Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase

Mohammad Bakhriansyah; Ronald H.B. Meyboom; Patrick C. Souverein; Anthonius De Boer; Olaf H. Klungel

doi:10.1002/pds.4629

Abstract

Background: Useofnon-steroidal anti-inflammatory drugs(NSAIDs) has been associated with many adverse events, including hypersensitivity reactions (HSRs), such as angioedemaand urticaria. However, no studies have investigated whether cyclooxygenase (COX) enzyme selectivity and/or chemical subgroups are associated with a difference in HSRs. Objectives: To describe and compare the frequency of HSRs among NSAIDs based on cyclooxygenase selectivity and chemical subgroups. Methods: A case/non-case study was performed using data from the World Health Organization global database of Individual Case Safety Report (ICSR), VigiBase, containing over 13 million ICSRs submitted by the participating member states enrolled 'under WHO's international drug monitoring program by June 2016. This study was nested among ICSRs where NSAIDs were a suspected drug. Cases were ICSRs mentioning HSRs (urticaria, angioedema, anaphylactic shock, anaphylactic reaction, anaphylactoid shock, and anaphylactoid reaction), whereas noncases were all ICSRs without HSRs. Based on the ratio of inhibitory concentration 80% of COX-1/COX-2, NSAIDs were categorized into coxibs, non-coxibNSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity. Only ICSRs with complete information on age and sex, and NSAIDs with first market authorization from 1978 onward were included. RORs and 95% confidence intervals (95% CIs) to assess the association between NSAIDs and the reporting of HSRs were calculated using logistic regression analysis. Results: We identified 16 289 HSR cases and 160 319 non-cases among ICSRs involving NSAIDs. Non-coxib NSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity were all associated with an increased reporting of HSRs (age-and sex-adjusted ROR 1.70, 95% CI: 1.61-1.79; age-and sexed justed 2.19, 95% CI: 2.11-2.77; and age-and sex-adjusted 1.26, 95% CI: 1.03-1.54, respectively) compared with coxibs. Conclusions: HSRs were more often reported for NSAIDs with poor selectivity, non-coxib NSAID with COX-2 preference, and NSAIDs with unknown selectivity compared with coxibs.

Original language	English
Pages (from-to)	264
Number of pages	1
Journal	Pharmacoepidemiology and Drug Safety
Volume	27
Issue number	S2
DOIs	https://doi.org/10.1002/pds.4629
Publication status	Published - 1 Aug 2018
Event	34th International conference on Pharmacoepidemiology & Therapeutic Risk Management - Prague Congress Centre, Prague, Czech Republic Duration: 22 Aug 2018 → 26 Aug 2018

Keywords

cyclooxygenase 1
cyclooxygenase 2
cyclooxygenase 2 inhibitor
endogenous compound
nonsteroid antiinflammatory agent
prostaglandin synthase
adverse drug reaction
allergic reaction
anaphylaxis
angioneurotic edema
conference abstract
controlled study
drug safety
drug surveillance program
female
human
inhibitory concentration
major clinical study
male
market
pharmacokinetics
side effect
world health organization

Access to Document

10.1002/pds.4629

CyclooxygenaseFinal published version, 57.4 KBLicence: Taverne

Cite this

Bakhriansyah, M., Meyboom, R. H. B., Souverein, P. C., De Boer, A., & Klungel, O. H. (2018). Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase. Pharmacoepidemiology and Drug Safety, 27(S2), 264. https://doi.org/10.1002/pds.4629

