Evidence map›Paper›PMID 36420373›Full record

ArticleTherapeutic advances in drug safety2022

Risk of venous thromboembolism among women receiving ospemifene: a comparative observational study.

Beth L Nordstrom, Bin Cai, Fabio De Gregorio, Lu Ban, Kathy H Fraeman, Yuki Yoshida, Trevor Gibbs

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 27% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

7 authors at 3 institutions in 2 countries.

Beth L NordstromEvidera, 5th Floor, 500 Totten Pond Road, Waltham, MA 02451, USA.ORCID https://orcid.org/0000-0003-1743-9610
Bin CaiShionogi Inc., Florham Park, NJ, USA.
Fabio De GregorioShionogi B.V., London, UK.
Lu BanPPD Beijing, Beijing, China.
Kathy H FraemanEvidera, Bethesda, MD, USA.
Yuki YoshidaShionogi & Co., Ltd., Osaka, Japan.
Trevor GibbsShionogi B.V., London, UK.
Ithaka Harbors · USShionogi (Japan) · JPShionogi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The primary aim of this study was to compare the incidence of venous thromboembolism (VTE) among women initiating ospemifene vs other selective estrogen receptor modulator (SERM) therapies for estrogen-deficiency conditions or breast cancer prevention, and vs women with untreated vulvar and vaginal atrophy (VVA). The secondary objective examined numerous additional safety outcomes. Methods: This was a retrospective cohort study using the IBM Watson MarketScan claims database. Women receiving ospemifene, another SERM, or with a new diagnosis of VVA with no treatment from 1 May 2013 to 2 October 2018 were followed through the claims for incident adverse outcomes. The primary outcome was the first occurrence of VTE following cohort entry; secondary outcomes included cerebrovascular events and other adverse events potentially associated with SERM use. Cox models compared the risk of VTE between ospemifene and comparators, using a variety of approaches to control for confounding. Results: The incidence of VTE during the first continuous treatment episode was 3.39 (95% confidence interval [CI]: 1.55-6.43) events per 1,000 person-years (PY) for ospemifene ( Conclusion: This real-world safety analysis found no increase in risk of VTE or other adverse events with use of ospemifene in postmenopausal women. Plain Language Summary:

Indexed as

ospemifenepost-authorization safety studyselective estrogen receptor modulatorvenous thromboembolismvulvar and vaginal atrophy

Identifiers

PMID36420373
PMCPMC9677319
OpenAlexW4310335049

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.