Evidence map›Paper›PMID 38434341›Full record

ArticleHeliyon2024

Comparing the risk of deep vein thrombosis of two combined oral contraceptives: Norethindrone/ethinyl estradiol and drospirenone/ethinyl estradiol.

Jennifer Stalas, Robert Morris, Kun Bu, Kevin von Bargen, Rebekah Largmann, Kathryn Sanford, Jacob Vandeventer, Weiru Han, Feng Cheng

Open access · goldAbstract read
In one paragraph

Article in Heliyon, 2024. 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
4.9field-weighted citation impact, top 5% 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, 9 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

9 authors at 1 institution in 1 country.

Jennifer StalasTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
Robert MorrisTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
Kun BuDepartment of Mathematics & Statistics, College of Art and Science, University of South Florida, Tampa, FL, 33620, USA.
Kevin von BargenTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
Rebekah LargmannTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
Kathryn SanfordTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
Jacob VandeventerTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
Weiru HanDepartment of Mathematics & Statistics, College of Art and Science, University of South Florida, Tampa, FL, 33620, USA.
Feng ChengTaneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd Tampa, FL, 33612, USA.
University of South Florida · US

Funding

Identification of Potential Drug-drug Interactions in Alzheimer's Disease PatientsR03AG070536 · NIA · UNIVERSITY OF SOUTH FLORIDA · PI CHENG, FENG · 2020 to 2021
$150k
NIA NIH HHS R03 AG070536
6 · The paper itself

Abstract

Background: Deep vein thrombosis (DVT) has been reported as an adverse event for patients receiving combined oral contraceptives. Norethindrone/ethinyl estradiol (NET/EE) and drospirenone/ethinyl estradiol (DRSP/EE) are two commonly prescribed combined hormonal oral contraceptive agents used in the United States, differing in their progestin component. Objective: The purpose of this study was to determine the association between the progestin component of a combined oral contraceptive and the risk of DVT in patients taking oral contraceptives for birth control using data derived from the FDA Adverse Event Reporting System (FAERS). Methods: The risk of DVT was compared between patients that had taken NET/EE with those that had taken the DRSP/EE COC formulation for birth control. In addition, age was assessed as a possible confounder and the outcome severity for those diagnosed with DVT were compared between the two groups. Finally, association rule mining was utilized to identify possible drug-drug interactions that result in elevated DVT risk. Results: DVT was the fourth most commonly adverse event reported for patients taking DRSP/EE accounting for 8558 cases and the seventeenth most commonly reported adverse event for NET/EE accounting for 298 cases. Age was found to be a significant confounder for users of DRSP/EE with regards to DVT risk across all age groups assessed: 20<Age ≤ 30 (ROR = 1.33, 95% CI 1.23-1.45), 30<Age ≤ 40 (ROR = 2.16, 95% CI 1.98-2.35), and Age>40 (ROR = 3.69, 95% CI 3.37-4.04) However, there was only a statistically significant elevated risk in patients over 40 years of age taking NET/EE (ROR = 1.98, 95% CI 1.36-2.88). Patients that had taken DRSP/EE and the corticosteroid prednisone simultaneously had an approximately 3-fold increase in DVT risk (ROR = 2.77, 95% CI 2.43-3.15) relative to individuals that had only taken DRSP/EE. Conclusion: Based on this analysis, there is a higher risk of developing DVT when taking DRSP/EE than when taking NET/EE as hormonal contraception. In addition, a possibly significant drug-drug interaction between different COC formulations and prednisone were identified. This interaction may result in elevated DVT risk due to a synergistic impairment of fibrinolysis and a decrease in plasmin production.

Indexed as

DDIDRSPDrug-drug interactionsDVTFAERSPharmacovigilancePrednisone

Identifiers

PMID38434341
PMCPMC10906292
OpenAlexW4391917165

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.