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Original Research

Pharmacokinetics of fixed-dose combination of atorvastatin and metformin compared with individual tablets

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Pages 1623-1632 | Published online: 13 May 2019

References

  • Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;339:229–234. doi:10.1056/NEJM1998072333904049673301
  • Stevens RJ, Kothari V, Adler AI, Stratton IM. The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56). Clin Sci. 2001;101:671–679.11724655
  • Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Diabetes Care. 2007;30:162–172. doi:10.2337/dc07-991717192355
  • International Diabetes Federation Guideline Development Group. Global guideline for type 2 diabetes. Diabetes Res Clin Pract. 2014;104:1–52. doi:10.1016/j.diabres.2012.10.00124508150
  • Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–1278. doi:10.1016/S0140-6736(05)67394-116214597
  • Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364:685–696. doi:10.1016/S0140-6736(04)16895-515325833
  • Kandhwal K, Dey S, Nazarudheen S, et al. Pharmacokinetics of a fixed-dose combination of atorvastatin and metformin extended release versus concurrent administration of individual formulations: a randomized, open-label, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study. Clin Drug Investig. 2011;31:853–863. doi:10.2165/11592920-000000000-00000
  • Nawrocki JW, Weiss SR, Davidson MH, et al. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arterioscler Thromb Vasc Biol. 1995;15:678–682.7749881
  • Adams SP, Tsang M, Wright JM. Lipid-lowering efficacy of atorvastatin. Cochrane Database Syst Rev. 2015;(3):Cd008226.25760954
  • Bakker-Arkema RG, Davidson MH, Goldstein RJ, et al. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA. 1996;275:128–133.8531308
  • Jacobsen W, Kuhn B, Soldner A, et al. Lactonization is the critical first step in the disposition of the 3-hydroxy-3-methylglutaryl-CoA reductase inhibitor atorvastatin. Drug Metab Dispos. 2000;28:1369–1378.11038166
  • UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352:854–865.9742977
  • Hardie DG. AMP-activated protein kinase as a drug target. Annu Rev Pharmacol Toxicol. 2007;47:185–210. doi:10.1146/annurev.pharmtox.47.120505.10530416879084
  • Graham GG, Punt J, Arora M, et al. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011;50:81–98. doi:10.2165/11534750-000000000-0000021241070
  • Derosa G, D’Angelo A, Romano D, Maffioli P. Effects of metformin extended release compared to immediate release formula on glycemic control and glycemic variability in patients with type 2 diabetes. Drug Des Devel Ther. 2017;11:1481–1488. doi:10.2147/DDDT.S131670
  • Pai MP, Paloucek FP. The origin of the “ideal” body weight equations. Ann Pharmacother. 2000;34:1066–1069. doi:10.1345/aph.1938110981254
  • Lennernas H. Clinical pharmacokinetics of atorvastatin. Clin Pharmacokinet. 2003;42:1141–1160. doi:10.2165/00003088-200342130-0000514531725
  • Mendoza L, Hajduch M, Plausinaitis R, Platilova V, Emritte N, Svoboda M. Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers. Pharmazie. 2006;61:805–806.17020163
  • Najib N, Idkaidek N, Beshtawi M, et al. Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon & Glucophage)–in healthy human volunteers. Biopharm Drug Dispos. 2002;23:301–306. doi:10.1002/bdd.32612355581
  • Center for Drug Evaluation and Research. U.S. Food and Drug Administration. Guidance for Industry, Clinical Drug Interaction Studies —Study Design, Data Analysis, and Clinical Implications; 10 2017.
