**Predictors of the Common Adverse Drug Reactions of Statins**

Hadeer Akram AbdulRazzaq1, Noorizan Abd Aziz2, Yahaya Hassan2, Yaman Walid Kassab1 and Omar Ismail3

*1Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains, Penang, 2Faculty of Pharmacy, UiTM, Puncak Alam Campus, Bandar Puncak Alam, Selangor DE, 3Department of Cardiology, Hospital Pulau Pinang, Penang, Malaysia* 

### **1. Introduction**

458 Dyslipidemia - From Prevention to Treatment

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Statins are common lipid lowering agents to reduce elevation of cholesterol or as prophylaxis against other cardiac diseases. It estimated that 62.5% to 91.7% of dyslipidemic patients in United State of America are using statins1 These agents widely used among cardiovascular patients in Malaysia2. In other countries, for example in UK, it has found that most patients who use statins are older than 35 years old and more of them are males (56%)3. In Canada, about 90% of cardiac patients are using statin, while in US, at least one third of all cardiac patients are using statins4. About 60% of American patients who older than 60 years old are using statin5. Thus, high number of users contributed to increase the risk of adverse drug reactions (ADRs).

The Food and Drug Administration (FDA) has determined that common statin-associated ADRs are fatigue, muscle pain, joints pain, back pain, visual disturbance and insomnia6,7. Previous studies have examined the incidence of these ADRs, and their results showed that more than half of the reported cases of muscle pain were related to statin use8,9. Clearfield et al found that fatigue, muscle pain, and bone pain were common and frequent ADRs in UK, and related to atorvastatin and rosuvastatin use10. Other studies exploring ADRs in patients using atorvastatin and lovastatin in the US found that muscle pain and fatigue were the most common statin-related ADRs11. The UK Committee on Safety of Medicines, as well as other studies, have reported that these symptoms should consider as early signs for more serious ADRs8,12-15. However, from our knowledge, no data available on the common ADRs statin-related and their predictors for Asian patients. Only a few studies (not related with Asian patients) have found out the predictors of the statin-related ADRs8,9,10,16,17. As health care professional, they should find methods to ensure patients not only receive effective medication but also feel comfortable with the therapy. Thus, the objectives of this study was to determine the common statin-related ADRs and their predictors in one of the referral hospital in Malaysia (one of country in South East Asia).

Predictors of the Common Adverse Drug Reactions of Statins 461

Female 149 (30%)

Chinese 188 (37.6%) Indian 133 (26.6%) Foreign 7 (1.4%)

51-65 year 258 (51%) 66-92 year 148 (30%)

No 441 (88%)

No 453 (91%)

Secondary 233 (48.5%)

I 13 (5.3%) IIa 125 (50.6%) IIb 59 (23.9%) III 7 (2.8%) IV 32 (13%) V 11 (4.5%)

Renal 17 (7.3%) Diabetes 201 (86.3%) Nephrotic syndrome 1 (0.4%) Liver 1 (0.4%) Drugs 2 (0.9%) Hypothyroidism 11 (4.7%)

Simvastatin 47 (9.4%) Lovastatin 405 (81%) others 8 (1.6)

No 465 (93%)

3months or less 16 (3.2%) 3months -1 year 133 (26.7%) 1-5 years 262 (52.5%) 5-20 years 89 (17.6%)

**Demographics Variables No (%)** 

Gender Male 351 (70%)

Race Malay 172 (34.4%)

Age (mean 60±10)year 28-50 year 94 (19%)

Smoke Yes 59 (12%)

Alcohol consuming Yes 47 (9%)

Type of statin Atorvastatin 40 (8%)

Combination therapy Yes 35 (7%)

Table 1. Demographic data of 500 cardiac outpatients in Penang General Hospital

Primary dyslipidemia

dyslipidemia subtype

Duration of therapy Mean (3.5±3.0) year

subtype

Secondary

Dyslipidiemia type Primary 247 (51.5%)
