Data from a Phase IV efficacy trial of Kos' Niaspan , presented at the International Symposium on Atherosclerosis June 20 in Rome, supports the value of adding niacin to statin therapy for the treatment of high cholesterol, the company reported.

Results of the COMPELL study showed that the addition of Niaspan (extended-release niacin) to Pfizer's Lipitor (atorvastatin) or AstraZeneca's Crestor (rosuvastatin) resulted in greater reductions in triglycerides and lipoprotein and a 2.5- to 3.5-fold increase in HDL cholesterol compared to treatment with higher dose Crestor or Merck/Schering-Plough's Vytorin (simvastatin/ezetimibe).

The study also showed that the Niaspan combination resulted in an equivalent reduction in LDL cholesterol compared to treatment with high-dose Crestor or Vytorin.

The 12-week, randomized, open-label study enrolled 292 patients, half of whom were women who required LDL-lowering to National Cholesterol Education Program guidelines.

The mean percent change in LDL-C, HDL-C, TG and Lp(a) from baseline to week 12 among patients treated with Lipitor 40 mg/Niaspan 2,000 mg was -56%, +22%, -47% and -20%. Similar results were seen in the Crestor 20 mg/Niaspan 1,000 mg arm: -51%, +24%, -40% and -6%.

In comparison, patients treated with Crestor 40 mg alone experienced a similar decrease in LDL-C (-54%), but HDL-C increased only 7%, TG decreased by 25% and Lp(a) actually increased 5%.

Likewise in the Vytorin arm, LDL-C decreased 58%, HDL-C increased 10%, TG decreased 33% and Lp(a) increased 7%.

The results show there is an opportunity to reduce LDL-C and increase HDL-C without using high-dose statins, study researcher Peter Jones, Baylor University, said.

In addition, patients currently are enrolling in a landmark outcomes trial supported in part by the National Institutes of Health to evaluate the effect of treating HDL-C and triglycerides with Niaspan and simvastatin (Merck's Zocor ) versus simvastatin alone in the prevention of heart attack and stroke (¹ Also see "Kos Statin/Niacin Fixed Dose Combo To Be Supported By NHLBI-Funded Trial" - Pink Sheet, 11 July, 2005., p. 11).

Enrollment in AIM-HIGH began in November and will continue for two years, followed by a two-year study period.

The combined research bodes well for Niaspan "in what we believe is an under-penetrated market with a growing emphasis on treating HDL cholesterol," Kos said.

Kos is developing a fixed-dose combination Niaspan/simvastatin product, with the proposed trade name Simcor . Phase III trial results on the combination are expected to be available later this year, with a regulatory submission anticipated in 2007 and a possible launch planned for 2008.

Niaspan has been on the market since 1997 and is indicated to reduce elevated total cholesterol, LDL-C, Apo B and triglyceride levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia.

Kos also markets Advicor , a combination of Niaspan 750 mg and lovastatin 20 mg (Merck's Mevacor ).

Merck is also evaluating a niacin/simvastatin combination. The firm recently granted funding to Oxford University to conduct a second Heart Protection Study.

The study would evaluate a fixed-dose combination of extended-release niacin with a prostaglandin D2 blocker (to combat flushing associated with niacin) to see if the combination, by increasing HDL-C, can further drive down the risk of heart attack and stroke.

Schering-Plough has also said it is in discussions with partners to develop an HDL-C raising product.

[Editor's note: This story was contributed by "The Pink Sheet" DAILY, your source for prescription drug news. For more information call 1-800-332-2181.]

Niaspan/Statin Combinations Improve Lipid Control, Study Says

More from Archive

More from Pink Sheet