Raising HDL-C With NIASPAN(R) (Prolonged-Release Nicotinic Acid) in Statin Treated Patients: Results of ARBITER 2 Study

11/10/04 - PRNewswire

Raising HDL-C With NIASPAN(R) (Prolonged-Release Nicotinic Acid) in Statin Treated Patients: Results of ARBITER 2 Study Presented for the First Time at American Heart Association (AHA) PRNewswire NEW ORLEANS, Louisiana November 10

NEW ORLEANS, Louisiana, November 10 /PRNewswire/ --

- Reduces Cardiovascular Events

- Slows Progression of Atherosclerosis in 12 Months

- Late Breaking Session at American Heart Association

- Published in Circulation Online

The first landmark study to measure the benefit of adding NIASPAN(R) (prolonged-release nicotinic acid) to a statin versus statin monotherapy shows that the combination slowed the progression of atherosclerosis by 68 per cent. There was also a 60 per cent reduction in cardiovascular events (which did not reach statistical significance).

The ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER 2) was the first surrogate endpoint study to compare the benefits of combining NIASPAN(R) and a statin versus active treatment with a statin alone in 167 patients with known coronary heart disease and low HDL-C (< 45 mg/dL). All the patients were already on a statin. It was presented in a late breaking session of the American Heart Association (AHA) and published online in Circulation - the official journal of the AHA.

In 12 months the patients receiving a statin alone had a significant progression in atherosclerosis measured by carotid intima medial thickness (CIMT) (+ 0.044 plus or minus 0.011 mm SEM, p<0.001).

Meanwhile, there was a non-significant progression (+ 0.014 plus or minus 0.011 mm SEM, p=0.23) in patients receiving statin plus NIASPAN(R).

Although not powered to show differences in cardiovascular endpoints, there was a strong trend towards greater reduction in cardiovascular events in the NIASPAN(R) patients (9.6 per cent in the statin only group versus 3.8 per cent in the NIASPAN(R) group, p=0.20).

NIASPAN(R) prescribed at a moderate dose of 1000 mg nightly raised "good cholesterol" - HDL-C - by 21 per cent (p=0.002) and significantly reduced triglycerides versus statin plus placebo.

More than 90 per cent of patients adhere to treatment with NIASPAN(R) plus statin

The only significant difference in tolerability was in flushing - a known side-effect of NIASPAN(R) which occurred in most patients. However, adherence was the same in both groups.

Additional study shows HDL-C may be a more accurate predictor of heart disease risk than LDL-C

In addition to the results of ARBITER 2, a second study presented at the AHA offered more evidence that raising blood levels of HDL-C may play a larger role in heart disease prevention than currently appreciated. The meta-analysis of 17 landmark clinical trials of mono and combination lipid interventions that included more than 44,000 patients revealed HDL-C levels to be a more accurate predictor of event reduction, more so than LDL-C, total cholesterol or triglycerides. Regression analyses were used to determine the relationships between changes in lipid levels and reductions in heart attack (fatal and non-fatal) across 3,869 events.

"Our analysis found that the effects on patients' HDL-C levels were considerably better than the effects on patients' LDL-C levels in predicting their risk of future heart disease," said Dr Richard Karas, Tufts University Researcher and Director of Preventive Cardiology at the New England Medical Center. "The results should send a wake-up call to alert both health care providers and patients to the importance of addressing HDL-C in addition to LDL-C."

The analysis found that raising HDL-C levels demonstrated a nearly first order relationship with event risk reduction, meaning that risk of heart attack fell immediately and steadily with a steady increase in HDL-C level. LDL-C showed a "threshold effect," where lipid levels had to improve considerably before having large impact on risk reduction.

References

Taylor, AJ. ARBITER 2: A Double-blind, Placebo-controlled Study of Long-acting Niacin on Atherosclerosis Progression in Secondary Prevention Patients Treated with Statins.

Alsheikh-Ali, AA. Increases in HDL-Cholesterol are the Strongest Predictors of Risk Reduction in Lipid Intervention Trials.

Notes to Editors:

NIASPAN(R) has been available in the USA since 1997. In Europe, after the successful MRP, NIASPAN(R) is marketed by Merck KGaA under licence from Kos Pharmaceuticals in the USA. Currently, it has been launched in Germany, the UK, Ireland and Austria. Other EU countries will follow soon. It will also be introduced in Asia and Latin America.

Merck is a global pharmaceutical and chemical company with sales of EUR 7.2 billion in 2003, a history that began in 1668, and a future shaped by 28,300 employees in 56 countries. Its success is characterised by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 74 per cent interest and free shareholders own the remaining 26 per cent. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917.