@article{4cd15c3fe5b34399bb6524cd15f1097b,

title = "Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase",

abstract = "Background: Useofnon-steroidal anti-inflammatory drugs(NSAIDs) has been associated with many adverse events, including hypersensitivity reactions (HSRs), such as angioedemaand urticaria. However, no studies have investigated whether cyclooxygenase (COX) enzyme selectivity and/or chemical subgroups are associated with a difference in HSRs. Objectives: To describe and compare the frequency of HSRs among NSAIDs based on cyclooxygenase selectivity and chemical subgroups. Methods: A case/non-case study was performed using data from the World Health Organization global database of Individual Case Safety Report (ICSR), VigiBase, containing over 13 million ICSRs submitted by the participating member states enrolled 'under WHO's international drug monitoring program by June 2016. This study was nested among ICSRs where NSAIDs were a suspected drug. Cases were ICSRs mentioning HSRs (urticaria, angioedema, anaphylactic shock, anaphylactic reaction, anaphylactoid shock, and anaphylactoid reaction), whereas noncases were all ICSRs without HSRs. Based on the ratio of inhibitory concentration 80% of COX-1/COX-2, NSAIDs were categorized into coxibs, non-coxibNSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity. Only ICSRs with complete information on age and sex, and NSAIDs with first market authorization from 1978 onward were included. RORs and 95% confidence intervals (95% CIs) to assess the association between NSAIDs and the reporting of HSRs were calculated using logistic regression analysis. Results: We identified 16 289 HSR cases and 160 319 non-cases among ICSRs involving NSAIDs. Non-coxib NSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity were all associated with an increased reporting of HSRs (age-and sex-adjusted ROR 1.70, 95% CI: 1.61-1.79; age-and sexed justed 2.19, 95% CI: 2.11-2.77; and age-and sex-adjusted 1.26, 95% CI: 1.03-1.54, respectively) compared with coxibs. Conclusions: HSRs were more often reported for NSAIDs with poor selectivity, non-coxib NSAID with COX-2 preference, and NSAIDs with unknown selectivity compared with coxibs.",

keywords = "cyclooxygenase 1, cyclooxygenase 2, cyclooxygenase 2 inhibitor, endogenous compound, nonsteroid antiinflammatory agent, prostaglandin synthase, adverse drug reaction, allergic reaction, anaphylaxis, angioneurotic edema, conference abstract, controlled study, drug safety, drug surveillance program, female, human, inhibitory concentration, major clinical study, male, market, pharmacokinetics, side effect, world health organization",

author = "Mohammad Bakhriansyah and Meyboom, {Ronald H.B.} and Souverein, {Patrick C.} and {De Boer}, Anthonius and Klungel, {Olaf H.}",

year = "2018",

month = aug,

day = "1",

doi = "10.1002/pds.4629",

language = "English",

volume = "27",

pages = "264",

journal = "Pharmacoepidemiology and Drug Safety",

issn = "1053-8569",

publisher = "John Wiley and Sons Ltd",

number = "S2",

note = "34th International conference on Pharmacoepidemiology & Therapeutic Risk Management ; Conference date: 22-08-2018 Through 26-08-2018",

}

Bakhriansyah, M, Meyboom, RHB, Souverein, PC , De Boer, A & Klungel, OH 2018, 'Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase', Pharmacoepidemiology and Drug Safety, vol. 27, no. S2, pp. 264. https://doi.org/10.1002/pds.4629

Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase. / Bakhriansyah, Mohammad; Meyboom, Ronald H.B.; Souverein, Patrick C. et al.
In: Pharmacoepidemiology and Drug Safety, Vol. 27, No. S2, 01.08.2018, p. 264.

Research output: Contribution to journal › Meeting Abstract › Academic

TY - JOUR

T1 - Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase

AU - Bakhriansyah, Mohammad

AU - Meyboom, Ronald H.B.

AU - Souverein, Patrick C.

AU - De Boer, Anthonius

AU - Klungel, Olaf H.

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Background: Useofnon-steroidal anti-inflammatory drugs(NSAIDs) has been associated with many adverse events, including hypersensitivity reactions (HSRs), such as angioedemaand urticaria. However, no studies have investigated whether cyclooxygenase (COX) enzyme selectivity and/or chemical subgroups are associated with a difference in HSRs. Objectives: To describe and compare the frequency of HSRs among NSAIDs based on cyclooxygenase selectivity and chemical subgroups. Methods: A case/non-case study was performed using data from the World Health Organization global database of Individual Case Safety Report (ICSR), VigiBase, containing over 13 million ICSRs submitted by the participating member states enrolled 'under WHO's international drug monitoring program by June 2016. This study was nested among ICSRs where NSAIDs were a suspected drug. Cases were ICSRs mentioning HSRs (urticaria, angioedema, anaphylactic shock, anaphylactic reaction, anaphylactoid shock, and anaphylactoid reaction), whereas noncases were all ICSRs without HSRs. Based on the ratio of inhibitory concentration 80% of COX-1/COX-2, NSAIDs were categorized into coxibs, non-coxibNSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity. Only ICSRs with complete information on age and sex, and NSAIDs with first market authorization from 1978 onward were included. RORs and 95% confidence intervals (95% CIs) to assess the association between NSAIDs and the reporting of HSRs were calculated using logistic regression analysis. Results: We identified 16 289 HSR cases and 160 319 non-cases among ICSRs involving NSAIDs. Non-coxib NSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity were all associated with an increased reporting of HSRs (age-and sex-adjusted ROR 1.70, 95% CI: 1.61-1.79; age-and sexed justed 2.19, 95% CI: 2.11-2.77; and age-and sex-adjusted 1.26, 95% CI: 1.03-1.54, respectively) compared with coxibs. Conclusions: HSRs were more often reported for NSAIDs with poor selectivity, non-coxib NSAID with COX-2 preference, and NSAIDs with unknown selectivity compared with coxibs.

