Evidence map›Paper›PMID 23344912›Full record

ArticleAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2013

Safety and efficacy of fimasartan in patients with arterial hypertension (Safe-KanArb study): an open-label observational study.

Jeong Bae Park, Ki-Chul Sung, Seok-Min Kang, Eun Joo Cho

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02466490 (A 24-week Trial of the Effectiveness and Safety of Fimasartan 60 mg Alone as Initial Treatment and Its Randomized Escalation to Fimasartan 120 mg or Fimasartan 60 mg/HCTZ 12.5 mg in Mexican Patients With Grade 1 and 2 Essential Hypertension), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
2.6field-weighted citation impact, top 9% 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.

NCT02466490 phase3completednot on this map

A 24-week Trial of the Effectiveness and Safety of Fimasartan 60 mg Alone as Initial Treatment and Its Randomized Escalation to Fimasartan 120 mg or Fimasartan 60 mg/HCTZ 12.5 mg in Mexican Patients With Grade 1 and 2 Essential Hypertension

TypeinterventionalSponsorStendhal Americas, S.A.Ran2013 to 2014Enrolled272ConditionsHypertension, EssentialArmsFimasartan, Fimasartan, Hydrochlorothiazide
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Blood Pressure-Lowering Therapy.Handbook of experimental pharmacology · 2022
    Article
  8. Article
  9. Article
  10. Article
  11. Fimasartan: A new armament to fight hypertension.Journal of family medicine and primary care · 2019
    Review
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Review
  18. The Different Therapeutic Choices with ARBs. Which One to Give? When? Why?American journal of cardiovascular drugs : drugs, devices, and other interventions · 2016
    Review
  19. Article
  20. 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

4 authors at 4 institutions in 1 country.

Jeong Bae ParkDepartment of Medicine/Cardiology, Cheil General Hospital, Kwandong University College of Medicine, 1-19 Mukjung-dong, Seoul 100-380, Korea. mdparkjb@gmail.com
Ki-Chul Sung
Seok-Min Kang
Eun Joo Cho
Catholic Kwandong University · KRGangnam Severance Hospital · KRSt. Paul's Hospital · KRSungkyunkwan University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAngiotensin II receptor blockers (ARBs) play a key role in hypertension therapy. Recently, fimasartan, the ninth ARB, was developed, but its safety and efficacy have not been well established.

objectiveThe objective of this study was to determine whether age, sex, concomitant disease, and current antihypertensive medications affect the safety and efficacy of fimasartan in patients with arterial hypertension.

methodsThis was a large-scale, open-label observational study to determine the safety and efficacy of fimasartan in patients with hypertension. Patients who were treated for more than 2 months with fimasartan (60 or 120 mg, once daily) were recruited, and the data were systematically collected using electronic case report forms. Written informed consent forms were obtained from all patients.

resultsA total of 14,151 patients (50.7 % males; mean age 59 ± 12 years) were evaluated, of whom 37.9 % were never treated with fimasartan, 53.5 % were switched to fimasartan, and 8.5 % had fimasartan added to their treatment. Overall, fimasartan reduced systolic blood pressure (SBP) from 145.4 ± 18.1 to 126.8 ± 12.6 mmHg and diastolic blood pressure (DBP) from 88.7 ± 11.8 to 79.0 ± 8.7 mmHg (all p < 0.001). The pulse rate decreased from 74.4 ± 10.3 to 71.9 ± 9.2 beats/min in comparison with before treatment (p < 0.001). The reductions were similar between sexes, age groups, and patients with and without co-morbidities, and were not dependent on prior or concomitant treatment with other antihypertensive drugs. Adverse events were reported in 3.31 % (treatment-emergent) and 2.35 % (drug-related) of patients; there were no dose differences for adverse events. The most frequent adverse events were dizziness (1.55 %) and headache (0.52 %); other adverse events were rare. The responder rate (DBP to <90 mmHg or a reduction of ≥10 mmHg) and the goal rate (combined SBP/DBP <140/90 mmHg) were 85.0 and 75.6 %, respectively. Global drug compliance was rated as excellent, very good, good, and poor in 68.1, 26.9, 3.4, and 1.7 % of patients, respectively.

conclusionThe safety, efficacy, and compliance of fimasartan were found to be excellent in a large patient population that included patients potentially at higher risk for adverse events.

Indexed as

AdultAgedAngiotensin Receptor AntagonistsAntihypertensive AgentsBiphenyl CompoundsBlood PressureDizzinessFemaleHeadacheHumansHypertensionMaleMiddle AgedPyrimidinesTetrazolesTreatment OutcomeAngiotensin Receptor AntagonistsAntihypertensive AgentsBiphenyl CompoundsfimasartanPyrimidinesTetrazoles

Identifiers

PMID23344912
PMCPMC3572372
OpenAlexW2077978072

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.