Efficacy Of Ezetimibe Research Articles

Effect of Combination Therapy with Ezetimibe and Statins versus Statin Monotherapy on Carotid Intima-Media Thickness: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background and Objectives: Lipid-lowering agents such as ezetimibe are recommended in uncontrolled hyperlipidemia for primary and secondary prevention of cardiovascular disease. Carotid intima-media thickness (CIMT) is a surrogate marker of atherosclerosis and a predictor of cardiovascular and cerebral events. The effects of ezetimibe on CIMT have been inconsistently reported. The aim of this meta-analysis is to compare the effects of ezetimibe/statin and statin alone therapies on CIMT reduction. Materials and Methods: The PubMed, Embase, and Cochrane library databases were searched for randomized controlled trials (RCTs) published prior to 26 January 2023 with the MeSH keywords 'Ezetimibe' and 'Carotid Intima-Media Thickness'. The results were presented as standard mean difference (SMD) with 95% confidence intervals using the random-effect model method, and heterogeneity was assessed. Subgroup, meta-regression, and sensitivity analyses were conducted. Results: Five RCTs with 642 participants were included. CIMT reduction was not significantly different between the ezetimibe/statin and statin alone groups. However, in subgroup analyses, CIMT in the ezetimibe/statin group was significantly reduced in patients with non-familial hypercholesterolemia (SMD: -0.34 mm and p = 0.002) and in patients with secondary prevention (SMD: -0.38 mm and p = 0.002). The low-density lipoprotein cholesterol level was significantly reduced in the ezetimibe/statin group (SMD: -0.58 mg/dL and p < 0.001). Conclusions: The effect of ezetimibe on CIMT reduction was shown in non-familial hypercholesterolemia and secondary prevention. These results suggest that the efficacy of ezetimibe may vary with potential CIMT reduction benefits in certain subpopulations.

Simulation of bempedoic acid in the lipid-lowering treatment pathway using the European contemporary SANTORINI cohort of high- and very high-risk patients

Abstract Background Lowering LDL-C treatment goals in the 2019 ESC/EAS guidelines necessitates greater use of combination therapies (1). Cost of PCSK9 inhibitors (PCSK9i) and efficacy of ezetimibe alone as add on therapies limit population level achievement of LDL-C goals. Purpose This simulation study assessed the addition of oral bempedoic acid (BA) to ezetimibe in the treatment pathway in a real-world cohort of patients in order to assess the proportion of patients who might reach goal. Methods SANTORINI is a cohort study of European patients at high or very-high CV risk. Patients who were receiving any known LLT regimen with available data on LDL-C at baseline were eligible for this analysis. For patients not at risk-based LDL-C goals, the following treatment algorithm was applied (Figure 1), first the addition of ezetimibe and subsequently BA for those on statins, or addition of BA for those on ezetimibe and not at goal. Patients on PCSK9i remained in the cohort but no simulation was done. LDL-C reductions associated with ezetimibe and BA treatment were based on probabilistic distributions sourced from clinical trial efficacies based on prior studies (2–3). The effect of treatment on LDL-C levels was simulated through a Monte Carlo simulation run 10,000 times. No statin intensification was simulated as we assumed statin therapy was at maximum tolerated dose. Results At baseline (N=6252), mean age was 66 years and mean baseline LDL-C was 80.6 mg/dL with 1444 patients (23%) at goal; 93% (n=5797) were very high risk and 7% (n=455) high risk, of whom 84% (n=5227) were on statins, 23% (n=1447) on ezetimibe and 9% (n=546) on PCSK9i. Out of 4486 patients entering the simulation, 3419 received ezetimibe add-on with a third of those predicted to be achieving their risk-based goal (32%, n=1078/3419). Of those on ezetimibe and not at goal, the addition of BA would be predicted to result in another 36% goal achievement (n=1218/3408). Overall, the number of patients at goal would be expected to increase from 1444 (23%) at baseline to 2522 (40%) and 3740 (60%) after addition of ezetimibe and BA, sequentially. The mean LDL-C for the whole cohort would be expected to fall through this pathway from 80.6 mg/dL at baseline to 69.2 mg/dL and 61.1 mg/dL, respectively. Conclusion Few patients in the SANTORINI cohort were at goal at baseline and few would have LDL-C eligible for PCSK9i use. Optimising use of ezetimibe and BA after statins in the ESC/EAS 2019 LLT pathway could result in significantly more patients attaining lipid goals with likely additional health benefits. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH

