American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
Efficacy and Safety of Ongericimab in Chinese Patients with Hypercholesterolemia: A Meta-analysis of Randomized Controlled Trials.
СтатьяМетаанализСистематический обзорНазвание и аннотация: Перевод в очереди
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Bhatti Muhammad Imaz, Safiullah Muhammad, Qadri Maria, Butt Anam Aamir, Ahmed Raheel
Аннотация
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition has emerged as an effective lipid-lowering strategy, particularly for patients with hypercholesterolemia not adequately managed with statins. Ongericimab is a novel monoclonal antibody targeting PCSK9. In this meta-analysis, we aim to evaluate the efficacy and safety of ongericimab in Chinese patients with hypercholesterolemia.
METHODS: A comprehensive literature search was conducted on PubMed, Embase, Scopus, and ClinicalTrials.gov from inception to November 2025, to identify studies assessing the lipid-lowering effects of ongericimab. Effect estimates and 95% confidence intervals (CIs) were calculated using a random-effects model.
RESULTS: Five RCTs (n = 1415; mean age 57.65 ± 10.94 years; 55.7% male) were included. Ongericimab significantly reduced LDL-C by approximately 71%, Lp(a) by 48%, ApoB by 60%, total cholesterol by 47%, and non-HDL-C by 65%. Subgroup analysis revealed dose-dependent effects for LDL-C, ApoB, TC, and non-HDL-C (p < 0.05), while Lp(a) reduction remained consistent across doses (p = 0.75). At the 150 mg dose, ongericimab also increased HDL-C by 10% and ApoA1 by 8%, and reduced triglycerides (TGs) by 23%. Adverse events were comparable between ongericimab and placebo groups.
CONCLUSIONS: Ongericimab reduces LDL-C and other atherogenic lipoproteins in Chinese patients with hypercholesterolemia, with a tolerability profile comparable to placebo. These findings support its potential role as an adjunct therapy for patients who do not meet LDL-C targets with statins.
REGISTRATION: PROSPERO identifier no. CRD420251086724.
METHODS: A comprehensive literature search was conducted on PubMed, Embase, Scopus, and ClinicalTrials.gov from inception to November 2025, to identify studies assessing the lipid-lowering effects of ongericimab. Effect estimates and 95% confidence intervals (CIs) were calculated using a random-effects model.
RESULTS: Five RCTs (n = 1415; mean age 57.65 ± 10.94 years; 55.7% male) were included. Ongericimab significantly reduced LDL-C by approximately 71%, Lp(a) by 48%, ApoB by 60%, total cholesterol by 47%, and non-HDL-C by 65%. Subgroup analysis revealed dose-dependent effects for LDL-C, ApoB, TC, and non-HDL-C (p < 0.05), while Lp(a) reduction remained consistent across doses (p = 0.75). At the 150 mg dose, ongericimab also increased HDL-C by 10% and ApoA1 by 8%, and reduced triglycerides (TGs) by 23%. Adverse events were comparable between ongericimab and placebo groups.
CONCLUSIONS: Ongericimab reduces LDL-C and other atherogenic lipoproteins in Chinese patients with hypercholesterolemia, with a tolerability profile comparable to placebo. These findings support its potential role as an adjunct therapy for patients who do not meet LDL-C targets with statins.
REGISTRATION: PROSPERO identifier no. CRD420251086724.