Clinical comparison of incidence of side effects of cilostazol analogs in treatment of diabetic foot syndrome

Abstract

The purpose of our study was to test the assumptions about possible side effects of two brand names of cilostazol. It included a total of 165 patients presenting with neuroischemic form of diabetic foot syndrome, stage IIA–IIB lower-limb chronic ischemia, moderate-to-severe distal sensorimotor neuropathy, as well as tissue damage according to the W (W1–W3) scale, with no urgent indications for limb amputation. The patients were willing to comply with the requirements for examination and treatment performed according to the algorithm at the “Diabetic Foot” Center of Kazan after obtaining written informed consent. Two trade names of cilostazol analogs, i. e., “Aducyl” and “Pletax”, were compared. The patients were divided into 2 groups, representative by the baseline data, in accordance with the received analog. The frequency of side effects, as well as the frequency of favorable and unfavorable outcomes were compared.

The side effects encountered in both groups were as follows: headache, edematous syndrome in the lower extremities, destabilization of blood pressure, dermatitis in the lower extremities, tachycardia, shortness of breath, nausea, and general malaise. Also, the frequency of complications and the frequency of refusal to take the drug were compared. When analyzing the data obtained, it was found that the group of patients receiving Aducyl® included in the complex therapy regimen had significantly more favorable outcomes. Taking Pletax® was associated with a higher level of clinically verified complications. The chance of an unfavorable outcome during treatment with Pletax® was 2.43 times higher than that with Aducyl®.

Keywords:diabetes mellitus; diabetic foot syndrome; chronic arterial insufficiency; cilostazol; Aducyl®; Pletax®

Funding. The study had no financial support.

Conflict of interest. The authors declare no conflicts of interest.

Authors’ contribution. Study conception and design – Koreiba K.A.; data collection and handling – Syuzev K.N., Serebryakova O.A., Makarimov E.Sh.; statistical processing – Syuzev K.N.; draft manuscript preparation – Koreiba K.A.; manuscript revision – Serebryakova O.A.

For citation: Koreiba K.A, Syuzev K.N., Serebryakova O.A., Makarimov E.Sh. Clinical comparison of incidence of side effects of cilostazol analogs in treatment of diabetic foot syndrome. Аngiology and Vascular Surgery. 2023; 29 (1): 16–22. DOI: https://doi.org/10.33029/1027-6661-2023-29-1-16-22 (in Russian)

References

1. International Diabetes Federation. IDF Diabetes Atlas, 10th ed. Brussels, Belgium: International Diabetes Federation. 2021.

2. Bensman V.M. Hirurgiya gnoyno-nekroticheskikh oslozhneniy diabeticheskoy stopy (rukovodstvo dlya vrachey). 2-e izdanie. M.: MEDPRAKTIKA–M. 2015; 496. (in Russian)

3. Yakovlev A.V., Yakovleva O.V., Sitdikova G.F. Adenilatciklaznaya i guanilatciklaznaya sistemy vnutrikletochnykh vtorichnykh posrednikov. Kazan’: Izdatel’stvo KGU. 2009; 48. (in Russian)

4. Koreyba K.A., Stupin V.A., Silina E.V., Syuzev K.N., Serebryakova O.A. Molecular study of mechanisms of action of cilostazol on certain families of phosphodiesterases. Angiology and Vascular Surgery. 2022; 28 (1): 22–28. DOI: https://doi.org/10.33029/1027-6661-2022-28-1-22-28 (in Russian)

5. National guidelines for the diagnosis and treatment of diseases of the arteries of the lower extremities. Moscow. 2019; 89. (in Russian)

6. Kazantsev A.N., Goryunov S.V., Ershova O.B., et al. randomized study of tolerability, safety and efficacy of pletax in intermittent claudication. Angiology and Vascular Surgery. 2021; 27 (1): 7–16. DOI: https://doi.org/10.33529/ANGIO2020405 (in Russian)

7. Wagner F.W., Jr. The dysvascular foot: a system for diagnosis and treatment. Foot and Ankle. 1981; 2 (2): 64–122. DOI: https://doi.org/10.1177/107110078100200202

8. Komelyagina E.Yu., Antsiferov M.B., Uvarova O.M. Validation and perspectives of the Russian version of the quality of life questionnaire in patients with diabetic peripheral polyneuropathy. Diabetes mellitus. 2014; 17 (2): 56–65. DOI: https://doi.org/10.14341/DM2014256-65 (in Russian)

