Premium
Efficacy and safety of dalcetrapib in type 2 diabetes mellitus and/or metabolic syndrome patients, at high cardiovascular disease risk
Author(s) -
Stalenhoef A. F. H.,
Davidson M. H.,
Robinson J. G.,
Burgess T.,
DuttlingerMaddux R.,
Kallend D.,
Goldberg A. C.,
Bays H.
Publication year - 2012
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2011.01485.x
Subject(s) - cholesterylester transfer protein , medicine , metabolic syndrome , placebo , type 2 diabetes mellitus , cholesterol , endocrinology , apolipoprotein b , diabetes mellitus , lipoprotein , pathology , alternative medicine
Aims: 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.