Evaluation Of Cardiovascular Risk With Nsaids: Limitations Arising From Inconsistent Reporting In Pharmacoepidemiological Studie

Patricia McGettigan, David A Henry

Research output: Contribution to journalMeeting AbstractResearchpeer-review

Abstract

Concerns about cardiovascular risks with NSAIDs arose from randomized studies of gastro-intestinal safety, Alzheimer’s disease and tumor protection. Subsequent pharmacoepidemiological studies explored risks associated with NSAID use in general populations. Factors important in judging risk include: dose, underlying cardiovascular risk, timeframe for risk onset. We investigated how these factors were reported in the pharmacoepidemiological studies. Methods: Review of studies included in a systematic review and metaanalysis of cardiovascular risk. Results: Of 51 eligible studies, 28 case–control studies included 184,946 cardiovascular events, 23 cohort studies described outcomes in >2.3 million exposed individuals. Dose: Of 38 studies reporting on rofecoxib and/or celecoxib, 14 and 8 respectively reported risk with different doses; all used the same low/ high dose stratifications. Of 42 studies reporting on one or more of three commonly-used NSAIDs (ibuprofen, diclofenac, naproxen), only nine reported low/high dose risk estimates and three different dose stratifications were used. Background: cardiovascular risk: Fourteen studies provided information on ‘high’ and ‘low’ risk populations. ‘High’ and ‘low’ risk definitions varied between studies. Timeframe for risk onset: Thirteen studies, reported events among newusers of NSAIDs; nine found risk elevated within 30 days; three within 14 days. Conclusion: In assessing NSAID-associated cardiovascular risk, a minority of studies reported three factors that are important potential effect modifiers. Among studies providing this information, betweenstudy variability in defining factor-related parameters impeded assessment of variation in cardiovascular risk. Agreement on reporting criteria would greatly improve the value of data from pharmacoepidemiological studies of NSAID-related risk and permit greater precision in risk estimates.
Original languageEnglish
Article numberP253
Pages (from-to)139
JournalBasic and Clinical Pharmacology and Toxicology
Volume109
Issue numberS1
DOIs
Publication statusPublished - 2011
Externally publishedYes

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Non-Steroidal Anti-Inflammatory Agents
Celecoxib
Naproxen
Diclofenac
Ibuprofen
Population
Alzheimer Disease
Cohort Studies
Safety

Cite this

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title = "Evaluation Of Cardiovascular Risk With Nsaids: Limitations Arising From Inconsistent Reporting In Pharmacoepidemiological Studie",
abstract = "Concerns about cardiovascular risks with NSAIDs arose from randomized studies of gastro-intestinal safety, Alzheimer’s disease and tumor protection. Subsequent pharmacoepidemiological studies explored risks associated with NSAID use in general populations. Factors important in judging risk include: dose, underlying cardiovascular risk, timeframe for risk onset. We investigated how these factors were reported in the pharmacoepidemiological studies. Methods: Review of studies included in a systematic review and metaanalysis of cardiovascular risk. Results: Of 51 eligible studies, 28 case–control studies included 184,946 cardiovascular events, 23 cohort studies described outcomes in >2.3 million exposed individuals. Dose: Of 38 studies reporting on rofecoxib and/or celecoxib, 14 and 8 respectively reported risk with different doses; all used the same low/ high dose stratifications. Of 42 studies reporting on one or more of three commonly-used NSAIDs (ibuprofen, diclofenac, naproxen), only nine reported low/high dose risk estimates and three different dose stratifications were used. Background: cardiovascular risk: Fourteen studies provided information on ‘high’ and ‘low’ risk populations. ‘High’ and ‘low’ risk definitions varied between studies. Timeframe for risk onset: Thirteen studies, reported events among newusers of NSAIDs; nine found risk elevated within 30 days; three within 14 days. Conclusion: In assessing NSAID-associated cardiovascular risk, a minority of studies reported three factors that are important potential effect modifiers. Among studies providing this information, betweenstudy variability in defining factor-related parameters impeded assessment of variation in cardiovascular risk. Agreement on reporting criteria would greatly improve the value of data from pharmacoepidemiological studies of NSAID-related risk and permit greater precision in risk estimates.",
author = "Patricia McGettigan and Henry, {David A}",
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Evaluation Of Cardiovascular Risk With Nsaids: Limitations Arising From Inconsistent Reporting In Pharmacoepidemiological Studie. / McGettigan, Patricia; Henry, David A.

