**6. Conclusion**

464 Dyslipidemia - From Prevention to Treatment

symptomatic related ADRs. Kashani A. et al. 23 found that incidences of patients discontinued their therapy because of symptomatic ADRs of statin (5.6%) were higher than patients had rhabdomyolysis (0.2%), hepatotoxicity (1.4%), and creatine kinase (CK) elevations (0.9%). Therefore, self-reporting of ADRs are useful to determine and predict the toxicities induced by medication24. There are few studies done on the common statin-related ADRs that use patient self-report. There was a previous study that focused on the common ADRs during statin therapy and their predictors in cardiac outpatients. They reported the use of a self-report questionnaire form is suitable approach to assess the common undesired symptoms found during statin therapy25. In the real-life practice, doctors are more focusing on dyslipidemia and its complications than statin-related ADRs of their patients. Furthermore, self-report approach allows the patients to express directly their unwanted problems associated with statin therapy. In addition, patients sometimes feel uncomfortable or inappropriate telling their doctor about these undesired symptoms of statin26,27. The finding in this study showed a higher incidence of fatigue and muscle pain in this cardiac

In this study, females reported having back and joint pain significantly more than males did. Female patients are more sensitive to ADRs than males possibly because of pharmacokinetic and pharmacodynamic differences between genders28. Not all ADRs of statin related to gender, this finding supported by FDA, Bayer reports and previous studies29-32. When compared to other races, Indian patients had significantly higher incidence of some common ADRs (fatigue, muscle pain, back pain and visual disturbance). This is because genetics also has contributed in adverse drug reactions23. This result was supported by FDA reports in which ADRs were different among races7. Cigarette smokers had increased incidence of these ADRs than nonsmokers, however this finding was not statistically significant. Alcohol consumers had significant problems with fatigue, back pain and insomnia, and increased incidence of ADRs in general30. This is because alcohol causes mitochondrial dysfunction, which would increase the risk of muscle disorders caused by statins33. There was no relationship between age and ADRs, as shown in Table 2, which supported by Kucukarslan et al study34. There was a relationship between duration of statin used and ADRs in previous studies29,35,36. Their finding were consistent with this present finding, where the

outpatients setting, which consistent with previous studies8,10.

duration of statin therapy has related to fatigue, muscle pain and back pain.

have back pain and insomnia than other subtypes.

Based on our knowledge, no previous studies reported the relationship between dyslipidemia types and the common ADRs. Significant relationship was found in this study between dyslipidemia type (primary and secondary) and common ADRs. Patients who had secondary dyslipidemia type had increase frequency of insomnia than with primary type. Patients with subtype IIb and renal induced dyslipidemia were significantly more likely to

Although statins differ in their pharmacokinetic properties37,38, there is no significant relationship found between statin types and common ADRs. However, simvastatin was more likely to cause fatigue, joint pain, back pain and visual disturbance than other statins. Although there is no significant relation found between atorvastatin and common ADRs. Atorvastatin found to cause muscle pain more often than other statin types, this finding also proved by Clearfield et al. and Golomb et al. 10,11. Patients on lovastatin therapy had higher incidence of insomnia than other types of statin. Higher doses for all types of statins have resulted in a higher incidence of ADRs. The higher dose of lovastatin (60 mg) significantly This paper explained that significant number of cardiac outpatients were experienced common ADRs related-statin through self-report approach and their predictors. Common ADRs of statin were fatigue, muscle pain, joint pain, back pain, insomnia and visual disturbances. The main predictors or contributing factors of common statin-related ADRs were gender, race, alcohol consumption, duration of statin used, renal induced-secondary dyslipidemia, subtype IIb of primary dyslipidemia and lovastatin dose. These predictors are useful in clinical practice to determine the likelihood of ADRs and to manage the common ADRs of statin in cardiac outpatients. Finding from this study was suggested appropriate dose and type of statin use and also adjustment of the preventable predictors may minimize common ADRs of statin in cardiac outpatients. Appropriate prospective study design with multicenter sites recommended determining the actual effects of these preventable predictors on common ADRs of statin.
