A Systematic Review of Randomized Clinical Trials on the Efficacy and Safety of Pitavastatin

Background: A subpopulation of statin users such as subjects with chronic kidney disease (CKD), Human Immune virus (HIV, acute coronary syndrome (ACS), revascularization, metabolic syndrome, and/or diabetes may particularly benefit from pitavastatin pharmacotherapy. Aim of the systematic review: The current systematic review aimed systematically evaluate the effect of pitavastatin on primary cardiac events in subjects receiving pitavastatin in comparison to the other four statin members. Methods: We have conducted a systematic review on phases III and IV of randomized controlled trials (RCT-s, 11 trials) for subjects with primary cardiac events who have received pitavastatin. Subjects were diagnosed with any type of dyslipidemia (population 4804), who have received pitavastatin (interventions) versus comparator (comparison) with the primary efficacy endpoint of minimization of LDL-C and non-HDL-C, having an increase in HDL-C and/or reduction in major adverse cardiac events (MACE, cardiovascular death, myocardial infarction (fatal/nonfatal), and stroke (fatal/nonfatal) and/or their composite (outcomes). The secondary safety endpoint was the development of any adverse effects. Results: In the included trials (11), participants (4804) randomized for pitavastatin or comparator (atorvastatin, pravastatin, rosuvastatin, simvastatin) and followed up for 12 to 52 weeks. In terms of the primary outcome (reduction in LDL-C), pitavastatin 4 mg was superior to pravastatin 40 mg in three trials, while the 2 mg was comparable to atorvastatin 10 mg in four trials and simvastatin 20 and 40 mg in two 2 trials. However, rosuvastatin 2.5 mg was superior to pitavastatin 2 mg in two trials. Pitavastatin increased HDL-C and reduced non-HDL-C at the majority of the eleven trials. Regarding the safety profile, pitavastatin has proved to be tolerated and safe. Conclusion: The FDA proven indications of pitavastatin are primary dyslipidemia and mixed dyslipidemia as adjunctive therapy to dietary changes to lower total cholesterol, LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C. Pitavastatin might be suitable for subjects with diabetes, ACS (reduced revascularization), metabolic syndrome, CKD, HIV, and subjects with low levels of HDL-C. We highly recommend rational individualization for the selection of statin.