The National Institute for Health and Care Excellence (NICE), in its press release, has recently issued the final draft guidance regarding the treatment of dyslipidemias and hypercholesterolemia. According to this guidance, NICE now recommends two new treatment options for people with severe lipids disorders, which put them at high risks of severe heart attacks and strokes.
These options include two new monoclonal antibodies i.e., alirocumab (Praluent by Sanofi) and evolucumab (Repatha, Amgen). These drugs can now be administered to the adult patients with mixed dyslipidemia and hypercholesterolemia, who do not respond to or are intolerant to alternative cholesterol lowering options such as statins. These drugs can help in reducing their LDL cholesterol and hence can be beneficial for the reduction of the risk factors involved in the development of serious cardiovascular diseases, like myocardial infarction, congestive heart failure and stroke.
“We are very pleased to be able to recommend alirocumab and evolocumab. People with hypercholesterolaemia or mixed dyslipidemia, who have a high risk of a heart attack or stroke despite taking the highest tolerated dose of other cholesterol-lowering drugs, have very few treatment options,” said Professor Carole Longson, the Director of Center for Health Technology Evaluation at NICE. She further stated that since both the new drugs are relatively costly, the draft guidelines recommend the cost effective use of both these new drugs, which can be attained only at the discounted prices agreed by the manufacturers. These drugs can only be used by those patients who are suffering from hypercholesterolemia and mixed dyslipidemia and whose levels of cholesterol cannot be properly controlled by statins, other lipid lowering drugs or by making changes in their lifestyles.
These drugs can lower the high LDL cholesterol to 3.5mmol/L in patients with familial hypercholesterolemia whose LDL cholesterol level continuously persists over 5.0mmol/L. The same results can be achieved in patients with recurrent CVS complications and dyslipidemias, in which LDL level is persistently over 4.0mmol/L.
This draft guidance also states that the provision of treatment for these two new options is not for everyone suffering from hypercholesterolemia. This treatment is only recommended for those patients in whom the cholesterol levels are not controlled effectively by statins and other lipid lowering drugs. The cost of treatment associated with alirocumab and evolucumab therapy is very high (US$ 5,780 per patient for one year approximately) as compared to the conventional anti-hyperlipidemic drugs such as eEzitemibe (Zetia), at US$ 504 per patient per year approximately. Therefore, NICE aims to sign an agreement with the manufacturers to provide these drugs at discounted rates for the hyperlipidemia patients. The manufacturers have also agreed to provide these drugs for the selected patients at discounted prices.
On What Basis Is The Use Of These Drugs Recommended?
This recommendation by NICE committee is based on the clinical trials data regarding the use of alirocumab in patients with hyperlipidemias. It was observed that this drug reduces the bad cholesterol or LDL cholesterol levels in the body up to 40% more in comparison with ezetimibe, which is another lipid lowering drug. Similarly, reduction in LDL cholesterol levels, which were observed in comparison with placebo, were up to 62%. Similar kind of results were also observed with the use of evolocumab.
Hypercholesterolemia is a condition which is characterized by high cholesterol levels in the body. Similarly, dyslipidemia is a condition in which there are abnormal levels of blood cholesterol in the body, which may be too high or too low than the normal levels. People having either of these conditions are at a high risk of developing serious cardiovascular complications. If the increased levels of fatty acids and cholesterol persist in the body, atherosclerosis may occur, a condition in which there is a constriction of arteries due to accumulation of cholesterols inside the arteries. It may cause resistance in the normal blood flow to the body, which may ultimately lead to stroke, heart failures and other cardiovascular diseases like angina. Some people have an inherited form of hypercholesterolemia, which is also called familial hypercholesterolemia. These people exhibit high level of cholesterols in their body, right from their birth. The risk of development of CVS disorders at a very early age in such patients increases up to 50% at age of 50 in case of males, and up to 30% at the age of 60 years in case of females.
About Alirocumab And Evolucumab
Both of these drugs are the monoclonal antibodies that act by inhibiting a protein called PCSK9 (proprotein convertase subtilisin/kexin type 9). As a result of this inhibition, the degradation of LDL receptors in the liver stops and hence the liver starts removing the LDL cholesterol from the body efficiently. This mechanism is different to that of some of the other lipid lowering drugs, such as statins, which act by decreasing the production rate of the cholesterols from liver. Both of these drugs are indicated for treating high cholesterol levels, familial hypercholesterolemia and atherosclerotic heart disease, and are administered as subcutaneous injection. The frequency of administration is once after every two weeks. The recommended dose of alirocumab is either 75mg or 150 mg, whereas for evolocumab it is 140mg. If the dose of evolocumab is 420mg, then it should be self-administered after one month.
NICE concluded that both of these drugs can be beneficial in lowering Low Density Lipoproteins (LDL) or bad cholesterols from the body more efficiently than other conventional lipid lowering drugs. They can be administered to the patients with hypercholesterolemia, familial hypercholesterolemia and high or mixed dyslipidemias who are at a very high risk of developing severe cardiovascular diseases.