Every day, at least 195 South Africans die because of some form of heart and blood vessel disease.
In response to the growing health and economic burdens of heart disease, AstraZeneca Pharmaceuticals has launched a landmark national study of 3000 patients, which started on 1 November.
The Centralised pan-South African Survey on the under-treatment of hypercholesterolaemia (CEPHEUS) will establish the effectiveness of current cholesterol treatments, and whether patients on lipid-lowering therapies do in fact reach their target low-density lipoprotein (LDL) cholesterol goals.
A critical study outcome is to understand the psyche of the South African patient on cholesterol-lowering medication. Do patients know if they have achieved their target cholesterol goal or how close they are to it? Do they even know their cholesterol goal?
With as many as 70 to 80% of the population having a cholesterol level higher than the recommended guideline, the relevance of this study is undeniable. These are questions that sorely need answers, particularly because cholesterol levels are greatly influenced by lifestyle and hereditary factors, with hereditary factors playing an important role in all ethnic groups in South Africa.
Being the first local study of this size and nature, CEPHEUS hopes to determine whether local doctors observe national lipid treatment guidelines when prescribing medication to patients, and what influences their prescribing decisions.
A fully representative sample
Private and state patients are being recruited for the CEPHEUS study and will be drawn from approximately 70 sites around the country, so as to ensure a fully representative sample.
No population group is immune from the disease; a disease which has been dubbed the "silent killer". Even as far back as 2000, data showed that as many as five million South African adults had high blood cholesterol levels.
The criteria for patient inclusion in the study is that patients must be 18 years or older, of any gender or race, agree to participate, comply with the survey procedures and have been on any lipid-lowering drug treatment for at least three months, with no dose change for a minimum of six weeks.
Few achieve target levels
According to the key clinical investigator Prof Derick Raal, there has been a significant increase in the number of patients treated with lipid-lowering drugs, particularly statins, over the last decade. However, there is evidence to suggest that few patients actually achieve their cholesterol target levels.
The current acceptable total cholesterol levels are 5mmol/L with an LDL ("bad") cholesterol level of 3mmol/L, and 2,5mmol/L in people who already have or are at high risk of heart disease. Local figures estimate that 4% of men and 5% of woman over the age of 30 die because of the impact of high blood cholesterol.
The results of an equivalent Pan-European study indicate that 40% of patients using lipid-lowering drugs were still not on target for LDL-cholesterol. A huge factor for this under-treatment was the fact that most of the patients had never been titrated or switched from their initial drug dosage. Patient compliance was also considered to be a major contributing factor.
More aggressive treatment needed
The important aspect of treatment is to start with the right drug and dose from the outset. This is as important as patient compliance in achieving treatment goals and avoiding under-treatment. Many patients are on lipid-lowering drug treatment, but if they're not achieving target goals, the impact on healthcare costs is huge, placing an unnecessary burden on the system.
"If local stats are similar to the European results, the study may be instrumental in helping revisit the treatment of high cholesterol. Globally, 17.5 million die of heart disease every year. The local picture isn't much brighter with one in every four South Africans developing heart disease before their 60th birthday," says Raal.
"We want to change stats like these through more aggressive treatment of the disease and better patient compliance. Trials like CEPHEUS in the long-term have the potential to save lives and we hope will be instrumental in changing the implementation of the current prescribing guidelines."
CEPHEUS data collection is a simple process. It will take place during a single patient visit and one fasting blood sample will also be taken and assessed in a central laboratory. The full study results will be published no later than June 2010.
(SIMONSAYS communications, November 2009)