Efficacy of Ezetimibe as Monotherapy in Hypercholesterolemic Patients with and without Diabetes: A Randomized Controlled Clinical Trial

Efficacy of Ezetimibe as Monotherapy in Hypercholesterolemic Patients with and without Diabetes: A Randomized Controlled Clinical Trial

Efficacy and Safety of Lipid-Lowering Drugs of Different Intensity on Clinical Outcomes: A Systematic Review and Network Meta-Analysis.

There have been many meta-analyses for statins, ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) to evaluate clinical outcomes, but the efficacy and safety of different intensity of these three drugs on clinical outcomes was absent. PCSK9i, ezetimibe, and statins were divided into seven interventions as follows: including PCSK9i + high-intensity statins (P9i+HT), PCSK9i + moderate-intensity statins (P9i+MT), ezetimibe + high-intensity statins (Eze+HT), ezetimibe + moderate-intensity statins (Eze+MT), high-intensity statins (HT), moderate-intensity statins (MT), and low-intensity statins (LT). The risk ratios (RR) and 95% confidence intervals (CI) were calculated to evaluate the clinical outcomes in all randomized controlled trials included. In traditional meta-analysis, the more intensive treatment had a lower risk of all-cause mortality (RR 0.91, 95% CI 0.88–0.95), cardiovascular mortality (RR 0.89, 95% CI 0.86–0.92), myocardial infarction (RR 0.79, 95% CI 0.77–0.81), coronary revascularization (RR 0.80, 95% CI 0.76-0.84), and cerebrovascular events (RR 0.84, 95% CI 0.80–0.88) compared with the less intensive treatment. However, the more intensive treatment had a higher risk of new-onset diabetes (RR 1.08, 95% CI 1.04-1.12). The network meta-analysis demonstrated that P9i+HT, P9i+MT, HT, and MT were significantly associated with a risk reduction in coronary revascularization and cerebrovascular events compared with PLBO. LT could effectively reduce the risk of cardiovascular mortality (RR 0.71, 95% CI 0.54–0.92), MI (RR 0.67, 95% CI 0.54-0.82), and coronary revascularization (RR 0.77, 95% CI 0.65–0.91) compared with PLBO. P9i+HT was superior to HT in reducing the risk of MI (RR 0.78, 95% CI 0.68–0.90), coronary revascularization (RR 0.84, 95% CI 0.73–0.96), and cerebrovascular events (RR 0.78, 95% CI 0.64–0.95). However, compared with PLBO, P9i+HT, HT, and MT could increase the risk of new-onset diabetes (RR 1.23, 95% CI 1.11–1.37; RR 1.23, 95% CI 1.14–1.33; RR 1.09, 95% CI 1.02–1.15, respectively). In conclusion, PCSK9i added to background statins may be recommended as preferred lipid-lowering therapy, and did not increase the additional risk of new-onset diabetes. The safety and efficacy of ezetimibe was not superior to that of statins. LT can be recommended as the initial therapy.

The safety and efficacy of Ezetimibe Plus Statins on ASVD and Related Diseases.

