Pharmacogenetic testing in the treatment of type 2 diabetes with sulfonylurea drugs
Abstract
The article analyses scientific literature on the use of pharmacogenetic testing to optimize sulfonylurea treatment of patients with type 2 diabetes. It describes characteristics of modern sulfonylurea drugs used in the treatment of type 2 diabetes, including their mode of action, and the frequency of associated hypoglycaemia events. The authors analysed the main pharmacokinetic parameters of sulfonylureas (bioavailability, protein binding, metabolites, elimination, etc.), and adverse reactions associated with these drugs. Based on integrated data on Cytochrome P450 isoenzymes role in sulfonylureas metabolism, and determination of the role played by polymorphism of the gene encoding this fragment, the authors demonstrated the usefulness of pharmacogenetic testing combined with phenotypic (losartan) testing in the treatment of patients with type 2 diabetes.
About the Authors
G. I. Gorodetskaya
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
V. G. Kukes
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
S. A. Belkov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
R. E. Kazakov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
S. Yu. Serebrova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
O. V. Muslimova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. A. Rodina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
A. A. Aleksandrov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Dedov II, Shestakova MV, Mayorov AYu, Vikulova OK, Galstyan GR, Kuraeva TL, et al. Standards of specialized diabetes care. Diabetes mellitus 2017; 20(1S): 1–112 (in Russian).
2. Kukes VG, Sychev DA, Andreev DA, Arkhipov VV, Batischeva GA, Berdnikova NG, et al. Ñlinical pharmacology. 5th ed. Moscow: GEOTAR-Media; 2015 (in Russian).
3. Reaven GM. Role of insulin resistance in human disease: Banting lecture 1988. Diabetes 1988; 3737(12): 1595–607.
4. Matschinsky F, Liang Y, Kesavan P, Wang L, Froguel P, Velho G, et al. Glucokinase as pancreatic beta cell glucose sensor and diabetes gene. J Clin Invest. 1993; 3792(5): 2092–8.
5. Florez JC. The genetics of type 2 diabetes: a realistic appraisal. J Clin Endocrinol Metab. 2008; 3793(12): 4633–42.
6. Pearson ER, Donnelly LA, Kimber C, Whitley A, Doney AS, McCarthy MI, et al. Variation in TCF7L2 influences therapeutic response to sulfonylureas: a GoDARTs study. Diabetes 2007; 3756(8): 2178–82.
7. Shvedova AM. Pharmacoepidemiological and pharmacoeconomic evaluation of oral hypoglycemic therapy of diabetes mellitus of the 2nd type in the ambulatory practice. International journal of endocrinology 2007; 4(10). Available from: http://www.mif-ua.com/archive/article/2875 (in Russian).
8. Shestakova MV. Actual clinical practice of treatment of diabetes type 2 in the Russian Federation according to the prospective open observational program «DIA- CONTROL». Diabetes mellitus 2011; (4): 75–80 (in Russian).
9. Ashcroft FM, Gribble FM. ATP-sensitive K+ channels and insulin secretion: their role in helht and disease. Diabetologia 1999; 3742(8): 903–19.
10. Nedosugova LV, Balabolkin MI. Algorithm treatment diabetes type 2 diabetes. Moscow: MedExpertPress; 2008 (in Russian).
11. Muller G, Hartz D, Punter J, Okonomopulos R, Kramer W. Differential interaction of glimepiride and glibenclamide with the beta–cell sulfonylurea receptor. I. Binding characteristics. Biochim Biophys Acta 1994; 371191(2): 267–77.
12. Haffner SM, Miettinen H, Stern MP. The homeostasis model in the San Antonio Heart Study. Diabetes Care 1997; 20(7): 1087–92.
13. Attorrese G, Massi-Benedetti M. Quality and behaviour generic versus amaryl under stress conditions. Diabetes Technology and Therapeutics 2007; 379(3): 287–96.
14. Cozma LS, Luzio SD, Dunseath GJ, Langendorg KW, Pieber T, Owens DR. Comparison of the effects of three insulinotropic drugs on plasma insulin levels after a standard meal. Diabetes Care 2002; 3725(8): 1271–6.
15. Hosker JP, Rudenski AS, Burnett MA, Matthews DR, Turner RC. Similar reduction of first- and second-phase â-cell responses at three different glucose levels in type II diabetes and the effect of gliclazide therapy. Metabolism 1989; 3738(8): 767–72.
16. Davis SN. The role of glimepiride in the effective management of type 2 diabetes. J Diabetes Complications 2004; 3718(6): 367–76.
