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Systemic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus  

Shanmugam, Srinivasan (College of pharmacy, Yeungnam University)
Jung, Hee-Yong (Graduate School of Clinical Pharmacy, Yengnam University)
Yong, Chul-Soon (College of pharmacy, Yeungnam University)
Choi, Han-Gon (College of pharmacy, Yeungnam University)
Kim, Jung-Ae (College of pharmacy, Yeungnam University)
Yoo, Bong-Kyu (College of pharmacy, Yeungnam University)
Publication Information
YAKHAK HOEJI / v.50, no.6, 2006 , pp. 386-392 More about this Journal
Abstract
Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.
Keywords
Pramlintide; Bridging study; Clinical trial; Pharmacokinetic study; Pharmacodynamic study;
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