ezetimibe--simvastatin-drug-combination and Diabetes-Mellitus--Type-2

Patients with diabetes represent a population at higher risk for cardiovascular disease. Diabetic dyslipidemia is characterized by the so-called atherogenic lipid triad, consisting of an increase in small dense low density lipoprotein particles and in triglyceride-rich lipoproteins, and a decrease in high-density lipoprotein cholesterol, with an increase in non-HDL cholesterol. Numerous trials have investigated the efficacy of add-on ezetimibe therapy for patients with type 2 diabetes and not controlled by statin therapy. The published data highly suggest that patients with type 2 diabetes may be more likely to benefit from ezetimibe/statin combination therapy. However, evidence specifically addressing hard clinical endpoints and prospective trials addressing differences in response between patients with or without diabetes are still needed.

Topics: Azetidines; Biomarkers; Diabetes Mellitus, Type 2; Drug Combinations; Dyslipidemias; Ezetimibe, Simvastatin Drug Combination; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipids; Simvastatin; Treatment Outcome

Patients with diabetes mellitus and cardiovascular disease may not achieve adequate low-density lipoprotein cholesterol (LDL-C) lowering on statin monotherapy, attributed partly to atherogenic dyslipidemia. More intensive LDL-C-lowering therapy can be considered for these patients. A previous randomized, controlled study demonstrated greater LDL-C lowering in diabetic patients with symptomatic cardiovascular disease who switched from simvastatin 20 mg (S20) or atorvastatin 10 mg (A10) to combination ezetimibe/simvastatin 10/20 mg (ES10/20) therapy, compared with statin dose-doubling (to S40 or A20) or switching to rosuvastatin 10 mg (R10). The effect of these regimens on novel biomarkers of atherogenic dyslipidemia (low- and high-density lipoprotein particle number and lipoprotein-associated phospholipase A2 [Lp-PLA2]) was assessed.. Treatment effects on low- and high-density lipoprotein particle number (by NMR) and Lp-PLA2 (by ELISA) were evaluated using plasma samples available from 358 subjects in the study. Switching to ES10/20 reduced low-density lipoprotein-particle number numerically more than did statin dose-doubling and was comparable with R10 (-133.3, -94.4, and -56.3 nmol/L, respectively; P>0.05). Increases in high-density lipoprotein particle number were significantly greater with switches to ES10/20 versus statin dose-doubling (1.5 and -0.5 μmol/L; P<0.05) and comparable with R10 (0.7 μmol/L; P>0.05). Percentages of patients attaining low-density lipoprotein particle number levels <990 nmol/L were 62.4% for ES10/20, 54.1% for statin dose-doubling, and 57.0% for R10. Switching to ES10/20 reduced Lp-PLA2 activity significantly more than did statin dose-doubling (-28.0 versus -3.8 nmol/min per mL, P<0.05) and was comparable with R10 (-28.0 versus -18.6 nmol/min per mL; P>0.05); effects on Lp-PLA2 concentration were modest.. In diabetic patients with dyslipidemia, switching from statins to combination ES10/20 therapy generally improved lipoprotein subclass profile and Lp-PLA2 activity more than did statin dose-doubling and was comparable with R10, consistent with its lipid effects.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00862251.

Topics: 1-Alkyl-2-acetylglycerophosphocholine Esterase; Aged; Biomarkers; Cardiovascular Diseases; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Substitution; Dyslipidemias; Europe; Ezetimibe, Simvastatin Drug Combination; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipoproteins; Male; Middle Aged; Risk Factors; South America; Time Factors; Treatment Outcome; United States

