SPECIAL REPORT / New medicines soon expected to hit the European market will allow patients to lower their levels of bad cholesterol more substantially than is currently possible, opening new avenues for tackling heart diseases.
A new type of cholesterol drug from Sanofi and Regeneron Pharmaceuticals won a green light from European regulators in February, two months behind a rival product from Amgen.
The European Medicines Agency (EMA) said its experts had recommended Praluent for patients unable to control their cholesterol despite taking optimal doses of conventional statin pills or those who cannot take statins.
Researchers at the European Society of Cardiology (ESC) congress in London last week described the development as a milestone in the fight against cardiovascular diseases.
They highlighted the linear link between levels of bad cholesterol, also known as LDL cholesterol, and the risk of a cardiovascular event.
“I think it has become very clear that when it comes to LDL cholesterol and risk for future cardiovascular events, lower is better,” said Peter Toth, a general practitioner from the United States.
“We are seeing more and more data that support this conclusion – the greater the reduction in LDL cholesterol, the larger the reduction in risk.”
Reducing the risk of heart disease
Maintaining healthy cholesterol levels is important, particularly for patients with diabetes. For those suffering from the disease, it’s important to reduce LDL cholesterol to lower their risk for heart disease and stroke.
For some years, the general guidelines for LDL cholesterol have been lower than 100 miligrams per deciliter (mg/dL) for patients with a high risk of a cardiovascular event and below 70 mg/dL for patients with a very high risk of a cardiovascular event.
Toth said that the newest drugs will be able to reduce LDL cholesterol for high risk patients to 50 mg/dL.
“There is no question that when you really push the LDL cholesterol down intensely, we can see much more substantial levels of risk reduction. This means that we have not even begun to scratch the bottom of the lower threshold of what we would consider to be an optimal LDL,” the doctor said.
In Europe, 54% of men and women have too much bad cholesterol in their blood.
A report by the Cardiovascular Resource Group from 2011 found that 133.3 million people in the five biggest EU countries (Germany, France, Italy, Spain and the UK) suffer from too much bad cholesterol.
Different reaction to drugs among patients
But Toth also urged doctors to look at the genes of their patients, as the cholesterol drugs can have a different impact on different patients.
He pointed to a study that focused on cholesterol reduction among black and white patients with high cardiovascular risk.
The study showed that white patients who had a 15% reduction in their LDL cholesterol with the help of the drugs, had a corresponding 47% reduction of cardiovascular events 15 years later. But the drugs had a much bigger effect among black patients, helping them reduce their LDL cholesterol by as much as 40%. 15 years later, this resulted in an impressive 88% relative risk reduction for cardiovascular events.
Dominique Lautsch, who represents a study group which has compared achievements with cholesterol drugs for more than 50,000 patients in Europe and China, agreed that cholesterol drugs can have a different impact on patients across the globe.
Lautsch said his study found that among high risk patients in Europe, 80% of UK patients were able to get below 100 mg/dL with the help of drugs. This was in contrast with Greece, Germany, Portugal, Spain and Austria, where only 35-50% of patients were able to achieve the same result.
Lautsch said the difference could be due to genes. But it could also be due to the fact that when the research started in 2007, the UK had a different health system with incentives to reach these treatment targets.
The researcher said that due to genes and different lifestyles, Chinese and Europeans patients for instance have significantly different cardiovascular profiles. This means doctors need to use different doses of drugs.
Alberico Catapano, Professor of Pharmacology at the University of Milan, corroborated this view, saying there was a big variability in response to drugs among patients in general.
“Studies of large groups of patients have indicated that reductions occur to a great extent, but in some patients, the benefit is less than expected and some patients might not even see a reduction.”
Toth also mentioned Familial Hypercholesterolemia (FH), a genetic disorder characterised by high cholesterol levels which can cause cardiovascular diseases. He said that FH “greatly magnifies” risk for developing premature cardiovascular diseases, urging doctors to keep this in mind when treating patients.
FH has recently been found to be more common than previously thought in countries such as the Netherlands, South Africa and the US.
The European Society of Cardiology (ESC) congress presents the world’s largest and most influential cardiovascular event. It showcases and debates the latest science and research in cardiology and how it can improve the lives of patients.
This year’s congress in London turned towards the patient with a focus on how to improve patient care by communicating significant advances in prevention, diagnosis and treatment of cardiovascular disease.
The congress included more than 500 sessions with a distinguished faculty from around the globe and over 4,600 abstract presentations.
- 29 September: EurActiv Institute stakeholder debate in the European Parliament, "Cholesterol at the heart of the family."