Combination Treatment Shown for First Time to Cause Regression of Atherosclerosis
New Study of NIASPAN(R) (Prolonged-Release Nicotinic Acid) Plus Statin
DALLAS, TX, Nov. 15 /CNW/ - 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 per cent
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 per cent (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 per cent 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.
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.
Note to Editors:
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.
Merck is a global pharmaceutical and chemical company with sales of EUR
5.9 billion in 2004, a history that began in 1668, and a future shaped by
28,600 employees in 54 countries. Its success is characterized by innovations
from entrepreneurial employees. Merck's operating activities come under the
umbrella of Merck KGaA, in which the Merck family holds a 73 per cent interest
and free shareholders own the remaining 27 per cent. The former U.S.
subsidiary, Merck & Co., has been completely independent of the Merck Group
since 1917.
For further information: Isabella Schmele, Phone: +49-(0)-61-51/72-5475 |
