Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks.
Adolescent
Adult
Aged
Canada
/ epidemiology
Cohort Studies
Female
Follow-Up Studies
Heart Failure
/ chemically induced
Humans
Hypoglycemic Agents
/ adverse effects
Incretins
/ adverse effects
Male
Middle Aged
Pancreatitis
/ chemically induced
Product Surveillance, Postmarketing
/ methods
Retrospective Studies
United States
/ epidemiology
Young Adult
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
10
06
2019
accepted:
12
09
2019
pubmed:
21
10
2019
medline:
28
10
2020
entrez:
21
10
2019
Statut:
ppublish
Résumé
The US Sentinel System and the Canadian Network for Observational Drug Effect Studies (CNODES) are two medical product safety surveillance networks. Using Sentinel's preprogrammed, parameterizable analytic tools, we reproduced two protocol-based studies conducted by CNODES to assess the risks of acute pancreatitis and heart failure (HF) associated with the use of incretin-based drugs, compared with use of ≥ 2 oral hypoglycemic agents. Results from the replication new-user cohort analyses aligned with those from the CNODES nested case-control studies. The adjusted hazard ratios were 0.95 (0.81-1.12; vs. 1.03 (0.87-1.22) in CNODES) for acute pancreatitis and 0.91 (0.84-1.00; vs. 0.82 (0.67-1.00) in CNODES) for HF among patients without HF history. The CNODES's common protocol approach allows studies tailored to specific safety questions, whereas the Sentinel's common data model plus pretested program approach enables more rapid analysis. Despite these differences, it is possible to obtain comparable results using both approaches.
Substances chimiques
Hypoglycemic Agents
0
Incretins
0
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
966-977Subventions
Organisme : FDA HHS
ID : HHSF223200910006I
Pays : United States
Organisme : CIHR
ID : DSE-146021
Pays : Canada
Informations de copyright
© 2019 The Authors. Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
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