Although the efficacy of ezetimibe/simvastatin and atorvastatin on traditional lipid parameters has been studied extensively, the apolipoprotein B/apolipoprotein A1 (ApoB/ApoA1) ratio, which has a better predictive value for cardiovascular events, has not previously been used as a primary endpoint in these two treatment groups.. Our objective was to compare the efficacy and safety of ezetimibe/simvastatin 10/20 mg versus atorvastatin 20 mg once daily in Korean patients with type 2 diabetes mellitus.. This study was an open-label, randomized, controlled study. Type 2 diabetes patients with high levels of low-density lipoprotein (LDL) cholesterol (>100 mg/dL) were randomized to receive ezetimibe/simvastatin or atorvastatin.. The primary endpoint was the difference in the percent change of ApoB/ApoA1 at 12 weeks, and secondary endpoints were changes in lipid profiles, glycosylated hemoglobin (HbA1c), homeostatic model assessment (HOMA) index, and C-reactive protein.. In total, 132 patients (66 for each group) were enrolled and randomized. After 12 weeks of treatment, the ApoB/ApoA1 ratio was significantly reduced in both groups; however, the difference of changes between the two groups was not statistically significant (ezetimibe/simvastatin -38.6 ± 18.0 % vs. atorvastatin -34.4 ± 15.5 %; p = 0.059). There were no significant differences in changes to total cholesterol, LDL cholesterol, high-density lipoprotein cholesterol, triglycerides, ApoB, and ApoB48 between the two groups. However, the increments of ApoA1 were significantly greater in the ezetimibe/simvastatin group than in the atorvastatin group (2.8 ± 10.0 vs. -1.8 ± 9.8 %; p = 0.002). In the per-protocol analysis, improvement in ApoB/ApoA1 was significantly greater in the ezetimibe/simvastatin group (-42.8 ± 11.8 vs. -36.7 ± 13.2 %; p = 0.019). The changes in HbA1c, HOMA index, and C-reactive protein were comparable between the two groups. The adverse reaction rate was similar between the two groups (24.2 vs. 34.9 %; p = 0.180).. Ezetimibe/simvastatin 10/20 mg is comparable to atorvastatin 20 mg for the management of dyslipidemia, and may have more favorable effects on apolipoprotein profiles than atorvastatin 20 mg in Korean patients with type 2 diabetes mellitus.

Topics: Aged; Anticholesteremic Agents; Apolipoprotein A-I; Apolipoproteins B; Asian People; Atorvastatin; Azetidines; Cholesterol, LDL; Diabetes Mellitus, Type 2; Drug Combinations; Dyslipidemias; Ezetimibe, Simvastatin Drug Combination; Female; Heptanoic Acids; Humans; Lipids; Male; Middle Aged; Pyrroles; Republic of Korea; Simvastatin; Treatment Outcome

The objective was to assess the consistency of effect of switching to ezetimibe/simvastatin 10/20 mg versus doubling the baseline statin dose (to simvastatin 40 mg or atorvastatin 20 mg) or switching to rosuvastatin 10 mg across subgroups of subjects with (n = 617) and without (n = 191) metabolic syndrome (MetS).. This was a post hoc analysis of a randomized, double-blind, 6-week study of adults 18-79 years with cardiovascular disease and diabetes mellitus with low-density lipoprotein cholesterol (LDL-C) ≥70 and ≤160 mg/dl. The percent change in LDL-C and other lipids was estimated within each subgroup separately. Safety and tolerability were assessed.. In subjects with MetS, percent changes in LDL-C and other lipids were greater with ezetimibe/simvastatin versus doubling baseline statin or numerically greater versus switching to rosuvastatin, except high-density lipoprotein cholesterol and apolipoprotein (Apo) AI (mean percent changes in LDL-C were: -22.49% ezetimibe/simvastatin, -9.64% doubled baseline statin and -19.20% rosuvastatin). In subjects without MetS, percent changes in LDL-C, total cholesterol and Apo B were greater with ezetimibe/simvastatin versus doubling baseline statin or numerically greater versus switching to rosuvastatin (mean percent changes in LDL-C were: -25.14% ezetimibe/simvastatin, -4.75% doubled baseline statin and -19.75% rosuvastatin). Safety profiles were generally similar.. These results showed that switching to ezetimibe/simvastatin 10/20 mg was more effective at reducing LDL-C, total cholesterol and Apo B versus doubling the baseline statin dose to simvastatin 40 mg or atorvastatin 20 mg or switching to rosuvastatin 10 mg regardless of MetS status. These results were generally similar to those of the full cohort.

