Comparative efficacy of pitavastatin and simvastatin in patients with hypercholesterolemia: a meta-analysis of randomized controlled clinical trials

Background: Simvastatin is a statin used to lower low-density lipoprotein cholesterol, but has limitations in patients on complicated regimens due to concerns about drug-drug interactions. Pitavastatin is a newly developed statin with limited drug-drug interactions. We conducted a meta-analysis to compare the clinical efficacy of simvastatin and pitavastatin in the control of hypercholesterolemia. Methods: Randomized clinical trials comparing the efficacy of pitavastatin and simvastatin were identified by searching PubMed (2000-2014) and EMBASE (2000-2014). The primary outcome subjected to meta-analysis was percent change in low-density lipoprotein cholesterol compared with baseline. Results: Four clinical trials were selected for meta-analysis. A total of 908 patients treated with pitavastatin (2 or 4 mg/day) and 381 patients treated with simvastatin (20 or 40 mg/day) were included in the final statistical analysis. No statistically significant difference was identified between treatment with pitavastatin 4 mg/day and treatment with simvastatin 40 mg/day for 12 weeks (mean difference -0.66; 95% confidence interval -2.92, 1.61; P=0.57). Similarly, no statistically significant difference was observed between pitavastatin 2 mg/day and simvastatin 20 mg/day for 4 weeks (mean difference -2.19; 95% confidence interval -0.11, 4.49; P=0.06). Treatment with pitavastatin was noninferior to simvastatin in all of the secondary outcomes and the safety profile was similar between the two statins. Conclusion: Pitavastatin is noninferior to simvastatin in lowering low-density lipoprotein cholesterol.