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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
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...
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| Published in: | American journal of cardiovascular drugs : drugs, devices, and other interventions devices, and other interventions, 2010-01, Vol.10 (2), p.73-84 |
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| container_title | American journal of cardiovascular drugs : drugs, devices, and other interventions |
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| creator | Jones, Peter H. Cusi, Kenneth Davidson, Michael H. Kelly, Maureen T. Setze, Carolyn M. Thakker, Kamlesh Sleep, Darryl J. Stolzenbach, C. |
| description | 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 |
| doi_str_mv | 10.2165/10061630-000000000-00000 |
| format | article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_733185127</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A223527387</galeid><sourcerecordid>A223527387</sourcerecordid><originalsourceid>FETCH-LOGICAL-c403t-10af1bfe4b4f39f419de8a0f64a5e0064ef6449b8cf643d0ad64fd2b91b6cca93</originalsourceid><addsrcrecordid>eNqFUltrFDEYHcRiL_oXJOhDn6bNZa6Py25rhV0qtIJvIZN8qSkzyZpkqPNT_LdmO92KIjQJfIfknJMv4WQZIviMkqo8JxhXpGI4x_sxo1fZESF1m5Om_vb6EZc5o3V9mB2HcI8xqWndvskOKSYsGRRH2a8LrY0UckLCKnQjNMQJOY0uwTptOm8kWkij0NLlCzUYa0IEDwo9mPgdrd1DjpxHG6fAiwj5ygVAN1FEY1FaXxIAG8PM3pifSbiaQm-2RsFgxOOdt9MWEEUrIzqIENAG-t7EMbzNDrToA7x7qifZ18uL2-VVvr7-9Hm5WOeywCzmBAtNOg1FV2jW6oK0ChqBdVWIEtI3FZBg0XaNTJUpLFRVaEW7lnSVlKJlJ9np7Lv17scIIfLBBJmaEBbcGHjNGGlKQuvE_PAP896N3qbmOKW0agmjOJE-zqQ70QM3VrvohdxZ8gWlrEw-zc7q7D-sNHf_Ip0FbdL-X4JmFkjvQvCg-dabQfiJE8x3meD7TPDnTMwoSd8_tT12A6hn4T4EidDOhJCO7B34P-960fw3iAjBGg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>222691320</pqid></control><display><type>article</type><title>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</title><source>Springer Nature</source><creator>Jones, Peter H. ; Cusi, Kenneth ; Davidson, Michael H. ; Kelly, Maureen T. ; Setze, Carolyn M. ; Thakker, Kamlesh ; Sleep, Darryl J. ; Stolzenbach, C.</creator><creatorcontrib>Jones, Peter H. ; Cusi, Kenneth ; Davidson, Michael H. ; Kelly, Maureen T. ; Setze, Carolyn M. ; Thakker, Kamlesh ; Sleep, Darryl J. ; Stolzenbach, C.</creatorcontrib><description>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 lowdensity lipoprotein cholesterol (LDL-C) [−34.0%] than fenofibric acid monotherapy (−5.3%). Similarly, fenofibric acid + moderate-dose statin resulted in significantly (p≤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.</description><identifier>ISSN: 1175-3277</identifier><identifier>EISSN: 1179-187X</identifier><identifier>DOI: 10.2165/10061630-000000000-00000</identifier><identifier>PMID: 20136164</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject><![CDATA[Aged ; Atorvastatin Calcium ; Cardiology ; Clinical Trials, Phase III as Topic ; Diabetes Mellitus, Type 2 - complications ; Dosage and administration ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug therapy ; Drug Therapy, Combination ; Dyslipidemias ; Dyslipidemias - complications ; Dyslipidemias - drug therapy ; Female ; Fenofibrate ; Fenofibrate - administration & dosage ; Fenofibrate - adverse effects ; Fenofibrate - analogs & derivatives ; Fenofibrate - therapeutic use ; Fluorobenzenes - administration & dosage ; Fluorobenzenes - adverse effects ; Fluorobenzenes - therapeutic use ; Health aspects ; Heptanoic Acids - administration & dosage ; Heptanoic Acids - adverse effects ; Heptanoic Acids - therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hypolipidemic Agents - administration & dosage ; Hypolipidemic Agents - adverse effects ; Hypolipidemic Agents - therapeutic use ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Research Article ; Patient outcomes ; Pharmacology/Toxicology ; Pharmacotherapy ; Pyrimidines - administration & dosage ; Pyrimidines - adverse effects ; Pyrimidines - therapeutic use ; Pyrroles - administration & dosage ; Pyrroles - adverse effects ; Pyrroles - therapeutic use ; Randomized Controlled Trials as Topic ; Rosuvastatin Calcium ; Simvastatin - administration & dosage ; Simvastatin - adverse effects ; Simvastatin - therapeutic use ; Statins ; Sulfonamides - administration & dosage ; Sulfonamides - adverse effects ; Sulfonamides - therapeutic use]]></subject><ispartof>American journal of cardiovascular drugs : drugs, devices, and other interventions, 2010-01, Vol.10 (2), p.73-84</ispartof><rights>Adis Data Information BV 2010</rights><rights>COPYRIGHT 2010 Wolters Kluwer Health, Inc.</rights><rights>Copyright Wolters Kluwer Health Adis International Apr 2010</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c403t-10af1bfe4b4f39f419de8a0f64a5e0064ef6449b8cf643d0ad64fd2b91b6cca93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20136164$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jones, Peter H.</creatorcontrib><creatorcontrib>Cusi, Kenneth</creatorcontrib><creatorcontrib>Davidson, Michael H.</creatorcontrib><creatorcontrib>Kelly, Maureen T.</creatorcontrib><creatorcontrib>Setze, Carolyn M.</creatorcontrib><creatorcontrib>Thakker, Kamlesh</creatorcontrib><creatorcontrib>Sleep, Darryl J.</creatorcontrib><creatorcontrib>Stolzenbach, C.</creatorcontrib><title>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</title><title>American journal of cardiovascular drugs : drugs, devices, and other interventions</title><addtitle>Am J Cardiovasc Drugs</addtitle><addtitle>Am J Cardiovasc Drugs</addtitle><description>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 lowdensity lipoprotein cholesterol (LDL-C) [−34.0%] than fenofibric acid monotherapy (−5.3%). Similarly, fenofibric acid + moderate-dose statin resulted in significantly (p≤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.</description><subject>Aged</subject><subject>Atorvastatin Calcium</subject><subject>Cardiology</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Dosage and administration</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Dyslipidemias</subject><subject>Dyslipidemias - complications</subject><subject>Dyslipidemias - drug therapy</subject><subject>Female</subject><subject>Fenofibrate</subject><subject>Fenofibrate - administration & dosage</subject><subject>Fenofibrate - adverse effects</subject><subject>Fenofibrate - analogs & derivatives</subject><subject>Fenofibrate - therapeutic use</subject><subject>Fluorobenzenes - administration & dosage</subject><subject>Fluorobenzenes - adverse effects</subject><subject>Fluorobenzenes - therapeutic use</subject><subject>Health aspects</subject><subject>Heptanoic Acids - administration & dosage</subject><subject>Heptanoic Acids - adverse effects</subject><subject>Heptanoic Acids - therapeutic use</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Hypolipidemic Agents - administration & dosage</subject><subject>Hypolipidemic Agents - adverse effects</subject><subject>Hypolipidemic Agents - therapeutic use</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Research Article</subject><subject>Patient outcomes</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Pyrimidines - administration & dosage</subject><subject>Pyrimidines - adverse effects</subject><subject>Pyrimidines - therapeutic use</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - adverse effects</subject><subject>Pyrroles - therapeutic use</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Rosuvastatin Calcium</subject><subject>Simvastatin - administration & dosage</subject><subject>Simvastatin - adverse effects</subject><subject>Simvastatin - therapeutic use</subject><subject>Statins</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - adverse effects</subject><subject>Sulfonamides - therapeutic