Various fats are normally present in the blood, but in some people, the concentration may increase to unhealthy levels. Low-density lipoprotein cholesterol (LDL-C) and triglycerides, 2 types of fats, are commonly evaluated in routine health check-ups. Higher levels of concentration of these fats are associated with higher risk of diseases of the heart and vessels.
There are various treatments and medications that reduce the levels of these fats. These medications are important for reducing the chance of heart disease or vascular diseases such as stroke. Physicians may prescribe individual medications or combinations of medications over time to provide the maximum improvement without causing adverse effects.
The proposed study will assess how commonly these fats have occurred at higher levels in the general population since 2019. It will also assess the number of people receiving relevant medications and how often people changed between types of medication.
A new medication, bempedoic acid (BA), was approved in the United Kingdom in 2021. The study will compare outcomes in patients being prescribed BA with those not prescribed BA. It will assess how well BA reduced the levels of LDL-C and how it affected the number of healthcare visits that were made. This information may guide treatment strategies for patients with high levels of LDL-C.
This study will use anonymous data from electronic health records for patients attending general practitioners in England. Researchers will not be able to determine from whom the data originated nor which medical practices contributed.
Primary hypercholesterolemia and mixed dyslipidaemia (PH/MD) are characterised by high levels of low-density cholesterol (LDL-C), which are known to be associated with higher risk of cardiovascular disease (CVD). Statins are commonly used to reduce risk for people at high risk of CVD. Alternative lipid-lowering therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, and bempedoic acid may be used because of statin intolerance or because statins are insufficient to reduce LDL-C levels. People not receiving statin alternatives may be at avoidably higher risk of CVD.
Previous work using CPRD data described prevalence, incidence, treatment patterns, achievement of LDL-C goals, and use of resources up to 31 December 2019. This did not cover the time since the National Institute for Health and Care Excellence (NICE) recommended bempedoic acid as a lipid-lowering therapy in April 2021.
This study aims to determine prevalence and incidence of PH/MD over time, treatment patterns, and achievement of LDL-C goals within specified follow-up periods. It will investigate rates of prescribing of lipid-lowering therapies and rates of change between types of lipid-lowering therapies. It will determine the proportion of patients who achieved target LDL-C levels.
The study will evaluate outcomes in patients who received bempedoic acid versus those who did not. The patient group will be those satisfying criteria for eligibility for bempedoic acid according to NICE recommendations. In order to estimate the efficacy of bempedoic acid in these patients, those receiving bempedoic acid will be matched to those not receiving bempedoic acid. Propensity score matching and balance checking will ensure the patient cohorts are comparable. The effect of bempedoic acid use on LDL-C levels, LDL-C target achievement, mortality, and primary care usage will be determined using generalised linear models adjusted for prior LDL-C level, patient characteristics, and prior lipid-lowering medication use.
Primary outcomes
Rate of low-density cholesterol goal attainment; number of primary care appointments identifiable as being associated with cardiovascular disease (CVD); mortality rate; rates of use and uptake of lipid-lowering therapies.
Secondary outcomes
Total cholesterol level; triglyceride level; numbers of urgent referral according to the referral mode; number of primary care appointments.
Yasuyuki Matsushita - Chief Investigator - Daiichi Sankyo Co. Ltd. (Japan)
Alan Fleming - Corresponding Applicant - RTI Health Solutions ( USA )
- Collaborator -
Alistair Gordon - Collaborator - Daiichi Sankyo UK Ltd (UK)
Daniel Robinson - Collaborator - Daiichi Sankyo UK Ltd (UK)
Emma Hawe - Collaborator - RTI Health Solutions ( USA )
Estel Plana Hortoneda - Collaborator - RTI Health Solutions ( USA )
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Katie Houghton - Collaborator - RTI Health Solutions ( USA )
Xingzhu Leng - Collaborator - RTI Health Solutions ( USA )
Benjamin Burgess - Collaborator - RTI Health Solutions ( USA )
CPRD Aurum Ethnicity Record