Identification of potential carcinogenic and chemopreventive effects of prescription drugs

A protocol for a Norwegian registry-based study

Bettina Kulle Andreassen*, Nathalie C. Støer, Jan Ivar Martinsen, Giske Ursin, Elisabete Weiderpass, G. Hege Thoresen, Karen Boldingh Debernard, Øystein Karlstad, Anton Pottegard, Søren Friis

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

50 Downloads (Pure)

Resumé

Introduction Surveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations. Methods and analysis The main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case-control design including all adult (∼200 000) incident cancer cases within the age-range 18-85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions' daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use-cancer-risk associations. Ethics and dissemination The study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.

OriginalsprogEngelsk
Artikelnummere028504
TidsskriftBMJ Open
Vol/bind9
Udgave nummer4
Antal sider7
ISSN2044-6055
DOI
StatusUdgivet - 8. apr. 2019

Fingeraftryk

Registries
Neoplasms
Norway
Pharmaceutical Preparations
Pharmacovigilance
Prescriptions
Logistic Models
Computer Security
Drug Evaluation
Population Control
Information Storage and Retrieval
Statistical Models
Drug-Related Side Effects and Adverse Reactions
Ethics
Comorbidity
Databases
Safety
Incidence

Citer dette

Andreassen, B. K., Støer, N. C., Martinsen, J. I., Ursin, G., Weiderpass, E., Thoresen, G. H., ... Friis, S. (2019). Identification of potential carcinogenic and chemopreventive effects of prescription drugs: A protocol for a Norwegian registry-based study. BMJ Open, 9(4), [e028504]. https://doi.org/10.1136/bmjopen-2018-028504
Andreassen, Bettina Kulle ; Støer, Nathalie C. ; Martinsen, Jan Ivar ; Ursin, Giske ; Weiderpass, Elisabete ; Thoresen, G. Hege ; Debernard, Karen Boldingh ; Karlstad, Øystein ; Pottegard, Anton ; Friis, Søren. / Identification of potential carcinogenic and chemopreventive effects of prescription drugs : A protocol for a Norwegian registry-based study. I: BMJ Open. 2019 ; Bind 9, Nr. 4.
@article{ea51496ab3ae48bcb0cc4b3871758777,
title = "Identification of potential carcinogenic and chemopreventive effects of prescription drugs: A protocol for a Norwegian registry-based study",
abstract = "Introduction Surveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations. Methods and analysis The main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case-control design including all adult (∼200 000) incident cancer cases within the age-range 18-85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions' daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use-cancer-risk associations. Ethics and dissemination The study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.",
keywords = "cancer risk, drug safety, pharmacoepidemiology",
author = "Andreassen, {Bettina Kulle} and St{\o}er, {Nathalie C.} and Martinsen, {Jan Ivar} and Giske Ursin and Elisabete Weiderpass and Thoresen, {G. Hege} and Debernard, {Karen Boldingh} and {\O}ystein Karlstad and Anton Pottegard and S{\o}ren Friis",
year = "2019",
month = "4",
day = "8",
doi = "10.1136/bmjopen-2018-028504",
language = "English",
volume = "9",
journal = "B M J Open",
issn = "2044-6055",
publisher = "BMJ Group",
number = "4",

}

Andreassen, BK, Støer, NC, Martinsen, JI, Ursin, G, Weiderpass, E, Thoresen, GH, Debernard, KB, Karlstad, Ø, Pottegard, A & Friis, S 2019, 'Identification of potential carcinogenic and chemopreventive effects of prescription drugs: A protocol for a Norwegian registry-based study', BMJ Open, bind 9, nr. 4, e028504. https://doi.org/10.1136/bmjopen-2018-028504

Identification of potential carcinogenic and chemopreventive effects of prescription drugs : A protocol for a Norwegian registry-based study. / Andreassen, Bettina Kulle; Støer, Nathalie C.; Martinsen, Jan Ivar; Ursin, Giske; Weiderpass, Elisabete; Thoresen, G. Hege; Debernard, Karen Boldingh; Karlstad, Øystein; Pottegard, Anton; Friis, Søren.

I: BMJ Open, Bind 9, Nr. 4, e028504, 08.04.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Identification of potential carcinogenic and chemopreventive effects of prescription drugs

T2 - A protocol for a Norwegian registry-based study

AU - Andreassen, Bettina Kulle

AU - Støer, Nathalie C.

AU - Martinsen, Jan Ivar

AU - Ursin, Giske

AU - Weiderpass, Elisabete

AU - Thoresen, G. Hege

AU - Debernard, Karen Boldingh

AU - Karlstad, Øystein

AU - Pottegard, Anton

AU - Friis, Søren

PY - 2019/4/8

Y1 - 2019/4/8

N2 - Introduction Surveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations. Methods and analysis The main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case-control design including all adult (∼200 000) incident cancer cases within the age-range 18-85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions' daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use-cancer-risk associations. Ethics and dissemination The study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.

AB - Introduction Surveillance of unintended effects of pharmaceuticals (pharmacovigilance or drug safety) is crucial, as knowledge of rare or late side effects is limited at the time of the introduction of new medications into the market. Side effects of drugs may involve increased or decreased risk of cancer, but these typically appear after a long induction period. This fact, together with low incidences of many cancer types, limits the usefulness of traditional pharmacovigilance strategies, primarily based on spontaneous reporting of adverse events, to identify associations between drug use and cancer risk. Postmarketing observational pharmacoepidemiological studies are therefore crucial in the evaluation of drug-cancer associations. Methods and analysis The main data sources in this project will be the Norwegian Prescription Database and the Cancer Registry of Norway. The underlying statistical model will be based on a multiple nested case-control design including all adult (∼200 000) incident cancer cases within the age-range 18-85 years from 2007 through 2015 in Norway as cases. 10 cancer-free population controls will be individually matched to these cases with respect to birth year, sex and index date (date of cancer diagnosis). Drug exposure will be modelled as chronic user/non-user by counting prescriptions, and cumulative use by summarising all dispensions' daily defined doses over time. Conditional logistic regression models adjusted for comorbidity (National Patient Register), socioeconomic parameters (Statistics Norway), concomitant drug use and, for female cancers, reproduction data (Medical Birth Registry), will be applied to identify drug-use-cancer-risk associations. Ethics and dissemination The study is approved by the regional ethical committee and the Norwegian data protection authority. Results of the initial screening step and analysis pipeline will be described in a key paper. Subsequent papers will report the evaluation of identified signals in replication studies. Results will be published in peer-reviewed journals, at scientific conferences and through press releases.

KW - cancer risk

KW - drug safety

KW - pharmacoepidemiology

U2 - 10.1136/bmjopen-2018-028504

DO - 10.1136/bmjopen-2018-028504

M3 - Journal article

VL - 9

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 4

M1 - e028504

ER -