Evidence map›Paper›PMID 28057081›Full record

Trial reportBMC pharmacology & toxicology2017

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia.

Moo-Yong Rhee, Taehoon Ahn, Kiyuk Chang, Shung Chull Chae, Tae-Hyun Yang, Wan Joo Shim, Tae Soo Kang, Jae-Kean Ryu, Deuk-Young Nah, Tae-Ho Park and 19 more

Registry-linked trialOpen access · goldFull text readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02166814. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 19% of its field
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.

NCT02166814 phase3completed

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia

Ran2014Enrolled140Registered outcomes2Posted comparisons0ConditionsEssential Hypertension, DyslipidemiaArmsFimasartan, Fimasartan and Rosuvastatin, Rosuvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. [Efficacy and safety of atorvastatin in major cardiovascular events: Meta-analysis].Revista medica del Instituto Mexicano del Seguro Social · 2023
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
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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

29 authors at 20 institutions in 1 country.

Moo-Yong RheeCardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
Taehoon AhnDivision of Cardiology, Gachon University Gil Hospital, Incheon, Republic of Korea.
Kiyuk ChangDivision of Cardiology, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
Shung Chull ChaeDepartment of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Tae-Hyun YangDivision of Cardiology, Inje University Busan Paik Hospital, Busan, Republic of Korea.
Wan Joo ShimDivision of Cardiology, Korea University Anam Hospital, Seoul, Republic of Korea.
Tae Soo KangDepartment of Cardiology, Dankook University Hospital, Cheonan, Republic of Korea.
Jae-Kean RyuDepartment of Internal Medicine, Daegu Catholic University Hospital, Daegu, Republic of Korea.
Deuk-Young NahDivision of Cardiology, Dongguk University Gyeongju Hospital, Gyeongju, Republic of Korea.
Tae-Ho ParkDepartment of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea.
In-Ho ChaeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Seung Woo ParkDivision of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Hae-Young LeeDivision of Cardiology, Seoul National University Hospital, Seoul, Republic of Korea.
Seung-Jea TahkDepartment of Cardiology, Ajou University Hospital, Suwon, Republic of Korea.
Young Won YoonDivision of Cardiology, Gangnam Severance Hospital, Seoul, Republic of Korea.
Chi Young ShimDivision of Cardiology, Severance Cardiovascular Hospital, Seoul, Republic of Korea.
Dong-Gu ShinDepartment of Cardiology, Yeungnam University Hospital, Daegu, Republic of Korea.
Hong Seog SeoDivision of Cardiology, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308, Republic of Korea.
Sung Yun LeeCardiac and Vascular Center, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Doo Il KimDepartment of Cardiology, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
Jun KwanDepartment of Cardiology, Inha University Hospital, Incheon, Republic of Korea.
Seung-Jae JooDivision of Cardiology, Jeju National University Hospital, Jeju, Republic of Korea.
Myung Ho JeongDepartment of Cardiovascular, Chonnam National University Hospital, Gwangju, Republic of Korea.
Jin-Ok JeongDivision of Cardiology, Chungnam National University Hospital, Daejeon, Republic of Korea.
Ki Chul SungDivision of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Seok Yeon KimDepartment of Cardiology, Seoul Medical Center, Seoul, Republic of Korea.
Sang-Hyun KimDivision of Cardiology, Seoul Metropolitan Government Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea.
Kook-Jin ChunCardiovascular Center, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
Dong Joo OhDivision of Cardiology, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308, Republic of Korea. ohdj@korea.ac.kr.
Korea University Medical Center · KRSNUH SMG-SNU Boramae Medical Center · KRAjou University Hospital · KRChonnam National University Hospital · KRChungnam National University Hospital · KRDankook University Hospital · KRDeleted InstitutionDong-A University · KRDongguk University Ilsan Hospital · KRDongguk University WISEGangnam Severance Hospital · KRInha University Hospital · KRInje University Busan Paik Hospital · KRInje University Haeundae Paik Hospital · KRInje University Ilsan Paik Hospital · KRJeju National University Hospital · KRKangbuk Samsung Hospital · KRKyungpook National University · KRPusan National University Yangsan Hospital · KRSeoul National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia.

methodsWe conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks.

resultsOf 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p < 0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p = 0.500 and p = 0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p < 0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p = 0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p < 0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments.

conclusionThis study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.

trial registrationClinicalTrials.gov Identifier: NCT02166814 . 16 June 2014.

Indexed as

AdultAgedAngiotensin II Type 1 Receptor BlockersAnticholesteremic AgentsBiphenyl CompoundsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypercholesterolemiaHypertensionMaleMiddle AgedPyrimidinesRosuvastatin CalciumTetrazolesAngiotensin II Type 1 Receptor BlockersAnticholesteremic AgentsBiphenyl CompoundsfimasartanPyrimidinesRosuvastatin CalciumTetrazolesFimasartanHypercholesterolemiaHypertensionRosuvastatin

Identifiers

PMID28057081
PMCPMC5217661
OpenAlexW2569984551

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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 OpenQuestion graph.