Here's some more KOSP stuff:
First from the FDA Consumer Mag:
fda.gov
Study: Treatment Reduces Risk of Heart Attack by 70 Percent
Cardiovascular disease is the No. 1 killer in most industrialized countries. A new study indicates that combining the use of a statin drug and niacin can reduce the risk of heart attack or hospitalization for chest pain by 70 percent among people likely to suffer heart attacks and/or death from coronary heart disease.
The treatment used in the study combined two well-known ways of improving cardiac health: the use of a statin drug called simvastatin to lower levels of the so-called "bad" cholesterol, LDL, and the use of niacin, also called vitamin B-3, to boost levels of the "good" cholesterol, HDL. Niacin is the best agent known to raise blood levels of HDL, which helps remove cholesterol deposits from the artery walls.
The study, done by researchers at the University of Washington and published in the Nov. 29, 2001, issue of the New England Journal of Medicine, found that the combined treatment, in people with low levels of HDL and average levels of LDL, could even reverse plaque buildup in the arteries.
"This study shows that improving cholesterol levels in people with heart disease--especially lowering LDL cholesterol substantially, together with raising HDL cholesterol--greatly reduces the risk for a heart attack and heart disease complications and can actually reverse the buildup of cholesterol in the arteries of the heart," said Claude Lenfant, M.D., director of the National Heart, Lung, and Blood Institute, which funded the study.
Researchers also looked at the effect of a mixture of antioxidant vitamins on cardiovascular outcomes. The antioxidants involved in this study include vitamins C and E, beta-carotene and selenium.
The study found that the mixture of antioxidant vitamins actually blunted the expected rise in the "good" HDL cholesterol usually seen with the simvastatin and niacin combination. Scientists are not sure why this is so, since there has been laboratory evidence that suggests antioxidants should be helpful.
At the start of the study and again after three years of treatment, doctors performed angiograms on the arteries of the 160 people in the study. The angiograms, using computerized measurements, showed that in most of the people who received the combination treatment, plaque buildup had actually decreased.
"This is the first demonstration of a striking clinical benefit from this form of combination drug therapy used in patients with a common type of coronary disease," says B. Greg Brown, M.D., lead author of the study and a cardiologist at the university's medical school.
Giving statins to people with cardiovascular disease is now common, and has been proven to reduce cardiovascular risk by 25 percent to 35 percent over five years of treatment. The study involved use of niacin at moderately high and carefully supervised levels. Brown said that patients should only take niacin under a doctor's supervision. Rarely, the unsupervised use of niacin can cause severe liver problems, including liver failure.
I wonder if the sales reps can bring along a copy of the FDA's own magazine? And then have the FDA enforcement department grumble about it... <g>
And then here's the recent abstract referred to previously:
Am J Cardiol 2002 Mar 15;89(6):672-8 Related Articles, Books, LinkOut
Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia*.
Kashyap ML, McGovern ME, Berra K, Guyton JR, Kwiterovich PO, Harper WL, Toth PD, Favrot LK, Kerzner B, Nash SD, Bays HE, Simmons PD.
Veterans Affairs Healthcare System, Long Beach, California, USA
Combination therapy is increasingly recommended for patients with multiple lipid disorders, especially those at high risk for coronary events. We investigated the long-term safety and effectiveness of a new drug formulation containing once-daily extended-release niacin and lovastatin. A total of 814 men and women (mean age 59 years) with dyslipidemia were enrolled in a 52-week multicenter, open-label study. We used 4 escalating doses (niacin/lovastatin in milligrams): 500/10 for the first month, 1,000/20 for the second, 1,500/30 for the third, and 2,000/40 for the fourth month through week 52. Dose-dependent effects were observed for all major lipid parameters. At week 16, mean low-density lipoprotein (LDL) cholesterol and triglycerides were reduced by 47% and 41%, respectively; mean high-density lipoprotein (HDL) cholesterol was increased by 30% (all p <0.001). LDL/HDL cholesterol and total/HDL cholesterol ratios were also decreased by 58% and 48%, respectively. These effects persisted through week 52, except for the mean increase in HDL cholesterol, which had increased to 41% at 1 year. Lipoprotein (a) and C-reactive protein also decreased in a dose-related manner (by 25% and 24%, respectively, on 2,000/40 mg; p <0.01 vs baseline). Treatment was generally well tolerated. The most common adverse event was flushing, which caused 10% of patients to withdraw. Other adverse events included gastrointestinal upset, pruritus, rash, and headache. Drug-induced myopathy did not occur in any patient. The incidence of elevated liver enzymes to >3 times the upper limit of normal was 0.5%. Once-daily niacin/lovastatin exhibits substantial effects on multiple lipid risk factors and represents a significant new treatment option in the management of dyslipidemia.
Early script numbers quoted on Yahoo were reasonable but not dramatic:
Kos Pharmaceuticals prescription data for the week ending 3/08/02:
Niaspan
New: 20,946
Total: 54,085
Advicor
New: 2,146
Total: 2,388
Kos Pharmaceuticals prescription data for the week ending 3/01/02:
Niaspan
New: 20,863
Total: 54,795
Advicor
New: 1,926
Total: 2,016
One poster claims that:
The advicor launch is outpacing the launch of niaspan, tricor, lescol, baycol and welchol. Clearly, nowhere near lipitor, but if you compare the size of the sales forces, advicor seems to be pacing well.
Weekly TRx for the above:
Niaspan 50K
Tricor 90K
Welchol 18K
Lescol 66K
Baychol no longer in the market.
Peter |