AB - Background: Useofnon-steroidal anti-inflammatory drugs(NSAIDs) has been associated with many adverse events, including hypersensitivity reactions (HSRs), such as angioedemaand urticaria. However, no studies have investigated whether cyclooxygenase (COX) enzyme selectivity and/or chemical subgroups are associated with a difference in HSRs. Objectives: To describe and compare the frequency of HSRs among NSAIDs based on cyclooxygenase selectivity and chemical subgroups. Methods: A case/non-case study was performed using data from the World Health Organization global database of Individual Case Safety Report (ICSR), VigiBase, containing over 13 million ICSRs submitted by the participating member states enrolled 'under WHO's international drug monitoring program by June 2016. This study was nested among ICSRs where NSAIDs were a suspected drug. Cases were ICSRs mentioning HSRs (urticaria, angioedema, anaphylactic shock, anaphylactic reaction, anaphylactoid shock, and anaphylactoid reaction), whereas noncases were all ICSRs without HSRs. Based on the ratio of inhibitory concentration 80% of COX-1/COX-2, NSAIDs were categorized into coxibs, non-coxibNSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity. Only ICSRs with complete information on age and sex, and NSAIDs with first market authorization from 1978 onward were included. RORs and 95% confidence intervals (95% CIs) to assess the association between NSAIDs and the reporting of HSRs were calculated using logistic regression analysis. Results: We identified 16 289 HSR cases and 160 319 non-cases among ICSRs involving NSAIDs. Non-coxib NSAIDs with COX-2 preference, NSAIDs with poor selectivity, and NSAIDs with unknown selectivity were all associated with an increased reporting of HSRs (age-and sex-adjusted ROR 1.70, 95% CI: 1.61-1.79; age-and sexed justed 2.19, 95% CI: 2.11-2.77; and age-and sex-adjusted 1.26, 95% CI: 1.03-1.54, respectively) compared with coxibs. Conclusions: HSRs were more often reported for NSAIDs with poor selectivity, non-coxib NSAID with COX-2 preference, and NSAIDs with unknown selectivity compared with coxibs.

KW - cyclooxygenase 1

KW - cyclooxygenase 2

KW - cyclooxygenase 2 inhibitor

KW - endogenous compound

KW - nonsteroid antiinflammatory agent

KW - prostaglandin synthase

KW - adverse drug reaction

KW - allergic reaction

KW - anaphylaxis

KW - angioneurotic edema

KW - conference abstract

KW - controlled study

KW - drug safety

KW - drug surveillance program

KW - female

KW - human

KW - inhibitory concentration

KW - major clinical study

KW - male

KW - market

KW - pharmacokinetics

KW - side effect

KW - world health organization

U2 - 10.1002/pds.4629

DO - 10.1002/pds.4629

M3 - Meeting Abstract

SN - 1053-8569

VL - 27

SP - 264

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

IS - S2

T2 - 34th International conference on Pharmacoepidemiology & Therapeutic Risk Management

Y2 - 22 August 2018 through 26 August 2018

ER -

Cyclooxygenase selectivity and chemical subgroup of non-steroidal anti-inflammatory drugs and frequency of spontaneous reporting of hypersensitivity reactions: A case/non-case study in Vigibase

Abstract

Keywords

Access to Document

Fingerprint

Cite this