Oseni.[19]
References
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External links
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