Topics: Adolescent; Adult; Aged; Anticholesteremic Agents; Apolipoproteins B; Atorvastatin; Azetidines; Blood Glucose; Cardiovascular Diseases; Cholesterol, LDL; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Ezetimibe, Simvastatin Drug Combination; Fasting; Female; Fluorobenzenes; Heptanoic Acids; Humans; Male; Metabolic Syndrome; Middle Aged; Pyrimidines; Pyrroles; Rosuvastatin Calcium; Simvastatin; Sulfonamides; Treatment Outcome

The effectiveness of the cholesterol absorption inhibitor ezetimibe on LDL subfractions and ultimately on the atherosclerotic risk profile remains controversial. We thus determined the concentration of atherogenic small, dense LDL (sdLDL) in patients with type 2 diabetes and an elevated cardiovascular risk profile.. Multicenter, randomized, open-label 6-week study investigating the effect of ezetimibe 10mg (E), simvastatin 20mg (S) and the combination of ezetimibe-/simvastatin 10/20mg (C) on the concentration of sdLDL separated from fresh plasma by gradient ultracentrifugation in patients with type 2 diabetes (NCT01384058).. Fifty-six patients were screened for sdLDL, 41 were randomized, and 40 patients (12 E, 14 S and 14 C) completed the study. Total and LDL cholesterol fell by 14% (p=0.004) and 15% (p=0.006) with E, 22% (p<0.001) and 32% (p<0.001) with S, and 32% (p<0.001) and 44% (p<0.001) with C, respectively. E reduced the concentration of sdLDL by 20% (p=0.043) whereas S and C reduced sdLDL by 24% (p=0.020) and 33% (p=0.003), respectively, and non-sdLDL by 28% (p=0.004) and 42% (p<0.001), respectively. However, the further drop in sdLDL by adding E to S was not significant.. Ezetimibe alone and in combination with simvastatin reduced the concentration of atherogenic sdLDL in patients with type 2 diabetes.

Topics: Aged; Analysis of Variance; Anticholesteremic Agents; Atherosclerosis; Azetidines; Biomarkers; Centrifugation, Density Gradient; Diabetes Mellitus, Type 2; Down-Regulation; Drug Combinations; Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Female; Germany; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Linear Models; Lipoproteins, LDL; Male; Middle Aged; Risk Assessment; Risk Factors; Simvastatin; Time Factors; Treatment Outcome

Lowering LDL-cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-κB. To our knowledge, anti-inflammatory potential of newer cholesterol lowering agents such as ezetimibe is less intensively studied. Therefore we analyzed the effects of equipotent LDL-lowering therapy with simvastatin alone compared to a combination with ezetimibe on NF-κB activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.. Thirty-one patients with type 2 diabetes were included in a double-blind, randomized trial receiving either 80 mg simvastatin (sim80; n = 10) or a combination of 10 mg simvastatin and 10 mg ezetimibe (sim10eze10; n = 11) or placebo (n = 9) for eight weeks. NF-κB binding activity and inflammatory markers (IL-6, hsCRP) were analyzed at baseline and after eight weeks of treatment. NF-κB binding activity was analyzed by electrophoretic mobility shift assay. IL-6 and hsCRP were measured by ELISA.. After eight weeks of treatment LDL-cholesterol was lowered to the same extent in both treatment groups (p = 0.40) but not in placebo. However, patients taking sim80 showed a significant reduction of mononuclear NF-κB binding activity compared to baseline (p = 0.009) while no effect was observed in the sim10eze10 group (p = 0.79). Similar differences in anti-inflammatory effects were also observed when analyzing hsCRP (sim80: p = 0.03; sim10eze10: p = 0.40) and IL-6 levels (sim80: p = 0.15; sim10eze10: p = 0.95).. High dose simvastatin therapy reduces proinflammatory transcription factor NF-κB binding activity and hsCRP levels, while combination of low dose simvastatin with ezetimibe resulting in a similar LDL-reduction does not affect these inflammatory markers.

Topics: Aged; Anti-Inflammatory Agents; Azetidines; Biomarkers; C-Reactive Protein; Cholesterol, LDL; Diabetes Mellitus, Type 2; Double-Blind Method; Down-Regulation; Drug Combinations; Electrophoretic Mobility Shift Assay; Enzyme-Linked Immunosorbent Assay; Ezetimibe, Simvastatin Drug Combination; Female; Germany; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Inflammation; Inflammation Mediators; Interleukin-6; Male; Middle Aged; NF-kappa B; Simvastatin; Time Factors; Treatment Outcome

