A new drug, which has been the subject of Australian trials and expected to be on the market within two years, looks likely to revolutionise the treatment of patients with high cholesterol.
The pill has a provisional name of Nexletol and has been the subject of a successful research and trial.The four-year clincal trial involved 14,000 people – including more than 300 Australians – in 32 countries, and demonstrated a number of benefits.
These benefits include:
- Lowered low-density lipoprotein (LDL) cholesterol, commonly referred to as ‘bad cholesterol’, by 20-25 per cent;
- Reduced cardiovascular complications by 13 per cent;
- Reduced heart attacks by 23 per cent; and,
- Reduced coronary revascularisations (a procedure to open blocked arteries) by 19 per cent.
One of the big advantages of Nexletol, is that it will be an alternative for high-cholesterol patients who have a demonstrated intolerance of statins, which are also used to lower cholesterol.
Statins have a number of potential side effects for some patients, including headache, nausea, dizziness, diarrhea, constipation or achy muscles or joints.
In more serious (though much rarer) cases, statins can also cause confusion, memory loss, liver damage or high blood sugar.
The results of the double-blind, randomized, placebo-controlled trial, published in the New England Journal of Medicine, came to the following conclusion:
“Among statin-intolerant patients, treatment with bempedoic acid was associated with a lower risk of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization).”
For Prof. Nicholls, the promising results are the culmination of more than a decade’s work on an alternative to statins.
“Statins have been great, but they are not going to be the magic elixir for everyone, and we needed other options,” he said.
“Patients who can’t tolerate statins are a real problem in clinical practice. It limits our ability to effectively lower cholesterol in many patients. This new drug has the potential to help between 100,000 and 500,000 people in Australia.”
That figure represents up to 20 per cent of the 2.5 million Australians who take statins to lower their cholesterol. On top of the 20 per cent with tolerance issues, about 50 per cent of high-risk patients didn’t get their cholesterol down to target levels so they need other options.
“This new drug provides another option for lowering cholesterol and is particularly important for patients that cannot tolerate statins,” Prof. Nicholls said.
A high amount of ‘bad cholesterol’ in your blood can make arteries narrow, which in turn makes it harder for blood to circulate, elevating the risk of heart attack or stroke.
Nexletol is being developed by US-based Esperion Therapeutics (which funded the trial) and will go to the Therapeutics Goods Administration for approval for use in Australia.
The TGA assessment process should be completed in a time frame that will see the drug, assuming it is approved, available to Australian patients in the next two years.
Do you suffer from high cholesterol? Has your treatment been limited by an intolerance to statins? Why not share your thoughts in the comments section below?
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