A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-bl...
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| Veröffentlicht in: | Clinical therapeutics 2022-10, Vol.44 (10), p.1310-1325 |
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| creator | Jeong, Han Saem Hong, Soon Jun Cho, Jin-Man Han, Ki Hoon Cha, Dong-Hun Jo, Sang-Ho Kang, Hyun-Jae Choi, So-Yeon Choi, Cheol Ung Cho, Eun Jeong Jeong, Young-Hoon Gwon, Hyeon-Cheol Kim, Byeong-Keuk Lee, Sung Yun Kim, Sang-Hyun Ahn, Jeong Cheon Hong, Young Joon Kim, Woo-Shik Woo, Seong-Ill Park, Tae-Ho Han, Kyoo-Rok |
| description | Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia.
Korean men and women aged >19 and 50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. ClinicalTrials.gov identifier: NCT04584736. |
| doi_str_mv | 10.1016/j.clinthera.2022.09.001 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2736292677</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0149291822003150</els_id><sourcerecordid>2736292677</sourcerecordid><originalsourceid>FETCH-LOGICAL-c448t-ff0d5f019c72a6f5a4445908f42d9322454259abea1d5f1bf124618253dcd3f3</originalsourceid><addsrcrecordid>eNqFUlFv0zAQDmiIdQOJXwCWeG2K7ThJ81h1Hau0iQoq4M1ynDN1lcTFdip1v55rO_aGkCyd7fu---6zL0k-MDphlBWfthPd2j5uwKsJp5xPaDWhlL1MRmxaVilj4udFMqJMVCmv2PQyuQphSynNqpy_Ti6zggsmimz04t2MPAxttBr6CH5Mvqq-cZ19hGZMbtxQt5DWqISnmY52D6l2ffSubY-AW6Wj81a15AaC_dWPyWqjApDlcknmyLIaU-sTIDqy2Kt2UBEItk0WxmBWHwjqkW_KQDwQZ8jcdbXtVbSuJ-uju93pemWj2qsQMdGfGItHiLazNZDv4MMQyIPrXfwHAdcKN-gwkB82bsjK2075A7k77MDrjWshoHkMnVVvkldGtQHePsXrZH27WM_v0vsvn5fz2X2qhZjG1Bja5IaySpdcFSZXQoi8olMjeFNlnItc8LxSNSiGOFYbxkXBpjzPGt1kJrtOPp7L7rz7PaC-3LrB96goeYnfU_GiLBFVnlHauxA8GLk7ty4ZlcdBkFv5PAjyOAiSVhIHAZnvn-oPdQfNM-_vzyNgdgYAmtxb8DJofCINjfWgo2yc_a_IHzNzzbM</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2736292677</pqid></control><display><type>article</type><title>A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Jeong, Han Saem ; Hong, Soon Jun ; Cho, Jin-Man ; Han, Ki Hoon ; Cha, Dong-Hun ; Jo, Sang-Ho ; Kang, Hyun-Jae ; Choi, So-Yeon ; Choi, Cheol Ung ; Cho, Eun Jeong ; Jeong, Young-Hoon ; Gwon, Hyeon-Cheol ; Kim, Byeong-Keuk ; Lee, Sung Yun ; Kim, Sang-Hyun ; Ahn, Jeong Cheon ; Hong, Young Joon ; Kim, Woo-Shik ; Woo, Seong-Ill ; Park, Tae-Ho ; Han, Kyoo-Rok</creator><creatorcontrib>Jeong, Han Saem ; Hong, Soon Jun ; Cho, Jin-Man ; Han, Ki Hoon ; Cha, Dong-Hun ; Jo, Sang-Ho ; Kang, Hyun-Jae ; Choi, So-Yeon ; Choi, Cheol Ung ; Cho, Eun Jeong ; Jeong, Young-Hoon ; Gwon, Hyeon-Cheol ; Kim, Byeong-Keuk ; Lee, Sung Yun ; Kim, Sang-Hyun ; Ahn, Jeong Cheon ; Hong, Young Joon ; Kim, Woo-Shik ; Woo, Seong-Ill ; Park, Tae-Ho ; Han, Kyoo-Rok</creatorcontrib><description>Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia.
Korean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4–8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients.
The percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (–52.8% [11.2%]) and pooled pitavastatin (–37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C–lowering effect than that with pitavastatin (difference, –15.8 mg/dL; 95% CI, –18.7 to –12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups.
Pitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. ClinicalTrials.gov identifier: NCT04584736.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2022.09.001</identifier><identifier>PMID: 36241463</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Angina pectoris ; Anticholesteremic Agents - adverse effects ; Blood pressure ; Cardiology ; Cardiovascular disease ; Cholesterol ; Cholesterol, LDL ; Clinical trials ; Combination therapy ; Coronary vessels ; Creatinine ; Diabetes ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Drug Therapy, Combination ; Dyslipidemia ; Dyslipidemias - diagnosis ; Dyslipidemias - drug therapy ; Effectiveness ; ezetimibe ; Ezetimibe - adverse effects ; Factorial design ; Female ; Gallbladder diseases ; Health services ; Heart ; High density lipoprotein ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hypercholesterolemia ; Hypercholesterolemia - drug therapy ; Laboratories ; Lipophilic ; Low density lipoprotein ; Male ; Medical treatment ; Metabolic disorders ; Patients ; pitavastatin ; Safety ; Side effects ; Statins ; Therapy ; Thyroid gland ; Treatment Outcome</subject><ispartof>Clinical therapeutics, 2022-10, Vol.44 (10), p.1310-1325</ispartof><rights>2022</rights><rights>Copyright © 2022. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Oct 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-ff0d5f019c72a6f5a4445908f42d9322454259abea1d5f1bf124618253dcd3f3</citedby><cites>FETCH-LOGICAL-c448t-ff0d5f019c72a6f5a4445908f42d9322454259abea1d5f1bf124618253dcd3f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0149291822003150$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36241463$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jeong, Han Saem</creatorcontrib><creatorcontrib>Hong, Soon Jun</creatorcontrib><creatorcontrib>Cho, Jin-Man</creatorcontrib><creatorcontrib>Han, Ki Hoon</creatorcontrib><creatorcontrib>Cha, Dong-Hun</creatorcontrib><creatorcontrib>Jo, Sang-Ho</creatorcontrib><creatorcontrib>Kang, Hyun-Jae</creatorcontrib><creatorcontrib>Choi, So-Yeon</creatorcontrib><creatorcontrib>Choi, Cheol Ung</creatorcontrib><creatorcontrib>Cho, Eun Jeong</creatorcontrib><creatorcontrib>Jeong, Young-Hoon</creatorcontrib><creatorcontrib>Gwon, Hyeon-Cheol</creatorcontrib><creatorcontrib>Kim, Byeong-Keuk</creatorcontrib><creatorcontrib>Lee, Sung Yun</creatorcontrib><creatorcontrib>Kim, Sang-Hyun</creatorcontrib><creatorcontrib>Ahn, Jeong Cheon</creatorcontrib><creatorcontrib>Hong, Young Joon</creatorcontrib><creatorcontrib>Kim, Woo-Shik</creatorcontrib><creatorcontrib>Woo, Seong-Ill</creatorcontrib><creatorcontrib>Park, Tae-Ho</creatorcontrib><creatorcontrib>Han, Kyoo-Rok</creatorcontrib><title>A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia.
Korean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4–8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients.
The percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (–52.8% [11.2%]) and pooled pitavastatin (–37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C–lowering effect than that with pitavastatin (difference, –15.8 mg/dL; 95% CI, –18.7 to –12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups.
Pitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. ClinicalTrials.gov identifier: NCT04584736.</description><subject>Angina pectoris</subject><subject>Anticholesteremic Agents - adverse effects</subject><subject>Blood pressure</subject><subject>Cardiology</subject><subject>Cardiovascular disease</subject><subject>Cholesterol</subject><subject>Cholesterol, LDL</subject><subject>Clinical trials</subject><subject>Combination therapy</subject><subject>Coronary vessels</subject><subject>Creatinine</subject><subject>Diabetes</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Drug Therapy, Combination</subject><subject>Dyslipidemia</subject><subject>Dyslipidemias - diagnosis</subject><subject>Dyslipidemias - drug therapy</subject><subject>Effectiveness</subject><subject>ezetimibe</subject><subject>Ezetimibe - adverse effects</subject><subject>Factorial design</subject><subject>Female</subject><subject>Gallbladder diseases</subject><subject>Health services</subject><subject>Heart</subject><subject>High density lipoprotein</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</subject><subject>Hypercholesterolemia</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Laboratories</subject><subject>Lipophilic</subject><subject>Low density lipoprotein</subject><subject>Male</subject><subject>Medical treatment</subject><subject>Metabolic disorders</subject><subject>Patients</subject><subject>pitavastatin</subject><subject>Safety</subject><subject>Side