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James C Stolzenbach - One of the best experts on this subject based on the ideXlab platform.
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a randomized double blind study of Fenofibric Acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease
Clinical Therapeutics, 2013Co-Authors: Debra L Weinstein, Maureen T Kelly, Carolyn M Setze, Dawn M Carlson, Laura A Williams, Aditya Lele, Kim M Burns, James C StolzenbachAbstract:Abstract Background Patients with chronic kidney disease (CKD) often have mixed dyslipidemia and high cardiovascular disease risk. Although statins reduce LDL-C, adding a fibrate may further improve lipid parameters. Objective This multicenter, randomized study evaluated the short-term efficacy and safety profile of Fenofibric Acid (FA) + rosuvastatin (R) combination therapy for improving lipid parameters in patients with stage 3 CKD and mixed dyslipidemia. The study also assessed estimated glomerular filtration rate after study drug washout. Methods Patients received FA 45 mg + R (5 mg for 8 weeks, then 10 mg for 8 additional weeks) or R monotherapy (5 mg for 8 weeks, then 10 mg for 8 additional weeks), followed by an 8-week washout period. Primary and secondary end points were percent changes in triglycerides and HDL-C, respectively, from baseline to week 8. Results FA 45 mg + R 5 mg, compared with R 5 mg, resulted in significant improvements in triglycerides (median % changes: week 8, −38.0% vs −22.4%, P P P P P Conclusions The data suggest that, after 16 weeks of therapy, FA + R has an acceptable safety profile and improved TG and HDL-C efficacy versus R. FA + R combination therapy may thus further improve lipid parameters in patients with stage 3 CKD and mixed dyslipidemia. ClinicalTrials.gov identifier: NCT00680017.
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study design rationale and baseline characteristics evaluation of Fenofibric Acid on carotid intima media thickness in patients with type iib dyslipidemia with residual risk in addition to atorvastatin therapy first trial
Cardiovascular Drugs and Therapy, 2012Co-Authors: Michael H Davidson, Carolyn M Setze, Dawn M Carlson, Christie M Ballantyne, Robert S Rosenson, Kevin C Maki, Stephen J Nicholls, James C StolzenbachAbstract:Purpose Elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDL-C) levels contribute to cardiovascular disease risk and can be effectively treated with Fenofibric Acid. A trial is under way to evaluate the effect of once-daily Fenofibric Acid or placebo on carotid intima-media thickness (CIMT) progression in patients with controlled low-density lipoprotein cholesterol (LDL-C) levels achieved through atorvastatin treatment, but with high TG and low HDL-C levels.
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long term efficacy of adding Fenofibric Acid to moderate dose statin therapy in patients with persistent elevated triglycerides
Cardiovascular Drugs and Therapy, 2011Co-Authors: Christie M Ballantyne, Maureen T Kelly, Carolyn M Setze, Peter H Jones, Aditya Lele, Kamlesh M Thakker, James C StolzenbachAbstract:Objective The objective of this study was to evaluate the long-term efficacy of adding Fenofibric Acid to moderate-dose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia.
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achievement of lipid targets with the combination of rosuvastatin and Fenofibric Acid in patients with type 2 diabetes mellitus
Cardiovascular Drugs and Therapy, 2011Co-Authors: Robert S Rosenson, Maureen T Kelly, Carolyn M Setze, Dawn M Carlson, James C Stolzenbach, Boaz Hirshberg, Laura A WilliamsAbstract:Objective The objective of this study was to assess the proportion of patients with type 2 diabetes mellitus (T2DM) attaining individual and combined targets of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), non-HDL-C, and apolipoprotein B (ApoB) after treatment with rosuvastatin (R) + Fenofibric Acid (FA) compared with corresponding-dose R monotherapy.
