Statins Plus Niacin: Safe?
Statins Plus Niacin: Safe?
Abstract & Commentary
By Michael H. Crawford, MD, Professor of Medicine, and Chief of Clinical Cardiology, at the University of California, San Francisco. Dr. Crawford is on the speaker's bureau for Pfizer.
Source: Alsheikh-Ali AA, Karas RH. Safety of Lovastatin/Extended Release Niacin Compared with Lovastatin Alone, Atorvastatin Alone, Pravastatin Alone, and Simvastatin Alone (from the United States Food and Drug Administration Adverse Event Reporting System). Am J Cardiol. 2007;99:379-381.
The Food and Drug Administration (FDA) cautions about increased risks of adverse events with the combination of statins and niacin, yet achieving current lipid treatment targets often requires multiple drug therapy. Thus, these investigators reviewed adverse events reported to the FDA over 5 years involving atorvastatin, simvastatin, pravastatin, lovastatin, niacin-extended release (ER) (Niaspan), and the combination of lovastatin and niacin-ER (Advicor). The primary analysis was adverse events associated with Advicor vs lovastatin or niacin-ER alone. Second, these results were compared to adverse events reported with the other statins with or without niacin-ER. Results: serious adverse events (SAEs) defined as fatal, life-threatening, or requiring hospitalization; occurred in 11.2 on Advicor, 7.5 lovastatin and 11.6 on niacin-ER per million prescriptions (p = NS). Also, the rate of SAEs on Advicor was less than that observed on simvastatin (22.6) and atorvastatin (19.6, p < 0.01 for both). Liver enzyme elevations were not significantly different with the agents analyzed, but rhabdomyolysis, although rare (≤ 1%) was significantly more common with simvastatin (p < 0.01). The authors concluded that these results do not support the idea that statins plus niacin-ER results in more adverse events and supports the use of such combination therapy in high-risk patients.
Commentary
The precaution about statins and niacin was based upon a small number of case reports. This analysis represents the first large systematic study of the combination of statins with niacin and does not support the impression gained from those prior case reports. This is good news for patients with low high-density lipoprotein (HDL) and high low-density lipoprotein (LDL) cholesterol, since niacin is one of the few approaches to raising HDL, and LDL-lowering is often best achieved with statins. The use of the FDA database allowed looking at a large group of patients from all over the United States, but there are disadvantages to this approach. The FDA database does not control for possible confounders and does not contain how many people were on these drugs or their combination. Also, more adverse effects could have occurred that were not reported to the FDA. In addition, since the analysis was from data collected between 1999 and March 2005, there was insufficient data on rosuvastatin, the most potent statin. Finally, other niacin preparations were not studied such as niacin slow- release (SLO-niacin, Nicobid) and short-acting niacin. Niacin-ER was chosen because it is associated with less flushing than immediate-release niacin and less hepatotoxicity than niacin-SR. Regardless, clinicians should be encouraged to use niacin/statin combinations in high-risk patients with HDL and LDL cholesterol levels that are not at recommended targets.
The Food and Drug Administration (FDA) cautions about increased risks of adverse events with the combination of statins and niacin, yet achieving current lipid treatment targets often requires multiple drug therapy.Subscribe Now for Access
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