Marisa, 58 years old, has been taking statins for several years, but her test results continue to show LDL, the "bad cholesterol", above recommended levels. She has heard about cholesterol-lowering injections, but the price and fear of needles have always made her give up. Cases like hers help us understand why the approval of a new medication, announced by the FDA (the agency that regulates medicines in the United States) this Thursday, has generated so much repercussion.
"The data and clinical case cited in this article are fictitious and are merely illustrative, serving to facilitate understanding of the topic addressed."
What was approved
The pharmaceutical company Merck received FDA authorisation to commercialise Lipfendra (scientific name enlicitide), the first PCSK9 inhibitor in tablet form. Until now, this class of medications, recognised for strongly reducing LDL, only existed in injectable form, with prices that usually exceed 500 to 600 dollars per month in the USA. The new tablet is taken once daily.
How it works in the body
PCSK9 is a protein produced by the liver that interferes with the removal of LDL from the blood. By blocking this protein, the medication helps the body "clear" more bad cholesterol from circulation, reducing the accumulation of plaques in the arteries, one of the main causes of heart attack and stroke.
Who can use it
The approval was aimed at people with hypercholesterolaemia (persistently high LDL cholesterol) who are already taking the maximum tolerated dose of statins and still cannot reach recommended levels. The study supporting the approval involved more than 3,000 adults in this situation. In other words, it is not a medication designed to replace statins for those who have not yet tried standard treatment, but rather to complement treatment for those who have done everything and still cannot control their cholesterol.
How it should be used
An important detail: the tablet needs to be taken on an empty stomach, without food, to work correctly. Apart from this requirement, the major advantage compared to injectable versions is precisely the practicality – it eliminates needles and can be incorporated into daily routine like any other oral medication. Nevertheless, any start of treatment should always be monitored by a doctor, who will evaluate test results, medical history and other medications in use.
Why high cholesterol is such an important risk factor
Excess LDL deposits on artery walls, forming plaques that can obstruct blood flow, the main pathway to heart attack and stroke. It is estimated that about 1 in every 4 adults has elevated LDL, and recent guidelines from cardiology societies recommend stricter targets: below 70 for those with increased cardiovascular risk, and below 55 for those who have already experienced a cardiac event, such as a heart attack.
What this could change in people's lives
For patients who are doing everything right – diet, physical activity, statins at maximum dose – and still cannot control their cholesterol, having an oral option could mean better treatment adherence, lower cost and fewer psychological barriers (fear of needles is real and keeps many people away from injections). This does not mean the tablet is for everyone nor that it replaces healthy habits: it adds to the therapeutic arsenal for the most resistant cases, increasing the chances of reducing the risk of heart attack and stroke in this specific population.
Important notice: this content is informative in nature and does not replace medical consultation. The use of Lipfendra or any cholesterol medication should be indicated and monitored by a healthcare professional, who will evaluate individual risks, benefits and interactions.