Abstract
Objective
Novel lipid-lowering therapies are being introduced. Few studies exist of the real-world effectiveness of adenosine-tri-phosphate citrate lyase inhibition with bempedoic acid.
Methods
This study audited bempedoic acid therapy in 216 consecutive patients from three hospital centres – a university hospital (n = 77) and two district general hospitals (n = 106 and 33). Cardiovascular disease (CVD) risk factors, prescription qualification criteria, efficacy and adverse effects were assessed.
Results
The population was aged 65.9 ± 11.0 years, 42% were male, 25% had type 2 diabetes, and 31% had familial hypercholesterolaemia. CVD was present in 19% and multibed vascular disease in 8%. Statin intolerance was reported in 92%. Bempedoic acid reduced total cholesterol by 1.58 ± 1.44 mmol/L (20%), LDL-C by 1.37 ± 1.31 mmol/L (27%), triglycerides by 0.22 mmol/L (2%) with an 0.06 mmol/L (1%) increase in HDL-C after 22 ± 9 months follow-up. An LDL-C <2.5 mmol/L was achieved in 40% and <2 mmol/L in 20%. Efficacy (r2 = .33) was predicted by baseline LDL-C (β = .54; p <.001). No significant changes were seen in transaminases, creatinine, creatine kinase, urate or HbA1c. Treatment was discontinued by 33% of patients and occurred due to myalgia (43%), lack of efficacy (16%) and gastrointestinal adverse effects (15%). No cases of gout were observed. In a logistic regression only the number of previous drug classes not tolerated (β = 1.60; p = .009) was a contributing factor to discontinuation.
Conclusion
This audit suggests that bempedoic acid therapy is effective but that adverse effects and discontinuation are common. This suggests nocebo effects might be generalizable to all lipid-lowering drug therapies in susceptible individuals.
Transparency
Declaration of funding
No sponsorship/funding.
Declaration of financial/other relationships
AJ conducts trials funded by: Eli Lilly, NewAmsterdam, and Novo Nordisk. AV has received lecture honoraria and/or travel support and/or conducts clinical trials funded by: Amarin, Amgen, Astra Zeneca, Boehringer Ingleheim, DaiichiSankyo, Lilly, Menarini, NewAmsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Takeda, and Tosoh. TMR has received lecture honoraria and/or travel support and/or conducted clinical trials funded by: Amarin, DaiichiSankyo, and Novartis. ASW is a site investigator for Amgen, Akcea, AstraZeneca, UCB, and Verve therapeutics.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
The authors contributed as follows: conception and design (AV, TMR, ASW), data gathering (AJ, TMR, WH), analysis and interpretation of the data (ASW, TMR); the drafting of the paper (ASW) or revising it critically for intellectual content (AV,TMR, ASW) and the final approval of the version to be published (AV, TMR, ASW). All authors agree to be accountable for all aspects of the work.
Acknowledgements
No assistance in the preparation of this article is to be declared.