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Evaluation of Adverse Events Associated with Niacin in Patients Treated in an Outpatient Lipid Clinic
476 189 Evaluation of Adverse Events Associated with Niacin in Patients Treated in an Outpatient Lipid Clinic Elise A. Albro, PharmD, MPA, Melissa J. Snider, PharmD, BCPS, BC, Andrea E. Hirsch, PharmD, BCPS, CL, Martha Gulati, MD, MS, FACC, FA, (Columbus, OH)
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.
Journal of Clinical Lipidology, Vol 9, No 3, June 2015
Conclusions: Anticipated study completion date of April 1, 2015.
Visceral Obesity, Metabolic Syndrome and Atherosclerosis 190 Normal Weight-Central Obesity Is Associated with the Highest Mortality Risk in Older Adults with Coronary Artery Disease*† Saurabh Sharma, MD, John A. Batsis, MD, Thais Coutinho, MD, Virend K. Somers, MD, Charlotte Kragelund, MD, Alka M. Kanaya, MD, Francisco Lopez-Jimenez, MD, FACC, FAHA, (Rochester, MN)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: In subjects with coronary artery disease (CAD), mortality is inversely related to body mass index (BMI) (‘‘obesity paradox’’), while central obesity is directly associated with mortality. Moreover, the combination of normal BMI with central obesity [normal weight-central obesity (NWCO)] confers the highest mortality risk. Whether these associations are also present in elderly subjects is unknown. Objective/Purpose: To study the relationship between BMI, central obesity, and mortality in elderly subjects with CAD and to determine if 1) the obesity paradox exists and 2) NWCO is associated with increased mortality risk. Methods: From a database of subjects with CAD from five cohort studies, we studied those who were $65 years old (n57057). Normal weight, overweight, and obese were
Figure 1A 5-Year Mortality in Older Adults with Coronary Artery Disease Based on Different Combinations of Body Mass Index and Waist-Hip Ratio. Abbreviations: CAD5 coronary artery disease; BMI 5 body mass index; WHR 5 waist-hip ratio.
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.
Journal of Clinical Lipidology, Vol 9, No 3, June 2015
Conclusions: Anticipated study completion date of April 1, 2015.
Visceral Obesity, Metabolic Syndrome and Atherosclerosis 190 Normal Weight-Central Obesity Is Associated with the Highest Mortality Risk in Older Adults with Coronary Artery Disease*† Saurabh Sharma, MD, John A. Batsis, MD, Thais Coutinho, MD, Virend K. Somers, MD, Charlotte Kragelund, MD, Alka M. Kanaya, MD, Francisco Lopez-Jimenez, MD, FACC, FAHA, (Rochester, MN)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: In subjects with coronary artery disease (CAD), mortality is inversely related to body mass index (BMI) (‘‘obesity paradox’’), while central obesity is directly associated with mortality. Moreover, the combination of normal BMI with central obesity [normal weight-central obesity (NWCO)] confers the highest mortality risk. Whether these associations are also present in elderly subjects is unknown. Objective/Purpose: To study the relationship between BMI, central obesity, and mortality in elderly subjects with CAD and to determine if 1) the obesity paradox exists and 2) NWCO is associated with increased mortality risk. Methods: From a database of subjects with CAD from five cohort studies, we studied those who were $65 years old (n57057). Normal weight, overweight, and obese were
Figure 1A 5-Year Mortality in Older Adults with Coronary Artery Disease Based on Different Combinations of Body Mass Index and Waist-Hip Ratio. Abbreviations: CAD5 coronary artery disease; BMI 5 body mass index; WHR 5 waist-hip ratio.