Canna Jagdish Ghia1, Archana Sushil Panda2, Linesh R Khobragade3, Rajesh Kumar Jha4, Gautam S Rambhad5. 1. Resident, Department of Pharmacology, Jawaharlal Nehru Medical College , Wardha, India . 2. Medical Advisor, Dr. Reddys Laboratories Ltd , India . 3. Associate Professor, Department of Pharmacology, Jawaharlal Nehru Medical College , Wardha, India . 4. Professor and Head, Department of Pharmacology, Jawaharlal Nehru Medical College , Wardha, India . 5. Associate Director, Medical Services, Wyeth Limited (*A Subsidiary of Pfizer Inc.) , India .
Abstract
INTRODUCTION:Statins (or HMG-CoA reductase inhibitors) have become drug of choice for raised Low-Density Lipoprotein Cholesterol (LDL-C) in treating. Of these, Atorvastatin, because of its prolonged 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibition has been considered for alternate day therapy in primary prevention of (CHD). OBJECTIVES: To compare the efficacy and safety of daily versus alternate day 10 mg Atorvastatin on reduction of lipid levels in patients of dyslipidemia and to evaluate the number of patients reaching the targetLow-Density Lipoprotein (LDL) goals in these groups. METHODOLOGY: In this comparative, randomized, parallel group, non-blinded study, 100 naïve dyslipidemic patients in low to moderate risk group as perNCEP ATP (III) Guidelines were divided in two groups. Group A (n=50) received Atorvastatin 10 mg every alternate day for three months and Group B (n=50) received Atorvastatin 10 mg daily for three months. Apart from general examination and baseline investigations, lipid profile was also done. Efficacy was assessed by the percentage reduction in LDL and attainment of LDL goals as per NCEP ATP III Guidelines at the end of the study. Safety of the medication was assessed. RESULTS:Atorvastatin 10 mg daily produced a significant reduction in Total Cholesterol (TC), LDL, Very Low Density Lipoprotein (VLDL) as compared to Atorvastatin 10 mg alternate day. The increase in the HDL level was also greater with a daily dose as compared to alternate day (but not statistically significant). In Low risk category 86.12 % patients (n=31) on daily dose reached their LDL-C goal vis-a-vis 66.67% (n=18) of patients on alternate day therapy. In the moderate risk category 100 % of daily Atorvastatin patients (n=10) achieved their LDL-C goal versus 33.33% patients (n=4) on alternate day therapy. Adverse events with alternate day therapy (n=4) were less as compared with daily treatment (n=10). CONCLUSION:Atorvastatin 10 mg daily was found to be safe and efficacious in patients with dyslipidemia compared to an alternate day therapy.
RCT Entities:
INTRODUCTION: Statins (or HMG-CoA reductase inhibitors) have become drug of choice for raised Low-Density Lipoprotein Cholesterol (LDL-C) in treating. Of these, Atorvastatin, because of its prolonged 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibition has been considered for alternate day therapy in primary prevention of (CHD). OBJECTIVES: To compare the efficacy and safety of daily versus alternate day 10 mg Atorvastatin on reduction of lipid levels in patients of dyslipidemia and to evaluate the number of patients reaching the target Low-Density Lipoprotein (LDL) goals in these groups. METHODOLOGY: In this comparative, randomized, parallel group, non-blinded study, 100 naïve dyslipidemic patients in low to moderate risk group as per NCEP ATP (III) Guidelines were divided in two groups. Group A (n=50) received Atorvastatin 10 mg every alternate day for three months and Group B (n=50) received Atorvastatin 10 mg daily for three months. Apart from general examination and baseline investigations, lipid profile was also done. Efficacy was assessed by the percentage reduction in LDL and attainment of LDL goals as per NCEP ATP III Guidelines at the end of the study. Safety of the medication was assessed. RESULTS:Atorvastatin 10 mg daily produced a significant reduction in Total Cholesterol (TC), LDL, Very Low Density Lipoprotein (VLDL) as compared to Atorvastatin 10 mg alternate day. The increase in the HDL level was also greater with a daily dose as compared to alternate day (but not statistically significant). In Low risk category 86.12 % patients (n=31) on daily dose reached their LDL-C goal vis-a-vis 66.67% (n=18) of patients on alternate day therapy. In the moderate risk category 100 % of daily Atorvastatinpatients (n=10) achieved their LDL-C goal versus 33.33% patients (n=4) on alternate day therapy. Adverse events with alternate day therapy (n=4) were less as compared with daily treatment (n=10). CONCLUSION:Atorvastatin 10 mg daily was found to be safe and efficacious in patients with dyslipidemia compared to an alternate day therapy.