Cited by 239Advanced Causal Inference TechniquesStatistical Methods in EpidemiologyDiabetes Treatment and Management

Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores: Prevalent New-user Designs

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Suissa, Samy, Moodie, Erica E. M., Dell'Aniello, Sophie·2017·Pharmacoepidemiology and Drug Safety

Abstract

PURPOSE: Studies of the real-world comparative effectiveness of drugs conducted using computerized healthcare databases typically involve an incident new-user cohort design for head-to-head comparisons between two medications, using exclusively treatment-naïve patients. However, the desired contrast often involves one new drug compared with an older drug, of which many users of the new drug may have switched from, seriously restricting the scope of incident new-user studies. METHODS: We introduce prevalent new-user cohort designs for head-to-head comparative drug effect studies, where incident new users are scarce. We define time-based and prescription-based exposure sets to compute time-conditional propensity scores of initiating the newer drug and to identify matched subjects receiving the comparator drug. We illustrate this approach using data from the UK's Clinical Practice Research Datalink to evaluate whether the newer glucagon-like peptide-1 receptor agonists (GLP-1 analogs) used to treat type 2 diabetes increase the risk of heart failure, in comparison with the older similarly indicated sulfonylureas. RESULTS: Of the 170 031 users of antidiabetic agents from 2000 onwards, 79 682 used sulfonylureas (first use 2000), while 6196 used GLP-1 analogs (first use 2007), 75% of which had previously used a sulfonylurea. After matching each GLP-1 analog user to a sulfonylurea user on the time-conditional propensity scores from prescription-based exposure sets, the hazard ratio of heart failure with GLP-1 use was 0.73 (95%CI: 0.57-0.93). CONCLUSION: The proposed prevalent new-user cohort design for comparative drug effects studies allows the use of all or most patients exposed to the newer drug, thus permitting a more comprehensive assessment of a new drug's safety. Copyright © 2016 John Wiley & Sons, Ltd.

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Authors
Suissa, S., Moodie, E. E. M., & Dell'Aniello, S.
Affiliations
  • Jewish General Hospital (CA)
  • McGill University (CA)
  • McGill Pharmacoepidemiology Research Unit; McGill University; Montreal Quebec Canada
Corresponding author
Suissa, Samy
Venue
Pharmacoepidemiology and Drug Safety
Publisher
Wiley
Published
2016-09-09
Volume
26
Issue
4
Pages
459-468
ISSN
1053-8569 (ISSN-L)
OpenAlex
W2519686100
Cited by
239
References
19
Citations by year
2026: 28 · 2025: 28 · 2024: 37 · 2023: 21 · 2022: 31 · 2021: 29 · 2020: 30 · 2019: 17 · 2018: 11 · 2017: 5 · 2013: 1
FWCI
11.12
Type
journal article
Language
en
Open access
Locations
  • Pharmacoepidemiology and Drug Safety (publishedVersion)
  • PubMed (publishedVersion)
  • eScholarship@McGill (McGill) (submittedVersion)
Funders
  • Canadian Institutes of Health Research
  • Canadian Foundation for Innovation
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
comparative drug effectiveness, drug switching, heart failure risk, GLP-1 receptor agonists, sulfonylureas, type 2 diabetes, antidiabetic drugs, Clinical Practice Research Datalink
MeSH terms
Glucagon-Like Peptide-1 Receptor Agonists, Aged, Diabetes Mellitus, Type 2, Female, United Kingdom, Heart Failure, Humans, Hypoglycemic Agents, Male, Middle Aged, Research Design, Sulfonylurea Compounds, Time Factors, Cohort Studies, Proportional Hazards Models, Databases, Factual, Pharmacoepidemiology, Comparative Effectiveness Research, Propensity Score

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