Ezetimibe Combination Therapy Research Articles

Effect of Combination Therapy of Ezetimibe and Atorvastatin on Remnant Lipoprotein Versus Double Atorvastatin Dose in Egyptian Diabetic Patients.

A high level of remnant lipoprotein cholesterol (RLP-C) is a predominant feature in diabetic patients with atherosclerosis. This study aimed to investigate the effect of ezetimibe added to statin therapy compared to doubling standard statin dose. Sixty-five eligible patients were recruited then prospectively randomized to receive ezetimibe 10 mg/day plus their 40 mg daily atorvastatin dose (group 1) or atorvastatin 80 mg/day (group 2) for 3 months. Efficacy was evaluated using plasma levels of RLP-C, apolipoprotein B, non-high-density lipoprotein cholesterol (non-HDL), percentage of brachial artery flow-mediated dilation, and lipid profile. Forty patients completed the study and provided efficacy data. Group 1 showed more reduction in RLP-C (45.7% vs 31.7%, P = .02), apolipoprotein B (28.5% vs 9.5%, P = .01), total cholesterol (34.7% vs 24.6%, P = .003), triglycerides (49% vs 24.4%, P = .000), non-HDL (49.3% vs 33%, P = .002), and low-density lipoprotein cholesterol (49.6% vs 35.2%, P = .02) compared to group 2. Group 1 showed a greater increase in HDL (66% vs 35%, P = .002); and flow-mediated dilation (30% vs 17%, P = .01) compared to group 2. It is concluded that adding ezetimibe 10 mg to atorvastatin 40 mg may be a better choice than doubling atorvastatin dose in improving RLPs, endothelial function, and lipid profile in diabetic cardiovascular patients who could not achieve their therapeutic treatment goals with the standard atorvastatin dose.

Factors Associated with Primary Medication Nonadherence in Patients Prescribed Statins, Ezetimibe, or Statin + Ezetimibe Combination Therapy

Factors Associated with Primary Medication Nonadherence in Patients Prescribed Statins, Ezetimibe, or Statin + Ezetimibe Combination Therapy

Effectiveness of a combination of ezetimibe and statins in patients with acute coronary syndrome and multiple comorbidities: A 6-year population-based cohort study

BackgroundThe clinical benefits of a combination of statins and ezetimibe in patients with acute coronary syndrome (ACS) were observed in a clinical trial. However, little is known regarding the effectiveness of using statins with or without ezetimibe in patients with ACS and multiple comorbidities in real-world clinical practice. MethodsThis is a nationwide population-based cohort study using Taiwan National Health Insurance Research Database. A total of 212,110 patients with ACS who had been discharged after their first ACS events between 2006 and 2010 were enrolled. A propensity score matching approach was used to create matched cohorts for adjusting potential confounders. Cox proportional hazards regressions were performed to estimate the risk of re-hospitalization for ACS and revascularization. ResultsPatients in the statins-plus-ezetimibe group had a significantly lower risk of re-hospitalization for ACS (adjusted hazard ratio [HR]=0.64, 95% confidence interval [CI]: 0.60–0.69) and revascularization (HR=0.69, 95% CI: 0.63–0.76) than those in the statins-alone group. In the statins-plus-ezetimibe group, female patients had a lower risk of re-hospitalization for ACS than male patients did, and patients without diabetes mellitus had a lower risk of re-hospitalization for ACS than did patients with diabetes mellitus. ConclusionsPatients with ACS and multiple comorbidities receiving a combination therapy of statins and ezetimibe had a lower risk of re-hospitalization for ACS and revascularization than those receiving statins alone. Significant interaction effects were observed between combination with ezetimibe, sex, and diabetes mellitus.

Statin and Ezetimibe Combination Therapy Decreases Mean Platelet Volume Compared to Statin Monotherapy.

Statin and Ezetimibe Combination Therapy Decreases Mean Platelet Volume Compared to Statin Monotherapy.

