duration of treatment with non steroidal 2

8/3/2019 Duration of Treatment With Non Steroidal 2

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Duration of Treatment With NonsteroidalAnti-Inflammatory Drugs and Impact on

Risk of Death andRecurrent Myocardial Infarction in

Patients With PriorMyocardial Infarction

A nationwide cohort study

By: Lina Daoud



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Introduction:

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NSAIDS are contradicted among patients withestablished cardiovascular disease.

• BUT many receive NSAIDs for a short period of

time.

• Little is known about the association between

NSAID duration and risk of cardiovascular disease.



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Previous relevant studies: • Time-to-event analyses for NSAID treatment, suggesting:

an increased risk at the initiation of therapy whichpersists afterward.

• 2 studies specifically determining the cardiovascular

safety of NSAID treatment

• one study showed that Valdecoxib* increased CV risk in

pts undergoing CABG aleady after 1 week of treatment.

• rofecoxib and valdecoxib were withdrawn from the

market (2004)



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Methods:

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Population with first-time admissionfor MI (January 1, 1997, -December31, 2006) in the Danish

National Patient Registry- without any prior admission for

MI in the previous 19 years.*

• Patients were censored at death or at the end

of the study period (December 31, 2006).

•Pharmacies in Denmark are required to register

each drug dispensing.



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NSAID Drug use:

The most commonly used NSAIDS after discharge:

• Selective COX-2 inhibitors: rofecoxib and

celecoxib.• nonselective NSAIDs: ibuprofen, diclofenac, and

naproxen.

• All other NSAIDs were analyzed in a common

group defined as other NSAIDs.



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Statistics

•5 exposure periods: 0 to 7, 8 to 14, 15 to30, 31 to 90,

and >90 days.

•All models were adjusted for age, sex, year of index

hospitalization, concomitant medication, comorbidity, and

socioeconomic status.



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Results



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Discussion•Risks of death and death/Re-MI were independent of the

duration of NSAID treatment

•Risk with some NSAIDs became apparent immediately

(diclofenac) or early (rofecoxib and ibuprofen) after

treatment onset.

• The results support previous studies showing that

patients with prior MI are at increased risk when taking

NSAIDs, especially diclofenac and the selective COX-2

inhibitors



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•These results challenge the view that NSAIDs

are not harmful during short-term (1 week)

treatment and indicate that a revision of currentrecommendations regarding NSAID treatment

•The present study, however, is the first to

report time-to-event analyses for selective

COX-2 inhibitors and nonselective NSAIDs in

patients with prior MI in a nationwide cohort.



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In accordance with other studies: naproxen wasthe NSAID with the lowest cardiovascular risk.

• The results might indicate that naproxen should

be the preferred NSAID if NSAID treatmentcannot be avoided.

•However, in the VIGOR study naproxen was

associated with higher risk of gastrointestinalbleeding than rofecoxib



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• Gastrointestinal bleeding in patientswith prior MI is associated with worseprognosis.

• Indeed, the adverse prognostic impactof gastrointestinal bleeding further

supports a very conservative approachto use of NSAIDs in patients with priorMI.



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Study strengths:

•Completeness of data from a nationwide cohort

•Avoidance of selection bias resulting from age,

sex, socioeconomic status, affiliation to selected

hospitals, or healthcare systems

• All Danish pharmacies are required to register

all dispensed prescriptions, ensuring completeregistration



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Study limitations:

•lack of information about important clinical

parameters such as blood pressure, body mass

index, smoking habits, lipid levels, and left

ventricular ejection fraction.

• Lack of information about the precise indication forinitiation of NSAID treatment. Thus, the disease or the

pain causing a condition treated with NSAID couldalone indicate a condition with increased risk ofcardiovascular disease or death.



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•The patients do not necessarily take their

medications consecutively, thus the

prescription may run longer exposing thepatients longer than the database might

indicate.

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no control group• no registered data of patients before 1978



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Conclusion and clinical implications:•Short-term treatment with most NSAIDs is

associated with increased cardiovascular risk.

• commonly used NSAIDs, such as diclofenac were

associated with increased risk treatment onset, and

the risk continued to persist during the course of

treatment.

•There is no apparent safe window for NSAIDs in patientswith prior MI and challenge the current recommendations

of low-dose and short-term use of NSAIDs as being safe.



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duration of treatment with non steroidal 2

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