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A Prospective Randomized, Double-Blind, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Olmesartan/Amlodipine plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia: A LEISURE Study

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dc.contributor.author강석민-
dc.date.accessioned2022-05-09T17:12:52Z-
dc.date.available2022-05-09T17:12:52Z-
dc.date.issued2022-01-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/188443-
dc.description.abstractBackground: This study was a multicenter, randomized, double-blinded, placebo-controlled phase III clinical trial to investigate the efficacy and safety of an olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with concomitant hypertension and dyslipidemia. Methods: Patients with both hypertension and dyslipidemia aged 20-80 were enrolled from 36 tertiary hospitals in Korea from January 2017 to April 2018. Patients were randomized to three groups in a 1:1:0.5 ratio, olmesartan/amlodipine single pill plus rosuvastatin (olme/amlo/rosu) or olmesartan plus rosuvastatin (olme/rosu) or olmesartan/amlodipine single pill (olme/amlo) combination. The primary endpoints were change of sitting systolic blood pressure (sitSBP) from baseline in the olme/amlo/rosu vs. olme/rosu groups and the percentage change of low-density lipoprotein cholesterol (LDL-C) from baseline in the olme/amlo/rosu vs. olme/amlo groups after 8 weeks of treatment. Results: A total of 265 patients were randomized, 106 to olme/amlo/rosu, 106 to olme/rosu and 53 to olme/amlo groups. Baseline characteristics among the three groups did not differ. The mean sitSBP change was significantly larger in the olme/amlo/rosu group with -24.30 ± 12.62 mmHg (from 153.58 ± 10.90 to 129.28 ± 13.58) as compared to the olme/rosu group, -9.72 ± 16.27 mmHg (from 153.71 ± 11.10 to 144.00 ± 18.44 mmHg). The difference in change of sitSBP between the two groups was -14.62± 1.98 mmHg with significance (95% CI -18.51 to -10.73, p < 0.0001). The mean LDL-C reduced significantly in the olme/amlo/rosu group, -52.31 ± 16.63% (from 154.52 ± 30.84 to 72.72 ± 26.08 mg/dL) as compared to the olme/amlo group with no change, -2.98 ± 16.16% (from 160.42 ± 32.05 to 153.81 ± 31.57 mg/dL). Significant difference in change was found in LDL-C between the two groups with -50.10 ± 2.73% (95% CI -55.49 to -44.71, p < 0.0001). Total adverse drug reaction rates were 10.48%, 5.66% and 3.7% in the olme/amlo/rosu, olme/rosu and olme/amlo groups, respectively with no statistical significance among the three groups. Serious adverse drug reactions did not occur. Conclusions: Olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with both hypertension and dyslipidemia is effective and safe as compared to either olmesartan plus rosuvastatin or olmesartan plus amlodipine treatment.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherMDPI AG-
dc.relation.isPartOfJOURNAL OF CLINICAL MEDICINE-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleA Prospective Randomized, Double-Blind, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Olmesartan/Amlodipine plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia: A LEISURE Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorSang-Ho Jo-
dc.contributor.googleauthorSeok Min Kang-
dc.contributor.googleauthorByung Su Yoo-
dc.contributor.googleauthorYoung Soo Lee-
dc.contributor.googleauthorHo Joong Youn-
dc.contributor.googleauthorKyungwan Min-
dc.contributor.googleauthorJae Myung Yu-
dc.contributor.googleauthorHyun Ju Yoon-
dc.contributor.googleauthorWoo Shik Kim-
dc.contributor.googleauthorGee Hee Kim-
dc.contributor.googleauthorJae Hyoung Park-
dc.contributor.googleauthorSeok Yeon Kim-
dc.contributor.googleauthorCheol Ho Kim-
dc.identifier.doi10.3390/jcm11020350-
dc.contributor.localIdA00037-
dc.relation.journalcodeJ03556-
dc.identifier.eissn2077-0383-
dc.identifier.pmid35054044-
dc.subject.keywordamlodipine-
dc.subject.keywordolmesartan-
dc.subject.keywordphase III clinical trial-
dc.subject.keywordrosuvastatin-
dc.subject.keywordsingle pill combination-
dc.contributor.alternativeNameKang, Seok Min-
dc.contributor.affiliatedAuthor강석민-
dc.citation.volume11-
dc.citation.number2-
dc.citation.startPage350-
dc.identifier.bibliographicCitationJOURNAL OF CLINICAL MEDICINE, Vol.11(2) : 350, 2022-01-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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