Kos says Niaspan improves lipid control

By Elaine Rigoli

Tampa, Fla., June 20 - Kos Pharmaceuticals, Inc. said the Compell phase 4 efficacy trial demonstrated that adding the HDL-boosting therapy Niaspan (niacin extended-release tablets) to statin therapy achieved superior raising of high-density lipoprotein cholesterol (HDL-C), or "good" cholesterol.

At the same time, Niaspan helped to increase triglyceride lowering, with equivalent lowering of low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, for patients compared to treatment with a high dose statin or Zocor/Zetia (simvastatin and ezetimibe).

Compell was a 12-week, randomized, multi-center, open-label study in 292 patients comparing the efficacy of combination therapy with Niaspan and low to moderate doses of Lipitor and Crestor against moderate to high dose Crestor and Zocor/Zetia (sold as the fixed-dose combination tablet, Vytorin).

The primary endpoint was percent change in LDL-C at week 12 from baseline compared across all treatment groups, according to a news release.

In a dose-escalation study design, Niaspan 1,000 mg with Crestor 10 mg, and 20 mg, or, Niaspan 1,000 mg and Lipitor 20 mg, and Niaspan 2000 mg with Lipitor 40 mg were compared with Crestor 20 mg and 40 mg or Zocor/Zetia 20mg/10mg and 40mg/10mg.

Study results showed that patients given Niaspan in combination with a low to moderate dose of Lipitor or Crestor achieved equivalent reduction in LDL-C (51% to 58%), 1.2 to 1.9-fold greater decreases in triglycerides and 2.5 to 3.5 fold greater increases in HDL-C, than patients who received high-dose Crestor or Zocor/Zetia, the release said.

Only patients receiving Niaspan experienced significant decreases in lipoprotein, which actually increased in patients on Crestor and Zocor/Zetia, the release said.

Kos is a specialty pharmaceutical company with headquarters in Cranbury, N.J.

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