In: Basic and Clinical Pharmacology and Toxicology, Vol. 109, No. S1, P253, 2011, p. 139.

Research output: Contribution to journalMeeting AbstractResearchpeer-review

TY - JOUR

T1 - Evaluation Of Cardiovascular Risk With Nsaids: Limitations Arising From Inconsistent Reporting In Pharmacoepidemiological Studie

AU - McGettigan, Patricia

AU - Henry, David A

PY - 2011

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N2 - Concerns about cardiovascular risks with NSAIDs arose from randomized studies of gastro-intestinal safety, Alzheimer’s disease and tumor protection. Subsequent pharmacoepidemiological studies explored risks associated with NSAID use in general populations. Factors important in judging risk include: dose, underlying cardiovascular risk, timeframe for risk onset. We investigated how these factors were reported in the pharmacoepidemiological studies. Methods: Review of studies included in a systematic review and metaanalysis of cardiovascular risk. Results: Of 51 eligible studies, 28 case–control studies included 184,946 cardiovascular events, 23 cohort studies described outcomes in >2.3 million exposed individuals. Dose: Of 38 studies reporting on rofecoxib and/or celecoxib, 14 and 8 respectively reported risk with different doses; all used the same low/ high dose stratifications. Of 42 studies reporting on one or more of three commonly-used NSAIDs (ibuprofen, diclofenac, naproxen), only nine reported low/high dose risk estimates and three different dose stratifications were used. Background: cardiovascular risk: Fourteen studies provided information on ‘high’ and ‘low’ risk populations. ‘High’ and ‘low’ risk definitions varied between studies. Timeframe for risk onset: Thirteen studies, reported events among newusers of NSAIDs; nine found risk elevated within 30 days; three within 14 days. Conclusion: In assessing NSAID-associated cardiovascular risk, a minority of studies reported three factors that are important potential effect modifiers. Among studies providing this information, betweenstudy variability in defining factor-related parameters impeded assessment of variation in cardiovascular risk. Agreement on reporting criteria would greatly improve the value of data from pharmacoepidemiological studies of NSAID-related risk and permit greater precision in risk estimates.

AB - Concerns about cardiovascular risks with NSAIDs arose from randomized studies of gastro-intestinal safety, Alzheimer’s disease and tumor protection. Subsequent pharmacoepidemiological studies explored risks associated with NSAID use in general populations. Factors important in judging risk include: dose, underlying cardiovascular risk, timeframe for risk onset. We investigated how these factors were reported in the pharmacoepidemiological studies. Methods: Review of studies included in a systematic review and metaanalysis of cardiovascular risk. Results: Of 51 eligible studies, 28 case–control studies included 184,946 cardiovascular events, 23 cohort studies described outcomes in >2.3 million exposed individuals. Dose: Of 38 studies reporting on rofecoxib and/or celecoxib, 14 and 8 respectively reported risk with different doses; all used the same low/ high dose stratifications. Of 42 studies reporting on one or more of three commonly-used NSAIDs (ibuprofen, diclofenac, naproxen), only nine reported low/high dose risk estimates and three different dose stratifications were used. Background: cardiovascular risk: Fourteen studies provided information on ‘high’ and ‘low’ risk populations. ‘High’ and ‘low’ risk definitions varied between studies. Timeframe for risk onset: Thirteen studies, reported events among newusers of NSAIDs; nine found risk elevated within 30 days; three within 14 days. Conclusion: In assessing NSAID-associated cardiovascular risk, a minority of studies reported three factors that are important potential effect modifiers. Among studies providing this information, betweenstudy variability in defining factor-related parameters impeded assessment of variation in cardiovascular risk. Agreement on reporting criteria would greatly improve the value of data from pharmacoepidemiological studies of NSAID-related risk and permit greater precision in risk estimates.

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JO - Pharmacology and Toxicology

JF - Pharmacology and Toxicology

SN - 0901-9928

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