Efficacy and Safety of Coadministration of Fenofibrate and Ezetimibe Compared with Each as Monotherapy in Patients with Type IIb Dyslipidemia and Features of the Metabolic Syndrome: A Prospective, Randomized, Double-Blind, Three-Parallel Arm, Multicenter, Comparative Study
Background Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduc...
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| Veröffentlicht in: | American journal of cardiovascular drugs : drugs, devices, and other interventions devices, and other interventions, 2009-01, Vol.9 (2), p.91-101 |
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| creator | Ansquer, Jean-Claude Bekaert, Ivan Guy, Martine Hanefeld, Markolf Simon, Alain |
| description | Background
Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduces TG and, more moderately, LDL-C, increases HDL-C and produces a shift from small to large LDL particle size; the main effect of ezetimibe is a reduction in LDL-C levels. Combined treatment with fenofibrate and ezetimibe may correct all the abnormalities of type IIb dyslipidemia.
Objective
To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal®) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome compared with administration of fenofibrate and ezetimibe alone (ClinicalTrials.gov Identifier: NCT00349284; Study ID: CLF178P 04 01).
Methods
This was a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Sixty ambulatory patients (mean age 56 years; 50% women, 50% men) were treated in each group. For inclusion in the study, patients were required to have LDL-C ≥4.13 mmol/L (≥ 160 mg/dL), TG ≥1.71 mmol/L and ≤4.57 mmol/L (≥150 mg/dL and ≤405 mg/dL), and at least two of the following National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome: low HDL-C or increased fasting plasma glucose, blood pressure, or waist circumference. Patients received fenofibrate 145 mg, ezetimibe 10 mg, or coadministration of both (fenofibrate/ezetimibe) daily for 12 weeks. The outcome measures were changes in lipids and related parameters, apolipoproteins, glucose metabolism parameters, and high-sensitivity C-reactive protein (hsCRP).
Results
Fenofibrate/ezetimibe was more effective than either fenofibrate or ezetimibe in reducing LDL-C (−36.2% vs −22.4% and −22.8%, respectively), non-HDL-C (−36.2% vs −24.8% and −20.9%, respectively), total cholesterol (TC) [−27.9% vs −18.9% and −17.1%, respectively], apolipoprotein B (−33.3% vs −24.5% and −18.7%, respectively), TC/HDL-C ratio (−34.2% vs −23.0% and −17.0%, respectively), and apolipoprotein B/apolipoprotein AI ratio (−37.5% vs −27.0% and −17.7%, respectively) [p |
| doi_str_mv | 10.1007/BF03256580 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_cross</sourceid><recordid>TN_cdi_gale_infotracmisc_A209477250</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A209477250</galeid><sourcerecordid>A209477250</sourcerecordid><originalsourceid>FETCH-LOGICAL-c254t-1ae09a9d80ea71ab4c5d3d78c438743e38d5d41e728c32a25953b3c8f9b6c3113</originalsourceid><addsrcrecordid>eNpt0c1q3DAQB3ATWkia9tInEOSW4kQfVmQf0-1uspDQQlLozYylUVZhLRlJoTjP1QesdjfQS08aht_8hTRV9ZnRC0apuvy6ooLLK9nSo-qEMdXVrFW_3u1rWQuu1HH1IaVnSpniqjup_iytdRr0TMAb8gAW80yCJYsAZnTepRwhu-B3vRX6YN1QGrjXy1fMbnQDFj1OENGQ3y5vyBL0hkAi98GHvMEI00ycJz9KEPqcDuhxnpCs1wP5Nqetm5zB0cE-doWQXyKm3ZVlnNxjhiFsnSYPszcxjPixem9hm_DT23la_VwtHxe39d33m_Xi-q7WXDa5ZoC0g860FEExGBotjTCq1Y1oVSNQtEaahqHirRYcuOykGIRubTdcacGYOK3ODrlPsMXeeRvKb-jRJd1fc9o1SnFJizo_KB1DShFtP0U3Qpx7RvvdVvp_Wyn4ywGngvwTxv45vERfXvE__ReoUI6q</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Efficacy and Safety of Coadministration of Fenofibrate and Ezetimibe Compared with Each as Monotherapy in Patients with Type IIb Dyslipidemia and Features of the Metabolic Syndrome: A Prospective, Randomized, Double-Blind, Three-Parallel Arm, Multicenter, Comparative Study</title><source>SpringerLink Journals</source><creator>Ansquer, Jean-Claude ; Bekaert, Ivan ; Guy, Martine ; Hanefeld, Markolf ; Simon, Alain</creator><creatorcontrib>Ansquer, Jean-Claude ; Bekaert, Ivan ; Guy, Martine ; Hanefeld, Markolf ; Simon, Alain ; The Study Investigators</creatorcontrib><description>Background
Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduces TG and, more moderately, LDL-C, increases HDL-C and produces a shift from small to large LDL particle size; the main effect of ezetimibe is a reduction in LDL-C levels. Combined treatment with fenofibrate and ezetimibe may correct all the abnormalities of type IIb dyslipidemia.
