Pharmaceutical Business review

Kos drug improves lipid control in trial

Results from the phase IV efficacy trial were presented at the XIV International Symposium on Atherosclerosis.

The results demonstrated that adding the HDL-boosting therapy Niaspan to statin therapy raised “good” cholesterol and lowered “bad” cholesterol more effectively than treatment with a high dose statin alone, or Vytorin (a combination tablet of Zocor and Zetia sold by Merck & Co and Schering-Plough).

The 12-week study in 292 patients compared the efficacy of combination therapy with Niaspan and low-to-moderate doses of Lipitor (Pfizer) and Crestor (AstraZeneca) against moderate-to-high dose Crestor and Vytorin.

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 “bad” cholesterol (51-58%), 1.2 to 1.9-fold greater decreases in triglycerides and 2.5 to 3.5 fold greater increases in HDL-C “good” cholesterol, than patients who received high-dose Crestor or Zocor/Zetia.

According to the company, only patients receiving Niaspan experienced significant decreases in lipoprotein (a), referred to as Lp(a), which actually increased in patients on Crestor and Zocor/Zetia. Similar numbers of patients reported adverse events and serious adverse events.

“These results are particularly powerful because they demonstrate that we can drive LDL-C levels down to goal and also raise the good cholesterol, HDL-C, without the need for high doses of statin medications,” said Dr Peter Jones, associate professor of cardiology, Baylor University.