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New Data: Cholesterol Management Analysis of Upsher-Smith's Slo-Niacin(R) Tablets in Combination with Lipitor(R)
Date:11/16/2009

MAPLE GROVE, Minn., Nov. 16 /PRNewswire/ -- 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 persons 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," explained Dr. Robert Knopp, 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

About the study

In this trial, forty-two 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.

About Slo-Niacin®

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, 4

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 ( >/= 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 contact a healthcare professional, call 1-800-654-2299 or visit www.slo-niacin.com.

About Upsher-Smith Laboratories, Inc.

Upsher-Smith Laboratories, Inc. is a rapidly growing pharmaceutical company that manufactures and markets both prescription and consumer products. Privately held since 1919, the company strives to recognize the unmet healthcare needs of our customers. Over the last 20 years that Upsher-Smith has been manufacturing Slo-Niacin®, more than 9.3 million bottles have been sold. Upsher-Smith prides itself in providing safe, effective, and economical therapies to the ever-challenged healthcare environment. For additional information about Upsher-Smith, visit www.upsher-smith.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, http://www.americanheart.org/presenter.jhtml?identifier=180, July 14, 2009. 3. Slo-Niacin website, http://www.slo-niacin.com/, July 14, 2009. 4. Brown BG et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med. 2001;345:1583-92.

Lipitor is a registered trademark of Pfizer Inc.

These statements have not been evaluated by the U.S. Food and Drug Administration.

SOURCE Upsher-Smith Laboratories, Inc.


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SOURCE Upsher-Smith Laboratories, Inc.
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