title: Statin adverse effects: patients' experiences and laboratory monitoring of muscle and liver injuries.
abstract: BACKGROUND
  Although statins have great benefit on the prevention of cardiovascular diseases with limited adverse effects (AEs), little is known about patients' contribution of AE reports in clinical practice.
  
  
  OBJECTIVE
  To explore patients' experiences of statin AEs and related laboratory monitoring in clinical practice.
  
  
  METHODS
  Outpatient clinics of two University hospitals in northeast Thailand.
  
  
  METHODS
  Generic symptom checklist questionnaires for self-reporting AEs were distributed to patients prescribed simvastatin, atorvastatin, or rosuvastatin at outpatient clinics. Clinical information was obtained from medical records. Reported symptoms were assessed for causality considering previously known statin AEs, concomitant diseases and drugs.
  
  
  METHODS
  Potential statin AEs reported by patients and monitoring of laboratory parameters related to musculoskeletal and liver disorders.
  
  
  RESULTS
  Of the total 718 valid responses, 76.0 % of patients reported at least one symptom, most of which (69.0 %) were probable/possible statin AEs. Musculoskeletal and liver-related symptoms were reported by 283 (39.4 %) and 134 patients (18.7 %), respectively. Probable/possible AEs were categorized in 56.7 % of their musculoskeletal and gastrointestinal symptoms. Majority of patients had at least one laboratory test on initiation of (64.8 %) and during statin treatment (61.8 %). Patients taking atorvastatin or rosuvastatin, and patients with history of chronic renal diseases were more likely to have creatine kinase (CK) monitored on initiation of and during statin treatment. Additionally, taking drugs which could potentially increase muscle injury (OR 1.929, P < 0.01) and self-reporting of musculoskeletal symptoms (OR 1.805, P < 0.01) were associated with CK monitoring during statin treatment. Reporters of musculoskeletal symptoms also had significantly higher mean CK level than those not reporting any musculoskeletal symptoms (207.35 ± 155.40 vs. 143.95 ± 83.07 U/L, respectively; P = 0.037). Patient reporting of liver AEs was not related to alanine aminotransferase (ALT) level and monitoring, however, prior history of liver disorders was significantly associated with monitoring of ALT on initiation of and during statin treatment (OR 5.745 and OR 23.063, respectively; P < 0.01).
  
  
  CONCLUSIONS
  Many patients experienced at least one possible adverse effects on a statin. The findings suggest that laboratory monitoring is relatively selective in relation to risks and patient-reported adverse symptoms.
authors: Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand.
authors: Nataporn
authors: N
authors: Chaipichit
authors: Janet
authors: J
authors: Krska
authors: Thongchai
authors: T
authors: Pratipanawatr
authors: Narumol
authors: N
authors: Jarernsiripornkul
mesh_terms: D000368:Aged; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood* / Q000453:epidemiology; D003430:Cross-Sectional Studies; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000097:blood*; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000097:blood* / Q000139:chemically induced* / Q000453:epidemiology; D057566:Self Report; D011795:Surveys and Questionnaires; D013785:Thailand / Q000453:epidemiology
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
references: Am J Cardiol. 2006 Apr 17;97(8A):69C-76C
references: 16581332
references: Epilepsy Behav. 2012 May;24(1):102-6
references: 22520583
references: East Mediterr Health J. 2011 May;17(5):460-4
references: 21796961
references: J Clin Lipidol. 2011 Jul-Aug;5(4):299-307
references: 21784376
references: J Public Health (Oxf). 2005 Sep;27(3):281-91
references: 15870099
references: Pharm World Sci. 2009 Oct;31(5):559-64
references: 19575308
references: Mayo Clin Proc. 2010 Apr;85(4):349-56
references: 20360293
references: Circulation. 2002 Dec 17;106(25):3143-421
references: 12485966
references: Am J Cardiol. 2006 Apr 17;97(8A):89C-94C
references: 16581336
references: Ann Oncol. 2009 Dec;20(12):1929-35
references: 19622510
references: Clin Ther. 2006 Jan;28(1):26-35
references: 16490577
references: Pharmacoepidemiol Drug Saf. 2009 Mar;18(3):240-5
references: 19148880
references: Drug Saf. 2012 Jan 1;35(1):45-60
references: 22149419
references: Br J Clin Pharmacol. 2002 Mar;53(3):318-25
references: 11874396
references: Drug Saf. 2011 May 1;34(5):429-36
references: 21513365
references: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934
references: 24239923
references: BMC Geriatr. 2010 Jun 10;10:37
references: 20537140
references: Br J Clin Pharmacol. 2009 May;67(5):558-64
references: 19552751
references: Am J Cardiol. 2006 Apr 17;97(8A):52C-60C
references: 16581329
references: Am J Cardiol. 2006 Apr 17;97(8A):77C-81C
references: 16581333
references: Ann Intern Med. 2006 Feb 21;144(4):257-61
references: 16490911
references: N Engl J Med. 2006 Feb 16;354(7):731-9
references: 16481640
references: J Gen Intern Med. 2000 Mar;15(3):149-54
references: 10718894
references: Drug Saf. 2012 Oct 1;35(10):807-18
references: 22928729
references: BMJ Qual Saf. 2012 Aug;21(8):685-99
references: 22562875
references: Am J Cardiol. 2003 Jul 15;92(2):152-60
references: 12860216
references: Am J Cardiol. 2012 Jul 15;110(2):307-13
references: 22497674
references: Drug Saf. 2013 Sep;36(9):779-87
references: 23615756
references: Drug Saf. 2007;30(8):669-75
references: 17696579
references: Eur J Clin Pharmacol. 2007 May;63(5):509-15
references: 17351768