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새로운 당뇨병 치료제 Pramlintide의 Systematic Review
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  • 새로운 당뇨병 치료제 Pramlintide의 Systematic Review
  • Systemic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus
저자명
스리니바산 샨무감,정희용,용철순,최한곤,김정애,유봉규,Shanmugam. Srinivasan,Jung. Hee-Yong,Yong. Chul-Soon,Choi. Han-Gon,Kim. Jung-Ae,Yoo. Bong-Kyu
간행물명
약학회지
권/호정보
2006년|50권 6호|pp.386-392 (7 pages)
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대한약학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

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.