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DOI 10.1007/s10557-011-6280-1 Long-Term Efficacy of Adding Fenofibric Acid to Moderate-Dose Statin Therapy in Patients with Persistent Elevated Triglycerides
2011Co-Authors: Christie M Ballantyne, Maureen T Kelly, Carolyn M Setze, James C Stolzenbach, Peter H Jones, Aditya Lele, Kamlesh M Thakker, J. C. StolzenbachAbstract:# The Author(s) 2011. This article is published with open access at Springerlink.com Objective The objective of this study was to evaluate the long-term efficacy of adding Fenofibric Acid to moderatedose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia. Methods This is a post hoc analysis of a subset of patients (N=92) with mixed dyslipidemia treated with moderatedose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg) for 12 weeks in three controlled trials who had achieved LDL-C <100 mg/dL but whose triglycerides remained>200 mg/dL, and had Fenofibric Acid 135 mg added to the moderate-dose statin in a 52-week open-label extension study. Lipid and apolipoprotein (Apo) values and the proportion of patients meeting individual and combined treatment targets with combination therapy were determined at scheduled visits during the 52-week study and compared with baseline (start of extension study). Results Addition of Fenofibric Acid to moderate-dose statin for 52 weeks resulted in significant (P<0.001) improvements in non–high-density lipoprotein cholesterol (non– HDL-C; –9.0%), ApoB (–9.8%), HDL-C (14.9%), and triglycerides (–37.6%) compared with baseline. At fina
Maureen T Kelly - One of the best experts on this subject based on the ideXlab platform.
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The Effects of Fenofibric Acid Alone and With Statins on the Prevalence of Metabolic Syndrome and Its Diagnostic Components in Patients With Mixed
2016Co-Authors: Harold E Bays, Maureen T Kelly, Eli M Roth, James M Mckenney, Carolyn M Setze, Kamlesh M Thakker, Darryl J SleepAbstract:OBJECTIVE — To compare Fenofibric Acid (FA) statin to respective monotherapies on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. RESEARCH DESIGN AND METHODS — Post hoc analysis of over 2,000 metabolic syndrome patients administered either FA low- or moderate-dose statin; FA alone; or low-, moderate-, or high-dose statin alone. RESULTS — FA low- or moderate-dose statin combination therapy reduced the presence of metabolic syndrome (35.7 or 35.9%, respectively) more than low-, moderate-, or high-dose statin monotherapy (15.5, 16.6, or 13.8%, respectively), mostly due to improvements in tri-glycerides and HDL cholesterol levels. Mean glucose levels slightly decreased with FA mono-therapy, slightly increased with statin monotherapy, and were essentially unchanged with FA statin. FA with or without statin also reduced non-HDL cholesterol, apolipoprotein B, total cholesterol, VLDL cholesterol, and high-sensitivity C-reactive protein. CONCLUSIONS — FA statin in patients with mixed dyslipidemia reduces the prevalence of metabolic syndrome
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effects of Fenofibric Acid on carotid intima media thickness in patients with mixed dyslipidemia on atorvastatin therapy randomized placebo controlled study first
Arteriosclerosis Thrombosis and Vascular Biology, 2014Co-Authors: Michael H Davidson, Dawn M Carlson, Laura A Williams, Christie M Ballantyne, Robert S Rosenson, Kevin C Maki, Stephen J Nicholls, Theodore Mazzone, Maureen T KellyAbstract:Objective—To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol, The Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy (FIRST) trial evaluated the effects of Fenofibric Acid (FA) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin. Approach and Results—This multicenter, double-blind, placebo-controlled study was performed in patients with mixed dyslipidemia (fasting triglycerides, ≥150 mg/dL; high-density lipoprotein cholesterol, ≤45 [men] or 55 mg/dL [women]; low-density lipoprotein cholesterol, ≤100 mg/dL once and averaging ≤105 mg/dL) and a history of coronary heart disease or risk equivalent. Patients on background atorvastatin (continued on starting dose or titrated to 40 mg, if needed) were randomized to FA 135 mg or placebo. The primary...
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a randomized double blind study of Fenofibric Acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease
Clinical Therapeutics, 2013Co-Authors: Debra L Weinstein, Maureen T Kelly, Carolyn M Setze, Dawn M Carlson, Laura A Williams, Aditya Lele, Kim M Burns, James C StolzenbachAbstract:Abstract Background Patients with chronic kidney disease (CKD) often have mixed dyslipidemia and high cardiovascular disease risk. Although statins reduce LDL-C, adding a fibrate may further improve lipid parameters. Objective This multicenter, randomized study evaluated the short-term efficacy and safety profile of Fenofibric Acid (FA) + rosuvastatin (R) combination therapy for improving lipid parameters in patients with stage 3 CKD and mixed dyslipidemia. The study also assessed estimated glomerular filtration rate after study drug washout. Methods Patients received FA 45 mg + R (5 mg for 8 weeks, then 10 mg for 8 additional weeks) or R monotherapy (5 mg for 8 weeks, then 10 mg for 8 additional weeks), followed by an 8-week washout period. Primary and secondary end points were percent changes in triglycerides and HDL-C, respectively, from baseline to week 8. Results FA 45 mg + R 5 mg, compared with R 5 mg, resulted in significant improvements in triglycerides (median % changes: week 8, −38.0% vs −22.4%, P P P P P Conclusions The data suggest that, after 16 weeks of therapy, FA + R has an acceptable safety profile and improved TG and HDL-C efficacy versus R. FA + R combination therapy may thus further improve lipid parameters in patients with stage 3 CKD and mixed dyslipidemia. ClinicalTrials.gov identifier: NCT00680017.