effects</subject><subject>Statins</subject><subject>Therapy</subject><subject>Thyroid gland</subject><subject>Treatment Outcome</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFUlFv0zAQDmiIdQOJXwCWeG2K7ThJ81h1Hau0iQoq4M1ynDN1lcTFdip1v55rO_aGkCyd7fu---6zL0k-MDphlBWfthPd2j5uwKsJp5xPaDWhlL1MRmxaVilj4udFMqJMVCmv2PQyuQphSynNqpy_Ti6zggsmimz04t2MPAxttBr6CH5Mvqq-cZ19hGZMbtxQt5DWqISnmY52D6l2ffSubY-AW6Wj81a15AaC_dWPyWqjApDlcknmyLIaU-sTIDqy2Kt2UBEItk0WxmBWHwjqkW_KQDwQZ8jcdbXtVbSuJ-uju93pemWj2qsQMdGfGItHiLazNZDv4MMQyIPrXfwHAdcKN-gwkB82bsjK2075A7k77MDrjWshoHkMnVVvkldGtQHePsXrZH27WM_v0vsvn5fz2X2qhZjG1Bja5IaySpdcFSZXQoi8olMjeFNlnItc8LxSNSiGOFYbxkXBpjzPGt1kJrtOPp7L7rz7PaC-3LrB96goeYnfU_GiLBFVnlHauxA8GLk7ty4ZlcdBkFv5PAjyOAiSVhIHAZnvn-oPdQfNM-_vzyNgdgYAmtxb8DJofCINjfWgo2yc_a_IHzNzzbM</recordid><startdate>202210</startdate><enddate>202210</enddate><creator>Jeong, Han Saem</creator><creator>Hong, Soon Jun</creator><creator>Cho, Jin-Man</creator><creator>Han, Ki Hoon</creator><creator>Cha, Dong-Hun</creator><creator>Jo, Sang-Ho</creator><creator>Kang, Hyun-Jae</creator><creator>Choi, So-Yeon</creator><creator>Choi, Cheol Ung</creator><creator>Cho, Eun Jeong</creator><creator>Jeong, Young-Hoon</creator><creator>Gwon, Hyeon-Cheol</creator><creator>Kim, Byeong-Keuk</creator><creator>Lee, Sung Yun</creator><creator>Kim, Sang-Hyun</creator><creator>Ahn, Jeong Cheon</creator><creator>Hong, Young Joon</creator><creator>Kim, Woo-Shik</creator><creator>Woo, Seong-Ill</creator><creator>Park, Tae-Ho</creator><creator>Han, Kyoo-Rok</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>202210</creationdate><title>A Multicenter, Randomized, Double-blind, Active-controlled, Factorial 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pressure</topic><topic>Cardiology</topic><topic>Cardiovascular disease</topic><topic>Cholesterol</topic><topic>Cholesterol, LDL</topic><topic>Clinical trials</topic><topic>Combination therapy</topic><topic>Coronary vessels</topic><topic>Creatinine</topic><topic>Diabetes</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Drug dosages</topic><topic>Drug Therapy, Combination</topic><topic>Dyslipidemia</topic><topic>Dyslipidemias - diagnosis</topic><topic>Dyslipidemias - drug therapy</topic><topic>Effectiveness</topic><topic>ezetimibe</topic><topic>Ezetimibe - adverse effects</topic><topic>Factorial design</topic><topic>Female</topic><topic>Gallbladder diseases</topic><topic>Health services</topic><topic>Heart</topic><topic>High density lipoprotein</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</topic><topic>Hypercholesterolemia</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Laboratories</topic><topic>Lipophilic</topic><topic>Low density lipoprotein</topic><topic>Male</topic><topic>Medical treatment</topic><topic>Metabolic disorders</topic><topic>Patients</topic><topic>pitavastatin</topic><topic>Safety</topic><topic>Side effects</topic><topic>Statins</topic><topic>Therapy</topic><topic>Thyroid gland</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jeong, Han Saem</creatorcontrib><creatorcontrib>Hong, Soon Jun</creatorcontrib><creatorcontrib>Cho, Jin-Man</creatorcontrib><creatorcontrib>Han, Ki Hoon</creatorcontrib><creatorcontrib>Cha, Dong-Hun</creatorcontrib><creatorcontrib>Jo, Sang-Ho</creatorcontrib><creatorcontrib>Kang, Hyun-Jae</creatorcontrib><creatorcontrib>Choi, So-Yeon</creatorcontrib><creatorcontrib>Choi, Cheol Ung</creatorcontrib><creatorcontrib>Cho, Eun Jeong</creatorcontrib><creatorcontrib>Jeong, Young-Hoon</creatorcontrib><creatorcontrib>Gwon, 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jeong, Han Saem</au><au>Hong, Soon Jun</au><au>Cho, Jin-Man</au><au>Han, Ki Hoon</au><au>Cha, Dong-Hun</au><au>Jo, Sang-Ho</au><au>Kang, Hyun-Jae</au><au>Choi, So-Yeon</au><au>Choi, Cheol Ung</au><au>Cho, Eun Jeong</au><au>Jeong, Young-Hoon</au><au>Gwon, Hyeon-Cheol</au><au>Kim, Byeong-Keuk</au><au>Lee, Sung Yun</au><au>Kim, Sang-Hyun</au><au>Ahn, Jeong Cheon</au><au>Hong, Young Joon</au><au>Kim, Woo-Shik</au><au>Woo, Seong-Ill</au><au>Park, Tae-Ho</au><au>Han, Kyoo-Rok</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2022-10</date><risdate>2022</risdate><volume>44</volume><issue>10</issue><spage>1310</spage><epage>1325</epage><pages>1310-1325</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile. However, the efficacy of adding ezetimibe to pitavastatin in patients with dyslipidemia has not been well investigated. Therefore, the objective of this double-blind, multicenter, randomized, Phase III study was to compare the efficacy and safety of pitavastatin and ezetimibe combination therapy with those of pitavastatin monotherapy in Korean patients with primary hypercholesterolemia.
