FDA rejects Merck s new cholesterol pill

Two years ago, cardiologists and researchers talked excitedly about a golden age of heart drugs, when the cholesterol market would expand beyond statins to novel medicines that would revolutionize the treatment of heart patients.

The announcement late Monday the Food and Drug Administration had rejected a new cholesterol pill from Merck was only the latest setback for cardiac medicine. Coming on the heels of the Vytorin controversy and, before that, the failure of Pfizer's torcetrapib, the denial of Merck's application for Cordaptive means there are no new therapies on the immediate horizon to treat an estimated 100 million Americans with high cholesterol, experts said yesterday.

The New Jersey drugmaker had been talking up its B-vitamin-based cholesterol tablet as a valuable addition to its cardiovascular franchise and a replacement for Zocor, the blockbuster statin that lost patent protection in June 2006. Wall Street analysts projected it could generate more than $1 billion in annual sales.

No wonder investors were disappointed yesterday, sending shares of Merck plummeting.

"We plan to meet with the FDA," Ron Rogers, a Merck spokesman, said yesterday. "We continue to believe in this product. It's an important option for physicians to manage their cholesterol."

Some heart experts said they were always cautious about the prospects for Cordaptive, but the FDA's rebuff is bigger than Merck. It's a clear setback in the hunt for the Holy Grail of heart pills: a safe, effective way to lower LDL, or bad cholesterol, while raising HDL, or good cholesterol. Doctors theorize raising HDL may reverse plaque build-up in the arteries, which figures in heart attacks and strokes.

The most promising HDL-raising candidate, Pfizer's torcetrapib, failed in clinical trials in late 2006 and left the world's largest drug company with no successor for Lipitor, the No. 1-selling statin, which loses patent protection in early 2010.

Statins, by far the top-selling pills in the $21.6 billion global cholesterol market, have been shown to reduce LDL, but they are not very effective at increasing HDL. The only HDL-boosting treatment currently on the market is Niaspan, a niacin-based drug marketed by Abbott Laboratories.

Niacin, one of the B vitamins, can be difficult to tolerate at doses necessary to raise HDL because it can cause flushing, itching and hot flashes. Abbott is working on a new version to cut the adverse side effects.

Merck's experimental pill combines niacin with a new medicine, called laropiprant, which is supposed to alleviate facial flushing. Yesterday, Merck and the FDA declined to specify the reasons the FDA gave for rejecting Cordaptive in a "nonapprovable letter" it issued Monday night. The company previously acknowledged "theoretical" safety concerns about its effect on the liver.

"I don't know what FDA was thinking, none of us do," said Allen Taylor, a research cardiologist at Walter Reed Army Medical Center who was skeptical of Merck's drug.

"There have not been any studies of laropiprant alone, and what the marginal benefit is of taking two drugs to do what one drug does," he said in a telephone interview yesterday. "There's a large degree of uncertainty."

Merck has a long-term, 20,000-patient study of Cordaptive under way that compares the drug to a placebo, rather than niacin alone. To be completed in 2012, it will be closely watched, because little is known about the long-term effects of its flushing-blocker.

Rogers said Merck is continuing development of yet another new heart pill, a combination of Cordaptive and generic Zocor. He said it plans to submit an application to the FDA later this year.

"There's no change on that at this time," he said.

Cordaptive is important to Merck because sales of Vytorin, which is co-marketed with Schering-Plough, have been hurt by controversy this year over a study that found it worked no better than generic Zocor -- a drug five times less expensive -- at reducing blockages that cause heart attacks.

The Vytorin controversy has touched off a wider debate about the importance of controlling LDL. The most extreme skeptics worry lower LDL may not translate into preventing heart attacks, strokes and deaths.

Because of excessive accumulation of cholesterol in various diseases caused by the large number of people today. But how can we help ourselves consumption out of surplus cholesterol? Now take a look at the U.S. experts to provide us with the health of fresh single.

Cholesterol is an essential human nutrient. It not only as a body composition, or material of many important raw materials, but the large number of long-term intake of cholesterol is not conducive to good health and will increase serum cholesterol, increasing the risk of suffering from cardiovascular diseases and induced fatty liver.

