|SRP. 2020; 11(12): 2333-2342
Protocol for Systematic Review and Meta-Analysis on Randomized Clinical Trials on the Efficacy and Safety of PitavastatinAdel Sadeq, Asim Ahmed, N Al Mazrouei, (Al Mazrouei N), Farah Hamad Farah, Judit Don, Ahmed Ibrahim Fathelrahman, Maisoun Alkaabi (Alkaabi M), Kishore Gnana, Islam Moahmmed Abd Alla, Abdulla Al Amoodi, Abubakar B. Abubakar, Abdelgadir Elamin, Sasha Mohammed Elamin Suliman, Israa Yousif Khidir, Salma Mohammed Magboul, Doaa Nassar, Nour Alhouda Kassem, Haia Abdulsamad, Asil Adel.
Background: Pitavastatin is a novel statin that possesses some advantages over conventional statin.
Aim of the review: The subjects with primary or secondary cardiac events (population) receiving pitavastatin (intervention) will be compared to placebo or other statin members (comparators), for the non-inferiority or superiority in terms of effects on low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and/or major cardiac events (outcome).
Methods: The protocol has been developed based on the PRISMA-P checklist by using (PICO [population, intervention, comparators, and outcome]) items, for adult subjects who have received pitavastatin in randomized clinical trials. We will search for databases such as Google Scholar, PubMed, and the Cochrane using specific MESH terms. The RevMan will be used to quantify the synthesis of data (I2 index, tau squared, and the Q-test P-value) for studies heterogeneity.
Results: Our current systematic review will provide highly relevant findings about the role of pitavastatin in the primary and secondary prevention of CVDs compared to the other statin. This will permit the prescribers to make informed decisions about the most efficacious and safest statin for their clients. The current study findings will contribute to inform evidence-based clinical practices and guidelines for policies and planning prevention strategies. The work will provide evidence by synthesis of well-designed and robust RCT-s conducted on one of the most efficacious and safest statins.
Conclusion: The current protocol will report the difference in efficacy of pitavastatin (intervention) compared to placebo or other statin members (comparators). Moreover, the protocol will assess the difference on the safety profile between the intervention and the comparators.
Key words: Dyslipidemia; efficacy; low-density lipoprotein cholesterol (LDL-C); pitavastatin; randomized clinical trial; safety; systematic review