Abstract | OBJECTIVES: The goal of this clinical trial was to determine the incidence of undesirable side effects, and to ascertain any occurrence of genetic polymorphisms. MATERIAL AND METHODS: Clinically, we looked for manifestations of a benign myositis and of serious rhabdomyolysis. We observed a group 198 patients treated with statins, primarially fluvastatin and rosuvastatin. There were 126 (mean age = 58.3 ± 4.1; male 91, mean age = 57.4 ± 5.9; female 35, mean age = 60.5 ± 6.5) patients in a subgroup where we administered rosuvastatin. Undesirable muscular signs and symptoms were present in 32 patients (25.39%). In 11 (8.73% of the total 126) CK level increased maximally to 4 times ULN, in 6 (4.7%) statins were excluded because of very intense subjective suffering. CK levels 2-5 times ULN were present in 9 (7.14%). CK blood levels over 10 times ULN or higher indicated statins exclusion in 2 (1.58%). Increased levels of the further muscular enzyme AST by 5 times ULN were present in 16 (12.69%), up to 10 times ULN in 2 (1.58%), and over 10 times ULN also in 2 (1.58%). RESULTS: We observed rhabdomyolysis in 6 patients (3.03% of the total 198 patients group) using other types of statins (three of them undergo chronic hemodialysis). In this group we performed molecular-genetic analysis of the following proteins relating to statin myopathy: SLCO1B1(388AA/AG-521TT) - (discovered polymorphism in 1 patient), further cytochroms Cyp 2C9 (in 1 patient), 2C8 (in 1 patient), Cyp SA/4 (non discovered positivity) and finally UGT1A1*2B (discovered in 2 patients). CONCLUSIONS:
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Authors | Michal Drobny, Rudolf Pullmann, Ivan Odalos, Maria Skerenova, Beata Saniova |
Journal | Neuro endocrinology letters
(Neuro Endocrinol Lett)
Vol. 35
Issue 2
Pg. 123-8
( 2014)
ISSN: 0172-780X [Print] Sweden |
PMID | 24878976
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Fatty Acids, Monounsaturated
- Fluorobenzenes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Indoles
- Pyrimidines
- Sulfonamides
- Fluvastatin
- Rosuvastatin Calcium
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Topics |
- Aged
- Electromyography
- Fatty Acids, Monounsaturated
(adverse effects)
- Female
- Fluorobenzenes
(adverse effects)
- Fluvastatin
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(adverse effects)
- Incidence
- Indoles
(adverse effects)
- Male
- Middle Aged
- Muscular Diseases
(chemically induced, diagnosis, epidemiology, genetics)
- Polymorphism, Genetic
- Pyrimidines
(adverse effects)
- Rhabdomyolysis
(chemically induced, diagnosis, epidemiology)
- Rosuvastatin Calcium
- Sulfonamides
(adverse effects)
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