Relationships Between Metabolic Syndrome and Other Baseline Factors and the Efficacy of Ezetimibe/Simvastatin and Atorvastatin in Patients With Type 2 Diabetes and Hypercholesterolemia

Abstract

OBJECTIVETo investigate relationships between baseline factors and treatment-associated efficacy changes in type 2 diabetes.RESEARCH DESIGN AND METHODSMultivariable 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.RESULTSIncreasing 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.CONCLUSIONSTreatment 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.

The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid‐lowering treatment strategies in diabetic subjects with and without metabolic syndrome

“…These were consistent with the expectations for the dyslipidaemia profiles in patients with diabetes and/or the MetS. Of note, greater lipid responses and/or target attainment were achieved with the combination of ezetimibe/simvastatin treatment regimen compared with statin monotherapy in all of the previous studies as well as the current analysis [14][15][16], supporting the premise that it may be necessary to use combination therapies or to intensify current statin therapy in patients with elevated cardiometabolic risk in order to achieve recommended treatment targets [6][7][8]. Whether these baseline differences impacted the magnitude of change in the lipids is unknown.…”

Interethnic variation in lipid profiles: implications for underidentification of African–Americans at risk for metabolic disorders

“…Trials of common statins have shown reduced LDL-C response in AA vs. EA, resulting in diminished LDL-C control despite high adherence in all subgroups [48,49]. Specific genetic loci with interethnic frequency differences that are associated with variable drug response have been identified.…”

Journal Club: A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease

“…At least one article describes some differences. 14 Other articles find no such differences. 15,16 In the present study, if the Hispanic population had been more likely to benefit from simvastatin administration, then a lower number of Hispanic patients in the treatment group could lead to type II error.…”

“…15,16 In the present study, if the Hispanic population had been more likely to benefit from simvastatin administration, then a lower number of Hispanic patients in the treatment group could lead to type II error. However, work by Goldberg et al 14 indicates that Hispanic patients were actually less responsive to statins than other ethnic groups. Therefore, the scarce evidence available might actually bolster the author's findings.…”