Evidence mapPaperPMID 37584254Full record

Trial reportJournal of clinical hypertension (Greenwich, Conn.)2023

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.

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 and 18 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Journal of clinical hypertension (Greenwich, Conn.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03951207. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03951207 phase4completed

Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia

Ran2019Enrolled259Registered outcomes9Posted comparisons0ConditionsDyslipidemias, HypertensionArmsAmlodipine/Atorvastatin 5/20mg, Rosuampin 10/5mg, Rosuampin 20/5mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Statins-From Fungi to Pharmacy.International journal of molecular sciences · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Hae Won JungDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.ORCID 0000-0003-2281-928X
Chang-Yeon KimDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Seung-Pyo HongDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.ORCID 0000-0002-0028-9647
Han-Joon BaeDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Ji Yong ChoiDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Jae Kean RyuDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.ORCID 0000-0002-4064-3276
Jin-Bae LeeDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Kyoung-Hoon LeeDepartment of Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Kyoo-Rok HanDepartment of Cardiology, Kangdong Sacred Heart Hospital, Gangdong-gu, Republic of Korea.
Dong-Heon YangDepartment of Cardiology, Kyungpook National University Hospital, Daegu, Republic of Korea.
Chang-Gyu ParkDepartment of Cardiology, Korea University Guro Hospital, Seoul, Republic of Korea.ORCID 0000-0001-9654-9257
Gheol-Woong YuDepartment of Cardiology, Korea University Anam Hospital, Seoul, Republic of Korea.
Moo-Yong RheeDepartment of Cardiology, Dongguk University Ilsan Medical Center, Goyang, Republic of Korea.ORCID 0000-0002-1595-3627
Sung-Ji ParkDepartment of Cardiology, Samsung Medical Center, Gangnam-gu, Republic of Korea.
Min-Su HyonDepartment of Cardiology, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.
Joon-Han ShinDepartment of Cardiology, Ajou University Hospital, Suwon, Republic of Korea.
Bum-Kee HongDepartment of Cardiology, Gangnam Severance Hospital, Republic of Korea.
Han-Young JinDepartment of Cardiology, Inje University Busan Paik Hospital, Seoul, Republic of Korea.
Sung-Yun LeeDepartment of Cardiology, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Sang-Hoon SeolDepartment of Cardiology, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
Sang-Rok LeeDepartment of Cardiology, Jeonbuk National University Hospital, Jeonju, Republic of Korea.
Song-Yi KimDepartment of Cardiology, Jeju National University Hospital, Jeju, Republic of Korea.
Kwang-Je LeeDepartment of Cardiology, Chung-Ang University Hospital, Seoul, Republic of Korea.
Eun-Joo ChoDepartment of Cardiology, Catholic University of Korea Yeouido St. Mary's Hospital, Yeongdeungpo-gu, Republic of Korea.
Chang-Wook NamDepartment of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
Tae-Ho ParkDepartment of Cardiology, Dong-a University Hospital, Busan, Republic of Korea.
Ung KimDepartment of Cardiology, Yeungnam University Medical Center, Daegu, Republic of Korea.
Kee-Sik KimDepartment of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

DyslipidemiasHypertensionLeukemia, Myeloid, AcuteAmlodipineAtorvastatinCholesterol, LDLDouble-Blind MethodHumansRosuvastatin CalciumTreatment OutcomeAmlodipineAtorvastatinCholesterol, LDLRosuvastatin Calciumamlodipineatorvastatindyslipidemiahypertensionrosuvastatin

Identifiers

PMID37584254
PMCPMC10497028

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.