Systemic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus
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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) |
1 | Cramer, J. A. : A systematic review of adherence with medications for diabetes. Diabetes Care 27, 1218 (2004) DOI ScienceOn |
2 | Fineman, M., Weyer, C., Maggs, D. G., Strobel, S. and Kolterman, O. G. : The human amylin analog, pramlintide, reduces postprandial hyperglucagonemia in patients with type 2 diabetes mellitus. Horm. Metab. Res. 34, 504 (2002) DOI ScienceOn |
3 | Kong, M. F., King, P., Macdonald, I. A., Stubbs, T. A., Perkins, A. C., Blackshaw, P. E., Moyses, C. and Tattersall, R. B. : Infusion of pramlintide, a human amylin analogue, delays gastric emptying in men with IDDM. Diabetologia 40, 82 (1997) DOI ScienceOn |
4 | Cada, D. J., Levien, T. and Baker, D. E. : Pramlintide acetate. Hospital Pharmacy 40, 599 (2005) DOI |
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6 | Ratner, R. E., Dickey, R., Fineman, M., Maggs, D. G., Shen, L., Strobel, S. A., Weyer, C. and Kolterman, O. G. : Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabet. Med. 21, 1204 (2004) DOI ScienceOn |
7 | Gottlieb, A., Fineman, M., Bahner, A., Parker, J., Waite O. and Kolterman, O. : Pramlintide therapy in addition to insulin in type 2 diabetes on metabolic control after 6 months. Diabetologia 42(suppl 1), Abstract 873 (1999) |
8 | Fineman, M. S., Koda, J. E., Shen, L. Z., Strobel, S. A., Maggs, D. G., Weyer, C. and Kolterman, O. G. : The human amylin analog, pramlintide, corrects postprandial hyperglucagonemia in patients with type 1 diabetes. Metabolism 51, 636 (2002) DOI ScienceOn |
9 | Ratner, R. E., Want, L. L., Fineman, M. S., Velte, M. J., Ruggles, J. A., Gottlieb, A., Weyer, C. and Kolterman, O. G. : Adjunctive therapy with the amylin analogue pramlintide leads to a combined improvement in glycemic and weight control in insulin-treated subjects with type 2 diabetes. Diabetes Technol. Ther. 4, 51 (2002).) DOI ScienceOn |
10 | 식품의약품안전청 의약품안전국 : 외국임상자료의 평가, 가교자료 평가 및 가교시험 결정을 위한 가이드라인. 의약 65625-13552호(2000. 12. 29) |
11 | Amylin Pharmaceuticals, Inc. Study 137-133 (A randomized, double-blind, placebo-controlled, single-dose, two-period cross-over study to evaluate the effect of pramlintide on the pharmacokinetics of ethinyl estradiol and norgestrel in healthy female subjects receiving the oral contraceptive, Lo/Ovral) filed in NDA 21-332 (2000) |
12 | Amylin Pharmaceuticals, Inc. Study 137-134 (A randomized, double-blind, placebo-controlled, single-dose, two-period cross-over study to determine the effect of pramlintide on the pharmacokinetics of ampicillin in healthy subjects) filed in NDA 21-332 (2000) |
13 | Vivian, E. M., Olarte, S. V. and Gutierrez, A. M. : Insulin strategies for type 2 diabetes mellitus. Ann. Pharmacother. 38, 1916 (2004) DOI ScienceOn |
14 | Nyholm, B., Orskov, L., Hove, K. Y., Gravholt, C. H., Moller, N., Alberti, K. G., Moyses, C., Kolterman, O. and Schmitz, O. : The amylin analog pramlintide improves glycemic control and reduces postprandial glucagon concentrations in patients with type 1 diabetes mellitus. Metabolism 48, 935 (1999) DOI ScienceOn |
15 | Chapman, I., Parker, B., Doran, S., Feinle-Bisset, C., Wishart, J., Strobel, S., Wang, Y., Burns, C., Lush, C., Weyer, C. and Horowitz, M. : Effect of pramlintide on satiety and food intake in obese subjects and subjects with type 2 diabetes. Diabetologia 48, 838 (2005) DOI ScienceOn |
16 | Stumvoll, M., Goldstein, B. J. and van Haeften, T. W. : Type 2 diabetes: principles of pathogenesis and therapy. Lancet 365, 1333 (2005) DOI ScienceOn |
17 | Whitehouse, F., Kruger, D. F., Fineman, M., Shen, L., Ruggles, J. A., Maggs, D. G., Weyer, C. and Kolterman, O. G. : A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care 25, 724 (2002) DOI ScienceOn |
18 | McQueen J. Pramlintide acetate. Am. J. Health-Sys. Pharm. 62, 2363 (2005) DOI ScienceOn |
19 | Hollander, P. A., Levy, P., Fineman, M. S., Maggs, D. G., Shen, L. Z., Strobel, S. A., Weyer, C. and Kolterman, O. G. : Pramlintide as an adjunct to insulin therapy improves longterm glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 26, 784 (2003) DOI ScienceOn |
20 | Havas, S. and Donner, T. : Tight control of type 1 diabetes: recommendations for patients. Am. Fam. Physician 74, 971 (2006) |
21 | Kong, M. F., Stubbs, T. A., King, P., Macdonald, I. A., Lambourne, J. E., Blackshaw, P. E., Perkins, A. C. and Tattersall, R. B. : The effect of single doses of pramlintide on gastric emptying of two meals in men with IDDM. Diabetologia 41, 577 (1998) DOI ScienceOn |
22 | Symlin (pramlintide acetate) injection package insert. San Diego, CA: Amylin Pharmaceuticals, Inc. (2005) |
23 | Amylin Pharmaceuticals, Inc. Study 137-119 (An open-lable, randomized, five-period cross-over study of the pharmacokinetics of subcutaneous pramlintide (AC137) versus placebo plus NPH and regular insulin mixed together and as separate single injections in patients with type 1 diabetes mellitus) filed in NDA 21-332 (2000) |
24 | Amylin Pharmaceuticals, Inc. Study 137-125 (An open-label, randomized, four-period cross-over study in normal volunteers of the bioavailability of selected concentrations of pramlintide in two different formulations) filed in NDA 21-332 (2000) |
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