Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia
Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia James M. McKenney, Michel Farnier, Kwok-Wing Lo, Harold E. Bays, Inna Perevozkaya, Gary Carlson, Michael J. Davies, Yale B. Mitchel, Barry Gumbiner This double-blind long-term extens...
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| description | Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia
James M. McKenney, Michel Farnier, Kwok-Wing Lo, Harold E. Bays, Inna Perevozkaya, Gary Carlson, Michael J. Davies, Yale B. Mitchel, Barry Gumbiner
This double-blind long-term extension study compared the safety and efficacy of co-administered fenofibrate and ezetimibe (FENO plus EZE) with fenofibrate monotherapy in 576 patients with mixed hyperlipidemia over 48 weeks. The FENO plus EZE produced significantly greater reductions in low-density lipoprotein C, total cholesterol, triglycerides, non–high-density lipoprotein C, and apolipoprotein B compared with FENO monotherapy. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. The FENO plus EZE was generally well tolerated with a safety profile similar to that of FENO monotherapy. Co-administration of FENO plus EZE provides complementary and beneficial effects on the lipid profile of patients with mixed hyperlipidemia.
This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia.
Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia.
After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively.
Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (−22% vs. −9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non–HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine a |
| doi_str_mv | 10.1016/j.jacc.2005.11.072 |
| format | Article |
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James M. McKenney, Michel Farnier, Kwok-Wing Lo, Harold E. Bays, Inna Perevozkaya, Gary Carlson, Michael J. Davies, Yale B. Mitchel, Barry Gumbiner
This double-blind long-term extension study compared the safety and efficacy of co-administered fenofibrate and ezetimibe (FENO plus EZE) with fenofibrate monotherapy in 576 patients with mixed hyperlipidemia over 48 weeks. The FENO plus EZE produced significantly greater reductions in low-density lipoprotein C, total cholesterol, triglycerides, non–high-density lipoprotein C, and apolipoprotein B compared with FENO monotherapy. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. The FENO plus EZE was generally well tolerated with a safety profile similar to that of FENO monotherapy. Co-administration of FENO plus EZE provides complementary and beneficial effects on the lipid profile of patients with mixed hyperlipidemia.
This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia.
Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia.
After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively.
Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (−22% vs. −9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non–HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase ≥3 times upper limit of normal were similar between the FENO plus EZE (1.2%) and FENO (1.7%) groups. No cases of creatine phosphokinase elevations ≥10 times upper limit of normal or myopathy were observed in either group.
Long-term, 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia.</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2005.11.072</identifier><identifier>PMID: 16630994</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Apolipoproteins ; Azetidines - administration & dosage ; Azetidines - adverse effects ; Azetidines - therapeutic use ; Cardiology ; Cholesterol ; Diabetes ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Ezetimibe ; Female ; Fenofibrate - administration & dosage ; Fenofibrate - adverse effects ; Fenofibrate - therapeutic use ; Gallbladder diseases ; Humans ; Hyperlipidemia, Familial Combined - blood ; Hyperlipidemia, Familial Combined - drug therapy ; Hypolipidemic Agents - administration & dosage ; Hypolipidemic Agents - adverse effects ; Hypolipidemic Agents - therapeutic use ; Lipids ; Lipids - blood ; Low density lipoprotein ; Male ; Middle Aged ; Proteins ; Treatment Outcome ; Triglycerides</subject><ispartof>Journal of the American College of Cardiology, 2006-04, Vol.47 (8), p.1584-1587</ispartof><rights>2006 American College of Cardiology Foundation</rights><rights>Copyright Elsevier Limited Apr 18, 2006</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c417t-ac08eb1139e6f825152e757958f4fa252420a8273918dd7a3b528a60b96ea53b3</citedby><cites>FETCH-LOGICAL-c417t-ac08eb1139e6f825152e757958f4fa252420a8273918dd7a3b528a60b96ea53b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jacc.2005.11.072$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16630994$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>McKenney, James M.</creatorcontrib><creatorcontrib>Farnier, Michel</creatorcontrib><creatorcontrib>Lo, Kwok-Wing</creatorcontrib><creatorcontrib>Bays, Harold E.</creatorcontrib><creatorcontrib>Perevozkaya, Inna</creatorcontrib><creatorcontrib>Carlson, Gary</creatorcontrib><creatorcontrib>Davies, Michael J.</creatorcontrib><creatorcontrib>Mitchel, Yale B.</creatorcontrib><creatorcontrib>Gumbiner, Barry</creatorcontrib><title>Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia
James M. McKenney, Michel Farnier, Kwok-Wing Lo, Harold E. Bays, Inna Perevozkaya, Gary Carlson, Michael J. Davies, Yale B. Mitchel, Barry Gumbiner
This double-blind long-term extension study compared the safety and efficacy of co-administered fenofibrate and ezetimibe (FENO plus EZE) with fenofibrate monotherapy in 576 patients with mixed hyperlipidemia over 48 weeks. The FENO plus EZE produced significantly greater reductions in low-density lipoprotein C, total cholesterol, triglycerides, non–high-density lipoprotein C, and apolipoprotein B compared with FENO monotherapy. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. The FENO plus EZE was generally well tolerated with a safety profile similar to that of FENO monotherapy. Co-administration of FENO plus EZE provides complementary and beneficial effects on the lipid profile of patients with mixed hyperlipidemia.