Efficacy of Combination Therapy of Rosuvastatin and Ezetimibe vs Rosuvastatin Monotherapy on Lipid Profile of Patients with Coronary Artery Disease

Efficacy of Combination Therapy of Rosuvastatin and Ezetimibe vs Rosuvastatin Monotherapy on Lipid Profile of Patients with Coronary Artery Disease

Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk

PurposeThe aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. MethodsThis was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. FindingsThe percentage change of LDL-C ranged from –45% to –56% (mean, –51%) in the monotherapy groups and from –58% to –63% (mean, –60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. ImplicationsRosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

The effect of Ezetimibe and Simvastatin Combination Therapy on percutaneous coronary intervention patients

AimsEvaluating the short-term influence of Ezetimibe and Simvastatin Combination Therapy on LDL-C, TG and hs-CRP expression level in patients with percutaneous coronary intervention. Methods57 cases of percutaneous coronary intervention patients were selected, and randomly divided into two groups: Simvastatin (40mg/day) and Ezetimibe (10mg/day) combination therapy group (observation group) with 28 patients, Simvastatin (40mg/day) group (control group) with 29 patients. Each group was treated for 10days. After treatment, compare blood lipid LDL-C, TG, hs-CRP levels with each other and the results before treatment. ResultsComparison of the results of the 10th day with the baseline: LDL-C, TG decreased significantly (P<0.01) in the observation group, while the control group did not have a significantly change (P>0.05). Comparison of observation group and control group: after treatment, LDL-C and TG decreased more significantly in the observation group than the control group (−27.2% vs −14.6%, P<0.05). Whether according to LDL-C <2.07mmol/L standard or LDL-C <1.8mmol/L standard, the compliance rate of the observation group was significantly better than the control group, the results were (69% vs 28.9%, P<0.05) and (47.6% vs 13.2% P<0.05), respectively. After 10days treatment, comparing to baseline, hs-CRP was significantly lowered in these two groups (P<0.01). And there is no liver and kidney toxicity, myopathy and other adverse reactions during treatment. ConclusionsCombination therapy of Ezetimibe (10mg/day) and Simvastatin (40mg/day) was more effective than mono-therapy with Simvastatin (40mg/day) on reducing LDL-C, TG and hs-CRP level in percutaneous coronary intervention patients, leading to more significant anti-inflammatory effect.

The difficult management of patients with type 2 diabetes and renal disease: from diagnosis to treatment

The prevalence of type 2 diabetes mellitus and arterial hypertension is on the rise in western countries and chronic kidney disease is certainly one of their most harmful complications. This condition greatly complicates patient management. The clinician needs to wisely identify the best diagnostic algorithm and carefully balance potential risks and benefits of each therapeutic decision.Even when recommended therapeutic targets can be achieved, often a challenging task in clinical practice, residual cardiovascular and renal risk remains unacceptably high for these patients.Here we present the case of a 72-year old woman, with arterial hypertension and diabetes mellitus type 2. Despite the long clinical history of the patient, being treated for over 20 years,blood pressure and metabolic control were not satisfactory. The authors trace the patient’s treatment pathway, following the different clinical questions that led them to the modification of the patient’s therapy. The new therapy is based on chlorthalidone, sitagliptin, a combinationtherapy of ezetimibe / simvastatin, and metformin. [Article in Italian]

Simvastatin–ezetimibe combination therapy is associated with a lower rate of major adverse cardiac events in type 2 diabetics than high potency statins alone: A population-based dynamic cohort study