To investigate relationships between baseline factors and treatment-associated efficacy changes in type 2 diabetes.. AND METHODS Multivariable analyses of treatment response in 1,229 type 2 diabetic patients with hypercholesterolemia who received ezetimibe/simvastatin or atorvastatin in a randomized double-blind 6-week study.. Increasing age was related to improvements in all lipid assessments. Men had greater triglyceride and non-HDL cholesterol reductions than women, and black/Hispanic patients had less favorable lipid effects than other races/ethnicities. Increasing baseline LDL cholesterol was associated with improvements in most lipids; higher baseline non-HDL cholesterol with improved HDL cholesterol and triglycerides; higher baseline HDL cholesterol with greater non-HDL cholesterol and high-sensitivity C-reactive protein (hs-CRP) reductions; and higher baseline hs-CRP with smaller LDL cholesterol, non-HDL cholesterol, and apolipoprotein B reductions. Patients with high baseline non-HDL cholesterol or triglycerides less frequently attained LDL cholesterol targets. Obesity was inversely related to HDL cholesterol and hs-CRP changes, and higher baseline A1C to smaller apolipoprotein B reductions. Metabolic syndrome was not a significant predictor.. Treatment responses in type 2 diabetic patients were related to baseline factors, although treatment effects (ezetimibe/simvastatin being more effective than atorvastatin) remained consistent. The presence of predictive factors should be considered in planning lipid-altering therapy.

Topics: Anticholesteremic Agents; Atorvastatin; Azetidines; Black People; C-Reactive Protein; Diabetes Mellitus, Type 2; Drug Combinations; Ezetimibe, Simvastatin Drug Combination; Female; Heptanoic Acids; Hispanic or Latino; Humans; Hypercholesterolemia; Male; Metabolic Syndrome; Multivariate Analysis; Predictive Value of Tests; Pyrroles; Risk Factors; Simvastatin

The primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD) is reducing low-density lipoprotein cholesterol (LDL-C). This was a multicenter, randomized, double-blind, double-dummy study in patients with type 2 diabetes mellitus (T2DM).. Adult patients with T2DM and CHD (N = 93) on a stable dose of simvastatin 20 mg with LDL-C >or= 2.6 mmol/L (100 mg/dL) and

Topics: Aged; Anticholesteremic Agents; Azetidines; Biomarkers; Blood Glucose; Cholesterol, HDL; Cholesterol, LDL; Coronary Disease; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combinations; Ezetimibe, Simvastatin Drug Combination; Female; Glycated Hemoglobin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Italy; Male; Middle Aged; Odds Ratio; Risk Assessment; Risk Factors; Simvastatin; Time Factors; Treatment Outcome; Triglycerides

To assess the efficacy and safety of ezetimibe/simvastatin (E/S) plus extended-release niacin (N) in hyperlipidaemic patients with diabetes mellitus (DM), metabolic syndrome (MetS) without DM (MetS/non-DM) or neither (non-DM/non-MetS).. A subgroup analysis of a double-blind, 64-week trial of 1220 randomized patients who received E/S (10/20 mg) + N (to 2 g) or E/S (10/20 mg) for 64 weeks, or N (to 2 g) for 24 weeks then E/S (10/20 mg) + N (2 g) or E/S (10/20 mg) for 40 additional weeks. The evaluable populations of this analysis included n = 765 patients at 24 weeks and n = 574 at 64 weeks. Among those receiving N, only those who attained the 2-g dose were included in the analysis.. E/S+N improved levels of low-density lipoprotein cholesterol, other lipids and lipoprotein ratios compared with N and E/S at 24 weeks and E/S at 64 weeks. The combination increased high-density lipoprotein cholesterol and apolipoprotein AI comparably to N and more than E/S. E/S+N reduced high-sensitivity C-reactive protein (hsCRP) levels more effectively than N and similarly to E/S. E/S+N was generally well tolerated. Discontinuations due to flushing with N and E/S+N were comparable and greater than E/S in all subgroups. Fasting glucose trended higher for N vs. E/S. Glucose elevations from baseline to 12 weeks were highest for patients with DM (24.9 mg/dl for N, 21.2 mg/dl for E/S+N, 17.5 mg/dl for E/S); fasting glucose then declined to pretreatment levels at 64 weeks in all subgroups. New-onset DM was more frequent among MetS patients than those without MetS during the first 24 weeks and trended higher among those assigned to N-containing regimens [n = 5(5.1%) for N, n = 2(1.7%) for E/S, n = 21(8.8%) for E/S+N]; during the 24-64 week extension study, diabetes was diagnosed in five additional patients in the E/S(cumulative incidence of 5.9%) and one in the E/S+N (cumulative incidence of 9.2%). Treatment-incident elevations in uric acid levels were increased among subjects assigned to N-containing regimens, but there were no effects on symptomatic gout.. Combination E/S+N is a safe treatment option for hyperlipidaemic patients including those with DM and MetS, but requires monitoring of glucose and potentially uric acid levels.

