Evidence map›Paper›PMID 33587654›Full record

ArticleCirculation2021

Sex, Permanent Drug Discontinuation, and Study Retention in Clinical Trials: Insights From the TIMI trials.

Emily S Lau, Eugene Braunwald, David A Morrow, Robert P Giugliano, Elliott M Antman, C Michael Gibson, Benjamin M Scirica, Erin A Bohula, Stephen D Wiviott, Deepak L Bhatt and 6 more

Open access · bronzeAbstract read
In one paragraph

Article in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
11.8field-weighted citation impact, top 2% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Should we consider gender aspects in pharmacology teaching? No-we must!Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  6. Article
  7. Article
  8. Artificial Intelligence in Cardiovascular Clinical Trials.Journal of the American College of Cardiology · 2024
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Understanding Study Drug Discontinuation Through EUCLID.Frontiers in cardiovascular medicine · 2022
    Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 2 countries.

Emily S LauCardiology Division, Massachusetts General Hospital, Boston, MA (E.S.L.).
Eugene BraunwaldTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
David A MorrowTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Robert P GiuglianoTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Elliott M AntmanTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
C Michael Gibson
Benjamin M SciricaTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Erin A BohulaTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Stephen D WiviottTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Deepak L BhattDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (D.L.B., C.P.C.).
Marc P BonacaCPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Denver, CO (M.P.B.).
Christopher P CannonDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (D.L.B., C.P.C.).
KyungAh ImTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Jianping GuoTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Marc S SabatineTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Michelle L O'DonoghueTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).
Thrombolysis in Myocardial Infarction Study Group · USBrigham and Women's Hospital · USGibson Energy (Canada) · CAMassachusetts General Hospital · USUniversity of Colorado Denver · US

Funding

Noninvasive Cardiovascular Imaging Research Training ProgramT32HL094301 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI Marcelo F DI CARLI · 2010 to 2026
$7.8M
NHLBI NIH HHS T32 HL094301
6 · The paper itself

Abstract

backgroundWomen are underrepresented across cardiovascular clinical trials. Whether women are more likely than men to prematurely discontinue study drug or withdraw consent once enrolled in a clinical trial is unknown.

methodsEleven phase 3/4 TIMI (Thrombolysis in Myocardial Infarction) trials were included (135 879 men and 51 812 women [28%]). The association between sex and premature study drug discontinuation and withdrawal of consent were examined by multivariable logistic regression after adjusting for potential confounders in each individual trial and combining the individual point estimates in random effects models.

resultsAfter adjusting for baseline differences, women had 22% higher odds of premature drug discontinuation (adjusted odds ratio [OR

conclusionsWomen were more likely than men to prematurely discontinue study drug and withdraw consent across cardiovascular outcome trials. Premature study drug discontinuation was not explained by baseline differences by sex or a higher proportion of adverse events. Future trials should better capture reasons for drug discontinuation and withdrawal of consent to understand barriers to continued study drug use and clinical trial participation, particularly among women.

Indexed as

AgedDrug TherapyEarly Termination of Clinical TrialsFemaleHumansMaleMiddle AgedSex Factorscardiovascular drugsclinical trialwomen

Identifiers

PMID33587654
PMCPMC7894618
OpenAlexW3129727398

What OpenQuestion holds

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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.