BackgroundRecent trials have shown a reduction in the risk of major adverse cardiac events (MACE) with simvastatin–ezetimibe therapy in patients with acute coronary syndrome. The potential benefits of simvastatin–ezetimibe for patients at a lower risk of MACE are unclear. This study aimed to investigate the differences of MACE risk between patients with type 2 diabetes mellitus (DM) using simvastatin–ezetimibe or high potency statins. MethodsThis population-based dynamic cohort study used data from the Taiwan National Health Insurance Database. The study subjects were patients with type 2 DM, aged between 40 and 75years. The simvastatin–ezetimibe group took simvastatin–ezetimibe only, and the statin group took atorvastatin or rosuvastatin but not simvastatin or ezetimibe. The two groups were matched for age, gender, medication date, DM diagnosis date, hypertension, and cardiovascular complications. The outcome variable was new-onset MACE. Univariate and multivariate survival analyses were performed. ResultsA total of 20,485 patients (53% male; 4099 in the simvastatin–ezetimibe group and 16,396 in the statin group) were included, with a mean age of 59.1years. In a total of 37,388person-years, 1100 patients developed new-onset MACE. The annual incidence rate of new-onset MACE was lower in the simvastatin–ezetimibe group (2.61%) than that in the statin group (3.02%) (p=0.0476). After Cox regression analysis, simvastatin–ezetimibe use was independently associated with a lower risk of MACE (HR, 0.77; 95% confidence interval 0.66–0.90). ConclusionsCompared to high potency statins alone, simvastatin–ezetimibe therapy was associated with a lower incidence of MACE in patients with type 2 DM.

Alterations of plant sterols, lathosterol, oxidative stress and inflammatory markers after the combination therapy of ezetimibe and statin drugs in type 2 diabetic patients

The elevation of serum plant sterols in addition to serum LDL-cholesterol (LDL-C) is one of the important risk factors for coronary heart disease. We investigated how to alterations of serum hepatic synthesised cholesterol and plant sterols levels, clinical markers for inflammation and oxidative stress after combination therapy with ezetimibe, an inhibitor of cholesterol transporter in the small intestinal colon, and statin drugs in type 2 diabetic patients. Studies were conducted in 28 patients with type 2 diabetes mellitus complicated with dyslipidemia. Patients were divided into 3 groups as follows: the 1st group is 7 patients treated with 10mg ezetimibe sequent on pretreatment with mild statin drug (MS+E group), and the 2nd group is 7 patients treated with 10mg ezetimibe sequent on pretreatment with strong statin drug (SS+E group), and then the 3rd group is 14 patients treated with 10mg ezetimibe alone without pretreatment with any statin drugs (naïve E group). In addition to various metabolic markers, serum plant sterols such as sitosterol and campesterol, and hepatic synthesised cholesterol such as lathosterol were measured by the gas liquid chromatography. Serum highly sensitive CRP (hsCRP) as an inflammation marker, and then malonyldealdehyde (MDA) and carbonyl-modified protein (CMP) as an oxidative stress were assayed by the conventional method, respectively. Fasting plasma glucose and serum glucosylated HbA1c (JDS value) did not show any significant changes after administration of ezetimibe in whole groups. Serum LDL-C was reduced significantly and serum triglyceride exhibited a tendency of reduction in whole groups. Serum sitosterol and campesterol were decreased significantly, while serum lathosterol was increased significantly or markedly in whole patients and also in each group. There were no significant changes in serum hsCRP in whole groups. Both serum MDA and CMP revealed significant or marked reductions in each group. The present investigation suggests that the combination therapy of the ezetimibe and statin drugs is potential to remarkably reduce serum LDL-C, plant sterols, MDA and CMP, and therefore might lead to prevent atherosclerosis.

The Effect of Simvastatin–Ezetimibe Combination Therapy on Adipose Tissue Hormones and Systemic Inflammation in Patients with Isolated Hypercholesterolemia

Pleiotropic effects of ezetimibe have only been investigated in a few studies. The aim of this article was to compare the effects of simvastatin and the combined treatment with simvastatin and ezetimibe on low-grade systemic inflammation and plasma levels of selected adipokines in patients with isolated hypercholesterolemia. The study included 69 patients with elevated cholesterol levels, who were allocated to one of the three groups treated for 12weeks, respectively, with simvastatin (40mg daily), simvastatin (40mg daily) plus ezetimibe (10mg daily), or placebo. Plasma levels of lipids, apolipoproteins, glucose homeostasis markers, leptin, adiponectin, visfatin, tumor necrosis factor-α (TNF-α), free fatty acids (FFA), and high-sensitive C-reactive protein (hsCRP) were determined on the allocation day and after 12weeks of therapy. Apart from improving lipid profile, simvastatin administered alone or in combination with ezetimibe, decreased plasma levels of hsCRP, FFA, leptin, visfatin, and TNF-α, as well as increased plasma levels of adiponectin. The combination therapy was superior to simvastatin in influencing plasma lipids/lipoproteins, hsCRP, FFA, and the investigated adipokines. The effect of the combination therapy, but not of simvastatin, on systemic inflammation and plasma adipokines was stronger in insulin-resistant than in insulin-sensitive subjects. The obtained results suggest that insulin-resistant patients with hypercholesterolemia and high cardiovascular risk may benefit the most from the combined treatment with simvastatin and ezetimibe.

