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ORIGINAL ARTICLE
Year : 2019  |  Volume : 8  |  Issue : 7  |  Page : 2249-2257

Safety and efficacy of alirocumab: A meta analysis of 12 randomized controlled trials


1 Department of Pharmacology, AIIMS, Bhopal, Madhya Pradesh, India
2 Department of Pharmacology, RKDF MCH/RC, Bhopal, Madhya Pradesh, India

Correspondence Address:
Dr. Rekha Mehani
Department of Pharmacology, RKDF MCH RC, Bhopal, Madhya Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jfmpc.jfmpc_406_19

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Background and Objective: Hypercholesterolemia is one of the major risk factor for atherosclerotic coronary heart disease, especially coronary heart disease. Most effective class of medications for prevention of cardiovascular events and LDL-C reduction are the statins. Approximately only one fourth of these high risk patients had achieved LDL-C levels <70 mg/dL with statins. Monoclonal antibody targeting PCSK9 is a novel class of drug used in the treatment of Hypercholesterolemia. Alirocumab is one such human monoclonal antibody directed against PCSK9. Binding of PCSK9 to the LDL-R on the hepatocytes promotes LDL-R degradation. Inhibition of PCSK9 binding to LDL-R leads to increased number of LDL-Rs to clear LDL, thus decreasing LDL-C levels. The purpose of this systematic study is to assess the safety and efficacy of Alirocumab in adults with hypercholesterolemia and Familial hypercholesterolemia. Materials and Methods: We searched Medline, PubMed Central database, Google scholar, EBSCO, Wiley library, conference proceedings and Clinical trials.gov registry through March 2017. Phase 3 randomized, controlled trials (RCTs) using Alirocumab in adults with hypercholesterolemia and Familial Hypercholesterolemia were selected. Results: In twelve RCTs comprising of 6019 patients included in the meta-analysis, significant favorable changes in LDL-C and HDL-C were found. Limitations: Results were derived from study level data rather than patient level data. Conclusions: Alirocumab substantially reduced the LDL-C level by over 50 %, increased the HDL-C level, and resulted in favorable changes in other lipids.


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