Evidence map›Paper›PMID 27843645›Full record

ArticleInternational journal of hypertension2016

Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan.

Shoko Takahashi, Megumi Hiramatsu, Shinichi Hotta, Yukie Watanabe, Osamu Suga, Yutaka Endo, Isamu Miyamori

Open access · goldAbstract read
In one paragraph

Article in International journal of hypertension, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
1.2field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  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

7 authors at 2 institutions in 1 country.

Shoko TakahashiMedical Affairs, Global Established Pharma Business, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.ORCID 0000-0003-4050-8100
Megumi HiramatsuPMS Planning & Operation, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.ORCID 0000-0001-9229-3354
Shinichi HottaClinical Informatics and Innovation, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.ORCID 0000-0001-5667-3990
Yukie WatanabeClinical Informatics and Innovation, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.ORCID 0000-0002-8713-9456
Osamu SugaMedical Writing and Document Management, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
Yutaka EndoClinical Statistics, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.ORCID 0000-0003-2006-7707
Isamu MiyamoriUniversity of Fukui, 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui Prefecture 910-1193, Japan.ORCID 0000-0002-9362-8395
Pfizer (Japan) · JPUniversity of Fukui · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Prospective postmarketing surveillance of Selara (eplerenone), a selective mineralocorticoid receptor antagonist, was performed to confirm its safety and efficacy for hypertension treatment in Japan. The change in blood pressure after initiation of eplerenone treatment was also examined. Patients with essential hypertension who were eplerenone-naïve were recruited regardless of the use of other antihypertensive drugs. For examination of changes in blood pressure, patients were excluded if eplerenone was contraindicated or used off-label. Patients received 50-100 mg of eplerenone once daily and were observed for 12 weeks. No treatments including antihypertensive drugs were restricted during the surveillance period. Across Japan, 3,166 patients were included for safety analysis. The incidence of adverse drug reactions was 2.4%. The major adverse drug reactions observed were hyperkalemia (0.6%), dizziness, renal impairment, and increased serum potassium (0.2% each). The mean systolic blood pressure decreased from 152.1 ± 19.0 mmHg to 134.8 ± 15.2 mmHg at week 12, and the mean diastolic blood pressure decreased from 85.8 ± 13.7 mmHg to 77.7 ± 11.4 mmHg. There were no significant new findings regarding the type or incidence of adverse reactions, and eplerenone had a clinically significant antihypertensive effect, leading to favorable blood pressure control.

Identifiers

PMID27843645
PMCPMC5098080
OpenAlexW2535176244

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.