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attainment of goal desirable lipid levels in patients with mixed dyslipidemia after 12 weeks of treatment with Fenofibric Acid and rosuvastatin combination therapy a pooled analysis of controlled studies
Journal of Clinical Lipidology, 2012Co-Authors: Eli M Roth, Maureen T Kelly, Carolyn M Setze, Peter H Jones, Michael H Davidson, Aditya Lele, Robert S Rosenson, Kamlesh M ThakkerAbstract:Background Goal/desirable lipid levels are underachieved in patients with mixed dyslipidemia. These patients may have substantial residual risk of cardiovascular disease even while receiving optimal LDL-C-lowering therapy and may require additional therapy to improve multiple lipid/lipoprotein levels. Objective To evaluate attainment of goal/desirable levels of lipids/lipoproteins after 12-week treatment with combination rosuvastatin + Fenofibric Acid versus rosuvastatin monotherapy. Methods This was a post hoc analysis of patients with mixed dyslipidemia who enrolled in one of two randomized controlled trials, and were treated (N = 2066) with rosuvastatin (5, 10, or 20 mg), Fenofibric Acid 135 mg, or rosuvastatin + Fenofibric Acid for 12 weeks. Data were pooled across doses of rosuvastatin as monotherapy and combination therapy. Results Compared with rosuvastatin monotherapy, combination therapy had comparable effects in achieving risk-stratified LDL-C goals; however, measures of total atherogenic burden were improved because significantly greater percentages of patients attained non-HDL-C goal in high- (62.9% vs 50.4%, P = .006) and moderate-risk groups (87.6% vs 80.4%, P = .016) and apolipoprotein B (ApoB) P 40/50 mg/dL in men/women ( P P P P P P Conclusion Rosuvastatin + Fenofibric Acid may be more efficacious than rosuvastatin alone in patients with mixed dyslipidemia.
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effects of combination therapy with rosuvastatin and Fenofibric Acid in patients with mixed dyslipidemia and high sensitivity c reactive protein 2 mg l
Journal of Clinical Lipidology, 2011Co-Authors: Christie M Ballantyne, Carolyn M Setze, Michael H Davidson, Maureen T KellyAbstract:Background Elevated levels of high-sensitivity C-reactive protein (hsCRP) correlate with an increased risk for cardiovascular events. Combination therapy with a statin and a fibrate may be more effective than statin monotherapy for reducing hsCRP, especially in patients with mixed dyslipidemia. Objective To characterize the treatment effects of rosuvastatin and Fenofibric Acid combination therapy compared with individual monotherapies in mixed dyslipidemic patients with baseline hsCRP ≥2 mg/L versus Methods Data for the post hoc analysis were derived from two 12-week controlled studies and a 52-week extension study. Patients were treated with Fenofibric Acid 135 mg; rosuvastatin 5, 10, 20, or 40 mg; or rosuvastatin 5, 10, or 20 mg and Fenofibric Acid 135 mg in the controlled studies; and with rosuvastatin 20 mg and Fenofibric Acid 135 mg in the extension study. Results In this analysis, 65% (1416/2182) of patients had pretreatment baseline hsCRP ≥2 mg/L. Among all treatment groups, larger decreases in hsCRP were observed in patients with greater baseline hsCRP; however, improvements in other lipids/apolipoprotein were comparable between the baseline hsCRP categories. Among patients with high hsCRP (≥2 mg/L) remaining after 12 weeks of rosuvastatin 10, 20, or 40 mg monotherapy, hsCRP was reduced by ∼36% after switching to rosuvastatin 20 mg and Fenofibric Acid 135 mg for up to 52 weeks, and ∼36% of patients shifted from hsCRP ≥2 mg/L to Conclusions Combination therapy with rosuvastatin and Fenofibric Acid may be effective for improving the inflammatory biomarker, hsCRP as well as other lipid abnormalities in patients with mixed dyslipidemia and high hsCRP.
Christie M Ballantyne - One of the best experts on this subject based on the ideXlab platform.
