Efficacy and safety of Tafolecimab in Chinese patients with type 2 diabetes and hypercholesterolemia: a post-hoc analysis of pooled data from three phase 3 trials.

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Clinical Guidelines
Authored By
Qi L, Shen H, Chai M, Chen B, He Y, Shi X, Lian Q, Zhao W, Qu Y, Qian L, Zhang J, Li H, Zhou Y, Huo Y
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Endocrinology
Cardiology
Internal/Family Medicine
Speciality
Cardiology
Endocrinology
Internal/Family Medicine
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volume
24
ISSN
1475-2840
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{"article_title":"Efficacy and safety of Tafolecimab in Chinese patients with type 2 diabetes and hypercholesterolemia: a post-hoc analysis of pooled data from three phase 3 trials.","author":"\"Qi, Litong , Shen, Hua , Chai, Meng , Chen, Beijian , He, Yongming , Shi, Xiaoxia , Lian, Qiufang , Zhao, Wang , Qu, Yanling , Qian, Lei , Zhang, Jianwei , Li, Haoyu , Zhou, Yujie , Huo, Yong\"","journal_title":"Cardiovascular diabetology","issn":"1475-2840 ; Electronic","isbn":"","publication_date":"20250703","volume":"24","issue":"1","first_page":"264","page_count":"","accession_number":"40611077","doi":"10.1186\/s12933-025-02816-3","publisher":"BioMed Central","doctype":"Clinical Trial","subjects":"Cardiology ","interest_area":["Endocrinology"," Cardiology"," Internal\/Family Medicine"],"abstract":"Declarations. Ethics approval and consent to participate: All studies adhered to the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The study protocols received approval from the institutional review boards or independent ethics committees, and all participants provided written informed consent. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.","url":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&db=mdl&AN=40611077&authtype=shib&custid=ns346513","isPdfLink":true,"isSAML":false,"additionalInfo":{"Authored_By":"Qi L, Shen H, Chai M, Chen B, He Y, Shi X, Lian Q, Zhao W, Qu Y, Qian L, Zhang J, Li H, Zhou Y, Huo Y","Journal_Info":"Publisher: BioMed Central Country of Publication: England NLM ID: 101147637 Publication Model: Electronic Cited Medium: Internet ISSN: 1475-2840 (Electronic) Linking ISSN: 14752840 NLM ISO Abbreviation: Cardiovasc Diabetol Subsets: MEDLINE","Publication_Type":"Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial","Published_Date":"2025-07-03","Source":"Cardiovascular diabetology [Cardiovasc Diabetol] 2025 Jul 03; Vol. 24 (1), pp. 264. Date of Electronic Publication: 2025 Jul 03.","Languages":"English","Electronic_ISSN":"1475-2840","MeSH_Terms":"Antibodies, Monoclonal, Humanized*\/therapeutic use , Antibodies, Monoclonal, Humanized*\/adverse effects , Anticholesteremic Agents*\/therapeutic use , Anticholesteremic Agents*\/adverse effects , Cholesterol, LDL*\/blood , Diabetes Mellitus, Type 2*\/drug therapy , Diabetes Mellitus, Type 2*\/diagnosis , Diabetes Mellitus, Type 2*\/blood , Diabetes Mellitus, Type 2*\/ethnology , Diabetes Mellitus, Type 2*\/epidemiology , Hypercholesterolemia*\/drug therapy , Hypercholesterolemia*\/blood , Hypercholesterolemia*\/diagnosis , Hypercholesterolemia*\/ethnology , Hypercholesterolemia*\/epidemiology, Aged ; Female ; Humans ; Male ; Middle Aged ; Biomarkers\/blood ; China\/epidemiology ; Down-Regulation ; Lipoprotein(a)\/blood ; Time Factors ; Treatment Outcome ; Triglycerides\/blood ; Apolipoprotein B-100 ; East Asian People","Subjects":"Aged, Female, Humans, Male, Middle Aged, Biomarkers blood, China epidemiology, Down-Regulation, Lipoprotein(a) blood, Time Factors, Treatment Outcome, Triglycerides blood, Apolipoprotein B-100, East Asian People, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Anticholesteremic Agents therapeutic use, Anticholesteremic Agents adverse effects, Cholesterol, LDL blood, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 ethnology, Diabetes Mellitus, Type 2 epidemiology, Hypercholesterolemia drug therapy, Hypercholesterolemia blood, Hypercholesterolemia diagnosis, Hypercholesterolemia ethnology, Hypercholesterolemia epidemiology","Title_Abbreviations":"Cardiovascular diabetology","Volume":"24"},"header":{"DbId":"mdl","DbLabel":"MEDLINE Ultimate","An":"40611077","RelevancyScore":"983","PubType":"Academic Journal","PubTypeId":"academicJournal","PreciseRelevancyScore":"982.519592285156"},"plink":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&site=eds-live&db=mdl&AN=40611077&authtype=shib&custid=ns346513&group=main&profile=eds","upload_link":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&site=eds-live&db=mdl&AN=40611077&authtype=shib&custid=ns346513&group=main&profile=eds"}