use</subject><issn>1175-3277</issn><issn>1179-187X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNqFUltrFDEYHcRiL_oXJOhDn6bNZa6Py25rhV0qtIJvIZN8qSkzyZpkqPNT_LdmO92KIjQJfIfknJMv4WQZIviMkqo8JxhXpGI4x_sxo1fZESF1m5Om_vb6EZc5o3V9mB2HcI8xqWndvskOKSYsGRRH2a8LrY0UckLCKnQjNMQJOY0uwTptOm8kWkij0NLlCzUYa0IEDwo9mPgdrd1DjpxHG6fAiwj5ygVAN1FEY1FaXxIAG8PM3pifSbiaQm-2RsFgxOOdt9MWEEUrIzqIENAG-t7EMbzNDrToA7x7qifZ18uL2-VVvr7-9Hm5WOeywCzmBAtNOg1FV2jW6oK0ChqBdVWIEtI3FZBg0XaNTJUpLFRVaEW7lnSVlKJlJ9np7Lv17scIIfLBBJmaEBbcGHjNGGlKQuvE_PAP896N3qbmOKW0agmjOJE-zqQ70QM3VrvohdxZ8gWlrEw-zc7q7D-sNHf_Ip0FbdL-X4JmFkjvQvCg-dabQfiJE8x3meD7TPDnTMwoSd8_tT12A6hn4T4EidDOhJCO7B34P-960fw3iAjBGg</recordid><startdate>20100101</startdate><enddate>20100101</enddate><creator>Jones, Peter H.</creator><creator>Cusi, Kenneth</creator><creator>Davidson, Michael H.</creator><creator>Kelly, Maureen T.</creator><creator>Setze, Carolyn M.</creator><creator>Thakker, Kamlesh</creator><creator>Sleep, Darryl J.</creator><creator>Stolzenbach, C.</creator><general>Springer International Publishing</general><general>Wolters Kluwer Health, Inc</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20100101</creationdate><title>Efficacy and Safety of Fenofibric Acid Co-Administered with Low- or Moderate-Dose Statin in Patients with Mixed Dyslipidemia and Type 2 Diabetes Mellitus</title><author>Jones, Peter H. ; Cusi, Kenneth ; Davidson, Michael H. ; Kelly, Maureen T. ; Setze, Carolyn M. ; Thakker, Kamlesh ; Sleep, Darryl J. ; Stolzenbach, C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c403t-10af1bfe4b4f39f419de8a0f64a5e0064ef6449b8cf643d0ad64fd2b91b6cca93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Aged</topic><topic>Atorvastatin Calcium</topic><topic>Cardiology</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Dosage and administration</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Dyslipidemias</topic><topic>Dyslipidemias - complications</topic><topic>Dyslipidemias - drug therapy</topic><topic>Female</topic><topic>Fenofibrate</topic><topic>Fenofibrate - administration & dosage</topic><topic>Fenofibrate - adverse effects</topic><topic>Fenofibrate - analogs & derivatives</topic><topic>Fenofibrate - therapeutic use</topic><topic>Fluorobenzenes - administration & dosage</topic><topic>Fluorobenzenes - adverse effects</topic><topic>Fluorobenzenes - therapeutic use</topic><topic>Health aspects</topic><topic>Heptanoic Acids - administration & dosage</topic><topic>Heptanoic Acids - adverse effects</topic><topic>Heptanoic Acids - therapeutic use</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Hypolipidemic Agents - administration & dosage</topic><topic>Hypolipidemic Agents - adverse effects</topic><topic>Hypolipidemic Agents - therapeutic use</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Research Article</topic><topic>Patient outcomes</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Pyrimidines - administration & dosage</topic><topic>Pyrimidines - adverse effects</topic><topic>Pyrimidines - therapeutic use</topic><topic>Pyrroles - administration & dosage</topic><topic>Pyrroles - adverse effects</topic><topic>Pyrroles - therapeutic use</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Rosuvastatin Calcium</topic><topic>Simvastatin - administration & dosage</topic><topic>Simvastatin - adverse effects</topic><topic>Simvastatin - therapeutic use</topic><topic>Statins</topic><topic>Sulfonamides - administration & dosage</topic><topic>Sulfonamides - adverse effects</topic><topic>Sulfonamides - therapeutic use</topic><toplevel>online_resources</toplevel><creatorcontrib>Jones, Peter H.</creatorcontrib><creatorcontrib>Cusi, Kenneth</creatorcontrib><creatorcontrib>Davidson, Michael H.</creatorcontrib><creatorcontrib>Kelly, Maureen T.</creatorcontrib><creatorcontrib>Setze, Carolyn M.</creatorcontrib><creatorcontrib>Thakker, Kamlesh</creatorcontrib><creatorcontrib>Sleep, Darryl J.</creatorcontrib><creatorcontrib>Stolzenbach, C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of cardiovascular drugs : drugs, devices, and other interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jones, Peter H.