새로운 당뇨병 치료제 Pramlintide의 Systematic Review

• 영문명: Systernic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus
• 발행기관: 대한약학회
• 저자명: 스리니바산 샨무감(Srinivasan Shanmugam) 정희용(Hee Yong Jung) 용철순(Chul Soon Yong) 최한곤(HAn-Gon Choi) 김정애(Jung Ae Kim) 유봉규(Bong Kyu Yoo)
• 간행물 정보: 『약학회지』제50권 제6호 (2006년), 386~392쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2006.12.31

영문 초록

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 from 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 1 and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase Ⅲ clinical trials were performed with mostly caucasian and some black and hispanic people.

키워드

Pramlintide Bridging study Clinical trial Pharmacokinetic study Pharmacodynamic study