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Safety and Risk of Pharmacotherapy

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UNEXPECTED ADVERSE REACTIONS OF THE DRUGS OF THE GROUP OF INHIBITORS OF DIPEPTIDYL PEPTIDASE-4

https://doi.org/10.30895/2312-7821-2018-6-2-54-60

Abstract

Diabetes mellitus is the most acute medical and social problem related to the priorities of national health systems. The dramatic and urgent problems of diabetes mellitus are determined by the high prevalence of diabetes, high mortality and early disability of patients. The prevalence of diabetes mellitus in Western countries is 2–5 % of the population, and in developing countries reaches 10–15 %. Inhibitors of dipeptidylpeptidase-4 are one of the classes of drugs for the treatment of patients with diabetes mellitus type II. Now days the analysis of regulatory reports from developed countries show that the number of reports FDA, Health Canada on the risk of serious adverse reactions has increased. Not all detected adverse reactions are listed in the instructions for use among the possible side effects of the group of inhibitors of DPP-4. The article deals with reports of adverse reactions detected during the monitoring of databases of the Russian Federation and regulatory authorities of foreign countries. The safety research of the use of DPP-4 inhibitors is ongoing.

About the Authors

T. V. Romanova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Romanova Tatyana V. Analyst of the 1st category of Department for Expert Analysis of Medicinal Products’ Safety of the DEMPS. 

8/2 Petrovsky Blvd, Moscow 127051



T. M. Bukatina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Bukatina Tatyana M. Senior Analyst of Department of Expert Analysis Methodology of the DEMPS. PhD. 

8/2 Petrovsky Blvd, Moscow 127051



E. O. Zhuravleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Zhuravleva Eugenia O. Head of Department for Expert Analysis of Medicinal Products’ Safety of the DEMPS. 

8/2 Petrovsky Blvd, Moscow 127051



G. V. Kutekhova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Kutekhova Galina V. Analyst of the 1st category of Department for Expert Analysis of Medicinal Products’ Safety of the DEMPS. 

8/2 Petrovsky Blvd, Moscow 127051



I. I. Snegireva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Snegireva Irina I. Head of Department for Evaluation of MIBPs Side Effects of the DEMPS. PhD. 

8/2 Petrovsky Blvd, Moscow 127051



M. A. Darmostukova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Darmostukova Maria A. Senior Analyst Department for Evaluation of MIBPs Side Effects of the DEMPS. 

8/2 Petrovsky Blvd, Moscow 127051



D. A. Kaperko
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Kaperko Dmitry A. Senior Analyst of Department of Expert Analysis Methodology of the DEMPS. 

8/2 Petrovsky Blvd, Moscow 127051



N. Yu. Velts
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Velts Natalia Yu. Senior Analyst of Department of Expert Ana-lysis Methodology of the DEMPS. PhD. 

8/2 Petrovsky Blvd, Moscow 127051



A. S. Kazakov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Kazakov Alexander S. Head of Department of Expert Analysis Methodology of the DEMPS. PhD. 

8/2 Petrovsky Blvd, Moscow 127051



E. V. Shubnikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Shubnikova Elena V. Senior Analyst of Department of Expert Analysis Methodology of the DEMPS. PhD. 

8/2 Petrovsky Blvd, Moscow 127051



R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Alyautdin Renad N. Head of Division for Evaluation of Medicinal Products’ Safety. MD, DSc (Med), prof.

 8/2 Petrovsky Blvd, Moscow 127051



References

1. Soldatov AA, Avdeeva ZhI, Olefir YuV, Merkulov VA, Bondarev VP. Safety of biological preparations. Report 1. Terminology and classifications issues. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16(1): 14–26. (In Russ.)

2. Alyautdin RN. Pharmacology. Moscow: GEOTAR Media; 2008. (In Russ.)

3. Holman RR, Paul SK, Bethel MA, et al. 10-years follow-up of intensive glucose control in type 2 diabetes. Engl J Med 2008; 359: 1577–89.

4. Antsiferov MB, Dorofeeva LG. The inhibitor of dipeptidyl peptidase4-vildagliptin a new drug in the therapy of diabetes mellitus of the 2nd type. Lechaschi Vrach 2010 [cited 01 Feb 2018]. Available from: https://www.lvrach.ru/2010/03/12348021/ (In Russ.)

5. Garber A. et al. Effects of Vildagliptin on Glucose Control in Patients with Type 2 Diabetes Inadequately Controlled with a Sulphonylurea. Diabetes, Obesity and Metabolism 2008; 10: 1326–463.

6. Sabanov AV, Petunina NA, Matveev NV, Luneva AV. Comparative evaluation of clinical and cost-effectiveness of inhibitors dipeptidylpeptidase-4 in the therapy of diabetes mellitus of the 2nd type. Endocrinology 2015; 3: 65–72. (In Russ.)

7. Bukatina TM, Kazakov AS, Velts NU, Darmostukova MA, Kolesnikova EY, Alyautdin RN, Romanov BK. Inhibitors of sodium-glucose cotransporter 2: risk of ketoacidosis. Safety and risk of pharmacotherapy 2016; 2: 33–40. (In Russ.)

8. Gorodetskaya GI, Kukes VG, Belkov SA, Kazakov RE, Serebrova SU, Muslimova OV, Rodina TA, Aleksandrov AA. Pharmacogenetic testing in optimization of treatment of type 2 diabetes mellitus with sulfonylurea drugs. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2017; 4: 233–41. (In Russ.)

9. FDA [Internet]. 2018 (дата обращения: 05.03.2018). Available from: https://www.fda.gov/Drugs/default.htm.

10. Health Canada [Internet]. 2018 (дата обращения: 05.03.2018) Available from: https://www.canada.ca/en/health-canada.html

11. Medical Dictionary for Regulatory Activities (MedDRA) [Internet] (cited 2018 March 3). Available from: https://www.meddra.org/ (In Russ.)


Review

For citations:


Romanova T.V., Bukatina T.M., Zhuravleva E.O., Kutekhova G.V., Snegireva I.I., Darmostukova M.A., Kaperko D.A., Velts N.Yu., Kazakov A.S., Shubnikova E.V., Alyautdin R.N. UNEXPECTED ADVERSE REACTIONS OF THE DRUGS OF THE GROUP OF INHIBITORS OF DIPEPTIDYL PEPTIDASE-4. Safety and Risk of Pharmacotherapy. 2018;6(2):54-60. (In Russ.) https://doi.org/10.30895/2312-7821-2018-6-2-54-60

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ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)