Reduction of cardiovascular events of Lomitapida versus Statins in patients with a diagnosis of familial hypercholesterolemia: A systematic review protocol Peer review protocols

Abstract

Introduction: Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder that produces hypercholesterolemia and premature development of cardiovascular diseases. Statins are the drug of choice in these patients; however, a high percentage of patients cannot achieve their therapeutic goals with the maximum recommended doses, so Lomitapide may prove to be useful as a new treatment alternative to traditional statins.

Objective: The objective of this systematic review is to determine if Lomitapide is better than statins at reducing cardiovascular events in patients with a diagnosis of FH.

Methods: Randomized controlled trials (RCTs) and quasi-randomized trials of patients diagnosed with FH will be included. Primary outcome measures included several parameters: 1. Post-treatment low- and high-density lipoprotein (LDL and HDL, respectively) levels and 2. Presence of cardiovascular events. Electronic searches will be conducted in PUBMED, The Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, and the scientific electronic library (Scielo). The assessment of the risk of bias will be used by the Cochrane tool. The measures of the treatment effect will be considered the mean differences (MD) and the 95% confidence intervals (CI). The evaluation of heterogeneity will be done by visual inspection of the funnel diagram. The evaluation of the quality of the evidence will be done using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.