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Pre-launch
JBM were asked to provide pre-launch support for a new formulation of an established lipid lowering product. The product provides comprehensive lipid management; lowering LDL-C by 45-50% and triglycerides by 30-35% and increasing HDL-C by 25-30% when used in combination with a statin. However, current UK guidance and practice focus on reducing total cholesterol and LDL-C, leaving the product without a place in therapy.
Our challenge was to establish a need for the product, by characterising the burden of dyslipidaemia, challenging current guidance and clinical practice and determining the patient group in which the product might best be used.
Using data from a large Primary Care database and working with the Primary Care Data Quality team at St Georges Hospital, University of London we were able to determine the proportion of patients at high risk of a cardiovascular event reaching total cholesterol and LDL-C targets, but with low HDL-C and high triglycerides.
The study revealed that overall around 60% of high risk patients have residual dyslipidaemias, despite achieving a total cholesterol target of 5 mmol/l or less.
A further paper modelled the potential reduction in coronary risk if the product was added into statin therapy in patients at high risk of a cardiovascular event. The model assumed that the addition of the product would decrease total cholesterol by 15% and increase HDL-C by 25%. Four-year coronary risk was significantly reduced by up to 30%, even in those patients reaching total cholesterol and LDL-C targets.
The work suggests that a considerable proportion of high risk patients have residual dyslipidaemias, despite reaching current total cholesterol targets. The addition of a product which provides comprehensive lipid management to current statin therapy has a significant potential to reduce coronary risk in statin-treated patients with pre-existing cardiovascular disease or diabetes.
Shortly after publication, a key note speaker at the European Society of Cardiology meeting referenced the papers in his presentation – much to our delight and that of our client!
"Congratulations to you and the team for a publication that has quickly found its way into
discussion at a major conference."Belsey J, de Lusignan S, Chan T et al. Abnormal lipids in high risk patients achieving cholesterol targets: A cross sectional study of routinely collected UK general practice data. Curr Med Res Opin 2008;24:2551-2560. PubMed abstract.
Belsey J, de Lusignan S, van Vlymen et al. Reducing coronary risk by raising HDL-cholesterol: Risk modelling the addition of nictotinic acid to existing therapy. Curr Med Res Opin 2008;24:2703-2709. PubMed abstract.
