Lipid modifying action of atorvastatin in escalating doses in patients of coronary artery disease

Background: A prospective, randomized controlled study with parallel treatment groups carried out to assess efficacy and tolerability of atorvastatin in escalating doses (10 mg, 20 mg, 40 mg and 80 mg) in modulating the lipid profile in patients of coronary artery disease in eastern Indian population and whether “Rule of six” commonly referred to in context of low-density lipoprotein (LDL) reduction by statins stands true in our population. Methods: Patients randomly allocated into four groups (n=632) as per selection criteria. Groups A, B, C, D received atorvastatin 10 mg, 20 mg, 40 mg and 80 mg, respectively once daily at bedtime, for 24 weeks after which evaluation of efficacy and tolerability was done. Comparison between groups performed with one-way ANOVA; p < 0.05 considered to be statistically significant. Results: There was a significant reduction in cholesterol, LDL and triglycerides in all the groups, but between group comparisons did not reveal any significant reduction in lipid parameters between Groups C and D. “Rule of six” was not observed at higher doses of atorvastatin (40, 80 mg). Further, there was significant reduction of high-density lipoprotein (HDL) in Groups C and D, which is not accepted especially in Indian context where it is already low at baseline. Conclusion: In Indian perspective, where HDL is low, and the LDL values are not very high, escalating dose of atorvastatin does not give additional clinical benefit. On the contrary, reduction of HDL itself predicts an adverse cardiovascular outcome. Increased adverse events and burden of cost must be taken into account, while prescribing atorvastatin.