Business Wire - Niaspan® Combined with Low/Moderate Dosed Statin Achieves Better Total Lipid Control vs. Higher Dose Statin Monotherapy or Zocor
CRANBURY, N.J. — Kos Pharmaceuticals, Inc. (Nasdaq: KOSP):
–COMPELL study shows significantly greater reductions in triglycerides and Lp(a), as well as superior 2.5-3.5 fold increases in HDL-C and comparable lowering of LDL-C with Niaspan combination therapy versus Crestor(R) and Zocor/Zetia
–Adding Niaspan to statin therapy achieves better total lipid control for patients at high risk for heart attack
Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) commented today on the results from the COMPELL (COMParative Effects on Lipid Levels of Niaspan and Statins Versus Other Lipid Therapies) Phase IV efficacy trial presented at the XIV International Symposium on Atherosclerosis. The results demonstrated that adding the HDL-boosting therapy Niaspan (niacin extended-release tablets) to statin therapy (HMG-CoA reductase inhibitors) achieved superior raising of high-density lipoprotein cholesterol (HDL-C), or “good” cholesterol, and increased 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).(1)
COMPELL was a 12-week, randomized, multicenter, open-label study in 292 patients comparing the efficacy of combination therapy with Niaspan and low to moderate doses of Lipitor(R) and Crestor against moderate to high dose Crestor and Zocor/Zetia (sold as the fixed-dose combination tablet, Vytorin(R)). One-half of the patients treated were women, who required LDL-C lowering therapy according to NCEP ATP III guidelines (LDL-C more than 100 mg/dL).(2) The primary endpoint was percent change in LDL-C at week 12 from baseline compared across all treatment groups.(3) In a dose-escalation study design, Niaspan 1000 mg with Crestor 10 mg, and 20 mg, or, Niaspan 1000 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/10 mg.
Mean Percent Change from Baseline at Study End (Week 12)
LDL-C HDL-C TG Lp(a)
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Atorvastatin 40mg/Niaspan 2000mg -56% 22% -47% -20%
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Rosuvastatin 20mg/Niaspan 1000mg -51% 24% -40% -6%
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Simvastatin 40mg/Ezetimibe 10mg -58% 10%* -33%* 7%*
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Rosuvastatin 40mg -54% 7%* -25%* 5%*
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* Significantly different (p is less than or equal to 0.05) versus atorvastatin/Niaspan
Lp(a) reported as median values
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 (51-58%), 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.(4) 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.(5) Similar numbers of patients reported adverse events and serious adverse events. No drug-related myopathy was observed.
COMPELL was presented by Peter Jones, M.D., Associate Professor of Cardiology, Baylor University. “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. Jones. “The patients in the study were at high risk for heart attack. For these patients, achieving optimal goal levels for all lipid parameters, including HDL-C, LDL-C and triglycerides is essential. We found that by combining the prescription form of niacin, called Niaspan, with a low to moderate dose of a statin, we could achieve these results. When heart disease patients achieve these three goals, their risk of heart disease goes down substantially.”
“The COMPELL study puts broad dyslipidemic control and efficacy in appropriate perspective. Lowering LDL cholesterol to ultra-low levels may not be enough to protect against heart disease,” said Adrian Adams, President and CEO of Kos Pharmaceuticals. “There seems to be a diminishing rate of return in reducing coronary events when LDL is lowered progressively below 100 mg/dL. Most LDL-lowering trials show that two-thirds to three-quarters of statin-treated patients who are at risk in fact progress to a cardiovascular event, despite treatment. This research points to combining statin therapy with Niaspan, the most effective drug available for increasing HDL, as the next clinical advance in risk reduction.”
