Evidence map›Paper›PMID 30587918›Full record

Trial reportDrug design, development and therapy2018

Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study.

Seung Hwan Han, Gyu Chul Oh, Hyuck Moon Kwon, Chang Gyu Park, In Jai Kim, Gyo-Seung Hwang, Byung Su Yoo, Seong Hoon Park, Kwang Je Lee, Hyo-Soo Kim

Open access · goldAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
In one paragraph

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 40% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

10 authors at 9 institutions in 2 countries.

Seung Hwan HanDivision of Cardiology, Department of Internal Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.
Gyu Chul OhDivision of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, hyosoo@snu.ac.kr.
Hyuck Moon KwonCardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Chang Gyu ParkDivision of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea.
In Jai KimDepartment of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
Gyo-Seung HwangDepartment of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
Byung Su YooDivision of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.
Seong Hoon ParkDivision of Cardiology, Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
Kwang Je LeeDivision of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea.
Hyo-Soo KimDivision of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, hyosoo@snu.ac.kr.
Seoul National University · KRAjou University · KRCHA University Bundang Medical Center · KRChung-Ang University Hospital · KRDeleted InstitutionEwha Womans University · KRKorea University Medical Center · KRWonju Severance Christian Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to compare the efficacy and safety of generic and branded irbesartan for 8 weeks in patients with mild-to-moderate essential hypertension. PATIENTS AND

methodsWe screened 221 patients with mild-to-moderate hypertension. After exclusion per study criteria, 177 subjects were randomized to receive 150 mg generic irbesartan (n=91) or branded irbesartan (n=86) as the intention to treat set. The primary efficacy endpoint of this study was the change in mean sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks between the generic and branded irbesartan groups. The secondary efficacy endpoints were the change in mean SiDBP at Week 4 from baseline and the change in mean sitting systolic blood pressure (SiSBP) at Weeks 4 and 8 from baseline in both groups. All safety issues were evaluated.

resultsAt Week 8, the generic and branded irbesartan groups showed significantly reduced SiDBP (-10.3±8.0, -10.7±7.7 mmHg, all

conclusionGeneric irbesartan treatment in patients with mild-to-moderate essential hypertension has shown effective antihypertensive effects comparable with the branded irbesartan treatment, with similar incidence of adverse effects.

Indexed as

AdultAgedAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBlood PressureDrugs, GenericFemaleHumansHypertensionIrbesartanMaleMiddle AgedRepublic of KoreaSeverity of Illness IndexTime FactorsTreatment OutcomeAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsDrugs, GenericIrbesartananti-hypertensivegeneric medicinehypertensionirbesartan

Identifiers

PMID30587918
PMCPMC6304086
OpenAlexW2905582625

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.