Prevention & lipidsRandomised controlled trial
Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
- phase 3
Authors' conclusion
Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia.
Study context
- Population
- Nonfamilial hypercholesterolaemia on stable moderate or high-intensity statin, low-density lipoprotein cholesterol (LDL-C) ≥1.8 mmol/L (with ASCVD) or ≥2.6 mmol/L (without ASCVD)randomised and treated
- Participants
- 689 participants
- Comparison
- Recaticimab vs placebo, add-on to statins
- Primary endpoint
- Percentage change in LDL-C from baseline
- Follow-up
- Week 24
Primary result
As reported in the abstract
Each group vs placeboLeast-squares mean difference, % (95% CI)P value
150 mg Q4W
−62.2(−67.0% to −57.4%)
P < 0.0001300 mg Q8W
−59.7(−65.0% to −54.4%)
P < 0.0001450 mg Q12W
−53.4(−58.7% to −48.2%)
P < 0.0001Further findings
LDL-C reduction · week 48
- Decreases in LDL-C with recaticimab maintained through week 48
Non-HDL cholesterol, apolipoprotein B, lipoprotein(a)
- Favoured the recaticimab groups
Safety
| Outcome | 150 mg Q4W | 300 mg Q8W | 450 mg Q12W | Placebo |
|---|---|---|---|---|
| Treatment-related adverse events · treatment period | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 26.6% |
| Serious treatment-related adverse events · treatment period | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 0.4% |
- Treatment-related adverse events: Recaticimab 28.5%
- Serious treatment-related adverse events: Recaticimab 0.4%
Original publication
Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia. J Am Coll Cardiol. Published 12 November 2024. doi:10.1016/j.jacc.2024.09.012
Summarised from the published abstract; every number is checked against it