October 29. 2009 – Results of the SLIM Study ("Slo-Niacin and Atorvastatin Treatment of Lipoproteins and Inflammatory Markers in Combined Hyperlipidemia") were recently published in the Journal of Clinical Lipidology.
The objective was to study the lipid and anti-inflammatory effects of Slo-Niacin 1.5 g/day and Lipitor (atorvastatin calcium) 10 mg/day, given alone and then together in people with features of combined hyperlipidemia, high triglycerides, low high-density lipoproteins (HDL - "good cholesterol") and above average low-density lipoproteins (LDL - "bad cholesterol").
The result of the combination therapy was a marked decrease in triglycerides and LDL and a significant increase in HDL. (1)
"The efficacy of controlled-release Slo-Niacin has never been studied with Lipitor," said Robert Knopp, M.D., main author of the SLIM study, professor of medicine at Harborview Medical Center and director of the Northwest Lipid Research Clinic. "The findings of the SLIM Study provide further foundation to the 20 years of experience with Slo-Niacin."
Heart disease and stroke develop when elevated levels of LDL circulate in the blood and build up in the walls of the arteries that feed the heart and brain. Elevated triglycerides further this process. The result is plaque, a thick, hard deposit that narrows arteries and makes them less flexible. This condition is known as atherosclerosis. HDL, on the other hand, protects the blood vessels by carrying cholesterol away from the arteries and back to the liver, where it is passed from the body. (2)
In this trial, 42 men and women ages 21 to 75 years with LDL levels greater than 130 mg/dL and HDL less than 45 mg/dL (women less than 55 mg/dL) were randomized to three months of Lipitor 10 mg/day or Slo-Niacin titrated to 1.5 g/day. The alternate drug was then added in the next three month segment. Lipid profiles and liver enzymes were measured monthly. Additionally, a questionnaire regarding flushing was completed at each visit. Thirty-six participants finished the study. (1)
Monotherapy with Slo-Niacin decreased median triglyceride levels 15 percent, mean LDL 12 percent and increased HDL 8 percent. Lipitor decreased median triglyceride levels 26 percent, mean LDL 36 percent and increased HDL 6 percent. Combined therapy decreased median triglycerides 33 percent, mean LDL 43 percent and increased HDL 10 percent.
Flushing symptoms were described as almost always tolerable. Only three subjects discontinued the study for niacin-related complaints and there was no indication of hepatotoxicity. Although not seen in this study, all niacin products carry the potential for liver function test elevations or hepatotoxicity, so monitoring is key. (1)
In summary, Slo-Niacin was well-tolerated alone and in combination with Lipitor and benefitted all lipoprotein levels (HDL, LDL, and trigylcerides), as expected of niacin treatment.
Slo-Niacin Tablets (polygel controlled-release niacin) are a niacin dietary supplement that have been trusted by healthcare professionals since 1988. Clinical trials have demonstrated that when dosed and monitored appropriately, Slo-Niacin is complementary to statin therapy for cholesterol management, as demonstrated in the SLIM Study. (1)
Slo-Niacin is economical and often costs less than an insurance copayment. It is widely available at pharmacies and other retailers without a prescription as a dietary supplement. Slo-Niacin is available in three dosage strengths (250 mg, 500 mg and 750 mg) for individual dosing. (3)
Because Slo-Niacin is a dietary supplement it is not intended to diagnose, treat, cure or prevent any disease. Patients taking more than 500 mg niacin daily should only do so under the advice and monitoring of a physician. Niacin may cause temporary flushing, particularly when beginning, increasing dosage or changing to other forms of niacin. Case reports of myopathy have been documented with the use of HMG-CoA reductase inhibitors in combination with lipid-altering doses of niacin therapy (greater than or equal to 1 g niacin/day). Abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacin.
For more information: www.slo-niacin.com
References:
1. Knopp, R., Retzlaff, B., Fish, B., Dowdy, A., Twaddell, B., Nguyen, T., & Paramsothy, P. "The SLIM study: Slo-Niacin and Atorvastatin Treatment of Lipoproteins and Inflammatory Markers in Combined Hyperlipidemia." Journal of Clinical Lipidology, 3(3), 167-178 (May 2009).
2. American Heart Association, www.americanheart.org/presenter.jhtml?identifier=180, July 14, 2009.
3. Slo-Niacin Web site, www.slo-niacin.com