Statin/Ezetimibe Combination VS Statin Monotherapy

Statin+ Ezetimibe Combination Therapy vs Statin Monotherapy in Patients with Diabetes: A Meta‑Analysis of Randomized Controlled Trials

Results from this meta-analysis of randomized controlled trials (RCTs) showed that statin–ezetimibe combination therapy improves levels of low-density lipoprotein cholesterol (LDL-C) and other lipids without increasing the risk of adverse events as compared to statin monotherapy.

• Patients with diabetes are at potentially increased risk of morbidity and mortality following atherosclerotic CVD.
• There is no consensus reported yet via a systematic review or meta-analysis for studies comparing the efficacy of statin monotherapy vs combination therapy with ezetimibe in patients with diabetes.
• This meta-analysis was conducted to evaluate and compare the efficacy and safety of statin alone and in combination with ezetimibe in patients with diabetes in RCTs.

• Overall, 17 articles were included in this meta-analysis

Effect on lipid parameters

• Changes in LDL-C levels: There was significantly greater reduction in LDL-C levels in combination therapy group vs statin monotherapy group (standard difference in means [SE] = 0.691; 95% confidence interval [CI]: 0.534–0.847)
• Changes in HDL-C levels: There was greater improvement in HDL-C levels in combination therapy group vs statin monotherapy group (SE = 0.280; 95% CI: 0.106–0.453)
• There were significant decreases in the levels of total cholesterol, triglycerides, and Apo B but not of Apo A1 in combination therapy group vs statin monotherapy group (total cholesterol, SE = 0.560; triglyceride, SE = 0.296; Apo B, SE = 0.471; Apo A1, SE = 0.093)
• A significantly higher percentage of patients on combination therapy reached the targeted LDL-C level vs statin monotherapy (odds ratio = 0.478; 95% CI: 0.318–0.718)

Effect on glucose parameters

• Changes in HbA1c levels: No significant difference was identified between the groups (SE = 0.106)
• Changes in FBG levels: Combination treatment significantly reduced FBG levels vs statin monotherapy (SE = 0.190)
  • Based on random-effects model: No significant difference was identified between the groups

Effect on adverse events

• Treatment-related adverse events: No significant difference was identified between the groups (relative risk [RR] = 0.774)
• Discontinuations due to TRAEs: No significant difference was identified between the groups (RR = 0.963)
• Alanine aminotransferase levels: No significant difference was identified between the groups (RR = 0.907)
• Other adverse events in both groups: Gastrointestinal-related adverse events, muscle-related adverse events, allergic reaction (generally low incidence rates and varied slightly from study to study)

• Since the analysis was based on previous reports, which were not necessarily complete or accurate, analyses of data, including sex, age, duration, or other factors was not possible.
• Outcomes based on overall statistical analysis could vary from the safety or efficacy evaluations in individual patients.