Objective
To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal®) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome compared with administration of fenofibrate and ezetimibe alone (ClinicalTrials.gov Identifier: NCT00349284; Study ID: CLF178P 04 01).
Methods
This was a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Sixty ambulatory patients (mean age 56 years; 50% women, 50% men) were treated in each group. For inclusion in the study, patients were required to have LDL-C ≥4.13 mmol/L (≥ 160 mg/dL), TG ≥1.71 mmol/L and ≤4.57 mmol/L (≥150 mg/dL and ≤405 mg/dL), and at least two of the following National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome: low HDL-C or increased fasting plasma glucose, blood pressure, or waist circumference. Patients received fenofibrate 145 mg, ezetimibe 10 mg, or coadministration of both (fenofibrate/ezetimibe) daily for 12 weeks. The outcome measures were changes in lipids and related parameters, apolipoproteins, glucose metabolism parameters, and high-sensitivity C-reactive protein (hsCRP).
Results
Fenofibrate/ezetimibe was more effective than either fenofibrate or ezetimibe in reducing LDL-C (−36.2% vs −22.4% and −22.8%, respectively), non-HDL-C (−36.2% vs −24.8% and −20.9%, respectively), total cholesterol (TC) [−27.9% vs −18.9% and −17.1%, respectively], apolipoprotein B (−33.3% vs −24.5% and −18.7%, respectively), TC/HDL-C ratio (−34.2% vs −23.0% and −17.0%, respectively), and apolipoprotein B/apolipoprotein AI ratio (−37.5% vs −27.0% and −17.7%, respectively) [p<0.001 for all comparisons between fenofibrate/ezetimibe and monotherapies]. Fenofibrate/ezetimibe was as effective as fenofibrate and more effective than ezetimibe in reducing remnant-like particle cholesterol (−36.2% and −30.7% vs −17.3%, respectively), and in increasing LDL size ( + 2.1% and + 1.9% vs + 0.7%, respectively), apolipoprotein AI (+7.9% and + 5.1% vs +0.2%, respectively) and apolipoprotein AII ( + 24.2% and +21.2% vs + 2.7%, respectively). Fenofibrate/ezetimibe and fenofibrate were equally effective in reducing TG (both −38.3%) and in increasing HDL-C (+11.5% and + 7.9%, respectively; p = 0.282). Ezetimibe had minor effects on TG (−10.4%) and HDL-C ( + 2.2%). Among patients with low HDL-C at baseline (<1.29 mmol/L [<50 mg/dL] in women, <1.03 mmol/L [<40 mg/dL] in men), normalization of HDL-C was observed in 52.9% with fenofibrate/ezetimibe and in 58.8% with fenofibrate, compared with 20.0% with ezetimibe. Changes in hsCRP were −25.9% with fenofibrate/ezetimibe, −27.8% with fenofibrate, and −10.2% with ezetimibe (not statistically significant). None of the treatments altered glucose metabolism parameters.
