A New Pill Against Bad Cholesterol

Context

The US FDA approval of a once-daily oral PCSK9 inhibitor, Lipfendra (enlicitide), marks a new era in cholesterol management.

Key Highlights

• The drug can decrease LDL, or “bad,” cholesterol by up to 60%.
• The development is important because high-risk individuals for whom the LDL target is not reached with statins may need further intervention.
• Previously, PCSK9 inhibitors had only been offered as costly injectables.

How Does the New Cholesterol Pill Work?

• Statins inhibit the liver’s ability to make cholesterol and are the initial choice of treatment for the majority of patients.
• PCSK9 inhibitors have a different biological action.
• Normally, LDL receptors on liver cells are destroyed by the PCK9 protein.
• The new drug prevents the body from degrading PCSK9, thereby increasing the number of LDL receptors available to the body.
• The liver is then able to take more LDL cholesterol out of the blood.
• The drug also lowers apolipoprotein B (ApoB), which indicates the level of cholesterol particles in the blood.

Who Can Benefit the Most?

• The greatest beneficiaries are patients at high or very high cardiovascular risk.
• Those who have a heart attack, angioplasty, stenting or have known coronary artery disease may need intense LDL reduction.
• Presently, treatment targets are extremely low for people with heart disease.
• Patients with familial hypercholesterolaemia, a strong family history of premature heart disease or multiple cardiovascular risk factors may also benefit.
• The drug may be beneficial for people who cannot take statins due to their side effects on muscles or for other reasons.
• But in the meantime, statins, ezetimibe and bempedoic acid are all good evidence-based treatments that must be tried first before advanced treatment options are considered.

Why ApoB Matters for Indians

• ApoB is important because it reflects the amount of potentially artery-clogging particles of lipoprotein, not just the amount of cholesterol.
• Some people can have the normal amount of LDL in their blood and yet have high numbers of small, dense LDL particles.
• There are higher prevalence rates of some patterns of dyslipidaemia among South Asians (including Indians) than in the populations of the West.
• This warrants the need for a thorough cardiovascular risk assessment in India.

Limitations and Public Health Concerns

• The drug has now been approved for the first time based on its effects on lowering LDL cholesterol.
• A dedicated cardiovascular outcomes trial is still ongoing to see how it affects heart attacks, strokes and cardiovascular deaths.
• The cost of the new therapy could limit access, especially in countries where a significant proportion of health care expenditure is out-of-pocket.
• The drug should not be considered a substitute for a healthy diet, regular exercise, or control of blood pressure or diabetes.

Way Ahead for India

• The routine screening of cholesterol and cardiovascular risk assessment should be strengthened in India.
• All adults need a cholesterol check at least once in early adulthood to detect inherited lipid disorders.
• Individuals with diabetes, hypertension, obesity or a family history of premature heart disease may require more frequent testing.
• Access to evidence-based lipid-lowering medicines is a priority for public health programmes and must be made affordable.
• Increasing awareness about high cholesterol among young Indians is critical for prevention of premature cardiovascular disease.

Conclusion

• The new oral PCSK9 inhibitor is a key step forward in cholesterol treatment.
• This dual action that it has to lower LDL as well as the fact that it is a pill to be taken daily makes it easier to adhere to treatment for high risk patients.
• The real public health impact, however, will be determined by cardiovascular benefits and affordability and equitable access in the long-term.
• India’s strategy should focus on using cutting-edge therapies, early detection, prevention, and cardiovascular risk reduction through lifestyle modifications.

Source: The Indian Express

Prelims PYQ

Q. A company marketing food products advertises that its items do not contain trans-fats. What does this campaign signify to the customers? (2011)

1. The food products are not made out of hydrogenated oils.
2. The food products are not made out of animal fats/ oils.
3. The oils used are not likely to damage the cardiovascular health of the consumers.

Which of the statements given above is/are correct?

(a) 1 only
(b) 2 and 3 only
(c) 1 and 3 only
(d) 1, 2 and 3

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