Efficacy and safety of fenofibric acid co-administered with low- or moderate-dose statin in patients with mixed dyslipidemia and type 2 diabetes mellitus: results of a pooled subgroup analysis from three randomized, controlled, double-blind trials.
Am J Cardiovasc Drugs
; 10(2): 73-84, 2010.
Article
em En
| MEDLINE
| ID: mdl-20136164
ABSTRACT
BACKGROUND:
Monotherapy with lipid-modifying medication is frequently insufficient to normalize lipid abnormalities in patients with mixed dyslipidemia and type 2 diabetes mellitus.OBJECTIVE:
To evaluate the efficacy and safety of fenofibric acid + statin combination therapy in this population. STUDYDESIGN:
A pooled, subgroup analysis of three randomized, controlled, double-blind, 12-week trials.SETTING:
Multiple clinical research facilities in the US and Canada. PATIENTS Patients with mixed dyslipidemia and type 2 diabetes (n = 586). INTERVENTION Fenofibric acid (Trilipix) 135 mg monotherapy; low-, moderate-, or high-dose statin monotherapy (rosuvastatin [Crestor] 10, 20, or 40 mg; simvastatin [Zocor] 20, 40, or 80 mg; or atorvastatin [Lipitor] 20, 40, or 80 mg); or fenofibric acid + low- or moderate-dose statin. MAIN OUTCOMEMEASURE:
Mean percentage changes in lipid parameters, percentages of patients achieving optimal serum lipid/apolipoprotein levels, and incidence of adverse events.RESULTS:
Fenofibric acid + low-dose statin resulted in significantly (p < 0.001) greater mean percentage changes in high-density lipoprotein cholesterol (HDL-C) [16.8%] and triglycerides (-43.9%) than low-dose statin monotherapy (4.7% and -18.1%, respectively) and significantly (p < 0.001) greater reductions in low-density lipoprotein cholesterol (LDL-C) [-34.0%] than fenofibric acid monotherapy (-5.3%). Similarly, fenofibric acid + moderate-dose statin resulted in significantly (p < or = 0.011) greater mean percentage changes in HDL-C (16.3%) and triglycerides (-43.4%) than moderate-dose statin monotherapy (8.7% and -24.2%, respectively) and significantly (p < 0.001) greater reductions in LDL-C (-32.6%) than fenofibric acid monotherapy (-5.3%). Compared with low- or moderate-dose statin, fenofibric acid + low- or moderate-dose statin resulted in over 5-fold higher percentages of patients achieving optimal levels of LDL-C, non-HDL-C, apolipoprotein B, HDL-C, and triglycerides simultaneously. Incidence of adverse events was generally similar among treatments.CONCLUSION:
Fenofibric acid + statin combination therapy in patients with mixed dyslipidemia and type 2 diabetes was well tolerated and resulted in more comprehensive improvement in the lipid/apolipoprotein profile than either monotherapy. [Clinical trials are registered at www.clinicaltrials.gov NCT00300482, NCT00300456, and NCT00300469].
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Fenofibrato
/
Inibidores de Hidroximetilglutaril-CoA Redutases
/
Diabetes Mellitus Tipo 2
/
Dislipidemias
Tipo de estudo:
Clinical_trials
Idioma:
En
Ano de publicação:
2010
Tipo de documento:
Article