Evaluation of Adverse Events Associated with Niacin in Patients Treated in an Outpatient Lipid Clinic

Abstract

Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: The incidence of serious medication-related adverse events has increased by greater than three-fold over the past 10 years. This is especially of concern in patients being placed on medications for the purpose of reducing overall risk of cardiovascular events. Lipid lowering medications are often an integral part of cardiovascular risk reduction due to the known relationship between cardiovascular risk and atherogenic lipoproteins. Niacin is known to reduce non-HDL and LDL cholesterol levels, and in the absence of high-intensity statin therapy, improve clinical outcomes. However recent literature has called attention to serious adverse events in patients when niacin therapy is added to a statin in the setting of wellcontrolled lipids. Therefore concerns have been raised about whether the adverse effects outweigh the benefits of its use. Objective/Purpose: The purpose of this study is to describe serious and non-serious adverse events associated with the use of niacin in an ambulatory lipid clinic. This study population has uncontrolled lipids and may or may not be on high-intensity statin therapy. In this population not represented in recent literature, it is possible that niacin can be used without serious adverse events in the treatment of patients with lipid disorders. Methods: Data will be obtained through retrospective chart review of patients treated with niacin in an outpatient clinic associated with The Ohio State University Wexner Medical Center. Expected results will include incidence of serious and non-serious adverse events, including incidence of adverse gastrointestinal, musculoskeletal, skin, infection, and bleeding related events, as well as the incidence of new onset diabetes. Results for the secondary objectives will include the proportion of patients treated with niacin who achieve patient-specific LDL and non-HDL cholesterol goals, as well as the incidence of major vascular events reported for those treated with niacin. Results: Data collection is ongoing, projected to include a total of 150 patients. Preliminary data showed niacin discontinuation rates of greater than 50% (27/51), however no serious adverse events were reported. Out of those who discontinued therapy, 63% (17/27), were due to a nonserious adverse event, primarily skin-related. Secondary outcomes show an increase in proportion of patients at LDL goal, 27% (14/51) of patients at LDL goal prior to initiation of therapy versus 41% (21/51) upon discontinuation of therapy or study date completion. No major vascular events were reported. Conclusions: Anticipated study completion date of April 1, 2015.