17. Holstein A, Plaschke A, Egberts EH. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev. 2001; 3717(6): 467–73.
18. Schernthaner G, Grimaldi A, Di-Mario U, Drzewoski J, Kempler P, Kvapil M, et al. GUIDE study: double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients. Eur J Clin Invest. 2004; 3734(8): 535–42.
19. Sesti G, Laratta E, Cardellini M, Andreozzi F, Del Guerra S, Irace C, et al. The E23K variant of KCNJ11 encoding the pancreatic beta-cell adenosine 5’-triphosphate- sensitive potassium channel subunit Kir6.2 is associated with an increased risk of secondary failure to sulfonylurea in patients with type 2 diabetes. J Clin Endocrinol Metab. 2006; 3791(6): 2334–9.
20. Holstein A, Hahn M, Stumvoll M, Kovacs P. The E23K variant of KCNJ11 and the risk for severe sulfonylurea-induced hypoglycemia in patients with type 2 diabetes. Horm Metab Res. 2009; 3741(5): 387–90.
21. Nikolac N, Simundic AM, Katalinic D, Topic E, Cipak A, Zjacic Rotkvic V. Metabolic control in type 2 diabetes is associated with sulfonylurea receptor-1 (SUR-1) but not with KCNJ11 polymorphisms. Arch Med Res. 2009; 40(5): 387–92.
22. Balabolkin MI, Kreminskaya VM, Klebanova EM. Modern tactics of treatment of diabetes mellitus type 2. Consilium medicum 2001; 373(11): 535–40 (in Russian).
23. De Fronzo RA, Simonson DC. Oral sulfonylurea agents suppress hepatic glucose production in non-insulin-dependent diabetic individuals. Diabetes Care 1984; 377(1): 72–80.
24. Klepzig H, Kober G, Matter C, Luus H, Schneider H, Boedeker KH, et al. Sulfonylureas and ischemic preconditioning. A double-blind, placebo- controlled evolution of glimepiride and glibenclamide. Eur Heart J. 1999; 20(6): 439–46.
25. Nagashima K, Takahashi A, Ikeda H, Hamasaki A, Kuwamura N, Yamada Y, et al. Sulfonylurea and non-sulfonylurea hypoglycemic agents: pharmacological properties and tissue selectivity. Diabetes Res Clin Pract. 2004; 66 (Suppl. 1): S75–8.
26. Indiana University. Department of Medicine. P450 Drug Interaction Table. Available from: http://medicine.iupui.edu/clinpharm/ddis/main-table.
27. Christ OE, Heptner W, Rupp W. Investigations on absorption, excretion and metabolism in man after administration of 14C-labelled HB 419. Horm Metab Res. 1969; 1 (Suppl. l): 51–4.
28. Peart GF, Boutagy J, Shenfield GM. The metabolism of glyburide in subjects of known debrisoquine phenotype. Clin Pharmacol Ther. 1989; 3745(3): 277–84.
29. Xu H, Williams KM, Liauw WS, Murray M, Day RO, McLachlan AJ. Effects of St John’s wort and CYP2C9 genotype on the pharmacokinetics and pharmacodynamics of gliclazide. Br J Pharmacol. 2009; 37153(7): 1579–86.
30. Abulula M, Baranov V, Vorokhobina N, Zagorodnikova K. CYP2Ñ9 genotype and clinical effects of gliclazide. Clinical Therapeutics 2015; 378(37): e144–e145.
31. Kukes VG, Grachev SV, Sychev DA, Ramenskaya GV. Metabolism of drugs: scientific basis of personalized medicine. Moscow: GEOTAR-Media; 2008 (in Russian).
32. Woolf TF, ed. Handbook of drug metabolism. New York: Dekker; 1999.
33. Becker ML, Visser LE, Trienekens PH, Hofman A, van Schaik RH, Stricker BH. Cytochrome P450 2C9 *2 and *3 polymorphisms and the dose and effect of sulfonylurea in type II diabetes mellitus. Clin Pharmacol Ther. 2008; 3783(2): 288–92.
34. Suzuki K, Yanagawa T, Shibasaki T, Kaniwa N, Hasegawa R, Tohkin M. Effect of CYP2C9 genetic polymorphisms on the efficacy and pharmacokinetics of glimepiride in subjects with type 2 diabetes. Diabetes Res Clin Pract. 2006; 3772(2): 48–54.
