Efficacy and safety of dalcetrapib in type 2 diabetes mellitus and/or metabolic syndrome patients, at high cardiovascular disease risk.

Abstract

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.

• Authors: A F H Stalenhoef, M H Davidson, J G Robinson, T Burgess, R Duttlinger-Maddux, D Kallend, A C Goldberg, H Bays
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 14 Issue 1 Pg. 30-9 (Jan 2012) ISSN: 1463-1326 [Electronic] England
• PMID: 21819519 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2011 Blackwell Publishing Ltd.

Chemical References

• Amides
• Anticholesteremic Agents
• Cholesterol, HDL
• Cholesterol, LDL
• Esters
• Sulfhydryl Compounds
• Triglycerides
• dalcetrapib

Topics

• Amides
• Anticholesteremic Agents (administration & dosage, adverse effects, pharmacology)
• Cardiovascular Diseases (blood, prevention & control)
• Cholesterol, HDL (blood, drug effects)
• Cholesterol, LDL (blood, drug effects)
• Clinical Trials, Phase II as Topic
• Controlled Clinical Trials as Topic
• Diabetes Mellitus, Type 2 (blood, drug therapy, epidemiology)
• Diabetic Angiopathies (blood, drug therapy, prevention & control)
• Dyslipidemias (blood, drug therapy)
• Esters
• Female
• Humans
• Male
• Metabolic Syndrome (blood, drug therapy)
• Middle Aged
• Netherlands (epidemiology)
• Risk Assessment
• Sulfhydryl Compounds (administration & dosage, adverse effects, pharmacology)
• Triglycerides (blood)