Topics: Anticholesteremic Agents; Azetidines; Cholesterol, LDL; Delayed-Action Preparations; Diabetes Mellitus, Type 2; Drug Combinations; Ezetimibe, Simvastatin Drug Combination; Female; Humans; Hyperlipidemias; Male; Metabolic Syndrome; Middle Aged; Niacin; Simvastatin; Treatment Outcome

One of the problems associated with reaching the low-density lipoprotein cholesterol (LDL-C) target during statin treatment is the emergence of laboratory or clinical side effects. The aim of our study was to evaluate the prevalence of statin-associated adverse events in diabetic and non-diabetic patients affected by polygenic hypercholesterolemia or combined hyperlipidemia and the efficacy and tolerability of treatment with ezetimibe/simvastatin 10/10 mg/day on the same subjects experiencing the adverse events.. Consecutively enrollment of patients affected by polygenic hypercholesterolemia or combined hyperlipidemia with or without type 2 diabetes mellitus. Each Centre used any of the available statins on the basis of current clinical judgement and monitored enrolled patients for adverse events during the following 2 years. Those patients with moderate adverse events suspended the current statin therapy for 1 month (washout period), and then were shifted to treatment with ezetimibe/simvastatin 10/10 mg/day and again monitored for adverse events in the following 6 months. We assessed body mass index, glycated haemoglobin, fasting plasma glucose, total cholesterol, LDL-C, high-density lipoprotein cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, creatinine phosphokinase and monitored adverse events such as asthenia and myalgia.. All 1170 Caucasian patients affected by polygenic hypercholesterolemia obtained a significant reduction in LDL-C during the observation period (P < 0*05), while those with combined hyperlipidemia also showed a reduction in TG plasma level (P < 0*05) and a significant increase in HDL-C (P < 0*05). Patients affected by polygenic hypercholesterolemia experiencing adverse event under statin treatment obtained a significantly lower reduction than those tolerating the treatment (P < 0*001). The prevalence of adverse events under statin treatment was 4*9% in non-diabetic patients with polygenic hypercholesterolemia, 8*6% in those with combined hyperlipidemia, 7*1% in diabetic patients with polygenic hypercholesterolemia and 7*6% in those with combined hyperlipidemia. Six months after the shift to treatment with ezetimibe/simvastatin 10/10 mg, all patients experienced a significant improvement in LDL-C, TG and HDL-C plasma level. No adverse event was registered during the ezetimibe/simvastatin 10/10 mg treatment period. It seems that previous side effects observed with statins did not re-appear with the administration of ezetimibe/simvastatin 10/10 mg/day.. The efficacy and adverse effect profile of the ezetimibe and simvastatin combination appear to be good for both diabetic and nondiabetic patients, and in both conditions.

Topics: Anticholesteremic Agents; Azetidines; Cholesterol, HDL; Cholesterol, LDL; Diabetes Mellitus, Type 2; Drug Combinations; Ezetimibe, Simvastatin Drug Combination; Female; Follow-Up Studies; Humans; Hyperlipidemia, Familial Combined; Male; Middle Aged; Prevalence; Simvastatin; Triglycerides

Atorvastatin 40 mg (ATOR 40) and ezetimibe 10 mg/simvastatin 20 mg (EZ-SIM 20) have similar reductions of low-density lipoprotein cholesterol (LDL-C) but cardiovascular (CV) outcomes between these two therapies are unclear. Our real-world cohort study is to test the hypothesis of pleiotropic effects of purely higher dose statin on CV outcomes beyond similar reductions of LDL-C, especially for extremely CV risk patients. Between January 1, 2007 and December 31, 2013, a total of 3,372 patients with type 2 diabetes mellitus (T2DM) admitted due to acute coronary syndrome (ACS) or acute ischemic stroke (AIS) were selected as the study cohort from the Taiwan National Health Insurance Research Database. Clinical outcomes were evaluated by ATOR 40 group (n = 1686) matched with EZ-SIM 20 group (n = 1686). Primary composite outcome includes CV death, non-fatal myocardial infarction, and non-fatal stroke. Secondary composite outcome includes hospitalization for unstable angina (HUA), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). With a mean follow-up of 2.4 years, no significant difference of primary composite outcome was observed between ATOR 40 and EZ-SIM 20 groups (subdistribution hazard ratio [SHR], 1.09; 95% confidence interval [CI], 0.95-1.25). Nevertheless, ATOR 40 group had lower risks of HUA (SHR, 0.50; 95% CI, 0.35-0.72), PCI (SHR, 0.82; 95% CI, 0.69-0.97) and CABG (SHR, 0.62; 95% CI, 0.40-0.97) than EZ-SIM 20 group. For T2DM patients after ACS or AIS, ATOR 40 and EZ-SIM 20 had similar major CV outcomes, which still supported the main driver for CV risk reductions is LDL-C lowering.

