In a major trial, a drug used globally and also in India to raise cholesterol levels in the body has failed to show protection against heart disease.
NEW DELHI: In a major trial, a drug used globally and also in India to raise cholesterol levels in the body has failed to show protection against heart disease.
National Institutes of Health (NIH) has announced that the study of cholesterol drug Niaspan would end 18 months ahead of the deadline. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease did not reduce the risk of cardiovascular events, including heart attacks and stroke.
Doctors in India believed that people with high levels of good cholesterol in their blood have more longevity. Hence, cholesterol-lowering statin drugs with HDL-boosting vitamin niacin were combined to benefit patients. But, the study, which followed 3,414 participants, found that niacin offered no benefits over statin therapy.
The salt name of the drug is Niacin (also called nicotinic acid, vitamin B-3 and nicotinamide), and is sold under three major brands in India — Nialip ( Dr Reddy's Lab), Nicinal (Cipla) and Neasyn SR (Torrent).
"It is not very popular, but is prescribed in India. Now, that we know the drug is not helpful, doctors in India should stop prescribing it. Doctors have to see the final outcome of a drug in a patient, not just how it behaves in a lab," Dr Gulati, drug expert and editor of MIMS, said.
Dr Anoop Misra, former HoD of medicine at AIIMS, said, "Niaspan is used by about 5%-10% of patients who need cholesterol drugs. In light of the latest study, doctors will have to take a call about prescribing it in future."
"So far, it was considered the best drug to increase good cholesterol. However it had its side-effects — flushing, headache, leg cramps and blurred vision, myopathy and hepatitis. Lack of good cholesterol is an abnormality among Indians as against whites, especially women. Though the drug is prescribed, it isn't well tolerated by patients," he added.
The NIH study said, "The combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures to improve blood flow in the arteries of the heart and brain."
The trial selected those participants, who were at risk for cardiovascular events despite well-controlled low-density lipoprotein (LDL or bad cholesterol). Their increased risk was due to a history of cardiovascular disease and a combination of low high-density lipoprotein (HDL or good cholesterol) and high triglycerides.
Low HDL and elevated triglycerides are associated with an increased risk of cardiovascular events. While lowering LDL decreases the risk of cardiovascular events, it has not been established that raising HDL similarly reduces the risk of cardiovascular events.
It was found that participants who took high dose, extended-release niacin and statin treatment had increased HDL cholesterol and lowered triglyceride levels compared to those who only took statin.
"Seeking new and improved ways to manage cholesterol levels is vital in the battle against cardiovascular disease," said Susan Shurin, acting director of NIH. However, efforts to find HDL-raising treatments that actually reduce the residual risk have so far proved disappointing.
"The lack of effect on cardiovascular events is unexpected, and a striking contrast to the results of earlier trials and studies," said Jeffrey Probstfield, co-principal investigator of the trial.
National Institutes of Health (NIH) has announced that the study of cholesterol drug Niaspan would end 18 months ahead of the deadline. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease did not reduce the risk of cardiovascular events, including heart attacks and stroke.
Doctors in India believed that people with high levels of good cholesterol in their blood have more longevity. Hence, cholesterol-lowering statin drugs with HDL-boosting vitamin niacin were combined to benefit patients. But, the study, which followed 3,414 participants, found that niacin offered no benefits over statin therapy.
The salt name of the drug is Niacin (also called nicotinic acid, vitamin B-3 and nicotinamide), and is sold under three major brands in India — Nialip ( Dr Reddy's Lab), Nicinal (Cipla) and Neasyn SR (Torrent).
"It is not very popular, but is prescribed in India. Now, that we know the drug is not helpful, doctors in India should stop prescribing it. Doctors have to see the final outcome of a drug in a patient, not just how it behaves in a lab," Dr Gulati, drug expert and editor of MIMS, said.
Dr Anoop Misra, former HoD of medicine at AIIMS, said, "Niaspan is used by about 5%-10% of patients who need cholesterol drugs. In light of the latest study, doctors will have to take a call about prescribing it in future."
"So far, it was considered the best drug to increase good cholesterol. However it had its side-effects — flushing, headache, leg cramps and blurred vision, myopathy and hepatitis. Lack of good cholesterol is an abnormality among Indians as against whites, especially women. Though the drug is prescribed, it isn't well tolerated by patients," he added.
The NIH study said, "The combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures to improve blood flow in the arteries of the heart and brain."
The trial selected those participants, who were at risk for cardiovascular events despite well-controlled low-density lipoprotein (LDL or bad cholesterol). Their increased risk was due to a history of cardiovascular disease and a combination of low high-density lipoprotein (HDL or good cholesterol) and high triglycerides.
Low HDL and elevated triglycerides are associated with an increased risk of cardiovascular events. While lowering LDL decreases the risk of cardiovascular events, it has not been established that raising HDL similarly reduces the risk of cardiovascular events.
It was found that participants who took high dose, extended-release niacin and statin treatment had increased HDL cholesterol and lowered triglyceride levels compared to those who only took statin.
"Seeking new and improved ways to manage cholesterol levels is vital in the battle against cardiovascular disease," said Susan Shurin, acting director of NIH. However, efforts to find HDL-raising treatments that actually reduce the residual risk have so far proved disappointing.
"The lack of effect on cardiovascular events is unexpected, and a striking contrast to the results of earlier trials and studies," said Jeffrey Probstfield, co-principal investigator of the trial.
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