Effect of combination therapy of ezetimibe and rosuvastatin on regression of coronary atherosclerosis in Japanese patients with stable coronary artery disease

Background: Recent clinical trials have demonstrated that intensive low-density lipoprotein-cholesterol (LDL-C) lowering therapy by strong statins could prevent recurrent cardiovascular event and have beneficial regressive effects on coronary plaques. Otherwise, the use of ezetimibe in combination with statin has been reported to provide greater reduction in LDL-C level than statin monotherapy. However, it is not established whether additional LDL-C lowering achieved with the addition of ezetimibe to statin monotherapy will lead to further reduction in coronary plaque volume. Methods: In this prospective, open-label, randomized study, 40 patients with stable coronary artery disease (CAD) requiring percutaneous coronary intervention (PCI), whose LDL-C levels were higher than 100 mg/dl, were divided into combination therapy group (n=21, rosuvastatin 5mg plus ezetimibe 10mg daily) or statin monotherapy group (n=19, rosuvastatin 5mg daily). Serial volumetric intravascular ultrasound (IVUS) analysis were performed at baseline and after 6 months of follow-up for a non-PCI site. Results: LDL-C level was significantly decreased by 54.1% in the combination group (from 132.7±31.7 mg/dl to 59.5±17.1 mg/dl, p<0.001) vs. 42.1% in the monotherapy group (from 122.0±15.7 mg/dl to 69.1±19.7 mg/dl, p<0.001). Plaque volume (PV) was significantly reduced in the combination group (14.2±12.9% decrease) compared with the monotherapy group (2.1±17.0% decrease; p=0.016). Moreover, percent change in PV showed a significantly positive correlation with percent change and nominal change of LDL-C (r=0.403, p=0.011, and r=0.418, p=0.008, respectively), and percent change of non high-density lipoprotein cholesterol (r=0.380, p=0.024). It also showed a significant positive correlation with follow-up small dense LDL level (r=0.455, p=0.006). Conclusions: Aggressive LDL-C lowering therapy by ezetimibe in addition to statin may exert significant regression of coronary plaque volume compared with usual-dose statin monotherapy in patients with stable CAD.

More on Cholesterol Trafficking in the Body!

More on Cholesterol Trafficking in the Body!

Efficacy and safety of the combination therapy of ezetimibe and fibrate in patients with mixed dyslipidemia who had an inadequate response to statin were recruited

Efficacy and safety of the combination therapy of ezetimibe and fibrate in patients with mixed dyslipidemia who had an inadequate response to statin were recruited

Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia—Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia

ObjectiveThe purpose of this study was to compare the efficacy and tolerability of combination therapy of ezetimibe and atorvastatin in patients with high LDL cholesterol that had not reached the lipid management target value with 10 mg atorvastatin monotherapy, against increasing the dose to 20 mg atorvastatin or switching to 2.5 mg rosuvastatin. Design, setting, and participantsThis was an open-label, randomized, multicenter, 3-parallel-group comparison trial at 23 community hospitals and clinics in Japan (enrollment period March 2009 to May 2010) in 125 patients with high LDL cholesterol. InterventionsA total of 125 Japanese patients with high LDL cholesterol level were randomized to 1 of the following 3 treatment groups: the ezetimibe (10 mg/d) and atorvastatin (10 mg/d) group, the atorvastatin (20 mg/d) group, or the rosuvastatin (2.5 mg/d) group for 12 weeks after treatment with 10 mg atorvastatin alone for 4 weeks. Main outcome measurePercent change in LDL cholesterol level from baseline (4 weeks after treatment with 10 mg atorvastatin alone) until study completion. ResultsThe percent change in LDL cholesterol level from baseline until study completion was statistically greater for the combination of 10 mg ezetimibe + 10 mg atorvastatin compared with increasing atorvastatin to 20 mg (−25.8% vs −15.1%; P < 0.0001). A similar result was observed for ezetimibe + atorvastatin compared with switching to 2.5 mgt rosuvastatin (−25.8% vs 0.8%; P < 0.0001). The proportion of patients who reached the target LDL cholesterol value with the combination of ezetimibe + atorvastatin was significantly higher than increasing atorvastatin and switching to rosuvastatin (78.7%, 41.3%, and 3.1%, respectively). Although 5 serious adverse experiences bearing no relation to the study medications were reported, there were no adverse reactions. ConclusionsThe combination of 10 mg ezetimibe +10 mg atorvastatin was more effective than increasing atorvastatin to 20 mg or switching to 2.5 mg rosuvastatin in patients with hypercholesterolemia whose LDL cholesterol levels had not reached the recommended target value with 10 mg atorvastatin monotherapy for 4 weeks. Ezetimibe coadministration with atorvastatin was well tolerated. ClinicalTrials.gov identifier: NCT00871351.

Retrospective study on antihyperlipidemic efficacy and safety of simvastatin, ezetimibe and their combination in Korean adults

Antihyperlipidemic agents such as 3-hydroxymethyglutaryl-coenzyme A reductase inhibitors and cholesterol transporter inhibitors are used in coronary heart disease. However, controversy remains over the pharmacologic effects and safety of these drugs, especially when used in combination therapies. This retrospective study evaluated the therapeutic effect and safety of simvastatin 20 mg and ezetimibe 10 mg combination therapy compared to simvastatin 20 mg or ezetimibe 10 mg monotherapy in Korean patients according to gender, age, baseline low-density lipoprotein cholesterol, and cardiovascular risk factors. We observed significant differences among patient subgroups. Simvastatin and ezetimibe monotherapies and combination therapy reduced low-density lipoprotein cholesterol levels by 27.6%, 10.1%, and 36.8% (p < 0.001) and total cholesterol levels by 17.5%, 9.2%, and 25.3% (p < 0.001), respectively. Both monotherapy and combination therapy groups had similar incidences of all types of adverse events. However, one case of rhabdomyolysis was observed in the combination therapy group. These results suggest that, compared to monotherapy, combination therapy has an additive effect that is not influenced by risk factors. Despite the low incidence of adverse events, caution is required when using these drugs, especially in the context of musculoskeletal side effects.

A Randomised Placebo-controlled Double-blind Trial to Evaluate Lipid-lowering Pharmacotherapy on Proteolysis and Inflammation in Abdominal Aortic Aneurysms

Objectives: Modulation of abdominal aortic aneurysm (AAA) expansion by HMG-CoA reductase inhibitors (statins) might be linked to reducing IL-6 and MMP-9, which may be consequent on reducing plasma cholesterol. Ezetimibe is a novel cholesterol absorption inhibitor used in combination with statins. This pilot study compared the biological effects of ezetimibe combination therapy with simvastatin alone on parameters relevant to aneurysm expansion including cytokines and proteolytic enzymes. Design: Randomised placebo-controlled double-blind trial. Materials & Methods: Eighteen patients scheduled for elective open AAA repair were randomised to simvastatin 40 mg plus ezetimibe 10 mg (n = 9), or simvastatin 40 mg plus placebo (n = 9), for 32.5 days (IQR 28–50.5) until the day of surgery. Total concentrations of TNF-α, IL-1β, IL-6, IL-8, IL-10, MMPs-1, -2, -3, -8, -9, -12, -13, TIMP-1 and -2 were measured in plasma, aortic wall homogenates and tissue culture explants. Results: Two patients in the placebo arm did not undergo open repair precluding aortic samples. Ezetimibe was associated with a significant reduction in aortic wall MMP-9 (p = 0.02) and aortic wall IL-6 (p = 0.02), associated with a reduction in plasma lipids. Conclusions: These results suggest that ezetimibe combination therapy reduces aortic wall proteolysis and inflammation, key processes that drive AAA expansion. A larger RCT is justified focussing on aneurysm growth rates in small AAA.

