PMID- 20151997 OWN - NLM STAT- MEDLINE DCOM- 20110321 LR - 20181201 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 12 IP - 3 DP - 2010 Mar TI - Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. PG - 210-8 LID - 10.1111/j.1463-1326.2009.01152.x [doi] AB - AIM: Type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) are both associated with increased risk for atherosclerotic coronary heart disease (CHD). Thus, it is useful to know the relative efficacy of lipid-altering drugs in these patient populations. METHODS: A double-blind, parallel group trial of adult patients with hypercholesterolaemia at high-CHD risk receiving atorvastatin 40 mg/day compared atorvastatin 40 mg plus ezetimibe 10 mg (ezetimibe) vs. doubling atorvastatin to 80 mg. This post hoc analysis reports lipid efficacy results in patients grouped by diagnosis of T2DM, MetS without T2DM or neither. Per cent change from baseline at week 6 was assessed for LDL-C, total cholesterol, HDL-C , non-HDL-C , Apo A-I, Apo B and triglycerides. Safety was monitored through clinical and laboratory adverse events (AEs). RESULTS: Compared with doubling atorvastatin, atorvastatin plus ezetimibe resulted in greater reductions in LDL-C, triglycerides, Apo B, non-HDL-C, total cholesterol and lipid ratios in the T2DM, MetS and neither groups. Treatment effects were of similar magnitude across patient groups with both treatments, except triglycerides, which were slightly greater in the T2DM and MetS groups vs. neither group. Changes in HDL-C , Apo A-I and high sensitivity C-reactive protein (hs-CRP) were comparable for both treatments in all three groups. Safety and tolerability profiles were generally similar between treatments and across patient groups, as were the incidence of liver and muscle AEs. CONCLUSIONS: Compared with doubling atorvastatin to 80 mg, addition of ezetimibe to atorvastatin 40 mg produced greater improvements in multiple lipid parameters in high-CHD risk patients with T2DM, MetS or neither, consistent with the significantly greater changes observed in the full study cohort (clinical trial # NCT00276484). FAU - Conard, S AU - Conard S AD - Family Practice, University of Texas Southwestern Medical School, Dallas, TX 75243, USA. sconard@med-edge.com FAU - Bays, H AU - Bays H FAU - Leiter, L A AU - Leiter LA FAU - Bird, S AU - Bird S FAU - Lin, J AU - Lin J FAU - Hanson, M E AU - Hanson ME FAU - Shah, A AU - Shah A FAU - Tershakovec, A M AU - Tershakovec AM LA - eng SI - ClinicalTrials.gov/NCT00276484 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Anticholesteremic Agents) RN - 0 (Azetidines) RN - 0 (Heptanoic Acids) RN - 0 (Pyrroles) RN - A0JWA85V8F (Atorvastatin) RN - EOR26LQQ24 (Ezetimibe) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anticholesteremic Agents/*administration & dosage MH - Atorvastatin MH - Azetidines/*administration & dosage MH - Canada MH - Coronary Artery Disease/drug therapy/*prevention & control MH - Diabetic Angiopathies/drug therapy/*prevention & control MH - Double-Blind Method MH - Drug Administration Schedule MH - Drug Therapy, Combination/methods MH - Ezetimibe MH - Heptanoic Acids/*administration & dosage MH - Humans MH - Hypercholesterolemia/*drug therapy MH - Male MH - Metabolic Syndrome/complications/*drug therapy MH - Middle Aged MH - Pyrroles/*administration & dosage MH - Risk Factors MH - Treatment Outcome MH - United States MH - Young Adult EDAT- 2010/02/16 06:00 MHDA- 2011/03/22 06:00 CRDT- 2010/02/16 06:00 PHST- 2010/02/16 06:00 [entrez] PHST- 2010/02/16 06:00 [pubmed] PHST- 2011/03/22 06:00 [medline] AID - DOM1152 [pii] AID - 10.1111/j.1463-1326.2009.01152.x [doi] PST - ppublish SO - Diabetes Obes Metab. 2010 Mar;12(3):210-8. doi: 10.1111/j.1463-1326.2009.01152.x.