Tags

Type your tag names separated by a space and hit enter

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. 2010; 10(2):73-84.AJ

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.

STUDY DESIGN

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 OUTCOME MEASURE

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].

Authors+Show Affiliations

Baylor College of Medicine, Houston, Texas, USA. jones@bcm.tmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

20136164

Citation

Jones, Peter H., et al. "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." American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions, vol. 10, no. 2, 2010, pp. 73-84.
Jones PH, Cusi K, Davidson MH, et al. 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. 2010;10(2):73-84.
Jones, P. H., Cusi, K., Davidson, M. H., Kelly, M. T., Setze, C. M., Thakker, K., Sleep, D. J., & Stolzenbach, J. C. (2010). 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. American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions, 10(2), 73-84. https://doi.org/10.2165/10061630-000000000-00000
Jones PH, et al. 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. 2010;10(2):73-84. PubMed PMID: 20136164.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Jones,Peter H, AU - Cusi,Kenneth, AU - Davidson,Michael H, AU - Kelly,Maureen T, AU - Setze,Carolyn M, AU - Thakker,Kamlesh, AU - Sleep,Darryl J, AU - Stolzenbach,James C, PY - 2010/2/9/entrez PY - 2010/2/9/pubmed PY - 2010/6/9/medline SP - 73 EP - 84 JF - American journal of cardiovascular drugs : drugs, devices, and other interventions JO - Am J Cardiovasc Drugs VL - 10 IS - 2 N2 - 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. STUDY DESIGN: 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 OUTCOME MEASURE: 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]. SN - 1175-3277 UR - https://www.unboundmedicine.com/medline/citation/20136164/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_ L2 - https://dx.doi.org/10.2165/10061630-000000000-00000 DB - PRIME DP - Unbound Medicine ER -