Dietary cholesterol reverses resistance to diet-induced weight gain in mice lacking Niemann-Pick C1-Like 1

Niemann-Pick C1-Like 1 (NPC1L1) mediates intestinal cholesterol absorption. NPC1L1 knockout (L1-KO) mice were recently shown to be resistant to high-fat diet (HFD)-induced obesity in one study, which was contrary to several other studies. Careful comparison of dietary compositions in these studies implies a potential role of dietary cholesterol in regulating weight gain. To examine this potential, wild-type (WT) and L1-KO mice were fed one of three sets of diets for various durations: (1) a HFD without added cholesterol for 5 weeks; (2) a high-carbohydrate diet with or without added cholesterol for 5 weeks; or (3) a synthetic HFD with or without added cholesterol for 18 weeks. We found that L1-KO mice were protected against diet-induced weight gain only on a diet without added cholesterol but not on a diet containing 0.16% or 0.2% (w/w) cholesterol, an amount similar to a typical Western diet, regardless of the major energy source of the diet. Food intake and intestinal fat absorption were similar between the two genotypes. Intestinal cholesterol absorption was blocked, and fecal cholesterol excretion increased in L1-KO mice. Under all diets, L1-KO mice were protected from hepatosteatosis. In conclusion, increasing dietary cholesterol restores diet-induced weight gain in mice deficient in NPC1L1-dependent cholesterol absorption.

Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia

Statin and ezetimibe combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides ≥150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C ≥130 mg/dL were randomized to 12 weeks of treatment with fenofibric acid 135 mg (FA) or placebo, each coadministered with atorvastatin 40 mg + ezetimibe 10 mg (Atorva/Eze). Both treatment regimens lowered LDL-C by >50%; however, FA + Atorva/Eze resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with Atorva/Eze. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination. In patients with mixed dyslipidemia, the combination of FA + Atorva/Eze significantly improved lipid and nonlipid parameters compared with Atorva/Eze and was generally well tolerated.

A Randomised Placebo-controlled Double-blind Trial to Evaluate Lipid-lowering Pharmacotherapy on Proteolysis and Inflammation in Abdominal Aortic Aneurysms

Objectives Modulation of abdominal aortic aneurysm (AAA) expansion by HMG-CoA reductase inhibitors (statins) might be linked to reducing IL-6 and MMP-9, which may be consequent on reducing plasma cholesterol. Ezetimibe is a novel cholesterol absorption inhibitor used in combination with statins. This pilot study compared the biological effects of ezetimibe combination therapy with simvastatin alone on parameters relevant to aneurysm expansion including cytokines and proteolytic enzymes. Design Randomised placebo-controlled double-blind trial. Materials & Methods Eighteen patients scheduled for elective open AAA repair were randomised to simvastatin 40 mg plus ezetimibe 10 mg ( n = 9), or simvastatin 40 mg plus placebo ( n = 9), for 32.5 days (IQR 28–50.5) until the day of surgery. Total concentrations of TNF-α, IL-1β, IL-6, IL-8, IL-10, MMPs-1, -2, -3, -8, -9, -12, -13, TIMP-1 and -2 were measured in plasma, aortic wall homogenates and tissue culture explants. Results Two patients in the placebo arm did not undergo open repair precluding aortic samples. Ezetimibe was associated with a significant reduction in aortic wall MMP-9 ( p = 0.02) and aortic wall IL-6 ( p = 0.02), associated with a reduction in plasma lipids. Conclusions These results suggest that ezetimibe combination therapy reduces aortic wall proteolysis and inflammation, key processes that drive AAA expansion. A larger RCT is justified focussing on aneurysm growth rates in small AAA.