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rare lpl gene variants attenuate triglyceride reduction and hdl cholesterol increase in response to Fenofibric Acid therapy in individuals with mixed dyslipidemia
Atherosclerosis, 2014Co-Authors: Feng Gao, Ariel Brautbar, Salim S Virani, Christie M Ballantyne, Alon KeinanAbstract:Abstract Objective Individuals with mixed dyslipidemia have elevated triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), and increased risk for coronary disease. Fibrate therapy is commonly used to lower TG and increase HDL-C. Common genetic variants are known to affect the response to fibrate therapy. We sought to identify rare genetic variants (frequency ≤ 1%) in genes involved in TG and HDL-C metabolism that affect the response to Fenofibric Acid (FA) therapy. Methods Four genes with a major role in HDL-C and TG metabolism APOA1 , APOC2 , APOC-III and LPL were sequenced in 2385 participants with mixed dyslipidemia in a randomized, double-blind, active-controlled study comparing therapy with FA alone, in combination with statins, or statin alone. Rare variants collapsing or SKAT methods were used for the analysis. Results Synonymous rare variants in the LPL gene were significantly associated with absolute HDL-C change ( P = 9 × 10 −4 ) and TG percent change ( P = 6.76 × 10 −4 ) in those treated with FA only. Participants with these rare variants had a 2 mg/dL increase in HDL-C and 39 mg/dL decrease in TG as compared to 6.2 mg/dL increase in HDL-C and 100 mg/dL decrease in TG in those without these variants. Rare variants in the APOC-III gene were associated with a modest 3 mg/dL less reduction in APOB ( P = 8.72 × 10 −4 ) in those receiving FA and statin. Conclusion In individuals with mixed dyslipidemia rare synonymous variants within LPL gene were associated with attenuated response to FA therapy while APOCIII rare variants were associated with a modest effect on APOB response to FA-statin therapy. These results should be replicated in a similar clinical trial for further confirmation.
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effects of Fenofibric Acid on carotid intima media thickness in patients with mixed dyslipidemia on atorvastatin therapy randomized placebo controlled study first
Arteriosclerosis Thrombosis and Vascular Biology, 2014Co-Authors: Michael H Davidson, Dawn M Carlson, Laura A Williams, Christie M Ballantyne, Robert S Rosenson, Kevin C Maki, Stephen J Nicholls, Theodore Mazzone, Maureen T KellyAbstract:Objective—To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol, The Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy (FIRST) trial evaluated the effects of Fenofibric Acid (FA) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin. Approach and Results—This multicenter, double-blind, placebo-controlled study was performed in patients with mixed dyslipidemia (fasting triglycerides, ≥150 mg/dL; high-density lipoprotein cholesterol, ≤45 [men] or 55 mg/dL [women]; low-density lipoprotein cholesterol, ≤100 mg/dL once and averaging ≤105 mg/dL) and a history of coronary heart disease or risk equivalent. Patients on background atorvastatin (continued on starting dose or titrated to 40 mg, if needed) were randomized to FA 135 mg or placebo. The primary...
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rare apoa5 promoter variants associated with paradoxical hdl cholesterol decrease in response to Fenofibric Acid therapy
Journal of Lipid Research, 2013Co-Authors: Ariel Brautbar, Maja Barbalic, Fengju Chen, John W Belmont, Salim S Virani, Stephen W Scherer, Robert A Hegele, Christie M BallantyneAbstract:Individuals with mixed dyslipidemia, including high triglycerides (TGs) and low high density lipoprotein cholesterol (HDL-C), have increased risk for coronary events. We examined the effect of rare genetic variants in the APOA5 gene region on plasma HDL-C, apolipoprotein A-I (apoA-I), and TG response to Fenofibric Acid monotherapy and in combination with statins. The APOA5 gene region was sequenced in 1,612 individuals with mixed dyslipidemia in a randomized trial of Fenofibric Acid alone and in combination with statins. Student's t-test and rare variant burden tests were used to examine plasma HDL-C, apoA-I, and TG response. Rare APOA5 promoter region variants were associated with decreased HDL-C and apoA-I levels in response to Fenofibric Acid therapy; rare missense variants were associated with increased TG response to combination therapy. Further study is needed to examine the effect of these rare variants on coronary outcomes in this population in response to Fenofibric Acid monotherapy or combined with statins
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interaction between snps in the rxra and near angptl3 gene region inhibits apob reduction after statin Fenofibric Acid therapy in individuals with mixed dyslipidemia