9. Stupin V.A., Silina E.V., Korejba K.A., Goryunov S.V. Sindrom diabeticheskoy stopy (epidemiologiya, patofiziologiya, diagnostika i lechenie). M.: LitTerra. 2019; 200. (in Russian)

10. Pokrovskiy A.V., Chupin A.V. Ishemicheskaya diabeticheskaya stopa. V knige: Klinicheskaya angiologiya: Rukovodstvo. V dvuh tomah. Tom 2. Pod red. A.V. Pokrovskogo. M.: Meditsina. 2004; 250–262. (in Russian)

11. Norgren L., Hiatt W.R., Dormandy J.A., et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). European Journal of Vascular and Endovascular Surgery. 2007; 33 (Suppl. 1): S1–S75. DOI: https://doi.org/10.1016/j.ejvs.2006.09.024

12. Koreyba K.A. Antiplatelet agents in complex medication therapy in diabetic foot disease. Russian Medical Inquiry. 2020; 4 (7): 457–462. DOI: https://doi.org/10.32364/2587-6821-2020-4-7-457-462 (in Russian)

13. Kotel’nikov G.P., SHpigel’ A.S. Dokazatel’naya meditsina. Nauchno-obosnovannaya meditsinskaya praktika: Monografiya. Samara: SamGMU. 2000; 116. (in Russian)

14. Korejba K.A., Klyushkin I.V., Minabutdinov A.R., Korejba E.A. Managed tissue regeneration mathematical model in patients with diabetic foot syndrome. The Bulletin of Contemporary Clinical Medicine. 2018; 11 (5): 51–54. DOI: https://doi.org/10.20969/VSKM.2018.11(5).51-54 (in Russian)

15. Ahmad F., Degerman E., Manganiello V.C. Cyclic nucleotide phosphodiesterase 3 signaling complexes. Hormone and Metabolic Research. 2012; 44 (10): 776–785. DOI: https://doi.org/10.1055/s-0032-1312646

16. Hiatt W.R. The US experience with cilostazol in treating intermittent claudication. Atherosclerosis Supplements. 2005; 6 (4): 21–31. DOI: https://doi.org/10.1016/j.atherosclerosissup.2005.09.004

17. Zubair M., Malik A., Ahmad J. Incidence, risk factors for amputation among patients with diabetic foot ulcer in a North Indian tertiary care hospital. Foot (Edinb). 2012; 22 (1): 24–30. DOI: https://doi.org/10.1016/j.foot.2011.09.003

18. Heikkinen M., Salmenperä M., Lepäntalo A., Lepäntalo M. Diabetes care for patients with peripheral arterial disease. European Journal of Vascular and Endovascular Surgery. 2007; 33 (5): 583–591. DOI: https://doi.org/10.1016/j.ejvs.2007.01.012

19. Li Z., Guo S., Yao F., et al. Increased ratio of serum matrix metalloproteinase-9 against TIMP-1 predicts poor wound healing in diabetic foot ulcers. Journal of Diabetic Complications. 2013; 27 (4): 380–382. DOI: https://doi.org/10.1016/j.jdiacomp.2012.12.007

20. de Franciscis S., Gallelli L., Battaglia L., et al. Cilostazol prevents foot ulcers in diabetic patients with peripheral vascular disease. International Wound Journal. 2015; 12 (3): 250–253. DOI: https://doi.org/10.1111/iwj.12085

21. Rosales R.L., Santos M.M., Mercado–Asis L.B. Cilostazol: a pilot study on safety and clinical efficacy in neuropathies of diabetes mellitus type 2 (ASCEND). Angiology. 2011; 62 (8): 625–635. DOI: https://doi.org/10.1177/0003319711410594

22. Chow S.C. Bioavailability and Bioequivalence in Drug Development. Wiley Interdisciplinary Reviews: Computational Statistics. 2014; 6 (4): 304–312. DOI: https://doi.org/10.1002/wics.1310

23. Dunne S., Shannon B., Dunne C., Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology. 2013; 14: 1. DOI: https://doi.org/10.1186/2050-6511-14-1

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CHIEF EDITOR
Akchurin Renat Suleymanovich
Doctor of Medical Sciences, Professor, Academician of the Russian Academy of Sciences, Deputy General Director for Surgery, Head of the Department of Cardiovascular Surgery, National Medical Research Center for Cardiology named after Academician E.I. Chazov, President of the Russian Society of Angiologists and Vascular Surgeons

 

In accordance with the decision of the Presidium of the Russian Society of Angiologists and Vascular Surgeons, the journal "Angiology and Vascular Surgery" will be named after Academician A.V. Pokrovsky starting from No. 2/2022.


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