It is well known that atherosclerotic vascular disease (ASVD) in the elderly is a global disease with high morbidity, mortality and disability, and plasma LDL-C correction is the most important strategy for ASVD control. However, a large proportion of patients failed to achieve their ideal LDL-C goals after statins use. Ezetimibe, a newly non-statin lipid-lowering agent, is an inhibitor of exogenous cholesterol absorption. Whereby, ezetimibe plus statins may reduce LDL-C more strongly than statins alone. Differed from any other papers published previously, which only involved ezetimibe plus statins for coronary heart disease, the highlight of this paper is to summarize the efficacy and safety of ezetimibe plus statins in all kinds of ASVD subtypes and their related diseases, mainly included aortic atherosclerosis, coronary artery disease, cerebrovascular and peripheral artery diseases. Obviously, this paper is inimitable, which will provide the readers an important reference, especially in treating the elderly with multi-organs atherosclerosis.

Review of LDL-C Lowering with Focus on New and Emerging Agents

Identify the benefits and limitations of statin therapy as a treatment option for lowering LDL-C. Intensify treatment in appropriate patients or refer for intensification. Describe the safety and efficacy of ezetimibe, bempedoic acid, PCSK9 inhibitors, LDL apheresis. Describe the safety and efficacy of medications in late-stage development or under review by the FDA for LDL-C reduction.

Age-Dependent Efficacy of Ezetimibe for Low-Density Lipoprotein Cholesterol Reduction in Japanese Patients with or without Type 2 Diabetes Mellitus.

Ezetimibe reduces cardiovascular risk by lowering the levels of low-density lipoprotein cholesterol (LDL-C). However, there is limited information regarding the factors associated with ezetimibe-mediated LDL-C reduction. We investigated the factors associated with LDL-C reduction after ezetimibe administration in Japanese patients with or without type 2 diabetes mellitus (T2DM). This single-center retrospective observational study enrolled a total of 266 consecutive ezetimibe-naïve patients, of which 154 were excluded because of either switching from statin or fenofibrate to ezetimibe (n = 52) or ezetimibe discontinuation (n = 102). Finally, 112 patients were eligible for analysis. To identify the factors influencing LDL-C levels, univariate and multivariate linear regression analyses were performed after 52 weeks of ezetimibe treatment. Overall, advanced age, T2DM, and high baseline LDL-C were significantly associated with a greater decrease in LDL-C levels. In the non-T2DM group, advanced age and high baseline LDL-C were associated with greater decrease in LDL-C levels. In the T2DM group, baseline LDL-C was the only factor that influenced the change in LDL-C levels. Advanced age was significantly associated with higher LDL-C reduction in non-T2DM patients, but not in T2DM patients. Ezetimibe use might be beneficial in older patients without T2DM. The lack of association between age and the LDL-C lowering effect by ezetimibe in patients with T2DM may be due to yet unknown mechanism except low statistical power.

Lipid-Lowering Efficacy of Ezetimibe in Patients with Atherosclerotic Cardiovascular Disease: A Systematic Review and Meta-Analyses.

IntroductionPatients with atherosclerotic cardiovascular disease (ASCVD), especially those with recent (< 1 year) acute coronary syndrome (ACS), are at high risk for recurrent cardiovascular events. This risk can be reduced by lowering low-density lipoprotein cholesterol (LDL-C) levels. A comprehensive meta-analysis on the LDL-C-lowering efficacy of ezetimibe is lacking. This study attempts to address this gap.MethodsA systematic literature review of randomized controlled trials evaluating the LDL-C-lowering efficacy of ezetimibe in the ASCVD population was conducted. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for publications from database inception to August 2018 and for conference abstracts from 2015 to August 2018. Meta-analyses were conducted to evaluate the LDL-C-lowering efficacy of ezetimibe in the ASCVD population and the recent ACS subgroup.ResultsIn total, 12 studies were eligible for the meta-analyses. Treatment with combination ezetimibe plus statin therapy showed greater absolute LDL-C reduction than statin monotherapy (mean difference − 21.86 mg/dL; 95% confidence interval [CI] − 26.56 to − 17.17; p < 0.0001) after 6 months of treatment (or at a timepoint closest to 6 months). Similarly, in patients with recent ACS, combination ezetimibe plus statin therapy was favorable compared with statin monotherapy (mean treatment difference − 19.19 mg/dL; 95% CI − 25.22 to − 13.16; p < 0.0001).ConclusionsEzetimibe, when added to statin therapy, provided a modest additional reduction in LDL-C compared with statin monotherapy. However, this may not be sufficient for some patients with ASCVD who have especially high LDL-C levels despite optimal statin therapy.Electronic supplementary materialThe online version of this article (10.1007/s40256-019-00379-9) contains supplementary material, which is available to authorized users.

