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

Abstract

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.

Impacto de la optimización del tratamiento hipolipemiante en el riesgo cardiovascular residual

“…El uso de estatinas de alta intensidad en los pacientes con antecedentes cardiovasculares está explícitamente recomendado por las guías actuales. (8,11,17,18) Sin embargo, las estatinas de alta intensidad están subutilizadas en la práctica habitual. ( 24) Estos problemas clínicamente relevantes en el manejo de la medicación hipolipemiante también ya se habían reportado previamente en nuestro país.…”

“…Para estimar cuál sería el descenso hipotético del C-LDL con cada tratamiento, consideramos las siguientes asunciones: a) duplicar la dosis de estatinas implica un descenso adicional del 6% en el valor de C-LDL; (12) b) agregar ezetimibe implica un descenso adicional del 23% en el valor de C-LDL; (13,14) c) agregar un iPCSK9 implica una reducción adicional del 54% en el valor de C-LDL; (15) d) cambiar de una estatina de moderada intensidad a una de alta intensidad implica un descenso adicional del 16% en el valor de C-LDL; (13,16) e) cambiar de una estatina de baja intensidad a una de alta intensidad implica un descenso adicional del 23% en el valor de C-LDL; (13) f) agregar altas dosis de una estatina de alta intensidad (atorvastatina 80 mg/día) en aquellos pacientes que no recibían dichos fármacos implica un descenso adicional del 50% en el valor de C-LDL; (13) g) dado que el modelo SMART-REACH no permite seleccionar a la pitavastatina, se eligió en esos casos una estatina de similar intensidad (atorvastatina 10 mg/día). (17) Finalmente, se calculó la reducción del riesgo cardiovascular residual a 10 años y a lo largo de la vida, y el NNT correspondiente, con cada paso de optimización necesario para que el paciente alcance la meta de C-LDL. El modelo SMART-REACH calculó automáticamente estos resultados luego de cambiar el tratamiento de cada paciente.…”

Effect of pitavastatin treatment on PON1 lactonase activity in patients with hypercholesterolaemia

“…Those who were non-compliant and had a statin intolerance were excluded. Pitavastatin [9] (n = 16: 1 mg/day, n = 2: 2 mg/day) was administered to the patients for a duration of 3 months. The levels of LDL-cholesterol, HDL-cholesterol, and triglycerides were evaluated enzymatically in fasting blood both before and after treatment.…”