Journal of Lipid Research, 2012Co-Authors: Christie M Ballantyne, John W Belmont, Alon Keinan, Ariel BrautbarAbstract:The mixed dyslipidemia phenotype is characterized by elevated triglycerides (TG), low HDL cholesterol (HDL-C), increased ApoB levels, and premature coronary atherosclerosis. Fibrate-statin combination therapy reduces ApoB levels and coronary events in the mixed dyslipidemia population. We sought to identify gene-gene interactions that affect ApoB response to statin-Fenofibric Acid therapy in the mixed dyslipidemia population. Using a predefined subset of single-nucleotide polymorphisms (SNPs) that were previously associated with TG, VLDL, or HDL-C, we applied gene-gene interaction testing in a randomized, double-blind, clinical trial examining the response to Fenofibric Acid (FNA) and its combination with statin in 1,865 individuals with mixed dyslipidemia. Of 11,783 possible SNP pairs examined, we detected a single significant interaction between rs12130333, located within the ANGPTL3 gene region, and rs4240705, within the RXRA gene, on ApoB reduction after statin-FNA therapy (P = 4.0 × 10−6). ApoB response to therapy gradually reduced with the increasing number of T alleles in the rs12130333 but only in the presence of the GG genotype of rs4240705. Individuals doubly homozygous for the minor alleles at rs12130333 and rs4240705 showed a paradoxical increase of 1.8% in ApoB levels after FNA-statin combination therapy. No gene-gene interaction was identified other than an interaction between SNPs in the ANGPTL3 and RXRA regions, which results in the inhibition of ApoB reduction in response to statin-FNA therapy. Further study is required to examine the clinical applicability of this genetic interaction and its effect on coronary events.
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study design rationale and baseline characteristics evaluation of Fenofibric Acid on carotid intima media thickness in patients with type iib dyslipidemia with residual risk in addition to atorvastatin therapy first trial
Cardiovascular Drugs and Therapy, 2012Co-Authors: Michael H Davidson, Carolyn M Setze, Dawn M Carlson, Christie M Ballantyne, Robert S Rosenson, Kevin C Maki, Stephen J Nicholls, James C StolzenbachAbstract:Purpose Elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDL-C) levels contribute to cardiovascular disease risk and can be effectively treated with Fenofibric Acid. A trial is under way to evaluate the effect of once-daily Fenofibric Acid or placebo on carotid intima-media thickness (CIMT) progression in patients with controlled low-density lipoprotein cholesterol (LDL-C) levels achieved through atorvastatin treatment, but with high TG and low HDL-C levels.
Carolyn M Setze - One of the best experts on this subject based on the ideXlab platform.
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The Effects of Fenofibric Acid Alone and With Statins on the Prevalence of Metabolic Syndrome and Its Diagnostic Components in Patients With Mixed
2016Co-Authors: Harold E Bays, Maureen T Kelly, Eli M Roth, James M Mckenney, Carolyn M Setze, Kamlesh M Thakker, Darryl J SleepAbstract:OBJECTIVE — To compare Fenofibric Acid (FA) statin to respective monotherapies on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. RESEARCH DESIGN AND METHODS — Post hoc analysis of over 2,000 metabolic syndrome patients administered either FA low- or moderate-dose statin; FA alone; or low-, moderate-, or high-dose statin alone. RESULTS — FA low- or moderate-dose statin combination therapy reduced the presence of metabolic syndrome (35.7 or 35.9%, respectively) more than low-, moderate-, or high-dose statin monotherapy (15.5, 16.6, or 13.8%, respectively), mostly due to improvements in tri-glycerides and HDL cholesterol levels. Mean glucose levels slightly decreased with FA mono-therapy, slightly increased with statin monotherapy, and were essentially unchanged with FA statin. FA with or without statin also reduced non-HDL cholesterol, apolipoprotein B, total cholesterol, VLDL cholesterol, and high-sensitivity C-reactive protein. CONCLUSIONS — FA statin in patients with mixed dyslipidemia reduces the prevalence of metabolic syndrome
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a randomized double blind study of Fenofibric Acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease
Clinical Therapeutics, 2013Co-Authors: Debra L Weinstein, Maureen T Kelly, Carolyn M Setze, Dawn M Carlson, Laura A Williams, Aditya Lele, Kim M Burns, James C StolzenbachAbstract:Abstract Background Patients with chronic kidney disease (CKD) often have mixed dyslipidemia and high cardiovascular disease risk. Although statins reduce LDL-C, adding a fibrate may further improve lipid parameters. Objective This multicenter, randomized study evaluated the short-term efficacy and safety profile of Fenofibric Acid (FA) + rosuvastatin (R) combination therapy for improving lipid parameters in patients with stage 3 CKD and mixed dyslipidemia. The study also assessed estimated glomerular filtration rate after study drug washout. Methods Patients received FA 45 mg + R (5 mg for 8 weeks, then 10 mg for 8 additional weeks) or R monotherapy (5 mg for 8 weeks, then 10 mg for 8 additional weeks), followed by an 8-week washout period. Primary and secondary end points were percent changes in triglycerides and HDL-C, respectively, from baseline to week 8. Results FA 45 mg + R 5 mg, compared with R 5 mg, resulted in significant improvements in triglycerides (median % changes: week 8, −38.0% vs −22.4%, P P P P P Conclusions The data suggest that, after 16 weeks of therapy, FA + R has an acceptable safety profile and improved TG and HDL-C efficacy versus R. FA + R combination therapy may thus further improve lipid parameters in patients with stage 3 CKD and mixed dyslipidemia. ClinicalTrials.gov identifier: NCT00680017.
