BACKGROUND: LDL and hs-CRP are risk factors for vascular events and can be modified by Statin. OBJECTIVE: To evaluate the baseline hs-CRP of a certain Thai population who would need Atorvastatin, to evaluate the dose response of Atorvastatin toward LDL and hs-CRP level, and to evaluate the efficacy and safety of different types of Atorvastatin. MATERIAL AND METHOD: Subjects, who needed Statin therapy, were randomized to receive either 20 mg of Berlin(B)-Atorvastatin(R) or Pfizer(P)-Atorvastatin(R). The cross over took place after 8 weeks of therapy and continued for 16 weeks. Baseline blood tests were compared to 8 and 16 weeks. The effect of two brands of 20 mg Atorvastatin toward serum lipid, LFT, muscle enzyme and hs-CRP were compared. RESULTS:One hundred and ten subjects aged between 20-75 years enrolled in the present study. Fifty-four and 56 patients were randomized to group A and B. Baseline total cholesterol, LDL, HDL, and TG were 251, 174, 55, and 160 mg/dl respectively. There was a wide variation of baseline hs-CRP level. One hundred and seven patients completed this 16 weeks study. Atorvastatin 20 mg lowered TC by 32%, LDL 44% and hs-CRP 10% at 16 weeks for the entire study (p < 0.003). The effect of either Atorvastatin the lipid profiles and hs-CRP were different. There was no significant change in LFT or muscle enzyme. CONCLUSION:Atorvastatin 20 mg has a dramatic effect on the lipid but moderate effect on CRP. The two different types of Atorvastatin (group A and B) have similar effect on both safety and efficacy.
RCT Entities:
BACKGROUND: LDL and hs-CRP are risk factors for vascular events and can be modified by Statin. OBJECTIVE: To evaluate the baseline hs-CRP of a certain Thai population who would need Atorvastatin, to evaluate the dose response of Atorvastatin toward LDL and hs-CRP level, and to evaluate the efficacy and safety of different types of Atorvastatin. MATERIAL AND METHOD: Subjects, who needed Statin therapy, were randomized to receive either 20 mg of Berlin(B)-Atorvastatin(R) or Pfizer(P)-Atorvastatin(R). The cross over took place after 8 weeks of therapy and continued for 16 weeks. Baseline blood tests were compared to 8 and 16 weeks. The effect of two brands of 20 mg Atorvastatin toward serum lipid, LFT, muscle enzyme and hs-CRP were compared. RESULTS: One hundred and ten subjects aged between 20-75 years enrolled in the present study. Fifty-four and 56 patients were randomized to group A and B. Baseline total cholesterol, LDL, HDL, and TG were 251, 174, 55, and 160 mg/dl respectively. There was a wide variation of baseline hs-CRP level. One hundred and seven patients completed this 16 weeks study. Atorvastatin 20 mg lowered TC by 32%, LDL 44% and hs-CRP 10% at 16 weeks for the entire study (p < 0.003). The effect of either Atorvastatin the lipid profiles and hs-CRP were different. There was no significant change in LFT or muscle enzyme. CONCLUSION:Atorvastatin 20 mg has a dramatic effect on the lipid but moderate effect on CRP. The two different types of Atorvastatin (group A and B) have similar effect on both safety and efficacy.