According to the U.S. daily health network, through long-term study, the United States Loma Linda University researchers of the latest research results show that has been suffering from hypercholesterolemia to the people ate 10 kinds of food the following:

Apple: because rich pectin, cellulose and vitamin C, a very good lipid-lowering effect. If eating two apples a day, adhere to a month, most people in the blood low-density lipoprotein cholesterol (harmful to the cardiovascular) will be reduced, and on cardiovascular beneficial high-density lipoprotein cholesterol level will rise.

Carrots: calcium-rich pectin, acid and bile from a chemical reaction in the stool from. The body is bound to generate will be spent on bile acid in the blood cholesterol, thereby contributing to the level of cholesterol in the blood decreased. Yein http://wf66.com/

Corn: rich in calcium, phosphorus, selenium and lecithin, vitamin E, have reduced the role of serum cholesterol.

Oysters: rich in zinc and bezoar acid, in particular the bezoar acid can promote decomposition cholesterol, help lower blood lipid levels.

Almond: normal or slightly higher cholesterol levels of people, can be used to replace the almond meal in the low density of food nutrition, to reduce blood cholesterol and maintaining heart health purposes.

Kelp: the rich bezoar acid, can reduce blood pressure and cholesterol in the bile; containing food fiber alginic acid, can also inhibit the absorption of cholesterol and promote excretion.

Garlic: synthesis of cholesterol can reduce the liver. Just a day to eat three garlic, would effectively reduce the harmful cholesterol, the good cholesterol increased, the incidence of heart disease by 50 per cent.

Milk: with more calcium, can inhibit the synthesis of cholesterol in the activity can also reduce the body s absorption of cholesterol.

Miju: rich in vitamin C, eat the liver detoxification can increase capacity, speed up the transformation of cholesterol, lower serum cholesterol and blood fat content.

Tea: containing caffeine and TP, refreshing, strong heart, diuretic, and lipid-lowering Consumers tired of the function. Regular tea drinking can prevent the body s cholesterol increased.

Because of excessive accumulation of cholesterol in various diseases caused by the large number of people today. But how can we help ourselves consumption out of surplus cholesterol? Now take a look at the U.S. experts to provide us with the health of fresh single.

Cholesterol is an essential human nutrient. It not only as a body composition, or material of many important raw materials, but the large number of long-term intake of cholesterol is not conducive to good health and will increase serum cholesterol, increasing the risk of suffering from cardiovascular diseases and induced fatty liver.

According to the U.S. daily health network, through long-term study, the United States Loma Linda University researchers of the latest research results show that has been suffering from hypercholesterolemia to the people ate 10 kinds of food the following:

Apple: because rich pectin, cellulose and vitamin C, a very good lipid-lowering effect. If eating two apples a day, adhere to a month, most people in the blood low-density lipoprotein cholesterol (harmful to the cardiovascular) will be reduced, and on cardiovascular beneficial high-density lipoprotein cholesterol level will rise.

Carrots: calcium-rich pectin, acid and bile from a chemical reaction in the stool from. The body is bound to generate will be spent on bile acid in the blood cholesterol, thereby contributing to the level of cholesterol in the blood decreased. Yein http://wf66.com/

Corn: rich in calcium, phosphorus, selenium and lecithin, vitamin E, have reduced the role of serum cholesterol.

Oysters: rich in zinc and bezoar acid, in particular the bezoar acid can promote decomposition cholesterol, help lower blood lipid levels.

Almond: normal or slightly higher cholesterol levels of people, can be used to replace the almond meal in the low density of food nutrition, to reduce blood cholesterol and maintaining heart health purposes.

Kelp: the rich bezoar acid, can reduce blood pressure and cholesterol in the bile; containing food fiber alginic acid, can also inhibit the absorption of cholesterol and promote excretion.

Garlic: synthesis of cholesterol can reduce the liver. Just a day to eat three garlic, would effectively reduce the harmful cholesterol, the good cholesterol increased, the incidence of heart disease by 50 per cent.

Milk: with more calcium, can inhibit the synthesis of cholesterol in the activity can also reduce the body s absorption of cholesterol.

Miju: rich in vitamin C, eat the liver detoxification can increase capacity, speed up the transformation of cholesterol, lower serum cholesterol and blood fat content.

