PMID- 25630895
OWN - NLM
STAT- MEDLINE
DCOM- 20160107
LR  - 20181113
IS  - 2210-7711 (Electronic)
VI  - 37
IP  - 2
DP  - 2015 Apr
TI  - Statin adverse effects: patients' experiences and laboratory monitoring of muscle 
      and liver injuries.
PG  - 355-64
LID - 10.1007/s11096-015-0068-5 [doi]
AB  - 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. OBJECTIVES: To explore 
      patients' experiences of statin AEs and related laboratory monitoring in clinical 
      practice. SETTING: 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. MAIN OUTCOME 
      MEASURE: 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). CONCLUSION: 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.
FAU - Chaipichit, Nataporn
AU  - Chaipichit N
AD  - Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen 
      University, Khon Kaen, 40002, Thailand.
FAU - Krska, Janet
AU  - Krska J
FAU - Pratipanawatr, Thongchai
AU  - Pratipanawatr T
FAU - Jarernsiripornkul, Narumol
AU  - Jarernsiripornkul N
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150129
PL  - Netherlands
TA  - Int J Clin Pharm
JT  - International journal of clinical pharmacy
JID - 101554912
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Aged
MH  - Chemical and Drug Induced Liver Injury/*blood/epidemiology
MH  - Cross-Sectional Studies
MH  - Drug Monitoring/*methods
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects/*blood
MH  - Male
MH  - Middle Aged
MH  - Muscular Diseases/*blood/*chemically induced/epidemiology
MH  - *Self Report
MH  - Surveys and Questionnaires
MH  - Thailand/epidemiology
EDAT- 2015/01/30 06:00
MHDA- 2016/01/08 06:00
CRDT- 2015/01/30 06:00
PHST- 2014/09/23 00:00 [received]
PHST- 2015/01/07 00:00 [accepted]
PHST- 2015/01/30 06:00 [entrez]
PHST- 2015/01/30 06:00 [pubmed]
PHST- 2016/01/08 06:00 [medline]
AID - 10.1007/s11096-015-0068-5 [doi]
PST - ppublish
SO  - Int J Clin Pharm. 2015 Apr;37(2):355-64. doi: 10.1007/s11096-015-0068-5. Epub 
      2015 Jan 29.