Good results from KOSP's Advicor:
Tuesday March 19, 11:48 am Eastern Time
Press Release
SOURCE: Kos Pharmaceuticals, Inc.
Advicor(TM) Shows Broad Efficacy in Managing Lipid Parameters in ADVOCATE Study Presented at American College of Cardiology Meeting
Newly-Published American Journal of Cardiology Report Also Shows Long-term Safety and Efficacy of Advicor
ATLANTA, March 19 /PRNewswire-FirstCall/ -- According to the results of the new ADVOCATE study presented yesterday at the 51st Annual Scientific Session of the American College of Cardiology (ACC) in Atlanta, Georgia, Advicor proved to be highly effective in managing the full spectrum of lipids when compared with various doses of the two leading statins. In addition, the results of a separate study, published in the March 15 issue of American Journal of Cardiology (AJC), not only demonstrated Advicor's broad efficacy in improving levels of LDL, HDL, triglycerides, Lp(a) and C-reactive protein, but also revealed that it was well-tolerated and safe when administered to patients during the one-year study period. Advicor, the first and only dual component cholesterol product approved by the U.S. Food and Drug Administration (FDA), consists of a single tablet formulation containing extended-release niacin (Niaspan®) and lovastatin and was launched by Kos Pharmaceuticals, Inc. (Nasdaq: KOSP - news) on January 28, 2002.
ADvicor Versus Other Cholesterol-modifying Agents Trial Evaluation (ADVOCATE), a 16-week, randomized, open-label, multicenter study of 315 patients, evaluated various doses of Advicor, Lipitor® (atorvastatin) and Zocor® (simvastatin) in the treatment of several lipid parameters including: LDL (``bad'') cholesterol, HDL (``good'') cholesterol, triglycerides and lipoprotein (a), known as ``Lp(a).'' At 12 weeks, using common maintenance doses, results with Advicor 1000/40 (1000mg Niaspan/40mg lovastatin), Lipitor 20mg and Zocor 20mg showed the following:
LDL HDL Triglycerides Lp(a)
Advicor 1000/40 -42%* +19%** -32%** -20%**
Lipitor 20mg -45% +3% -23% +3%
Zocor 20mg -35% +8% -6% -1%
* p<0.001 vs. Zocor
** p<0.001 vs. Lipitor and Zocor
By the end of the 16-week trial, patients titrated to the maximum recommended dose of Advicor 2000mg/40mg, experienced even greater improvement in triglycerides, Lp(a) and HDL, exceeding the magnitude of improvement of Lipitor 40mg and Zocor 40mg.
``ADVOCATE suggests that combination therapy may be an important option when treating patients who require a global improvement in lipid abnormalities,'' said Harold Bays, MD, FACP, Medical Director and President, Louisville Metabolic and Atheroslcerosis Research Center, Louisville, KY, 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-center, 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 percent and 42 percent, respectively, while increasing HDL cholesterol by 41 percent (p<0.001 for all values) 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 percent and 24 percent, respectively, with the 2000mg/40mg dose (p<0.01 vs. baseline). 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, MD, Professor of Medicine, University of California at Irvine and Director, Cholesterol Research Center, Veterans Affairs Healthcare System, Long Beach, CA, 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.''
Advicor is indicated for the treatment of primary hypercholesterolemia and mixed dyslipidemia in patients previously treated with either component and who require additional lipid modification for LDL and HDL cholesterol and triglycerides beyond that achieved by the individual components. Advicor is not indicated for initial therapy. In multicenter clinical trials, Advicor was generally well-tolerated with a safety profile comparable to that of Niaspan and lovastatin alone. The most frequently reported adverse events included flushing, upset stomach and rash. As with other lipid-altering drugs, periodic monitoring of liver enzymes is recommended as is observation for rare but serious adverse events such as myopathy. Advicor is contraindicated for pregnant or nursing women or for patients with liver problems or active peptic ulcer.
Peter |
