Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia
Abstract The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment group...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-09-01
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| Series: | The Journal of Clinical Hypertension |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jch.14715 |
| _version_ | 1797645264354279424 |
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| author | Hae Won Jung Chang‐Yeon Kim Seung‐Pyo Hong Han‐Joon Bae Ji Yong Choi Jae Kean Ryu Jin‐bae Lee Kyoung‐Hoon Lee Kyoo‐Rok Han Dong‐Heon Yang Chang‐Gyu Park Gheol‐Woong Yu Moo‐Yong Rhee Sung‐Ji Park Min‐Su Hyon Joon‐Han Shin Bum‐Kee Hong Han‐Young Jin Sung‐Yun Lee Sang‐Hoon Seol Sang‐Rok Lee Song‐Yi Kim Kwang‐Je Lee Eun‐Joo Cho Chang‐Wook Nam Tae‐Ho Park Ung Kim Kee‐Sik Kim |
| author_facet | Hae Won Jung Chang‐Yeon Kim Seung‐Pyo Hong Han‐Joon Bae Ji Yong Choi Jae Kean Ryu Jin‐bae Lee Kyoung‐Hoon Lee Kyoo‐Rok Han Dong‐Heon Yang Chang‐Gyu Park Gheol‐Woong Yu Moo‐Yong Rhee Sung‐Ji Park Min‐Su Hyon Joon‐Han Shin Bum‐Kee Hong Han‐Young Jin Sung‐Yun Lee Sang‐Hoon Seol Sang‐Rok Lee Song‐Yi Kim Kwang‐Je Lee Eun‐Joo Cho Chang‐Wook Nam Tae‐Ho Park Ung Kim Kee‐Sik Kim |
| author_sort | Hae Won Jung |
| collection | DOAJ |
| description | Abstract The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL‐C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL‐C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: −7.08%, 95% CI: −11.79 to −2.38, p = .0034, per‐protocol analysis set [PPS]: −6.97%, 95% CI: −11.76 to −2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL‐C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: −10.13%, 95% CI: −15.41 to −4.84, p = .0002, PPS: −10.96%, 95% CI: −15.98 to −5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL‐C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207). |
| first_indexed | 2024-03-11T14:43:50Z |
| format | Article |
| id | doaj.art-dcd367a8963148ea91c9d1000d664c1a |
| institution | Directory Open Access Journal |
| issn | 1524-6175 1751-7176 |
| language | English |
| last_indexed | 2024-03-11T14:43:50Z |
| publishDate | 2023-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Journal of Clinical Hypertension |
| spelling | doaj.art-dcd367a8963148ea91c9d1000d664c1a2023-10-30T13:26:20ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762023-09-0125982884410.1111/jch.14715Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemiaHae Won Jung0Chang‐Yeon Kim1Seung‐Pyo Hong2Han‐Joon Bae3Ji Yong Choi4Jae Kean Ryu5Jin‐bae Lee6Kyoung‐Hoon Lee7Kyoo‐Rok Han8Dong‐Heon Yang9Chang‐Gyu Park10Gheol‐Woong Yu11Moo‐Yong Rhee12Sung‐Ji Park13Min‐Su Hyon14Joon‐Han Shin15Bum‐Kee Hong16Han‐Young Jin17Sung‐Yun Lee18Sang‐Hoon Seol19Sang‐Rok Lee20Song‐Yi Kim21Kwang‐Je Lee22Eun‐Joo Cho23Chang‐Wook Nam24Tae‐Ho Park25Ung Kim26Kee‐Sik Kim27Department of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaDepartment of Cardiology Gachon University Gil Medical Center Incheon Republic of KoreaDepartment of Cardiology Kangdong Sacred Heart Hospital Gangdong‐gu Republic of KoreaDepartment of Cardiology Kyungpook National University Hospital Daegu Republic of KoreaDepartment of Cardiology Korea University Guro Hospital Seoul Republic of KoreaDepartment of Cardiology Korea University Anam Hospital Seoul Republic of KoreaDepartment of Cardiology Dongguk University Ilsan Medical Center Goyang Republic of KoreaDepartment of Cardiology Samsung Medical Center Gangnam‐gu Republic of KoreaDepartment of Cardiology Soonchunhyang University Seoul Hospital Seoul Republic of KoreaDepartment of Cardiology Ajou University Hospital Suwon Republic of KoreaDepartment of Cardiology Gangnam Severance Hospital Republic of KoreaDepartment of Cardiology Inje University Busan Paik Hospital Seoul Republic of KoreaDepartment of Cardiology Inje University Ilsan Paik Hospital Goyang Republic of KoreaDepartment of Cardiology Inje University Haeundae Paik Hospital Busan Republic of KoreaDepartment of Cardiology Jeonbuk National University Hospital Jeonju Republic of KoreaDepartment of Cardiology Jeju National University Hospital Jeju Republic of KoreaDepartment of Cardiology Chung‐Ang University Hospital Seoul Republic of KoreaDepartment of Cardiology Catholic University of Korea Yeouido St. Mary's Hospital Yeongdeungpo‐gu Republic of KoreaDepartment of Cardiology Keimyung University Dongsan Hospital Daegu Republic of KoreaDepartment of Cardiology Dong‐a University Hospital Busan Republic of KoreaDepartment of Cardiology Yeungnam University Medical Center Daegu Republic of KoreaDepartment of Cardiology Daegu Catholic University Medical Center Daegu Republic of KoreaAbstract The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL‐C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL‐C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: −7.08%, 95% CI: −11.79 to −2.38, p = .0034, per‐protocol analysis set [PPS]: −6.97%, 95% CI: −11.76 to −2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL‐C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: −10.13%, 95% CI: −15.41 to −4.84, p = .0002, PPS: −10.96%, 95% CI: −15.98 to −5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL‐C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207).https://doi.org/10.1111/jch.14715amlodipineatorvastatindyslipidemiahypertensionrosuvastatin |
| spellingShingle | Hae Won Jung Chang‐Yeon Kim Seung‐Pyo Hong Han‐Joon Bae Ji Yong Choi Jae Kean Ryu Jin‐bae Lee Kyoung‐Hoon Lee Kyoo‐Rok Han Dong‐Heon Yang Chang‐Gyu Park Gheol‐Woong Yu Moo‐Yong Rhee Sung‐Ji Park Min‐Su Hyon Joon‐Han Shin Bum‐Kee Hong Han‐Young Jin Sung‐Yun Lee Sang‐Hoon Seol Sang‐Rok Lee Song‐Yi Kim Kwang‐Je Lee Eun‐Joo Cho Chang‐Wook Nam Tae‐Ho Park Ung Kim Kee‐Sik Kim Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia The Journal of Clinical Hypertension amlodipine atorvastatin dyslipidemia hypertension rosuvastatin |
| title | Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia |
| title_full | Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia |
| title_fullStr | Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia |
| title_full_unstemmed | Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia |
| title_short | Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia |
| title_sort | randomized multicenter parallel open phase 4 study to compare the efficacy and safety of rosuvastatin amlodipine polypill versus atorvastatin amlodipine polypill in hypertension patient with dyslipidemia |
| topic | amlodipine atorvastatin dyslipidemia hypertension rosuvastatin |
| url | https://doi.org/10.1111/jch.14715 |
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