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attainment of goal desirable lipid levels in patients with mixed dyslipidemia after 12 weeks of treatment with Fenofibric Acid and rosuvastatin combination therapy a pooled analysis of controlled studies
Journal of Clinical Lipidology, 2012Co-Authors: Eli M Roth, Maureen T Kelly, Carolyn M Setze, Peter H Jones, Michael H Davidson, Aditya Lele, Robert S Rosenson, Kamlesh M ThakkerAbstract:Background Goal/desirable lipid levels are underachieved in patients with mixed dyslipidemia. These patients may have substantial residual risk of cardiovascular disease even while receiving optimal LDL-C-lowering therapy and may require additional therapy to improve multiple lipid/lipoprotein levels. Objective To evaluate attainment of goal/desirable levels of lipids/lipoproteins after 12-week treatment with combination rosuvastatin + Fenofibric Acid versus rosuvastatin monotherapy. Methods This was a post hoc analysis of patients with mixed dyslipidemia who enrolled in one of two randomized controlled trials, and were treated (N = 2066) with rosuvastatin (5, 10, or 20 mg), Fenofibric Acid 135 mg, or rosuvastatin + Fenofibric Acid for 12 weeks. Data were pooled across doses of rosuvastatin as monotherapy and combination therapy. Results Compared with rosuvastatin monotherapy, combination therapy had comparable effects in achieving risk-stratified LDL-C goals; however, measures of total atherogenic burden were improved because significantly greater percentages of patients attained non-HDL-C goal in high- (62.9% vs 50.4%, P = .006) and moderate-risk groups (87.6% vs 80.4%, P = .016) and apolipoprotein B (ApoB) P 40/50 mg/dL in men/women ( P P P P P P Conclusion Rosuvastatin + Fenofibric Acid may be more efficacious than rosuvastatin alone in patients with mixed dyslipidemia.
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study design rationale and baseline characteristics evaluation of Fenofibric Acid on carotid intima media thickness in patients with type iib dyslipidemia with residual risk in addition to atorvastatin therapy first trial
Cardiovascular Drugs and Therapy, 2012Co-Authors: Michael H Davidson, Carolyn M Setze, Dawn M Carlson, Christie M Ballantyne, Robert S Rosenson, Kevin C Maki, Stephen J Nicholls, James C StolzenbachAbstract:Purpose Elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDL-C) levels contribute to cardiovascular disease risk and can be effectively treated with Fenofibric Acid. A trial is under way to evaluate the effect of once-daily Fenofibric Acid or placebo on carotid intima-media thickness (CIMT) progression in patients with controlled low-density lipoprotein cholesterol (LDL-C) levels achieved through atorvastatin treatment, but with high TG and low HDL-C levels.
