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Systemic review of randomized clinical trials on the efficacy and safety of pitavastatin

  • At: PPR SIG 2021 (2021)
  • Type: Digital
  • By: ELNOUR, Asim Ahmed (Al Ain University, Gulf medical University, United Arab Emirates)
  • Co-author(s): Asim Ahmed Elnour, Azza Ramadan, Judit Don
  • Abstract:


    A subpopulation of statin users such as those 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.


    The aim of the current systematic review was to systematically evaluate the effect of pitavastatin on primary cardiac events in subjects receiving pitavastatin in comparison to other four statin members.


    We 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. The types of subjects were those diagnosed with any type of dyslipidemia (population 4804) who received pitavastatin (interventions) versus comparator (comparison) with the primary efficacy endpoint of minimization of LDL-C and non-HDL-C, 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 adverse events development.


    In the included trials (11), participants (4804) had been randomized for either pitavastatin or comparators (atorvastatin, pravastatin, rosuvastatin, simvastatin) and followed up for 12 to 52 weeks. In terms of 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 to simvastatin 20 and 40 mg in two 2 trials. However rosuvastatin 2.5 mg was clearly superior to pitavastatin 2 mg in two trials. Pitavastatin has shown significant increase in HDL-C and significant decrease in non-HDL-C at the majority of the eleven trials. In terms of safety, pitavastatin was generally a safe and well-tolerated drug.


    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.

Last update 4 October 2019

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