This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia.
Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia.
After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively.
Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (−22% vs. −9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non–HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase ≥3 times upper limit of normal were similar between the FENO plus EZE (1.2%) and FENO (1.7%) groups. No cases of creatine phosphokinase elevations ≥10 times upper limit of normal or myopathy were observed in either group.
Long-term, 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia.</description><subject>Adult</subject><subject>Aged</subject><subject>Anticholesteremic Agents - administration & dosage</subject><subject>Anticholesteremic Agents - adverse effects</subject><subject>Anticholesteremic Agents - therapeutic use</subject><subject>Apolipoproteins</subject><subject>Azetidines - administration & dosage</subject><subject>Azetidines - adverse effects</subject><subject>Azetidines - therapeutic use</subject><subject>Cardiology</subject><subject>Cholesterol</subject><subject>Diabetes</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Ezetimibe</subject><subject>Female</subject><subject>Fenofibrate - administration & dosage</subject><subject>Fenofibrate - adverse effects</subject><subject>Fenofibrate - therapeutic use</subject><subject>Gallbladder diseases</subject><subject>Humans</subject><subject>Hyperlipidemia, Familial Combined - blood</subject><subject>Hyperlipidemia, Familial Combined - drug therapy</subject><subject>Hypolipidemic Agents - administration & dosage</subject><subject>Hypolipidemic Agents - adverse effects</subject><subject>Hypolipidemic Agents - therapeutic use</subject><subject>Lipids</subject><subject>Lipids - blood</subject><subject>Low density lipoprotein</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Proteins</subject><subject>Treatment Outcome</subject><subject>Triglycerides</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMGKFDEQhoMo7rj6Ah4k4LnbVHqS7oCXZdh1F0YUXPEY0klF02x3xiSzOD69GWZgb54Cle__i_oIeQusBQbyw9ROxtqWMyZagJb1_BlZgRBD0wnVPycr1neiAab6C_Iq54kxJgdQL8kFSNkxpdYrsv9mPJYDNYuj194Ha-yBRk-3cfnZ3GOa6SY2V24OS8glmRLicvy-wSX6MNYBnqJ_sYQ5jEjDQr9WDJeS6Y9QftHP4Q86envYYXoIu-BwDuY1eeHNQ8Y35_eSfL-5vt_cNtsvn-42V9vGrqEvjbFswBGgUyj9wAUIjr3olRj82hsu-JozM_C-UzA415tuFHwwko1KohHd2F2S96feXYq_95iLnuI-LXWlBsEkSMUEVIqfKJtizgm93qUwm3TQwPTRtJ700bQ-mtYAupquoXfn6v04o3uKnNVW4OMJwHrgY8Cks61aLLqQ0BbtYvhf_z-w3I6P</recordid><startdate>20060418</startdate><enddate>20060418</enddate><creator>McKenney, James M.</creator><creator>Farnier, Michel</creator><creator>Lo, Kwok-Wing</creator><creator>Bays, Harold E.</creator><creator>Perevozkaya, Inna</creator><creator>Carlson, Gary</creator><creator>Davies, Michael J.</creator><creator>Mitchel, Yale B.</creator><creator>Gumbiner, Barry</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><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>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20060418</creationdate><title>Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia</title><author>McKenney, James M. ; 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James M. McKenney, Michel Farnier, Kwok-Wing Lo, Harold E. Bays, Inna Perevozkaya, Gary Carlson, Michael J. Davies, Yale B. Mitchel, Barry Gumbiner
This double-blind long-term extension study compared the safety and efficacy of co-administered fenofibrate and ezetimibe (FENO plus EZE) with fenofibrate monotherapy in 576 patients with mixed hyperlipidemia over 48 weeks. The FENO plus EZE produced significantly greater reductions in low-density lipoprotein C, total cholesterol, triglycerides, non–high-density lipoprotein C, and apolipoprotein B compared with FENO monotherapy. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. The FENO plus EZE was generally well tolerated with a safety profile similar to that of FENO monotherapy. Co-administration of FENO plus EZE provides complementary and beneficial effects on the lipid profile of patients with mixed hyperlipidemia.
This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia.
Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia.
After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively.
Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (−22% vs. −9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non–HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase ≥3 times upper limit of normal were similar between the FENO plus EZE (1.2%) and FENO (1.7%) groups. No cases of creatine phosphokinase elevations ≥10 times upper limit of normal or myopathy were observed in either group.
Long-term, 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>16630994</pmid><doi>10.1016/j.jacc.2005.11.072</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Access via ScienceDirect (Elsevier); Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | Adult Aged Anticholesteremic Agents - administration & dosage Anticholesteremic Agents - adverse effects Anticholesteremic Agents - therapeutic use Apolipoproteins Azetidines - administration & dosage Azetidines - adverse effects Azetidines - therapeutic use Cardiology Cholesterol Diabetes Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Ezetimibe Female Fenofibrate - administration & dosage Fenofibrate - adverse effects Fenofibrate - therapeutic use Gallbladder diseases Humans Hyperlipidemia, Familial Combined - blood Hyperlipidemia, Familial Combined - drug therapy Hypolipidemic Agents - administration & dosage Hypolipidemic Agents - adverse effects Hypolipidemic Agents - therapeutic use Lipids Lipids - blood Low density lipoprotein Male Middle Aged Proteins Treatment Outcome Triglycerides |
| title | Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia |
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