Korean men and women aged >19 and <80 years with primary hypercholesterolemia requiring medical treatment were included in this study. During the 8-week screening period, all patients were instructed to make therapeutic lifestyle changes. The screening period consisted of a 4-week washout period and a placebo run-in period (4–8 weeks). During treatment period I, patients were randomly assigned to receive 1 of 4 treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients.
The percentages in LDL-C from baseline after 8 weeks of double-blind treatment decreased significantly in the pooled pitavastatin/ezetimibe (–52.8% [11.2%]) and pooled pitavastatin (–37.1% [14.1%]) groups. Treatment with pitavastatin/ezetimibe resulted in a significantly greater LDL-C–lowering effect than that with pitavastatin (difference, –15.8 mg/dL; 95% CI, –18.7 to –12.9; P < 0.001). The precentages of achieving LDL-C goal in pooled pitavastatin/ezetimibe and pooled pitavastatin groups were 94.2% and 69.1%, respectively (P < 0.001). There were no significant differences in the incidence of overall AEs and adverse drug reactions. Serious AEs were comparable between the groups.
Pitavastatin and ezetimibe combinations effectively and safely decreased LDL-C levels by >50% in patients with dyslipidemia. The safety and tolerability of pitavastatin and ezetimibe combination therapy were comparable with those of pitavastatin monotherapy. ClinicalTrials.gov identifier: NCT04584736.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36241463</pmid><doi>10.1016/j.clinthera.2022.09.001</doi><tpages>16</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-2918 |
| ispartof | Clinical therapeutics, 2022-10, Vol.44 (10), p.1310-1325 |
| issn | 0149-2918 1879-114X |
| language | eng |
| recordid | cdi_proquest_journals_2736292677 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Angina pectoris Anticholesteremic Agents - adverse effects Blood pressure Cardiology Cardiovascular disease Cholesterol Cholesterol, LDL Clinical trials Combination therapy Coronary vessels Creatinine Diabetes Double-Blind Method Double-blind studies Drug dosages Drug Therapy, Combination Dyslipidemia Dyslipidemias - diagnosis Dyslipidemias - drug therapy Effectiveness ezetimibe Ezetimibe - adverse effects Factorial design Female Gallbladder diseases Health services Heart High density lipoprotein Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hypercholesterolemia Hypercholesterolemia - drug therapy Laboratories Lipophilic Low density lipoprotein Male Medical treatment Metabolic disorders Patients pitavastatin Safety Side effects Statins Therapy Thyroid gland Treatment Outcome |
| title | A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T09%3A48%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Multicenter,%20Randomized,%20Double-blind,%20Active-controlled,%20Factorial%20Design,%20Phase%20III%20Clinical%20Trial%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Combination%20Therapy%20of%20Pitavastatin%20and%20Ezetimibe%20Versus%20Monotherapy%20of%20Pitavastatin%20in%20Patients%20With%20Primary%20Hypercholesterolemia&rft.jtitle=Clinical%20therapeutics&rft.au=Jeong,%20Han%20Saem&rft.date=2022-10&rft.volume=44&rft.issue=10&rft.spage=1310&rft.epage=1325&rft.pages=1310-1325&rft.issn=0149-2918&rft.eissn=1879-114X&rft_id=info:doi/10.1016/j.clinthera.2022.09.001&rft_dat=%3Cproquest_cross%3E2736292677%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2736292677&rft_id=info:pmid/36241463&rft_els_id=S0149291822003150&rfr_iscdi=true |