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effects of combination therapy with rosuvastatin and Fenofibric Acid in patients with mixed dyslipidemia and high sensitivity c reactive protein 2 mg l
Journal of Clinical Lipidology, 2011Co-Authors: Christie M Ballantyne, Carolyn M Setze, Michael H Davidson, Maureen T KellyAbstract:Background Elevated levels of high-sensitivity C-reactive protein (hsCRP) correlate with an increased risk for cardiovascular events. Combination therapy with a statin and a fibrate may be more effective than statin monotherapy for reducing hsCRP, especially in patients with mixed dyslipidemia. Objective To characterize the treatment effects of rosuvastatin and Fenofibric Acid combination therapy compared with individual monotherapies in mixed dyslipidemic patients with baseline hsCRP ≥2 mg/L versus Methods Data for the post hoc analysis were derived from two 12-week controlled studies and a 52-week extension study. Patients were treated with Fenofibric Acid 135 mg; rosuvastatin 5, 10, 20, or 40 mg; or rosuvastatin 5, 10, or 20 mg and Fenofibric Acid 135 mg in the controlled studies; and with rosuvastatin 20 mg and Fenofibric Acid 135 mg in the extension study. Results In this analysis, 65% (1416/2182) of patients had pretreatment baseline hsCRP ≥2 mg/L. Among all treatment groups, larger decreases in hsCRP were observed in patients with greater baseline hsCRP; however, improvements in other lipids/apolipoprotein were comparable between the baseline hsCRP categories. Among patients with high hsCRP (≥2 mg/L) remaining after 12 weeks of rosuvastatin 10, 20, or 40 mg monotherapy, hsCRP was reduced by ∼36% after switching to rosuvastatin 20 mg and Fenofibric Acid 135 mg for up to 52 weeks, and ∼36% of patients shifted from hsCRP ≥2 mg/L to Conclusions Combination therapy with rosuvastatin and Fenofibric Acid may be effective for improving the inflammatory biomarker, hsCRP as well as other lipid abnormalities in patients with mixed dyslipidemia and high hsCRP.
Peter H Jones - One of the best experts on this subject based on the ideXlab platform.
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attainment of goal desirable lipid levels in patients with mixed dyslipidemia after 12 weeks of treatment with Fenofibric Acid and rosuvastatin combination therapy a pooled analysis of controlled studies
Journal of Clinical Lipidology, 2012Co-Authors: Eli M Roth, Maureen T Kelly, Carolyn M Setze, Peter H Jones, Michael H Davidson, Aditya Lele, Robert S Rosenson, Kamlesh M ThakkerAbstract:Background Goal/desirable lipid levels are underachieved in patients with mixed dyslipidemia. These patients may have substantial residual risk of cardiovascular disease even while receiving optimal LDL-C-lowering therapy and may require additional therapy to improve multiple lipid/lipoprotein levels. Objective To evaluate attainment of goal/desirable levels of lipids/lipoproteins after 12-week treatment with combination rosuvastatin + Fenofibric Acid versus rosuvastatin monotherapy. Methods This was a post hoc analysis of patients with mixed dyslipidemia who enrolled in one of two randomized controlled trials, and were treated (N = 2066) with rosuvastatin (5, 10, or 20 mg), Fenofibric Acid 135 mg, or rosuvastatin + Fenofibric Acid for 12 weeks. Data were pooled across doses of rosuvastatin as monotherapy and combination therapy. Results Compared with rosuvastatin monotherapy, combination therapy had comparable effects in achieving risk-stratified LDL-C goals; however, measures of total atherogenic burden were improved because significantly greater percentages of patients attained non-HDL-C goal in high- (62.9% vs 50.4%, P = .006) and moderate-risk groups (87.6% vs 80.4%, P = .016) and apolipoprotein B (ApoB) P 40/50 mg/dL in men/women ( P P P P P P Conclusion Rosuvastatin + Fenofibric Acid may be more efficacious than rosuvastatin alone in patients with mixed dyslipidemia.
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lpl gene variants affect apoc iii response to combination therapy of statins and Fenofibric Acid in a randomized clinical trial of individuals with mixed dyslipidemia
Journal of Lipid Research, 2012Co-Authors: Ariel Brautbar, Peter H Jones, John W Belmont, Salim S Virani, Vijay Nambi, Christie M BallantyneAbstract:ApoC-III is a proatherogenic protein associated with elevated triglycerides; its deficiency is associated with reduced atherosclerosis. Mixed dyslipidemia, characterized by elevated triglyceride and apoC-III levels and low HDL cholesterol level, with or without elevated LDL cholesterol, increases cardiovascular disease risk and is commonly treated with combined statin and fibrate therapy. We sought to identify single nucleotide polymorphisms (SNPs) associated with apoC-III level response to combination therapy with statins and Fenofibric Acid (FA) in individuals with mixed dyslipidemia. Participants (n = 1,250) in a multicenter, randomized, double-blind, active-controlled study examining response to FA alone and in combination with statin were genotyped for candidate SNPs. Multivariate linear regression and two-way ANOVA for percent change in apoC-III level were performed. SNPs in the lipoprotein lipase (LPL) gene region, rs1801177 (P = 4.7 × 10(-8)), rs7016529 (P = 1.2 × 10(-6)), and rs249 (P = 4.1 × 10(-5)), were associated with apoC-III response to combination therapy. A haplotype composed of the minor alleles of these SNPs, with 2% population frequency, was associated with an unexpected apoC-III increase in response to statins and FA. This is the first report to show that genetic variation within the LPL gene region can affect the response of apoC-III levels to combined statin and FA therapy.
