Evidence map›Paper›PMID 35287233›Full record

ArticleAdvances in therapy2022

Efficacy and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution: A Retrospective Analysis of Real-World Data in Japan.

Atsuya Miki, Etsuyo Miyamoto, Naruhiro Ishida, Daisuke Shii, Kiyotaka Hori, LESPOIR Research Group

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

4 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. 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

6 authors at 2 institutions in 1 country.

Atsuya MikiDepartment of Ophthalmology, Osaka University Graduate School of Medicine, 2-15, Yamadaoka, Suita, Osaka, 565-0821, Japan. amiki@ophthal.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0002-5618-7287
Etsuyo MiyamotoJapan Medical Affairs Group, Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Naruhiro IshidaJapan Medical Affairs Group, Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Daisuke ShiiJapan Medical Affairs Group, Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Kiyotaka HoriJapan Medical Affairs Group, Santen Pharmaceutical Co., Ltd., Osaka, Japan.
LESPOIR Research Group
Santen (Japan) · JPOsaka City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to clarify the efficacy and safety of omidenepag isopropyl (OMDI) in a retrospective, real-world, multicenter setting.

methodsA retrospective medical chart review of patients with glaucoma and ocular hypertension receiving OMDI from November 2018 to November 2019 with at least 12 weeks of follow-up was conducted in 11 eye clinics in Japan. The participants were categorized into three therapy groups, designated the naïve monotherapy, switching monotherapy, and concomitant therapy groups. The main outcome measures were the change in intraocular pressure (IOP) at week 4 and week 12 after the initiation of OMDI treatment, and frequency of adverse drug reactions.

resultsData were collected from 827 patients. The baseline IOP in the naïve group was 16.6 ± 4.2 mmHg. The mean IOP reduction at week 4 and week 12 was - 2.9 ± 3.2 mmHg (P < 0.0001) and - 2.5 ± 2.9 mmHg (P < 0.0001), respectively. Eyes with baseline IOP less than 16 mmHg also showed a significant reduction of IOP of - 1.4 ± 2.0 mmHg at week 12. OMDI significantly reduced IOP not only in eyes with primary open-angle glaucoma but also in eyes with primary angle-closure glaucoma and secondary glaucoma. In the switching monotherapy group, IOP did not change significantly after switching from most classes of medications to OMDI, but further IOP reduction was observed in the case of switching from beta-blockers to OMDI. The frequency of adverse drug reactions was 14.1% in all participants, and the most common adverse reaction was ocular hyperemia (7.6%). No serious and severe side effects were observed in this study.

conclusionOMDI showed an IOP-lowering effect in eyes with various types of glaucoma and using various therapeutic regimens in real-world clinical practice. In addition, OMDI did not show any serious and severe side effects, suggesting the potential of OMDI as a first-line medicine for the treatment of glaucoma.

trial registrationUniversity Hospital Medical Information Network (UMIN): 000040040.

Indexed as

Drug-Related Side Effects and Adverse ReactionsGlaucomaGlaucoma, Open-AngleOcular HypertensionAntihypertensive AgentsGlycineHumansIntraocular PressureJapanOphthalmic SolutionsPyrazolesPyridinesRetrospective StudiesTreatment OutcomeAntihypertensive AgentsGlycineomidenepag isopropylOphthalmic SolutionsPyrazolesPyridinesGlaucomaIOP-lowering effectOmidenepag isopropylProstanoid EP2 receptor agonistRetrospective real-world study

Identifiers

PMID35287233
PMCPMC9056475
OpenAlexW4220667744

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Registered trials

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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.