title: Incidence of skeletal muscle disorders after statins' treatment: consequences in clinical and EMG picture.
abstract: OBJECTIVE
  The goal of this clinical trial was to determine the incidence of undesirable side effects, and to ascertain any occurrence of genetic polymorphisms.
  
  
  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
  In the group of patients treated by rosuvastatin, we discovered not one case of rhabdomyolysis. In each patient with rhabdomyolysis (brown urine discoloration, mal-odorous urine, painful muscle cramps, muscle weakness, fatigue) at least one polymorphism of "statins´ genes" was present.
authors.affiliation: Clinic of Anesthesiology and Intensive Medicine, Jessenius Faculty of Medicine in Martin, Comenius University Bratislava, University Hospital in Martin, Slovakia.
authors.forename: Michal
authors.initials: M
authors.lastname: Drobny
authors.affiliation: Department of Clinical Biochemistry, Jessenius Faculty of Medicine in Martin, Comenius University Bratislava, University Hospital in Martin, Slovakia.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Pullmann
authors.affiliation: Department of Clinical Biochemistry, Jessenius Faculty of Medicine in Martin, Comenius University Bratislava, University Hospital in Martin, Slovakia.
authors.forename: Ivan
authors.initials: I
authors.lastname: Odalos
authors.affiliation: Department of Clinical Biochemistry, Jessenius Faculty of Medicine in Martin, Comenius University Bratislava, University Hospital in Martin, Slovakia.
authors.forename: Maria
authors.initials: M
authors.lastname: Skerenova
authors.affiliation: Clinic of Anesthesiology and Intensive Medicine, Jessenius Faculty of Medicine in Martin, Comenius University Bratislava, University Hospital in Martin, Slovakia.
authors.forename: Beata
authors.initials: B
authors.lastname: Saniova
mesh_terms: D000368:Aged; D004576:Electromyography; D005229:Fatty Acids, Monounsaturated / Q000009:adverse effects; D005260:Female; D005464:Fluorobenzenes / Q000009:adverse effects; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D015994:Incidence; D007211:Indoles / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology* / Q000235:genetics; D011110:Polymorphism, Genetic; D011743:Pyrimidines / Q000009:adverse effects; D012206:Rhabdomyolysis / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects
chemical_list: D005229:Fatty Acids, Monounsaturated; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D011743:Pyrimidines; D013449:Sulfonamides; D000077340:Fluvastatin; D000068718:Rosuvastatin Calcium