How to improve the cholesterol-lowering efficacy of ezetimibe in statin-intolerant patients in clinical practice: A retrospective study

How to improve the cholesterol-lowering efficacy of ezetimibe in statin-intolerant patients in clinical practice: A retrospective study

The efficacy of ezetimibe does not seem a credible real effect

The efficacy of ezetimibe does not seem a credible real effect

Efficacy of ezetimibe: A real effect?

We do not agree with the methods and the conclusions of the systematic review of Savarese et al. [1]. Their meta-analysis of seven randomized controlled trials tests the safety and the efficacy of ezetimibe (E), added to a statin, in comparison indifferently versus placebo or active treatment and shows a favorable effect of E on risks of major non-fatal endpoints (myocardial infarction RR: 0.865, 95% CI: 0.801–0.934; stroke RR: 0.840, 95% CI: 0.744–0.949), with a neutral effect on mortality outcomes (all-cause death RR: 1.003, 95% CI: 0.954– 1.055; CV death RR: 0.958, 95% CI: 0.879–1.044) and new cancer risk (RR: 1.040, 95% CI: 0.965–1.120). The authors emphasize the need to assess the safety and efficacy of E using “robust available information”; nevertheless their pooling was a mix of comparisons versus active drug and versus placebo. This method does not allow any real quantification of the net effect of E. In our metaanalysis [2] we conducted these analyses in separate poolings, finding a not significant effect for all the outcomes considered, both versus active comparators (E/statin combination versus the same statin at the same dosage) and versus placebo (E/statin combination versus placebo). When ourmeta-analysis was carried out, the data of IMPROVE-IT [3] (E/simvastatin versus simvastatin at the same dosage) were not yet available; adding these data to our calculations of E/statin versus active comparators (results not yet published), we have found a significant though modest reduction of the myocardial infarction risk (RR: 0.88,

Safety and efficacy of ezetimibe: A meta-analysis

BackgroundThe addition of ezetimibe to statin therapy has been widely demonstrated to significantly reduce low-density lipoprotein cholesterol levels. However, the efficacy of ezetimibe in reducing CV events and its safety has been less investigated. The aim of the current meta-analysis was to report efficacy and safety of ezetimibe from randomized clinical trials. MethodsRandomized clinical trials with a follow-up of at least 24weeks, enrolling more than 200 patients, comparing ezetimibe versus placebo or ezetimibe plus another hypolipidemic agent versus the same hypolipidemic drug alone and reporting at least one event among all-cause and CV mortality, myocardial infarction (MI), stroke and new onset of cancer were included in the analysis. Results7 trials enrolling 31,048 patients (median follow-up 34.1±26.3months; 70% women; mean age 61±8years) were included in the analysis. Compared to control therapy, ezetimibe significantly reduced the risk of MI by 13.5% (RR: 0.865, 95% CI: 0.801 to 0.934, p<0.001) and the risk of any stroke by 16.0% (RR: 0.840, 95% CI: 0.744 to 0.949, p=0.005), without any effect on all-cause and CV mortality (RR: 1.003, 95% CI: 0.954 to 1.055, p=0.908; RR: 0.958, 95% CI: 0.879 to 1.044, p=0.330; respectively) and risk of new cancer (RR: 1.040, 95% CI: 0.965 to 1.120, p=0.303). ConclusionsEzetimibe significantly reduces the risk of MI and stroke without any effect on all-cause and CV mortality and risk of cancer.

Efficacy of ezetimibe is not related to NPC1L1 gene polymorphisms in a pilot study of Chilean hypercholesterolemic subjects.

