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Obicetrapib promising add on treatment for high risk ASCVD patients on statin therapy: ROSE trial
UK: The addition of obicetrapib 5 and 10 mg to high intensity statin therapy reduces median LDL-c levels from baseline by 42% and 51%, respectively in patients enrolled in the ROSE trial. Also, obicetrpib was well-tolerated. The findings of the study were presented at the European Atherosclerosis Society (EAS) Congress 2022.
This indicates that obicetrapib can be a valuable addition for patients with higher risk for atherosclerotic cardiovascular disease (ASCVD) who did not achieve their target LDL-c goals despite high intensity statin therapy.
Previous research has show that monotherapy of CETP inhibitor obicetrapib or in combination with low statin therapy reduces LDL-c by 45%. Recently, evidence has emerged resulting in increased interest in the potential of inhibiting CETP for CV protection.
ROSE study was conducted with an aim to evaluate the lipid-lowering efficacy, safety and tolerability of obicetrapib 5 and 10 mg in patients treated with high-intensity statin therapy versus placebo.
The study included 120 patients on a stable high intensity statin with fasting LDL-c levels >1.8 mmol/L. They were randomized to placebo, obicetrapib 5 mg or obicetrapib 10 mg for 8 weeks and followed for safety, efficacy and tolerability.
Percent change from baseline in LDL-c compared to the placebo group was the primary efficacy outcome. There was a pre-specified assessment of LDL-c levels by preparative ultracentrifugation or Friedewald calculation.
Based on the study, the following findings were revealed:
- When analyzing the data of LDL-c obtained by preparative ultra-centrifugation, there was a dose-dependent decrease in LDL-c by obicetrapib (42% reduction in the 5 mg group and 51% reduction in the 10 mg group).
- Looking at the LDL-c data by the Friedewald method, a similar pattern was observed (43% reduction in the 5 mg group and 46% in the 10 mg group).
- When patients were stratified by LDL-c baseline, comparable effects on LDL-c lowering by obicetrapib were observed, with a slightly higher LDL-c reduction in those with baseline LDL ≥100 mg/dL than in those <100 mg/dL.
- Waterfall plots showed that almost all patients had some degree of LDL-c lowering with obicetrapib.
- Dose-dependent lowering of ApoB (up to 30%) and non-HDL-c (up to 44%) was observed with obecitrapib.
- HDL-c was dose-dependently increased by obecitrapib (up to 165%), as was ApoA1 (up to 48%).
- There was a reduction in Lp(a) and triglyceride levels in the obecitrapib groups.
- Addition of obecitrapib to high-intensity statin resulted in a greater proportion of patients achieving lipid goals.
- Obecitrapib was well-tolerated, and there was no increase rate of adverse events or serious adverse events.
The researchers concluded, "obicetrapib can be a valuable addition for high risk ASCVD patients who do not achieve their target LDL-c goals despite high intensity statin therapy."
Currently, obicetrapib is being evaluated in phase 3 lipid lowering and CV outcome trials.
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at  editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751