Advicor, the cholesterol control product from Kos Pharmaceuticals, has been found to be highly effective in controlling the full range of lipids when compared to two other leading statin products, according to a new study presented earlier this week at the 51st Annual Scientific Session of the American College of Cardiology (ACC) in Atlanta, Georgia.
In addition, the results of a separate study, published in the March 15 issue of American Journal of Cardiology (AJC), also showed that Advicor helped improve levels of LDL, HDL, triglycerides, Lp(a) and C-reactive protein, and that it was well-tolerated and safe when administered to patients during the one-year study period.
Advicor consists of a single tablet formulation containing extended-release niacin (Niaspan) and lovastatin and was launched by Kos Pharmaceuticals in January.
The ADvicor Versus Other Cholesterol-modifying Agents Trial Evaluation (ADVOCATE) study, evaluated various doses of Advicor, Lipitor (atorvastatin) and Zocor (simvastatin) in the treatment of several lipid parameters over a 16-week period. The researchers looked at the effects of the three products on LDL ('bad') cholesterol, HDL ('good') cholesterol, triglycerides and lipoprotein (a), known as "Lp(a).
After 12 weeks, the results showed that Advicor had increased levels of HDL by 19 per cent, compared to just 3 per cent and 8 per cent respectively for Lipitor and Zocor. At the same time, LDL levels fell by 42 per cent in patients receiving Advicor, compared to 45 per cent and 35 per cent for the other two products.
"ADVOCATE suggests that combination therapy may be an important option when treating patients who require a global improvement in lipid abnormalities," said Harold Bays, medical director and president of the Louisville Metabolic and Atheroslcerosis Research Center and principal study investigator. "Although lowering LDL cholesterol remains the primary goal of therapy, managing other lipid parameters is becoming an increasingly important goal for clinicians."
Advicor was also profiled in the March 15 issue of American Journal of Cardiology. The report described the findings of a long-term, multi-centre, open-label trial of 814 patients in which escalating doses of Advicor were given to dyslipidemic patients for one year.
Advicor demonstrated a dose response efficacy in all lipid parameters with the highest dose (2000mg/40mg) reducing LDL and triglycerides by 47 per cent and 42 per cent respectively, while increasing HDL cholesterol by 41 per cent for patients receiving 52 weeks of therapy. Advicor also decreased levels of Lp(a) and C-reactive protein in a dose-dependent manner by 25 per cent and 24 percent respectively. The long-term study revealed that Advicor was generally well-tolerated by patients with no serious adverse events being observed.
"The results of our study confirm the effectiveness of the niacin/statin combination in the treatment of lipid disorders," said Moti L. Kashyap, Professor of Medicine, University of California at Irvine and principal investigator of the study. "It's clear that moving beyond monotherapy can make a real difference for certain patients."
"Such compelling clinical research showing the long-term safety and broad efficacy of Advicor will support its use as a multi-dimensional lipid modifier to treat the millions of patients who have dyslipidemia," said Adrian Adams, president and chief executive officer of Kos. "Additionally, the strong uptake of Advicor since its launch by both cardiologists and primary care physicians indicates the increased awareness of the clinical value of combination therapy in managing multiple lipid disorders in high-risk patients."