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Original Research

A Fixed-Dose Combination Of Gemigliptin And Rosuvastatin Exhibits Similar Pharmacokinetics, Pharmacodynamics, And Safety Compared To That Of A Loose Combination In Healthy Subjects

ORCID Icon, ORCID Icon, ORCID Icon, &
Pages 3879-3885 | Published online: 13 Nov 2019

References

  • Iglay K, Hannachi H, Joseph Howie P, et al. Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus. Curr Med Res Opin. 2016;32(7):1243–1252. doi:10.1185/03007995.2016.116829126986190
  • Khavandi M, Duarte F, Ginsberg HN, Reyes-Soffer G. Treatment of dyslipidemias to prevent cardiovascular disease in patients with type 2 diabetes. Curr Cardiol Rep. 2017;19(1):7. doi:10.1007/s11886-017-0818-128132397
  • Mooradian AD. Dyslipidemia in type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab. 2009;5(3):150–159. doi:10.1038/ncpendmet106619229235
  • Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm - 2018 executive summary. Endocr Pract. 2018;24(1):91–120. doi:10.4158/CS-2017-015329368965
  • Kim SH, Yoo JH, Lee WJ, Park CY. Gemigliptin: an update of its clinical use in the management of type 2 diabetes mellitus. Diabetes Metab J. 2016;40(5):339–353. doi:10.4093/dmj.2016.40.5.33927766241
  • Kim SH, Lee SH, Yim HJ. Gemigliptin, a novel dipeptidyl peptidase 4 inhibitor: first new anti-diabetic drug in the history of Korean pharmaceutical industry. Arch Pharm Res. 2013;36(10):1185–1188. doi:10.1007/s12272-013-0171-x23771499
  • Noh YH, Lim HS, Jin SJ, et al. Effects of ketoconazole and rifampicin on the pharmacokinetics of gemigliptin, a dipeptidyl peptidase-IV inhibitor: a crossover drug-drug interaction study in healthy male Korean volunteers. Clin Ther. 2012;34(5):1182–1194. doi:10.1016/j.clinthera.2012.04.00122534255
  • Kim N, Patrick L, Mair S, et al. Absorption, metabolism and excretion of [14C]gemigliptin, a novel dipeptidyl peptidase 4 inhibitor, in humans. Xenobiotica. 2014;44(6):522–530. doi:10.3109/00498254.2013.86585624304170
  • Lim KS, Kim JR, Choi YJ, et al. Pharmacokinetics, pharmacodynamics, and tolerability of the dipeptidyl peptidase IV inhibitor LC15-0444 in healthy Korean men: a dose-block-randomized, double-blind, placebo-controlled, ascending single-dose, phase I study. Clin Ther. 2008;30(10):1817–1830. doi:10.1016/j.clinthera.2008.10.01319014837
  • Yang SJ, Min KW, Gupta SK, et al. A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes. Diabetes Obes Metab. 2013;15(5):410–416. doi:10.1111/dom.1204223170990
  • Tuomilehto J, Leiter LA, Kallend D, A review of the efficacy of rosuvastatin in patients with type 2 diabetes. Int J Clin Pract Suppl. 2004;143:30–40. doi:10.1111/j.1368-504X.2004.00390.x16035394
  • Ullah F, Afridi AK, Rahim F, Rahman SU, Ashfaq M. Efficacy of 5 Mg and 10 Mg rosuvastatin in type-2 diabetes mellitus with hypercholesteroalemia. J Ayub Med Coll Abbottabad. 2015;27(3):564–568.26721008
  • Wolffenbuttel BH, Franken AA, Vincent HH, Dutch Corall Study G. Cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes – CORALL study. J Intern Med. 2005;257(6):531–539. doi:10.1111/j.1365-2796.2005.01499.x15910557
  • Olsson AG, McTaggart F, Raza A. Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor. Cardiovasc Drug Rev. 2002;20(4):303–328.12481202
  • Choi HY, Lim HS, Kim YH, et al. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015;31(2):229–241. doi:10.1185/03007995.2014.98088625350224
  • Lee E, Ryan S, Birmingham B, et al. Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin Pharmacol Ther. 2005;78(4):330–341. doi:10.1016/j.clpt.2005.06.01316198652
  • Tzeng TB, Schneck DW, Birmingham BK, et al. Population pharmacokinetics of rosuvastatin: implications of renal impairment, race, and dyslipidaemia. Curr Med Res Opin. 2008;24(9):2575–2585. doi:10.1185/0300799080231280718674408
  • AstraZeneca. Label of CRESTOR (ROSUVASTATIN CALCIUM) Tablets; 2016.
  • Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an ANDA. Draft Guidance; 2013.
  • Shin D, Cho YM, Lee S, et al. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014;34(6):383–393. doi:10.1007/s40261-014-0184-3
  • LG Chem. Clinical Study Protocol (LG-GSCL003). version 3.2. 2016 Unpublished.
  • Ahren B. DPP-4 inhibitors. Best Pract Res Clin Endocrinol Metab. 2007;21(4):517–533. doi:10.1016/j.beem.2007.07.00518054733
  • Olsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. Am J Cardiol. 2001;88(5):504–508. doi:10.1016/s0002-9149(01)01727-111524058