Tea: containing caffeine and TP, refreshing, strong heart, diuretic, and lipid-lowering Consumers tired of the function. Regular tea drinking can prevent the body s cholesterol increased.

Because of excessive accumulation of cholesterol in various diseases caused by the large number of people today. But how can we help ourselves consumption out of surplus cholesterol? Now take a look at the U.S. experts to provide us with the health of fresh single.

Cholesterol is an essential human nutrient. It not only as a body composition, or material of many important raw materials, but the large number of long-term intake of cholesterol is not conducive to good health and will increase serum cholesterol, increasing the risk of suffering from cardiovascular diseases and induced fatty liver.

According to the U.S. daily health network, through long-term study, the United States Loma Linda University researchers of the latest research results show that has been suffering from hypercholesterolemia to the people ate 10 kinds of food the following:

Apple: because rich pectin, cellulose and vitamin C, a very good lipid-lowering effect. If eating two apples a day, adhere to a month, most people in the blood low-density lipoprotein cholesterol (harmful to the cardiovascular) will be reduced, and on cardiovascular beneficial high-density lipoprotein cholesterol level will rise.

Carrots: calcium-rich pectin, acid and bile from a chemical reaction in the stool from. The body is bound to generate will be spent on bile acid in the blood cholesterol, thereby contributing to the level of cholesterol in the blood decreased. Yein http://wf66.com/

Corn: rich in calcium, phosphorus, selenium and lecithin, vitamin E, have reduced the role of serum cholesterol.

Oysters: rich in zinc and bezoar acid, in particular the bezoar acid can promote decomposition cholesterol, help lower blood lipid levels.

Almond: normal or slightly higher cholesterol levels of people, can be used to replace the almond meal in the low density of food nutrition, to reduce blood cholesterol and maintaining heart health purposes.

Kelp: the rich bezoar acid, can reduce blood pressure and cholesterol in the bile; containing food fiber alginic acid, can also inhibit the absorption of cholesterol and promote excretion.

Garlic: synthesis of cholesterol can reduce the liver. Just a day to eat three garlic, would effectively reduce the harmful cholesterol, the good cholesterol increased, the incidence of heart disease by 50 per cent.

Milk: with more calcium, can inhibit the synthesis of cholesterol in the activity can also reduce the body s absorption of cholesterol.

Miju: rich in vitamin C, eat the liver detoxification can increase capacity, speed up the transformation of cholesterol, lower serum cholesterol and blood fat content.

Tea: containing caffeine and TP, refreshing, strong heart, diuretic, and lipid-lowering Consumers tired of the function. Regular tea drinking can prevent the body s cholesterol increased.

Apple to eat every day, every week to eat 2 - 3, black edible fungus, Chi Feirou, eat, eat eggs and coarse grain. A week to eat 2 - 3, lean meat.

The above are my success by the experience of high cholesterol. Only a year to reduce the (original 50% higher than the normal value). Now the fifth year, all the normal review last week.

Yahoo knowledge appear only to provide information storage services, its content provided by the client, Yahoo Church does not guarantee that knowledge is correct.

According to the dissemination of information networks to protect the rights , some content may not be right to give notice, please click here to

Additional information :

From www.nj.com:
Lower your risk of a heart attack by reducing your cholesterol levels. In terms of cholesterol reduction food raw garlic has always.
Cholesterol reducing food. The catalogue of the best drugs sites on the Internet! Drugs search. Most popular drugs. Here the most popular.
Help reduce cholesterol, eat a healthy diet, and learn about heart problems. fat and dietary cholesterol were listed on food labels in the United.
If you fall into the first category, the best cholesterol reducing method is quite logical change your dietary patterns. Keep a food record.
Low fat dog food calories in food reduce cholesterol food. what foods are high in cholesterol cholesterol reducing food fat food sources.
There is provided a blood cholesterol reducing oral composit. A pharmaceutical or food product containing the composition described.
A nutritional product having a solid matrix containing protein, fat and carbohydrate has disposed therein particles of dietary fiber encapsulated.
There are varying degrees regarding the food that you can consume. One of cholesterol reducing foods is extra virgin.