Conclusion
In patients with type IIb dyslipidemia and features of the metabolic syndrome, coadministration of fenofibrate 145 mg and ezetimibe 10 mg daily was more effective than either monotherapy in reducing LDL-C, non-HDL-C, apolipoprotein B, and cardiovascular risk ratios, and was as effective as fenofibrate 145 mg alone in reducing TG and in increasing HDL-C in patients with low baseline HDL-C levels.</description><identifier>ISSN: 1175-3277</identifier><identifier>EISSN: 1179-187X</identifier><identifier>DOI: 10.1007/BF03256580</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Cardiology ; Complications and side effects ; Dosage and administration ; Drug therapy ; Drug therapy, Combination ; Dyslipidemias ; Fenofibrate ; Health aspects ; Medicine ; Medicine & Public Health ; Metabolic syndrome X ; Original Research Article ; Pharmacology/Toxicology ; Pharmacotherapy ; Risk factors</subject><ispartof>American journal of cardiovascular drugs : drugs, devices, and other interventions, 2009-01, Vol.9 (2), p.91-101</ispartof><rights>Adis Data Information BV 2009</rights><rights>COPYRIGHT 2009 Wolters Kluwer Health, Inc.</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c254t-1ae09a9d80ea71ab4c5d3d78c438743e38d5d41e728c32a25953b3c8f9b6c3113</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/BF03256580$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/BF03256580$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids></links><search><creatorcontrib>Ansquer, Jean-Claude</creatorcontrib><creatorcontrib>Bekaert, Ivan</creatorcontrib><creatorcontrib>Guy, Martine</creatorcontrib><creatorcontrib>Hanefeld, Markolf</creatorcontrib><creatorcontrib>Simon, Alain</creatorcontrib><creatorcontrib>The Study Investigators</creatorcontrib><title>Efficacy and Safety of Coadministration of Fenofibrate and Ezetimibe Compared with Each as Monotherapy in Patients with Type IIb Dyslipidemia and Features of the Metabolic Syndrome: A Prospective, Randomized, Double-Blind, Three-Parallel Arm, Multicenter, Comparative Study</title><title>American journal of cardiovascular drugs : drugs, devices, and other interventions</title><addtitle>Am J Cardiovasc Drugs</addtitle><description>Background
Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduces TG and, more moderately, LDL-C, increases HDL-C and produces a shift from small to large LDL particle size; the main effect of ezetimibe is a reduction in LDL-C levels. Combined treatment with fenofibrate and ezetimibe may correct all the abnormalities of type IIb dyslipidemia.
Objective
To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal®) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome compared with administration of fenofibrate and ezetimibe alone (ClinicalTrials.gov Identifier: NCT00349284; Study ID: CLF178P 04 01).
Methods
This was a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Sixty ambulatory patients (mean age 56 years; 50% women, 50% men) were treated in each group. For inclusion in the study, patients were required to have LDL-C ≥4.13 mmol/L (≥ 160 mg/dL), TG ≥1.71 mmol/L and ≤4.57 mmol/L (≥150 mg/dL and ≤405 mg/dL), and at least two of the following National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome: low HDL-C or increased fasting plasma glucose, blood pressure, or waist circumference. Patients received fenofibrate 145 mg, ezetimibe 10 mg, or coadministration of both (fenofibrate/ezetimibe) daily for 12 weeks. The outcome measures were changes in lipids and related parameters, apolipoproteins, glucose metabolism parameters, and high-sensitivity C-reactive protein (hsCRP).
Results
Fenofibrate/ezetimibe was more effective than either fenofibrate or ezetimibe in reducing LDL-C (−36.2% vs −22.4% and −22.8%, respectively), non-HDL-C (−36.2% vs −24.8% and −20.9%, respectively), total cholesterol (TC) [−27.9% vs −18.9% and −17.1%, respectively], apolipoprotein B (−33.3% vs −24.5% and −18.7%, respectively), TC/HDL-C ratio (−34.2% vs −23.0% and −17.0%, respectively), and apolipoprotein B/apolipoprotein AI ratio (−37.5% vs −27.0% and −17.7%, respectively) [p<0.001 for all comparisons between fenofibrate/ezetimibe and monotherapies]. Fenofibrate/ezetimibe was as effective as fenofibrate and more effective than ezetimibe in reducing remnant-like particle cholesterol (−36.2% and −30.7% vs −17.3%, respectively), and in increasing LDL size ( + 2.1% and + 1.9% vs + 0.7%, respectively), apolipoprotein AI (+7.9% and + 5.1% vs +0.2%, respectively) and apolipoprotein AII ( + 24.2% and +21.2% vs + 2.7%, respectively). Fenofibrate/ezetimibe and fenofibrate were equally effective in reducing TG (both −38.3%) and in increasing HDL-C (+11.5% and + 7.9%, respectively; p = 0.282). Ezetimibe had minor effects on TG (−10.4%) and HDL-C ( + 2.2%). Among patients with low HDL-C at baseline (<1.29 mmol/L [<50 mg/dL] in women, <1.03 mmol/L [<40 mg/dL] in men), normalization of HDL-C was observed in 52.9% with fenofibrate/ezetimibe and in 58.8% with fenofibrate, compared with 20.0% with ezetimibe. Changes in hsCRP were −25.9% with fenofibrate/ezetimibe, −27.8% with fenofibrate, and −10.2% with ezetimibe (not statistically significant). None of the treatments altered glucose metabolism parameters.
