title: Efficacy and safety of dalcetrapib in type 2 diabetes mellitus and/or metabolic syndrome patients, at high cardiovascular disease risk.
abstract: OBJECTIVE
  Mixed dyslipidaemia, characterized by low levels of high-density lipoprotein cholesterol (HDL-C) and high levels of triglycerides, is common in patients with type 2 diabetes mellitus (T2DM) and/or metabolic syndrome. Dalcetrapib effectively increases HDL-C levels by modulating cholesteryl ester transfer protein (CETP) activity. The aim of this analysis was to investigate the lipid modifying efficacy and safety of dalcetrapib in patients with T2DM and/or metabolic syndrome.
  
  
  METHODS
  Post hoc analysis of dalcetrapib therapy in five placebo-controlled, Phase II trials (4-48 weeks of duration) involving T2DM and/or metabolic syndrome, in dyslipidaemic patients with coronary heart disease (CHD) or CHD risk equivalent.
  
  
  RESULTS
  Both in patients with and without T2DM and/or metabolic syndrome, dalcetrapib decreased CETP activity by 26-58% and increased HDL-C levels by 23-34%, depending on dose and duration of treatment. Dalcetrapib did not significantly affect low-density lipoprotein cholesterol (LDL-C) or apolipoprotein B levels. Treatment with dalcetrapib was generally well tolerated with a similar number of adverse events reported between patient groups and between those receiving dalcetrapib compared with placebo.
  
  
  CONCLUSIONS
  Dalcetrapib similarly decreased CETP activity and increased HDL-C levels in patients with and without T2DM or metabolic syndrome; the ongoing Phase III dal-OUTCOMES study will help to determine if dalcetrapib's improvement in lipid levels also reduces cardiovascular morbidity and mortality.
authors.affiliation: Department of Internal Medicine, Division of Vascular Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. a.stalenhoef@aig.umcn.nl
authors.forename: A F H
authors.initials: AF
authors.lastname: Stalenhoef
authors.forename: M H
authors.initials: MH
authors.lastname: Davidson
authors.forename: J G
authors.initials: JG
authors.lastname: Robinson
authors.forename: T
authors.initials: T
authors.lastname: Burgess
authors.forename: R
authors.initials: R
authors.lastname: Duttlinger-Maddux
authors.forename: D
authors.initials: D
authors.lastname: Kallend
authors.forename: A C
authors.initials: AC
authors.lastname: Goldberg
authors.forename: H
authors.initials: H
authors.lastname: Bays
mesh_terms: D000577:Amides; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002318:Cardiovascular Diseases / Q000097:blood / Q000517:prevention & control*; D008076:Cholesterol, HDL / Q000097:blood / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D017322:Clinical Trials, Phase II as Topic; D018849:Controlled Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D003925:Diabetic Angiopathies / Q000097:blood / Q000188:drug therapy* / Q000517:prevention & control; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy*; D004952:Esters; D005260:Female; D006801:Humans; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D018570:Risk Assessment; D013438:Sulfhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D014280:Triglycerides / Q000097:blood
chemical_list: D000577:Amides; D000924:Anticholesteremic Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004952:Esters; D013438:Sulfhydryl Compounds; D014280:Triglycerides; C411602:dalcetrapib