Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism

The widespread use of statins in clinical practice necessitates a systematic approach to the risk and safety assessment. The aim of the study was to analyze information about adverse reactions to statins and their specific causes in patients with hypercholesterolemia accompanied by diabetes and hypo...

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Main Authors: V. V. Arkhipov, G. I. Gorodetskaya, O. A. Demidova, T. V. Alexandrova, A. A. Alexandrov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2019-12-01
Series:Безопасность и риск фармакотерапии
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Online Access:https://www.risksafety.ru/jour/article/view/152
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author V. V. Arkhipov
G. I. Gorodetskaya
O. A. Demidova
T. V. Alexandrova
A. A. Alexandrov
author_facet V. V. Arkhipov
G. I. Gorodetskaya
O. A. Demidova
T. V. Alexandrova
A. A. Alexandrov
author_sort V. V. Arkhipov
collection DOAJ
description The widespread use of statins in clinical practice necessitates a systematic approach to the risk and safety assessment. The aim of the study was to analyze information about adverse reactions to statins and their specific causes in patients with hypercholesterolemia accompanied by diabetes and hypothyroidism. The paper compares statin products (simvastatin, atorvastatin, pravastatin, rosuvastatin, and fluvastatin) in terms of the frequency of the most significant adverse reactions—statin-induced myopathy, liver damage, secondary hyperglycemia. It dis­cusses specific causes of adverse reactions to statins in patients with hypothyroidism and dia­betes. It was demonstrated that the use of statins in patients with compensated hypothyroid­ism, who have CC and TC allelic variants of the SLCO1B1*5 gene (c.521T>C), is associated with a higher risk of developing statin-induced myopathies. The adjustment of statin doses, especially in patients with hypothyroidism and diabetes, should be made based on the results of pharmaco­genetic testing for SLCO1B1*5 (c.521T>C) allelic variants. The results of dynamic clinical and laboratory control of the hepatic transaminase level, as well as the levels of glucose, glycated hemoglobin, and thyroid-stimulating hormone should be the key factors to be taken into account when adjusting treatment plans in this group of patients. The paper analyses polymorphisms of genes which are associated with resistance to statin therapy in patients with diabetes. Thus, the use of statins for primary prevention and treatment of cardiovascular diseases in patients with hypercholesterolemia accompanied by diabetes and/or hypothyroidism, requires a comprehen­sive assessment of the risk/benefit ratio.
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institution Kabale University
issn 2312-7821
2619-1164
language Russian
publishDate 2019-12-01
publisher Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
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spelling doaj-art-73dfd9f33159483ea1047b34e5812d252025-08-20T03:43:01ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642019-12-017416317510.30895/2312-7821-2019-7-4-163-175150Analysis of Safety Issues of Using Statins in Patients with Diabetes and HypothyroidismV. V. Arkhipov0G. I. Gorodetskaya1O. A. Demidova2T. V. Alexandrova3A. A. Alexandrov4Scientific Centre for Expert Evaluation of Medicinal Products,Scientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical University,Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe widespread use of statins in clinical practice necessitates a systematic approach to the risk and safety assessment. The aim of the study was to analyze information about adverse reactions to statins and their specific causes in patients with hypercholesterolemia accompanied by diabetes and hypothyroidism. The paper compares statin products (simvastatin, atorvastatin, pravastatin, rosuvastatin, and fluvastatin) in terms of the frequency of the most significant adverse reactions—statin-induced myopathy, liver damage, secondary hyperglycemia. It dis­cusses specific causes of adverse reactions to statins in patients with hypothyroidism and dia­betes. It was demonstrated that the use of statins in patients with compensated hypothyroid­ism, who have CC and TC allelic variants of the SLCO1B1*5 gene (c.521T>C), is associated with a higher risk of developing statin-induced myopathies. The adjustment of statin doses, especially in patients with hypothyroidism and diabetes, should be made based on the results of pharmaco­genetic testing for SLCO1B1*5 (c.521T>C) allelic variants. The results of dynamic clinical and laboratory control of the hepatic transaminase level, as well as the levels of glucose, glycated hemoglobin, and thyroid-stimulating hormone should be the key factors to be taken into account when adjusting treatment plans in this group of patients. The paper analyses polymorphisms of genes which are associated with resistance to statin therapy in patients with diabetes. Thus, the use of statins for primary prevention and treatment of cardiovascular diseases in patients with hypercholesterolemia accompanied by diabetes and/or hypothyroidism, requires a comprehen­sive assessment of the risk/benefit ratio.https://www.risksafety.ru/jour/article/view/152statinsadverse reactionssecurity applicationsstatin-induced myopathyhyperglycemiadiabetes mellitushypothyroidism
spellingShingle V. V. Arkhipov
G. I. Gorodetskaya
O. A. Demidova
T. V. Alexandrova
A. A. Alexandrov
Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism
Безопасность и риск фармакотерапии
statins
adverse reactions
security applications
statin-induced myopathy
hyperglycemia
diabetes mellitus
hypothyroidism
title Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism
title_full Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism
title_fullStr Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism
title_full_unstemmed Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism
title_short Analysis of Safety Issues of Using Statins in Patients with Diabetes and Hypothyroidism
title_sort analysis of safety issues of using statins in patients with diabetes and hypothyroidism
topic statins
adverse reactions
security applications
statin-induced myopathy
hyperglycemia
diabetes mellitus
hypothyroidism
url https://www.risksafety.ru/jour/article/view/152
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AT tvalexandrova analysisofsafetyissuesofusingstatinsinpatientswithdiabetesandhypothyroidism
AT aaalexandrov analysisofsafetyissuesofusingstatinsinpatientswithdiabetesandhypothyroidism