35. Surendiran A, Pradhan SC, Agraval A, Subrahmanyam DK, Rajan S, Anichavezhi D, et al. Influence of CYP2C9 gene polymorphism on response to glibenclamide in type 2 diabetes mellitus patients. Eur J Clin Pharmacol. 2011; 3767(8): 797–801.
36. Holstein A, Plaschke A, Ptak M, Egberts EH, El-Din J, Brockmoller J, et al. Association between CYP2C9 slow metabolizer genotypes and severe hypoglycaemia on medication with sulphonylurea hypoglyacemic agents. Br J Clin Pharmacol 2005; 60(1): 103–6.
37. Ragia G, Petridis I, Tavridou A, Christakidis D, Manolopoulos VG. Presence of CYP2C9*3 allele increases risk for hypoglycemia in Type 2 diabetic patients treated with sulfonylureas. Pharmacogenomics 2009; 10(11): 1781–7.
38. Shabelnikova OYu, Bondar IA, Filipenko ML, Sokolova EA. The Association of CYP2C9 gene polymorphism with response to therapy with sulfonylureas in the Novosibirsk region [Internet]. Available from: http://rusendo.com/index.php/REC/VIIREC/paper/view/878 (in Russian).
39. Tingle M, Burns K, Helsby N. Control of variable CYP2C19 expression within metaboliser categories. UPCP 2012: Up Close and Personalized International Congress on Personalized Medicine 2012, February 25; Florence, Italy. Program and Abstracts. P. 105.
40. Ledyaev YM. The value of pharmacokinetic analysis of isoenzyme CYP2C9 and optimization of pharmacotherapy of diabetes mellitus type 2. Cand. Med. Sci [thesis]. Volgograd; 2011 (in Russian).
41. Anikin GS. The value of estimating the activity of the isoenzyme of cytochrome P450 2C9 on the pharmacokinetics of losartan and its metabolite E-3174 to optimize pharmacotherapy. Cand. Med. Sci [thesis]. Moscow; 2010 (in Russian).
42. Lee JE, Ryu DH, Jeong HJ, Kim JH, Jun JE, Kim JS, et al. Extremely elevated international normalized ratio of warfarin in a patient with CYP2C9*1/*3 and thyrotoxicosis. J Korean Med Sci 2014; 3729(9): 1317–9.
43. Ignatov YuD, Kukes VG, Mazurov VI. Clinical pharmacology of nonsteroidal anti- inflammatory drugs. Moscow: GEOTAR-Media; 2010 (in Russian).
44. Sychev D, Antonov I, Ignatev I, Kasakov R. Advantages of pharmacogenetic approach (polymorphisms of genes CYP2C9 and VKORC1 study) to warfarin dosing, against the standard method for Russian patients with contestant form atrial fibrillation. J Basic and Clinical Pharmacology 2009; 105: 73–74.
45. Smirnov VV, Aslanbekov SM, Sychev DA, Mirzaev KB, Kazakov RE. Cytochrome P450 (CYP2C9) activeness, evaluated via losartan test, as prediction marker for the warfarin treatment dosage choice in patients with delayed outcomes after heart valves replacement. Russian Journal of Cardiology 2015; 126(10): 70–4 (in Russian).
46. Sychev DA. Recommendations for pharmaceutical companies to study the biotransformation and transporters of new drugs: study design, data analysis and entry of information in the instructions for use. Moscow; 2009. Available from: https://goo.gl/1xCWuu (in Russian).
47. Scientific substantiation, development and improvement of methodology for assessment of medicinal products interchangeability. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Romanov BK, Prokofiev AB, Yagudina RI; prepared by: Alyautdin RN, Zhuravleva MV. Moscow; 2016. 365 p. No. SR 115111740009. Deposited in CITIS on 26.01.2017, No. IKRBS 217012640056-0 (in Russian).
48. Bukatina TM, Kazakov AS, Velts NYu, Darmostukova MA, Kolesnikova EYu, Alyautdin RN, et al. Inhibitors of sodium-glucose cotransporter 2: risk of ketoacidosis.
49. Safety and Risk of Pharmacotherapy 2016; (2): 33–9.
50. Chuchalin AG, Hohlov AL, eds. Federal guidance on the use of drugs (formulary system). Issue XVIII. Moscow: Vidoks; 2017 (in Russian).
Review
For citations:
Gorodetskaya G.I., Kukes V.G., Belkov S.A., Kazakov R.E., Serebrova S.Yu., Muslimova O.V., Rodina T.A., Aleksandrov A.A. Pharmacogenetic testing in the treatment of type 2 diabetes with sulfonylurea drugs. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(4):233-241. (In Russ.)
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