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Combination Treatment Shown for First Time to Cause Regression of Atherosclerosis

New Study of Niaspan (Prolonged-Release Nicotinic Acid) Plus Statin

DALLAS, TX -- November 16, 2005 -- A new study has shown for the first time that reversal of atherosclerosis - a primary cause of stroke and heart attacks - can be achieved with a combination of Niaspan (prolonged-release nicotinic acid) and a statin.

Results of the open-label phase of the ARterial Biology for the Investigation of the Treatment Effects of Reducing cholesterol (ARBITER 3) study, presented at the Scientific Sessions of the American Heart Association, show that patients treated with Niaspan and a statin achieved significant regression of carotid atherosclerosis[1]. An earlier phase of this study (ARBITER 2) demonstrated that the Niaspan combination halted the progression of atherosclerosis measured while it progressed in patients treated with statin alone.

In ARBITER 3, the atherosclerosis was measured by carotid intima media thickness (CIMT): an accepted surrogate measure of atherosclerosis. Patients treated for an additional 12 months after ARBITER 2 finished had a significant reduction in CIMT (-0.040 + 0.014 mm; p=0.008).

This significant reduction in CIMT was associated with a 23.7% increase in high density lipoprotein cholesterol (HDL-C - the "good" cholesterol) leading to a reduction in atherosclerosis.

ARBITER 3 was conducted in 148 patients who had previously participated in ARBITER 2. They were typical of at-risk patients seen in daily practice with target levels of low density lipoprotein cholesterol (LDL-C) mean 82 mg/dL (2.12 mmol/L); HDL-C 40 mg/dL (1.0 mmol/L). They received Niaspan 1000 mg daily in addition to statin (usually simvastatin 40 mg daily).

Commenting on these results, the lead investigator of ARBITER 3, Professor Allen Taylor, Chief, Cardiology Service, Walter Reed Army Medical Center, Washington, USA, said: "These results have potentially important implications for treatment of many patients with established cardiovascular disease. ARBITER 2 clearly showed that statins alone are not enough to halt the progression of atherosclerosis even when the LDL-C target is met. However, the addition of Niaspan 1000 mg stopped the progression of atherosclerosis in 12 months.

"Now, ARBITER 3 shows that a further 12 months of treatment with Niaspan and a statin actually achieves regression of atherosclerosis including among patients with diabetes mellitus or the metabolic syndrome. This is an exciting advance in our knowledge of the benefits of raising HDL-C, which previous studies with CIMT suggest should be translated into reduced risk of fatal and non-fatal events."

This hypothesis will be tested in a landmark US National Institutes of Health study which begins recruiting patients this month. Atherothrombosis Intervention in Metabolic Syndrome with Low HDL-C / High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) will compare clinical endpoints of coronary death, non-fatal events, and stroke in 3,300 patients with established heart disease treated either with the combination of Niaspan and simvastatin or simvastatin alone. This is the first large, comparative, randomized outcome study to compare these regimens.

Combination therapy reduces events by 30% [2]

Meanwhile at AHA, in addition to ARBITER 3, a retrospective analysis including 44,351 patients with a mean follow-up of 30 ± 12 months showed that raising HDL-C, in addition to lowering LDL-C and triglycerides, significantly improves outcomes in a wide spectrum of patients.

Patients were categorized by primary or secondary prevention, sex, and the presence or absence of diabetes mellitus. Optimal lipid values were defined according to published guidelines and 10,899 cardiovascular events were experienced by 6,722 patients.

Achieving optimal lipid values for HDL-C in addition to LDL-C and triglycerides resulted in a significant 30% reduction in cardiovascular event risk, overall and across all subgroups. Combined optimal lipid management therefore has the potential to significantly improve outcome across the wide spectrum of patients typically seen in clinical practice, the investigators conclude.

Niaspan has been available in the USA by Kos Pharmaceuticals since 1997. In Europe, after the successful MRP, Niaspan is marketed by Merck KGaA under license from Kos Pharmaceuticals, USA. Currently, it has been launched in nine European countries including Germany and the United Kingdom, plus another eight countries outside of Europe. Further launches are scheduled this year.

REFERENCES:
1. Taylor AJ, Sullenberger LE, Lee HJ. Atherosclerosis regression during open-label extended-release niacin following ARBITER 2, Abstract American Heart Association, November 2005.
2. Stanek EJ, Sarawate C, Cziraky MJ, Charland SL. Impact of combined optimal lipid value achievement on risk of cardiovascular events in prevention, gender, and diabetes subgroups. Abstract American Heart Association, November 2005.


SOURCE: Merck KGaA

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