Niemann-Pick C1 Like 1 (NPC1L1) is a multi-transmembrane transport protein highly expressed in the small intestine. It mediates sterol transfer throughout the brush border membrane of enterocytes, becoming essential for intestinal cholesterol absorption and ensuing whole-body cholesterol homeostasis. This protein is targeted by ezetimibe, a potent cholesterol absorption inhibitor. Single nucleotide polymorphisms (SNPs) in NPC1L1 have been associated to variation in both plasma low-density lipoprotein (LDL) cholesterol levels and lipid-lowering medication with ezetimibe. However, there are no data evaluating the impact of NPC1L1 variants on Chilean subjects medicated with ezetimibe monotherapy. Therefore, we assessed the contribution of two unexplored NPC1L1 variants on plasma lipids and response to ezetimibe in Chilean hypercholesterolemic individuals. Using PCR-restriction fragment length polymorphism (RFLP), we analyzed the SNP distribution of two common variants; -133A>G (rs17655652) and 1679C>G (rs2072183), and their relation with plasma lipids and lipid-lowering response to ezetimibe in 60 hypercholesterolemic Chilean subjects. Genotype distribution for the rs17655652 variant was AA 57 %, 40 % AG and 3 % GG, whereas for the rs2072183 SNP was 57 % CC, 35 % CG and 8 % GG. Minor allele frequencies (MAFs) were 0.23 and 0.26, respectively. No association was observed between NPC1L1 SNPs and baseline cholesterol. After therapy, none of the polymorphisms affected ezetimibe response in the studied cohort (P > 0.05). Data obtained indicates that polymorphisms rs17655652 and rs2072183 were not related to cholesterol variability. Also, lipid-lowering response to ezetimibe is not impacted by the NPC1L1 polymorphisms studied in Chilean hypercholesterolemic subjects.

A case of sitosterolaemia with stomatocyticanaemia and thrombocytopenia treated with Ezetimibe with good response

Sitosterolaemia is a rare autosomal recessive lipid disorder characterized by increased absorption of plant sterols in the gut and decreased biliary excretion of sterols causing accumulation of plasma sterols, which can lead to premature atherosclerosis. Here we reported a boy presented with multiple tuberous xanthomas at 4 year sold and was diagnosed sitosterolaemia [1]. The fasting plasma total cholesterol and low-density lipoprotein (LDL) cholesterol levels were 18.3 mmol/L and 16.41 mmol/L respectively. Gas chromatography and mass spectrometry showed thatthefasting plasma sterols contained elevated beta-sitosterol 880 µmol/L (Reference range<12 µmol/L), campesterol489 µmol/L (Reference range <17.5 µmol/L) and stigmasterol38.9 µmol/L (Reference range <3.5 µmol/L).Molecular study identified compound heterozygous mutations (R419H and IVS12+IG→A)in the adenosine triphosphate (ATP) binding cassette subfamily G, member 5 (ABCG5) gene. Initial management included dietary restriction in cholesterol and plant sterols and cholestyraminetreatment.The total cholesterol and LDL cholesterol levels decreased. The boy developed bleeding tendency with gum bleeding and epistaxis and hepatosplenomegalyat 7 years old. Blood test confirmed and thrombocytopenia and peripheralsmear revealed stomatocytichaemolyticanaemia and giant platelets [2]. Bone marrow study showed hypercellular marrow. He was treated with increasing dose of cholestyraminebut the drug compliance was fair.The haematological problems persisted. At the age of 13,Ezetimibe 10mg daily was added. Ezetimibe blocks the absorption of dietary and biliary sources of cholesterol and plant sterols. The platelet count rose from 58 x 109/L to 107 x 109/L in 4 weeks’ time and normalized after 10 months of Ezetimibe treatment. The haemoglobin level rose from 11 g/dL to 13.8 g/dL in 4 months. The plant sterol level also showed significant improvement (see table ​table1).1). There were decreased liver and spleen size. The drug was well tolerated with no adverse effect. The efficacy of Ezetimibe in our patient was sustained after 4 years of treatment which was consistent with the other studies on long-term Ezetimibe treatment [3-6]. Table 1 In conclusion, Ezetimibe treatment was effective in lowering the plasma cholesterol and sterols level in our patient with sitosterolaemia. It is also effective in reversing the stomatolyticanaemia and thrombocytopenia.