</au><au>Cusi, Kenneth</au><au>Davidson, Michael H.</au><au>Kelly, Maureen T.</au><au>Setze, Carolyn M.</au><au>Thakker, Kamlesh</au><au>Sleep, Darryl J.</au><au>Stolzenbach, C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>American journal of cardiovascular drugs : drugs, devices, and other interventions</jtitle><stitle>Am J Cardiovasc Drugs</stitle><addtitle>Am J Cardiovasc Drugs</addtitle><date>2010-01-01</date><risdate>2010</risdate><volume>10</volume><issue>2</issue><spage>73</spage><epage>84</epage><pages>73-84</pages><issn>1175-3277</issn><eissn>1179-187X</eissn><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 lowdensity lipoprotein cholesterol (LDL-C) [−34.0%] than fenofibric acid monotherapy (−5.3%). Similarly, fenofibric acid + moderate-dose statin resulted in significantly (p≤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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>20136164</pmid><doi>10.2165/10061630-000000000-00000</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1175-3277 |
| ispartof | American journal of cardiovascular drugs : drugs, devices, and other interventions, 2010-01, Vol.10 (2), p.73-84 |
| issn | 1175-3277 1179-187X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_733185127 |
| source | Springer Nature |
| subjects | Aged Atorvastatin Calcium Cardiology Clinical Trials, Phase III as Topic Diabetes Mellitus, Type 2 - complications Dosage and administration Dose-Response Relationship, Drug Double-Blind Method Drug therapy Drug Therapy, Combination Dyslipidemias Dyslipidemias - complications Dyslipidemias - drug therapy Female Fenofibrate Fenofibrate - administration & dosage Fenofibrate - adverse effects Fenofibrate - analogs & derivatives Fenofibrate - therapeutic use Fluorobenzenes - administration & dosage Fluorobenzenes - adverse effects Fluorobenzenes - therapeutic use Health aspects Heptanoic Acids - administration & dosage Heptanoic Acids - adverse effects Heptanoic Acids - therapeutic use Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Hypolipidemic Agents - administration & dosage Hypolipidemic Agents - adverse effects Hypolipidemic Agents - therapeutic use Male Medicine Medicine & Public Health Middle Aged Original Research Article Patient outcomes Pharmacology/Toxicology Pharmacotherapy Pyrimidines - administration & dosage Pyrimidines - adverse effects Pyrimidines - therapeutic use Pyrroles - administration & dosage Pyrroles - adverse effects Pyrroles - therapeutic use Randomized Controlled Trials as Topic Rosuvastatin Calcium Simvastatin - administration & dosage Simvastatin - adverse effects Simvastatin - therapeutic use Statins Sulfonamides - administration & dosage Sulfonamides - adverse effects Sulfonamides - therapeutic use |
| title | 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 |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T14%3A10%3A07IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20Safety%20of%20Fenofibric%20Acid%20Co-Administered%20with%20Low-%20or%20Moderate-Dose%20Statin%20in%20Patients%20with%20Mixed%20Dyslipidemia%20and%20Type%202%20Diabetes%20Mellitus:%20Results%20of%20a%20Pooled%20Subgroup%20Analysis%20from%20Three%20Randomized,%20Controlled,%20Double-Blind%20Trials&rft.jtitle=American%20journal%20of%20cardiovascular%20drugs%20:%20drugs,%20devices,%20and%20other%20interventions&rft.au=Jones,%20Peter%20H.&rft.date=2010-01-01&rft.volume=10&rft.issue=2&rft.spage=73&rft.epage=84&rft.pages=73-84&rft.issn=1175-3277&rft.eissn=1179-187X&rft_id=info:doi/10.2165/10061630-000000000-00000&rft_dat=%3Cgale_proqu%3EA223527387%3C/gale_proqu%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c403t-10af1bfe4b4f39f419de8a0f64a5e0064ef6449b8cf643d0ad64fd2b91b6cca93%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=222691320&rft_id=info:pmid/20136164&rft_galeid=A223527387&rfr_iscdi=true |