that often result in high cholesterol levels are often treated with medications to prevent complications like heart disease. Statins
are the commonly used drugs to reduce cholesterol levels. They reduce the levels of LDL-cholesterol, the bad cholesterol that chokes blood vessels. They also reduce triglycerides and increase the levels of HDL-cholesterol or good cholesterol. Other cholesterol lowering drugs, known as fibrates and niacin mainly reduce triglyceride levels
. High blood triglyceride levels have been associated with conditions like pancreatitis (inflammation of the pancreas).
‘Some combinations of cholesterol-lowering drugs like niacin or fenofibrate with statin cause more harm than provide benefit.’
Several drug companies were in the process of developing a combination of statin with delayed release fenofibrate or fenofibric acid, a fibrate, or extended-release niacin. However, the combination does not appear to have any additional benefit with respect to preventing heart disease
over the use of statin alone. In fact the side effects associated with the combination ensure that the benefits of the combination do not outweigh the risks, thus making the combination irrational.
communication from the FDA had alerted that fenofibrate did not reduce the risk of heart attack or stroke. This was based on
inputs from the Action to Control
Cardiovascular Risk in Diabetes (ACCORD)
Lipid trial conducted in diabetes
patients, where patients who received a combination of the statin simvastatin
and fenofibrate did not experience additional benefit in preventing a serious
cardiac event over those who were administered only simvastatin.
Based on another
study that used niacin with or without simvastatin, the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High
Triglycerides: Impact on Global Health Outcomes (AIM-HIGH),
concluded that the combination of niacin and a statin did not provide additional benefit and was in fact associated with
additional side effects. The trial was prematurely terminated.
Another trial, The Heart Protection Study 2-Treatment of
HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) study
evaluated the use of niacin along with another drug laropiprant in patients taking simvastatin with or without
ezetimibe. The lack of efficacy along with a higher incidence of complications
were noted with the combination containing niacin.
Thus, the use of
these combinations containing delayed release fenofibrate
or extended-release niacin with a statin is not warranted. Physicians should
avoid using fenofibrate or niacin in patients already taking a statin to
control their cholesterol levels. The manufacturing pharmaceutical companies
have themselves advised the FDA regarding withdrawal of the approval and will
not be applying for a hearing against the withdrawal.
- Hassan M. HPS2-THRIVE, AIM-HIGH and dal-OUTCOMES: HDL-cholesterol under attack. Glob Cardiol Sci Pract. 2014; 2014(3): 235-240.