Evidence map›Paper›PMID 32158190›Full record

Trial reportDrug design, development and therapy2020

Effect of Fimasartan versus Valsartan and Olmesartan on Office and Ambulatory Blood Pressure in Korean Patients with Mild-to-Moderate Essential Hypertension: A Randomized, Double-Blind, Active Control, Three-Parallel Group, Forced Titration, Multicenter, Phase IV Study (Fimasartan Achieving Systolic Blood Pressure Target (FAST) Study).

Woo-Baek Chung, Sang-Hyun Ihm, Sung-Won Jang, Sung-Ho Her, Chul Soo Park, Jong-Min Lee, Kiyuk Chang, Doo-Soo Jeon, Ki-Dong Yoo, Ki-Bae Seung

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02495324 (A Randomized, Double-blind, Active Control, 3-parallel Group, Forced Titration, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Fimasartan Versus Valsartan Monotherapy in Patients With Mild to Moderate Essential Hypertension), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT02495324 phase4completednot on this map

A Randomized, Double-blind, Active Control, 3-parallel Group, Forced Titration, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Fimasartan Versus Valsartan Monotherapy in Patients With Mild to Moderate Essential Hypertension

TypeinterventionalSponsorBoryung Pharmaceutical Co., LtdRan2015 to 2017Enrolled369ConditionsEssential,HypertensionArmsPlacebo, Fimasartan, Valsartan, Olmesartan medoxomil
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
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 8 institutions in 2 countries.

Woo-Baek ChungDivision of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0002-6933-2957
Sang-Hyun IhmDivision of Cardiology, Department of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0001-5017-5421
Sung-Won JangDivision of Cardiology, Department of Internal Medicine, St. Paul's Hospital.ORCID 0000-0001-5272-0665
Sung-Ho HerDaejeon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Chul Soo ParkDivision of Cardiology, Department of Internal Medicine, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Jong-Min LeeDivision of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Kiyuk ChangDivision of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Doo-Soo JeonDivision of Cardiology, Department of Internal Medicine, In-Cheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Ki-Dong YooDivision of Cardiology, Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Ki-Bae SeungDivision of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
The Catholic University of Korea Seoul St. Mary's Hospital · KRCatholic University of Korea · KRSt. Paul's Hospital · CAThe Catholic University of Korea Bucheon St. Mary's Hospital · KRThe Catholic University of Korea Daejeon St. Mary's Hospital · KRThe Catholic University of Korea St. Vincent's Hospital · KRThe Catholic University of Korea Uijeongbu St. Mary's Hospital · KRThe Catholic University of Korea Yeouido St. Mary's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHead-to-head comparison of the blood pressure (BP) lowering effect of fimasartan versus valsartan, with olmesartan as a reference, on office blood pressure and ambulatory BP. PATIENTS AND

methodsOf the 369 randomly assigned patients in this study, 365 hypertensive patients were referred as the full analysis set and divided into 3 groups with a 3:3:1 ratio (fimasartan group: 155, valsartan group: 157, olmesartan group: 53). After the 2-week single-blind placebo run-in period, initial standard doses of 60-mg fimasartan, 80-mg valsartan, and 10-mg olmesartan were administered for 2 weeks, then forcibly up-titrated higher doses (fimasartan 120 mg, valsartan 160 mg, olmesartan 20 mg) were given for 4 weeks. ABP was measured before and after the 6-week treatment. Primary endpoint was reduction of sitting office systolic BP (SiSBP) of fimasartan compared to valsartan after 6 weeks. Secondary endpoints were reduction of sitting office diastolic BP (SiDBP) and 24 hrs, day-time, and night-time mean systolic and diastolic ABP (ASBP, ADBP) after 6 weeks.

resultsPatients' mean age was 58.34±7.68 years, and 289 patients were male (79.18%). After the 6-week treatment, SiSBP reduction of fimasartan and valsartan were -16.26±15.07 and -12.81±13.87 (p=0.0298) and SiDBP were -7.63±9.67 and -5.14±8.52 (p=0.0211). Reductions in 24 hrs mean ASBP were -15.22±13.33 and -9.45±12.37 (p=0.0009), and ADBPs were -8.74±7.55 and -5.98±7.85 (p=0.0140). Reductions of night-time ASBPs were -16.80±15.81 and -10.32±14.88 (p=0.0012), and those of night-time ADBPs were -8.89±9.93 and -5.55±9.70 (p=0.0152). Reduction of BP in olmesartan group did not demonstrate significant difference with fimasartan group in all end-points.

conclusionFimasartan 120-mg treatment demonstrated superior efficacy in reduction of SiSBP, SiDBP, and 24 hrs ASBP and ADBP compared to valsartan 160 mg. Reduction of night-time ASBP from baseline was largest in fimasartan group, suggesting that fimasartan may be effective for recovering dipping pattern. NCT NUMBER: NCT02495324 (Fimasartan Achieving SBP Target (FAST) study).

Indexed as

Blood Pressure Monitoring, AmbulatoryAdultAgedAntihypertensive AgentsBiphenyl CompoundsBlood PressureDose-Response Relationship, DrugDouble-Blind MethodEssential HypertensionFemaleHumansImidazolesMaleMiddle AgedPyrimidinesRepublic of KoreaAntihypertensive AgentsBiphenyl CompoundsfimasartanImidazolesolmesartanPyrimidinesTetrazolesValsartan24 hr ambulatory blood pressure monitoringangiotensin receptor blockerantihypertensiveessential hypertension

Identifiers

PMID32158190
PMCPMC6986172
OpenAlexW3001770977

What Socratic 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 Socratic graph.