»õ·Î¿î ´ç´¢º´ Ä¡·áÁ¦ PramlintideÀÇ Systematic Review
Systernic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus
¾àÇÐȸÁö 2006³â 50±Ç 6È£ p.386 ~ p.392
½º¸®´Ï¹Ù»ê ¼¢¹«°¨(Srinivasan Shanmugam) - ¿µ³²´ëÇб³ ¾àÇдëÇÐ
¿ëö¼ø(Yong Chul-Soon) - ¿µ³²´ëÇб³ ¾àÇдëÇÐ
ÃÖÇÑ°ï(Choi Han-Gon) - ¿µ³²´ëÇб³ ¾àÇдëÇÐ
Á¤Èñ¿ë(Jung Hee-Yong) - ¿µ³²´ëÇб³ ÀÓ»ó¾àÇдëÇпø
±èÁ¤¾Ö(Kim Jung-Ae) - ¿µ³²´ëÇб³ ¾àÇдëÇÐ
À¯ºÀ±Ô(Yoo Bong-Kyu) - ¿µ³²´ëÇб³ ¾àÇдëÇÐ
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 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 ¥² clinical trials were performed with mostly caucasian and some black and hispanic people.
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Pramlintide, Bridging study, Clinical trial, Pharmacokinetic study, Pharmacodynamic study
KMID :
0370220060500060386
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À¯È¿¼º°á°ú(Recomendation)
Clinical trials whose participants were mostly caucasian and some black and hispanic people, 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.