Conclusion
In patients with type IIb dyslipidemia and features of the metabolic syndrome, coadministration of fenofibrate 145 mg and ezetimibe 10 mg daily was more effective than either monotherapy in reducing LDL-C, non-HDL-C, apolipoprotein B, and cardiovascular risk ratios, and was as effective as fenofibrate 145 mg alone in reducing TG and in increasing HDL-C in patients with low baseline HDL-C levels.</description><subject>Cardiology</subject><subject>Complications and side effects</subject><subject>Dosage and administration</subject><subject>Drug therapy</subject><subject>Drug therapy, Combination</subject><subject>Dyslipidemias</subject><subject>Fenofibrate</subject><subject>Health aspects</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metabolic syndrome X</subject><subject>Original Research Article</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Risk factors</subject><issn>1175-3277</issn><issn>1179-187X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><recordid>eNpt0c1q3DAQB3ATWkia9tInEOSW4kQfVmQf0-1uspDQQlLozYylUVZhLRlJoTjP1QesdjfQS08aht_8hTRV9ZnRC0apuvy6ooLLK9nSo-qEMdXVrFW_3u1rWQuu1HH1IaVnSpniqjup_iytdRr0TMAb8gAW80yCJYsAZnTepRwhu-B3vRX6YN1QGrjXy1fMbnQDFj1OENGQ3y5vyBL0hkAi98GHvMEI00ycJz9KEPqcDuhxnpCs1wP5Nqetm5zB0cE-doWQXyKm3ZVlnNxjhiFsnSYPszcxjPixem9hm_DT23la_VwtHxe39d33m_Xi-q7WXDa5ZoC0g860FEExGBotjTCq1Y1oVSNQtEaahqHirRYcuOykGIRubTdcacGYOK3ODrlPsMXeeRvKb-jRJd1fc9o1SnFJizo_KB1DShFtP0U3Qpx7RvvdVvp_Wyn4ywGngvwTxv45vERfXvE__ReoUI6q</recordid><startdate>20090101</startdate><enddate>20090101</enddate><creator>Ansquer, Jean-Claude</creator><creator>Bekaert, Ivan</creator><creator>Guy, Martine</creator><creator>Hanefeld, Markolf</creator><creator>Simon, Alain</creator><general>Springer International Publishing</general><general>Wolters Kluwer Health, Inc</general><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20090101</creationdate><title>Efficacy and Safety of Coadministration of Fenofibrate and Ezetimibe Compared with Each as Monotherapy in Patients with Type IIb Dyslipidemia and Features of the Metabolic Syndrome</title><author>Ansquer, Jean-Claude ; Bekaert, Ivan ; Guy, Martine ; Hanefeld, Markolf ; Simon, Alain</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c254t-1ae09a9d80ea71ab4c5d3d78c438743e38d5d41e728c32a25953b3c8f9b6c3113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Cardiology</topic><topic>Complications and side effects</topic><topic>Dosage and administration</topic><topic>Drug therapy</topic><topic>Drug therapy, Combination</topic><topic>Dyslipidemias</topic><topic>Fenofibrate</topic><topic>Health aspects</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolic syndrome X</topic><topic>Original Research Article</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Risk factors</topic><toplevel>online_resources</toplevel><creatorcontrib>Ansquer, Jean-Claude</creatorcontrib><creatorcontrib>Bekaert, Ivan</creatorcontrib><creatorcontrib>Guy, Martine</creatorcontrib><creatorcontrib>Hanefeld, Markolf</creatorcontrib><creatorcontrib>Simon, Alain</creatorcontrib><creatorcontrib>The Study Investigators</creatorcontrib><collection>CrossRef</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>Ansquer, Jean-Claude</au><au>Bekaert, Ivan</au><au>Guy, Martine</au><au>Hanefeld, Markolf</au><au>Simon, Alain</au><aucorp>The Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Coadministration of Fenofibrate and Ezetimibe Compared with Each as Monotherapy in Patients with Type IIb Dyslipidemia and Features of the Metabolic Syndrome: A Prospective, Randomized, Double-Blind, Three-Parallel Arm, Multicenter, Comparative Study</atitle><jtitle>American journal of cardiovascular drugs : drugs, devices, and other interventions</jtitle><stitle>Am J Cardiovasc Drugs</stitle><date>2009-01-01</date><risdate>2009</risdate><volume>9</volume><issue>2</issue><spage>91</spage><epage>101</epage><pages>91-101</pages><issn>1175-3277</issn><eissn>1179-187X</eissn><abstract>Background
Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduces TG and, more moderately, LDL-C, increases HDL-C and produces a shift from small to large LDL particle size; the main effect of ezetimibe is a reduction in LDL-C levels. Combined treatment with fenofibrate and ezetimibe may correct all the abnormalities of type IIb dyslipidemia.
