Gailin B Sebastian1, T M Anoop2, Joby K Thomas1, Raju George1. 1. Department of Cardiology, Kottayam Medical College, Kottayam, Kerala, India. 2. Department of Medicine, Kottayam Medical College, Kottayam, Kerala, India.
Abstract
OBJECTIVE: To compare the efficacy and adverse effects of high and standard dose atorvastatin in ST elevation myocardial infarction (STEMI) patients. DESIGN: A prospective, single-centre, randomised, double blind study. SETTING:A tertiary care centre in Kerala, India, from January to June 2009. PATIENTS: 121 consecutive acute STEMI patients eligible for thrombolytic therapy. INTERVENTIONS:Pharmacological thrombolysis and atorvastatin therapy. MAIN OUTCOME MEASURES: Primary end points were mean change in low density lipoprotein and total cholesterol, serum glutamic pyruvic transaminase (SGPT), creatine phosphokinase (CPK) at 3 months of high dose (80 mg) and standard dose (20 mg) of atorvastatin. RESULTS: There was no significant difference in the mean cholesterol levels at 3 months of therapy (mean reduction in total cholesterol and low density lipoprotein cholesterol were 48 mg%, 49 mg% in the 20 mg group compared with 54 mg% and 53 mg%, respectively, in the 80 mg group; p 0.39 and 0.4). There was a significant increase in SGPT at 1 week in the 80 mg group and atorvastatin was stopped in a significantly higher number of patients due to the increase in SGPT and CPK at 1 week in the high dose group (12% and 7% of patients; (p=0.04 and p=0.06, respectively). CONCLUSION: In acute STEMI patients treated with pharmacological thrombolysis, standard dose atorvastatin is equally effective as high dose atorvastatin in terms of reduction in cholesterol, with higher and earlier incidence of asymptomatic SGPT and CPK elevation in the high dose group.
RCT Entities:
OBJECTIVE: To compare the efficacy and adverse effects of high and standard dose atorvastatin in ST elevation myocardial infarction (STEMI) patients. DESIGN: A prospective, single-centre, randomised, double blind study. SETTING: A tertiary care centre in Kerala, India, from January to June 2009. PATIENTS: 121 consecutive acute STEMI patients eligible for thrombolytic therapy. INTERVENTIONS: Pharmacological thrombolysis and atorvastatin therapy. MAIN OUTCOME MEASURES: Primary end points were mean change in low density lipoprotein and total cholesterol, serum glutamic pyruvic transaminase (SGPT), creatine phosphokinase (CPK) at 3 months of high dose (80 mg) and standard dose (20 mg) of atorvastatin. RESULTS: There was no significant difference in the mean cholesterol levels at 3 months of therapy (mean reduction in total cholesterol and low density lipoprotein cholesterol were 48 mg%, 49 mg% in the 20 mg group compared with 54 mg% and 53 mg%, respectively, in the 80 mg group; p 0.39 and 0.4). There was a significant increase in SGPT at 1 week in the 80 mg group and atorvastatin was stopped in a significantly higher number of patients due to the increase in SGPT and CPK at 1 week in the high dose group (12% and 7% of patients; (p=0.04 and p=0.06, respectively). CONCLUSION: In acute STEMI patients treated with pharmacological thrombolysis, standard dose atorvastatin is equally effective as high dose atorvastatin in terms of reduction in cholesterol, with higher and earlier incidence of asymptomatic SGPT and CPK elevation in the high dose group.
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