Efficacy and safety of hybutimibe in the treatment of hypercholesterolemia: a meta-analysis
10.3760/cma.j.cn114015-20230406-00252
- VernacularTitle:海博麦布治疗高胆固醇血症有效性和安全性的meta分析
- Author:
Zhenwei FANG
1
;
Yiru ZHAO
;
Ying ZHANG
;
Yang LIN
Author Information
1. 首都医科大学附属北京安贞医院药事部，北京 100029
- Publication Type:Journal Article
- Keywords:
Hypercholesterolemia;
Anticholesteremic agents;
Meta-analysis;
Efficiency;
Safety;
Hybutimibe
- From:
Adverse Drug Reactions Journal
2024;26(1):25-32
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of hybutimibe in the treatment of hypercholesterolemia.Methods:Relevant databases and clinical trial registration websites at home and abroad were searched (up to March 27, 2023), and randomized controlled trials (RCTs) of hybutimibe in the treatment of hypercholesterolemia have been collected. Patients in the trial group were given hybutimibe with or without other hypolipidemic agents, and those in the control group were given placebo or other hypolipidemic agents as same as that in the trial group. The primary outcome in effectiveness was the change rate of low-density lipoprotein cholesterol (LDL-C). The primary outcomes in safety were incidences of overall adverse events (AEs), serious AEs (SAEs), the trial termination due to AEs, and trial drug-related AEs. The secondary outcome in safety was incidence of the major AE reported in ≥ 2 trials. Meta-analysis was performed using RevMan 5.4 software. The effect sizes of counting data were expressed by the relative risk ( RR) and its 95% confidence interval ( CI). The effect sizes of measurement data were expressed by mean difference ( MD) and its 95% CI. Results:A total of 4 RCTs and 1 488 patients were entered in the analysis, including 952 patients in the trial group and 536 in the control group. The results of meta-analysis showed that at 8-12 weeks of treatment, the decrease rate of LDL-C in the trial group (hybutimibe 20 or 10 mg daily with or without atorvastatin 10 mg daily) was significantly greater than that in the control group (hybutimibe 20 mg daily: MD=-13.36%, 95% CI: -15.28% - -11.44%, P<0.001; hybutimibe 10 mg daily: MD=-10.80%, 95% CI: -14.90%- -6.71%, P<0.001); at 52 weeks of treatment, the average decrease rate (from baseline) of LDL-C in the trial group (hybutimibe 20 or 10 mg combined with atorvastatin 10 mg daily) was significantly greater than that in the control group with atorvastatin 10 mg daily monotherapy (-41.92% and -39.34% vs. -31.56%, all P<0.001); the incidences of overall AEs [47.94% (338/705) vs. 49.75% (202/406), RR=0.99, 95% CI: 0.87-1.12], SAEs[2.64% (16/606) vs. 2.79% (10/358), RR=1.19, 95% CI: 0.53-2.66], trial termination due to AEs[4.11% (29/705) vs. 4.68% (19/406), RR=0.67, 95% CI: 0.17-2.65], and trial drug-related AEs [12.38% (75/606) vs. 11.45% (41/358), RR=0.87, 95% CI: 0.37-2.06] were similar between the 2 groups at 8-12 weeks of treatment (all P>0.05). Conclusion:Hybutimibe could effectively reduce LDL-C level in patients with hypercholesterolemia, with good medication safety.