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variants in the apoa5 gene region and the response to combination therapy with statins and Fenofibric Acid in a randomized clinical trial of individuals with mixed dyslipidemia
Atherosclerosis, 2011Co-Authors: Ariel Brautbar, Peter H Jones, John W Belmont, Salim S Virani, Daniel Covarrubias, Fremiet Laragarduno, Suzanne M Leal, Christie M BallantyneAbstract:Abstract Objective Atherogenic dyslipidemia is highly associated with coronary heart disease and is characterized by elevated triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), and elevated low-density lipoprotein cholesterol (LDL-C). The combination of statins and fibrates is a common modality to treat individuals with atherogenic dyslipidemia. We sought to identify single nucleotide polymorphisms (SNPs) associated with HDL-C, TG, and apolipoprotein A1 (ApoA-I) response to combination therapy with statins and Fenofibric Acid (FA) in individuals with atherogenic dyslipidemia. Methods 2228 individuals with mixed dyslipidemia who were participating in a multicenter, randomized, double-blind, active-controlled study comparing FA alone, in combination with a statin, or statin alone for a 12-week period, were genotyped for 304 candidate SNPs. A multivariate linear regression analysis for percent change in HDL-C, ApoA-I and TG levels was performed. Results SNPs in the apolipoprotein ( APO ) A5-ZNF259 region rs3741298 ( P =1.8×10 −7 ), rs964184 ( P =3.6×10 −6 ), rs651821 ( P =4.5×10 −5 ), and rs10750097 ( P =1×10 −4 ), were significantly associated with HDL-C response to combination therapy with statins and FA, with a similar association identified for ApoA-I. A haplotype composed of the minor alleles of SNPs rs3741298, rs964184, and rs10750097, was associated with a positive response to statins and FA ( P =8.7×10 −7 ) and had a frequency of 18% in the study population. Conclusion In a population with atherogenic dyslipidemia, common SNPs and haplotypes within the APOA5-ZNF259 region are highly associated with HDL-C and ApoA-I response to combination therapy with statins and FA.
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long term efficacy of adding Fenofibric Acid to moderate dose statin therapy in patients with persistent elevated triglycerides
Cardiovascular Drugs and Therapy, 2011Co-Authors: Christie M Ballantyne, Maureen T Kelly, Carolyn M Setze, Peter H Jones, Aditya Lele, Kamlesh M Thakker, James C StolzenbachAbstract:Objective The objective of this study was to evaluate the long-term efficacy of adding Fenofibric Acid to moderate-dose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia.
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DOI 10.1007/s10557-011-6280-1 Long-Term Efficacy of Adding Fenofibric Acid to Moderate-Dose Statin Therapy in Patients with Persistent Elevated Triglycerides
2011Co-Authors: Christie M Ballantyne, Maureen T Kelly, Carolyn M Setze, James C Stolzenbach, Peter H Jones, Aditya Lele, Kamlesh M Thakker, J. C. StolzenbachAbstract:# The Author(s) 2011. This article is published with open access at Springerlink.com Objective The objective of this study was to evaluate the long-term efficacy of adding Fenofibric Acid to moderatedose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia. Methods This is a post hoc analysis of a subset of patients (N=92) with mixed dyslipidemia treated with moderatedose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg) for 12 weeks in three controlled trials who had achieved LDL-C <100 mg/dL but whose triglycerides remained>200 mg/dL, and had Fenofibric Acid 135 mg added to the moderate-dose statin in a 52-week open-label extension study. Lipid and apolipoprotein (Apo) values and the proportion of patients meeting individual and combined treatment targets with combination therapy were determined at scheduled visits during the 52-week study and compared with baseline (start of extension study). Results Addition of Fenofibric Acid to moderate-dose statin for 52 weeks resulted in significant (P<0.001) improvements in non–high-density lipoprotein cholesterol (non– HDL-C; –9.0%), ApoB (–9.8%), HDL-C (14.9%), and triglycerides (–37.6%) compared with baseline. At fina