Cited 4 times in
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
DC Field | Value | Language |
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dc.contributor.author | 강석민 | - |
dc.date.accessioned | 2022-05-09T17:12:52Z | - |
dc.date.available | 2022-05-09T17:12:52Z | - |
dc.date.issued | 2022-01 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/188443 | - |
dc.description.abstract | Background: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | MDPI AG | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Sang-Ho Jo | - |
dc.contributor.googleauthor | Seok Min Kang | - |
dc.contributor.googleauthor | Byung Su Yoo | - |
dc.contributor.googleauthor | Young Soo Lee | - |
dc.contributor.googleauthor | Ho Joong Youn | - |
dc.contributor.googleauthor | Kyungwan Min | - |
dc.contributor.googleauthor | Jae Myung Yu | - |
dc.contributor.googleauthor | Hyun Ju Yoon | - |
dc.contributor.googleauthor | Woo Shik Kim | - |
dc.contributor.googleauthor | Gee Hee Kim | - |
dc.contributor.googleauthor | Jae Hyoung Park | - |
dc.contributor.googleauthor | Seok Yeon Kim | - |
dc.contributor.googleauthor | Cheol Ho Kim | - |
dc.identifier.doi | 10.3390/jcm11020350 | - |
dc.contributor.localId | A00037 | - |
dc.relation.journalcode | J03556 | - |
dc.identifier.eissn | 2077-0383 | - |
dc.identifier.pmid | 35054044 | - |
dc.subject.keyword | amlodipine | - |
dc.subject.keyword | olmesartan | - |
dc.subject.keyword | phase III clinical trial | - |
dc.subject.keyword | rosuvastatin | - |
dc.subject.keyword | single pill combination | - |
dc.contributor.alternativeName | Kang, Seok Min | - |
dc.contributor.affiliatedAuthor | 강석민 | - |
dc.citation.volume | 11 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 350 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL MEDICINE, Vol.11(2) : 350, 2022-01 | - |
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