  • Wang Y, Tang Y, Gu J, Fawcett JP, Bai X. Rapid and sensitive liquid chromatography-tandem mass spectrometric method for the quantitation of metformin in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2004;808:215–219. doi:10.1016/j.jchromb.2004.05.006
  • He BX, Shi L, Qiu J, et al. Quantitative determination of atorvastatin and ortho-hydroxy atorvastatin in human plasma by liquid chromatography tandem mass spectrometry and pharmacokinetic evaluation. Methods Find Exp Clin Pharmacol. 2010;32:481–487. doi:10.1358/mf.2010.32.7.148708621069099
  • Team RC. R. a language and environment for statistical computing. R Foundation for Statistical Computing; 2013 Available from: http://www.R-projectorg/. Accessed April 08, 2019.
  • Sharma P, Butters CJ, Smith V, Elsby R, Surry D. Prediction of the in vivo OATP1B1-mediated drug-drug interaction potential of an investigational drug against a range of statins. Eur J Pharm Sci. 2012;47:244–255. doi:10.1016/j.ejps.2012.04.00322538052
  • Balasubramanian R, Varadharajan S, Kathale A, et al. Assessment of the efficacy and tolerability of a fixed dose combination of atorvastatin 10 mg + metformin SR 500 mg in diabetic dyslipidaemia in adult Indian patients. J Indian Med Assoc. 2008;106:464–467.18975505
  • Park JE, Kim KB, Bae SK, Moon BS, Liu KH, Shin JG. Contribution of cytochrome P450 3A4 and 3A5 to the metabolism of atorvastatin. Xenobiotica. 2008;38:1240–1251. doi:10.1080/0049825080233439118720283
  • Wu X, Whitfield LR, Stewart BH. Atorvastatin transport in the Caco-2 cell model: contributions of P-glycoprotein and the proton-monocarboxylic acid co-transporter. Pharm Res. 2000;17:209–215.10751037
  • Chen C, Mireles RJ, Campbell SD, et al. Differential interaction of 3-hydroxy-3-methylglutaryl-coa reductase inhibitors with ABCB1, ABCC2, and OATP1B1. Drug Metab Dispos. 2005;33:537–546. doi:10.1124/dmd.104.00247715616150
  • Tousoulis D, Koniari K, Antoniades C, et al. Combined effects of atorvastatin and metformin on glucose-induced variations of inflammatory process in patients with diabetes mellitus. Int J Cardiol. 2011;149:46–49. doi:10.1016/j.ijcard.2009.11.03820034685
  • Matafome P, Louro T, Rodrigues L, et al. Metformin and atorvastatin combination further protect the liver in type 2 diabetes with hyperlipidaemia. Diabetes Metab Res Rev. 2011;27:54–62. doi:10.1002/dmrr.115721218508
  • Tousoulis D, Koniari K, Antoniades C, et al. Impact of 6 weeks of treatment with low-dose metformin and atorvastatin on glucose-induced changes of endothelial function in adults with newly diagnosed type 2 diabetes mellitus: a single-blind study. Clin Ther. 2010;32:1720–1728. doi:10.1016/j.clinthera.2010.09.00721194594
  • Madsen A, Bozickovic O, Bjune JI, Mellgren G, Sagen JV. Metformin inhibits hepatocellular glucose, lipid and cholesterol biosynthetic pathways by transcriptionally suppressing steroid receptor coactivator 2 (SRC-2). Sci Rep. 2015;5:16430. doi:10.1038/srep1643026548416
  • Whitfield LR, Stern RH, Sedman AJ, Abel R, Gibson DM. Effect of food on the pharmacodynamics and pharmacokinetics of atorvastatin, an inhibitor of HMG-CoA reductase. Eur J Drug Metab Pharmacokinet. 2000;25:97–101. doi:10.1007/BF0319007411112089
  • Choi HY, Noh YH, Kim YH, et al. Effects of food on the pharmacokinetics of gemigliptin/metformin sustained-release 50/1,000 mg (25/500 mg x 2 tablets) fixeddose combination tablet in healthy male volunteers. Int J Clin Pharmacol Ther. 2014;52:381–391. doi:10.5414/CP20203824495314
  • Company B-MS. Glucophage XR(metformin Hydrochloride Extended-Release Tablets) FDA Approved Drug Products Label Information. Princeton, NJ: Bristol-Myers Squibb Company; 2017 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf. Accessed April 08, 2019.