Topics: Adult; Aged; Aged, 80 and over; Anticholesteremic Agents; Atherosclerosis; Diabetes Mellitus, Type 2; Disease Management; Disease Susceptibility; Ezetimibe, Simvastatin Drug Combination; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Risk Factors; Treatment Outcome

Statin is the main lipid-lowering therapy for type 2 diabetes mellitus patients. Recent evidence suggested the cardiovascular protective effects of ezetimibe-simvastatin in acute coronary syndrome patients.. To investigate the effect of ezetimibe-simvastatin combination therapy on stroke prevention among diabetic stroke patients. Design, Setting, Participants, and Outcome Measures: This is a retrospective cohort study. Between March 1, 2009 and December 31, 2011, all patients with type 2 diabetes mellitus in Taiwan's National Health Insurance Research Database were screened. Those admitted for ischemic stroke (IS) were recruited and divided into 10-mg ezetimibe-20-mg simvastatin (EZ-SIM), 40-mg atorvastatin (ATOR), and 20-mg simvastatin (SIM) groups for further analyses. The primary outcomes were IS, myocardial infarction, and death from any cause. Patients were followed from index hospitalization to the date of death, loss of follow-up, or study termination.. During the 34-month follow-up period, the risk of recurrent IS in the SIM group was higher than that of the ATOR (hazard ratio [HR], 2.03; 95% confidence interval [CI], 1.46-2.82) and EZ-SIM (HR, 1.69; 95% CI, 1.14-2.50) groups. The risk of recurrent IS was not significantly lower in the EZ-SIM compared with the ATOR group (HR, 1.20; 95% CI, 0.85-1.69). The incidence of composite endpoint was highest in the SIM group (28.2%), followed by the ATOR (16.1%) and EZ-SIM (15.4%) groups. The multivariate adjusted survival curve showed lower trends of recurrent IS in the EZ-SIM and ATOR groups compared with the SIM group.. High-potency lipid-lowering therapy effectively reduces the risk of recurrent IS in diabetic patients regardless of ATOR or EZ-SIM combination therapy.

Topics: Aged; Anticholesteremic Agents; Diabetes Mellitus, Type 2; Ezetimibe, Simvastatin Drug Combination; Female; Humans; Ischemic Attack, Transient; Male; Middle Aged; Recurrence; Retrospective Studies; Risk Factors; Stroke; Taiwan

Recent 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.. This 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 75 years. 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.. A 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 59.1 years. In a total of 37,388 person-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).. Compared to high potency statins alone, simvastatin-ezetimibe therapy was associated with a lower incidence of MACE in patients with type 2 DM.

Topics: Adult; Aged; Anticholesteremic Agents; Cohort Studies; Diabetes Mellitus, Type 2; Drug Combinations; Ezetimibe, Simvastatin Drug Combination; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Longitudinal Studies; Male; Middle Aged; Population Surveillance; Taiwan; Treatment Outcome

Topics: Awareness; Azetidines; Blood Glucose; Brain Concussion; Delivery of Health Care; Diabetes Mellitus, Type 2; Diagnostic Imaging; Drug Combinations; Drugs, Generic; Ezetimibe, Simvastatin Drug Combination; Genetic Testing; Genomics; Health Care Reform; Humans; Hypertension; Periodicals as Topic; Simvastatin; Stem Cells; Warfare

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anticholesteremic Agents; Atorvastatin; Azetidines; Diabetes Mellitus, Type 2; Drug Combinations; Ezetimibe, Simvastatin Drug Combination; Heptanoic Acids; Humans; Hypercholesterolemia; Middle Aged; Multicenter Studies as Topic; Pyrroles; Random Allocation; Research Design; Simvastatin