Objective
To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal®) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome compared with administration of fenofibrate and ezetimibe alone (ClinicalTrials.gov Identifier: NCT00349284; Study ID: CLF178P 04 01).
Methods
This was a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Sixty ambulatory patients (mean age 56 years; 50% women, 50% men) were treated in each group. For inclusion in the study, patients were required to have LDL-C ≥4.13 mmol/L (≥ 160 mg/dL), TG ≥1.71 mmol/L and ≤4.57 mmol/L (≥150 mg/dL and ≤405 mg/dL), and at least two of the following National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome: low HDL-C or increased fasting plasma glucose, blood pressure, or waist circumference. Patients received fenofibrate 145 mg, ezetimibe 10 mg, or coadministration of both (fenofibrate/ezetimibe) daily for 12 weeks. The outcome measures were changes in lipids and related parameters, apolipoproteins, glucose metabolism parameters, and high-sensitivity C-reactive protein (hsCRP).
Results
Fenofibrate/ezetimibe was more effective than either fenofibrate or ezetimibe in reducing LDL-C (−36.2% vs −22.4% and −22.8%, respectively), non-HDL-C (−36.2% vs −24.8% and −20.9%, respectively), total cholesterol (TC) [−27.9% vs −18.9% and −17.1%, respectively], apolipoprotein B (−33.3% vs −24.5% and −18.7%, respectively), TC/HDL-C ratio (−34.2% vs −23.0% and −17.0%, respectively), and apolipoprotein B/apolipoprotein AI ratio (−37.5% vs −27.0% and −17.7%, respectively) [p<0.001 for all comparisons between fenofibrate/ezetimibe and monotherapies]. Fenofibrate/ezetimibe was as effective as fenofibrate and more effective than ezetimibe in reducing remnant-like particle cholesterol (−36.2% and −30.7% vs −17.3%, respectively), and in increasing LDL size ( + 2.1% and + 1.9% vs + 0.7%, respectively), apolipoprotein AI (+7.9% and + 5.1% vs +0.2%, respectively) and apolipoprotein AII ( + 24.2% and +21.2% vs + 2.7%, respectively). Fenofibrate/ezetimibe and fenofibrate were equally effective in reducing TG (both −38.3%) and in increasing HDL-C (+11.5% and + 7.9%, respectively; p = 0.282). Ezetimibe had minor effects on TG (−10.4%) and HDL-C ( + 2.2%). Among patients with low HDL-C at baseline (<1.29 mmol/L [<50 mg/dL] in women, <1.03 mmol/L [<40 mg/dL] in men), normalization of HDL-C was observed in 52.9% with fenofibrate/ezetimibe and in 58.8% with fenofibrate, compared with 20.0% with ezetimibe. Changes in hsCRP were −25.9% with fenofibrate/ezetimibe, −27.8% with fenofibrate, and −10.2% with ezetimibe (not statistically significant). None of the treatments altered glucose metabolism parameters.
Conclusion
In patients with type IIb dyslipidemia and features of the metabolic syndrome, coadministration of fenofibrate 145 mg and ezetimibe 10 mg daily was more effective than either monotherapy in reducing LDL-C, non-HDL-C, apolipoprotein B, and cardiovascular risk ratios, and was as effective as fenofibrate 145 mg alone in reducing TG and in increasing HDL-C in patients with low baseline HDL-C levels.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><doi>10.1007/BF03256580</doi><tpages>11</tpages></addata></record> |
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| subjects | Cardiology Complications and side effects Dosage and administration Drug therapy Drug therapy, Combination Dyslipidemias Fenofibrate Health aspects Medicine Medicine & Public Health Metabolic syndrome X Original Research Article Pharmacology/Toxicology Pharmacotherapy Risk factors |
| title | Efficacy and Safety of Coadministration of Fenofibrate and Ezetimibe Compared with Each as Monotherapy in Patients with Type IIb Dyslipidemia and Features of the Metabolic Syndrome: A Prospective, Randomized, Double-Blind, Three-Parallel Arm, Multicenter, Comparative Study |
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