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1475-2840 ; Electronic
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true
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["Qi L, Shen H, Chai M, Chen B, He Y, Shi X, Lian Q, Zhao W, Qu Y, Qian L, Zhang J, Li H, Zhou Y, Huo Y","Publisher: BioMed Central Country of Publication: England NLM ID: 101147637 Publication Model: Electronic Cited Medium: Internet ISSN: 1475-2840 (Electronic) Linking ISSN: 14752840 NLM ISO Abbreviation: Cardiovasc Diabetol Subsets: MEDLINE","Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial","2025-07-03","Cardiovascular diabetology [Cardiovasc Diabetol] 2025 Jul 03; Vol. 24 (1), pp. 264. Date of Electronic Publication: 2025 Jul 03.","English","1475-2840","Antibodies, Monoclonal, Humanized*\/therapeutic use , Antibodies, Monoclonal, Humanized*\/adverse effects , Anticholesteremic Agents*\/therapeutic use , Anticholesteremic Agents*\/adverse effects , Cholesterol, LDL*\/blood , Diabetes Mellitus, Type 2*\/drug therapy , Diabetes Mellitus, Type 2*\/diagnosis , Diabetes Mellitus, Type 2*\/blood , Diabetes Mellitus, Type 2*\/ethnology , Diabetes Mellitus, Type 2*\/epidemiology , Hypercholesterolemia*\/drug therapy , Hypercholesterolemia*\/blood , Hypercholesterolemia*\/diagnosis , Hypercholesterolemia*\/ethnology , Hypercholesterolemia*\/epidemiology, Aged ; Female ; Humans ; Male ; Middle Aged ; Biomarkers\/blood ; China\/epidemiology ; Down-Regulation ; Lipoprotein(a)\/blood ; Time Factors ; Treatment Outcome ; Triglycerides\/blood ; Apolipoprotein B-100 ; East Asian People","Aged, Female, Humans, Male, Middle Aged, Biomarkers blood, China epidemiology, Down-Regulation, Lipoprotein(a) blood, Time Factors, Treatment Outcome, Triglycerides blood, Apolipoprotein B-100, East Asian People, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Anticholesteremic Agents therapeutic use, Anticholesteremic Agents adverse effects, Cholesterol, LDL blood, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 ethnology, Diabetes Mellitus, Type 2 epidemiology, Hypercholesterolemia drug therapy, Hypercholesterolemia blood, Hypercholesterolemia diagnosis, Hypercholesterolemia ethnology, Hypercholesterolemia epidemiology","Cardiovascular diabetology","24"]
Description
Background: This study evaluated the efficacy and safety of tafolecimab in patients with type 2 diabetes (T2D) and hypercholesterolemia by a post-hoc analysis of pooled data from three phase 3 trials.<br />Methods: Data from up to 12 weeks were analyzed to assess the effects of tafolecimab 450 mg every four weeks (Q4W) in patients with T2D and hypercholesterolemia. The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Secondary endpoints included the proportion of participants achieving LDL-C levels below 1.8 mmol/L at weeks 12, the proportion of patients achieving LDL-C ≥ 50% reduction and LDL-C &lt; 1.4 mmol/L, as well as percentage changes from baseline to week 12 in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), lipoprotein(a) [Lp(a)], and triglyceride (TG) levels.<br />Results: The reduction in LDL-C from baseline was significantly greater in patients receiving tafolecimab than in those receiving placebo (estimated treatment difference: - 64.02%, 95% confidence interval: [- 68.08%, - 59.96%], P &lt; 0.0001). The proportion of patients achieving a reduction of over 50% and an absolute LDL-C value below 1.4 mmol/L was significantly higher in the tafolecimab group than that in the placebo group (P &lt; 0.0001). Furthermore, a significantly greater proportion of patients in the tafolecimab group achieved LDL-C levels below 1.8 mmol/L at week 12 compared to the placebo group (P &lt; 0.0001). The tafolecimab group also showed significant reductions in TG, non-HDL-C, apo B, and Lp(a) from baseline to week 12 compared to the placebo group (all P &lt; 0.001). The incidence of adverse events was generally similar between the two groups.<br />Conclusion: Tafolecimab 450 mg Q4W demonstrated a superior lipid-lowering efficacy and favorable safety profile compared to placebo. This suggests it could be a promising new treatment option for Chinese patients with T2D and hypercholesterolemia.<br /> (© 2025. The Author(s).)
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