Comparative evaluation of hypolipidemic activity of ezetimibe and atorvastatin in coronary artery disease patients

Statins are the first line drugs for the treatment of hypercholesterolemia patients. In the treatment of hyperlipidemia combination therapy has showed significant results. This study was conducted to find the efficacy of hypolipidemic drugs in cardiovascular diseases. 75 patients were included in the study. Randomly all the patients were divided in to three groups. Group-I (Ezetimibe 10mg/day), Group-II (Atorvastatin 10mg/day), Group-III (Ezetimibe 10mg/day+Atorvastatin 10mg/day) given for 4 weeks. Blood samples were collected from all the patients before and at the end of study to estimate lipid profile. Mono therapy with drugs decreased the lipid levels but combination therapy significantly showed 33.75% reduction in LDL-cholesterol level. Ezetimibe showed 21.9%, Atorvastation 31.54 reduction in LDL-cholesterol levels. There was significant reduction in other lipids and increase the HDL levels. Co-administration of Ezetimibe with statins shows significant results with less adverse effects. More studies required to find safety, efficacy of Ezetimibe with other hypolipidemic drugs.

Warnings Without Guidance

In January 2008, the Food and Drug Administration (FDA) communicated concerns about the efficacy of ezetimibe, but did not provide clear clinical guidance, and substantial media attention ensued. We investigated the proportion of patients who discontinued therapy and switched to a clinically appropriate alternative after the FDA communication. Using claims data from a national pharmacy benefits manager, we created a rolling cohort of new users of ezetimibe between January 2006 and August 2008 and created a supply diary for each patient in the year after cohort entry. A patient was identified as nonpersistent if a gap of 90 days was seen in the diary. Using segmented linear regression, we compared rates of nonpersistence before and after the FDA communication and assessed patient-level characteristics associated with discontinuation. Among nonpersistent patients, we determined whether a patient made a clinically appropriate switch in the subsequent 90 days by adding a new cholesterol-lowering medication or by increasing the dose of an existing one. We used a weighted t test to compare the rates of appropriate switching before and after the communication. Among 867,027 new ezetimibe users, 407,006 (46.9%) were nonpersistent in the first year. After the FDA communication, the monthly level of ezetimibe nonpersistence increased by 5.7 percentage points (P<0.0001). Younger patients, those who lived in low-income zip codes, and female patients were less likely to discontinue therapy (P<0.0001 for all). Among nonpersistent patients, rates of clinically appropriate switching increased from 10.8% before to 16.5% after the FDA warning (P = 0.004). A substantial increase in ezetimibe nonpersistence rates was seen after an FDA communication regarding its efficacy and following associated media attention, and a small proportion of patients made a clinically appropriate switch after discontinuation. Further consideration is needed to deliver messages that promote appropriate use of chronic therapy rather than simply reduce use.

Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial

BackgroundReducing low-density lipoprotein cholesterol (LDL-C) is associated with reduced risk for major coronary events. Despite statin efficacy, a considerable proportion of statin-treated hypercholesterolemic patients fail to reach therapeutic LDL-C targets as defined by guidelines. This study compared the efficacy of ezetimibe added to ongoing statins with doubling the dose of ongoing statin in a population of Taiwanese patients with hypercholesterolemia.MethodsThis was a randomized, open-label, parallel-group comparison study of ezetimibe 10 mg added to ongoing statin compared with doubling the dose of ongoing statin. Adult Taiwanese hypercholesterolemic patients not at optimal LDL-C levels with previous statin treatment were randomized (N = 83) to ongoing statin + ezetimibe (simvastatin, atorvastatin or pravastatin + ezetimibe at doses of 20/10, 10/10 or 20/10 mg) or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg or pravastatin 40 mg) for 8 weeks. Percent change in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C) and triglycerides, and specified safety parameters were assessed at 4 and 8 weeks.ResultsAt 8 weeks, patients treated with statin + ezetimibe experienced significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026) and total cholesterol (20.8% vs 12.2%, p = 0.0003). Percentage of patients achieving treatment goal was greater for statin + ezetimibe (58.6%) vs doubling statin (41.2%), but the difference was not statistically significant (p = 0.1675). The safety and tolerability profiles were similar between treatments.ConclusionEzetimibe added to ongoing statin therapy resulted in significantly greater lipid-lowering compared with doubling the dose of statin in Taiwanese patients with hypercholesterolemia. Studies to assess clinical outcome benefit are ongoing.Trial registrationRegistered at ClinicalTrials.gov: NCT00652327

Efficacy of Ezetimibe is Associated with Gender and Baseline Lipid Levels in Patients with Type 2 Diabetes

The combination of ezetimibe and a statin provides greater LDL-C reduction by inhibiting both intestinal cholesterol absorption and endogenous production of cholesterol. The present study was designed to examine the influence of ageing, gender, BMI, levels of LDL-C, and HbA1c on the response to ezetimibe add-on therapy. Patients who had been taking a statin for >3 months at the usual dose and whose LDL-C was >120 mg/dL were eligible for this study. Patients were assigned to receive add-on ezetimibe at 10 mg once daily for 12 weeks. Adding ezetimibe to basal statin therapy resulted in a further 15.0% reduction of TC, 20.5% reduction of LDL-C, and 19.7% reduction of non-HDL-C. The change in TC was significantly greater in males than in females. The change in TG was significantly greater in patients with a baseline TG level ≥150 mg/dL. Multivariate regression analysis showed that male sex and LDL-C ≥140 mg/dL were independent predictors of TC reduction after adjustment for age, BMI, and HbA1c. A baseline TG ≥150 mg/dL was also an independent predictor of TG reduction. Addition of ezetimibe to ongoing statin therapy was effective in patients with type 2 diabetes. Male sex and baseline LDL-C levels are independent predictors of marked TC reduction by ezetimibe treatment.

Efficacy of ezetimibe as monotherapy or combination therapy in hypercholesterolemic patients with and without diabetes

Ezetimibe selectively inhibits dietary and biliary cholesterol absorption and reduces serum cholesterol levels when administered alone (monotherapy) and along with common lipid-regulating agents (combination therapy). To evaluate the effect of ezetimibe therapy on the lipid profile, glucose metabolism, and levels of cholesterol absorption and synthesis markers, we administered 10 mg ezetimibe to 50 hypercholesterolemic patients with or without diabetes. The serum levels of low-density lipoprotein cholesterol and total cholesterol were significantly reduced at 4 and 12 weeks of ezetimibe therapy in diabetic patients of both the monotherapy and combination-therapy groups and in nondiabetic patients of the combination-therapy group. The serum levels of the cholesterol absorption markers were significantly reduced, while those of the cholesterol synthesis markers were significantly increased at 12 weeks of ezetimibe therapy. No significant differences were noted in the values of the parameters of glucose metabolism in all patients. We also investigated the clinical characteristics of patients who exhibited a good response to ezetimibe (ezetimibe responders); however, multivariate regression analysis did not reveal a correlation between ezetimibe efficacy and patient characteristics such as gender, age, BMI, diabetic condition, method of ezetimibe administration, and the initial absolute values of cholesterol absorption/synthesis markers levels. In conclusion, ezetimibe therapy significantly improved the lipid profile without disturbing glucose metabolism. We were unable to identify the specific characteristics of ezetimibe responders among our subjects. However, we may interpret this result as suggesting that ezetimibe can be used in any population to lower low-density lipoprotein cholesterol levels.

The efficacy of ezetimibe on nonalcoholic fatty liver disease (NAFLD)

The efficacy of ezetimibe on nonalcoholic fatty liver disease (NAFLD)