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Potential limitations of electronic database studies of prescription non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and risk of myocardial infarction (MI).
Pharmacoepidemiol Drug Saf 2005; 14(8):513-22PD

Abstract

PURPOSE

To determine whether specific limitations in electronic database studies may lead to biased estimates of the association between prescription, non-selective non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and myocardial infarction (MI) METHODS: Using our case-control study of NANSAIDs and first, non-fatal MI, we determined the odds ratio (OR) for prescription NANSAIDs and MI. In the 'Replicating Electronic Database Analysis,' we considered non-prescription NANSAID users to be 'non-users,' did not stratify by aspirin use, and did not adjust for confounders typically unavailable or incomplete in existing databases. In the 'Misclassification Assessment Analysis,' we removed non-prescription NANSAIDs from the 'non-user' category. In the 'Confounding Assessment Analysis #1,' we additionally adjusted for smoking, family history, and years of education. In the 'Confounding Assessment Analysis #2,' we also adjusted for body mass index (BMI) and physical activity. In the 'Interaction Assessment Analysis,' we stratified on aspirin use and repeated the latter analysis.

RESULTS

The prevalence of current NANSAID and aspirin use was higher in our controls than in electronic database studies, consistent with the fact that non-prescription NANSAIDs accounted for 81% of all NANSAID use. Education, physical activity, and BMI also were associated with prescription NANSAID use. When each potential source of bias was removed, the OR for NANSAIDs moved further from 1.0 (i.e., toward a protective association with MI): 'Replicating Electronic Database' analysis (OR 1.00, 95% confidence interval [CI]: 0.78--1.28); 'Misclassification Assessment Analysis' (OR 0.89, 95%CI: 0.70--1.14); 'Confounding Assessment Analysis #1' (OR 0.85, 95%CI: 0.66--1.10); 'Confounding Assessment Analysis #2' (OR 0.78, 95%CI: 0.60--1.01); 'Interaction Assessment Analysis' (OR 0.69, 95%CI: 0.51--0.95).

CONCLUSIONS

Limitations in electronic databases may be responsible for the lack of association of NANSAIDs on lower MI risk noted in these studies. Further studies-preferably randomized trials-are needed to address the risk-benefit ratio of NANSAID use.

Authors+Show Affiliations

Department of Medicine, Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15959879

Citation

Ilkhanoff, Leonard, et al. "Potential Limitations of Electronic Database Studies of Prescription Non-aspirin Non-steroidal Anti-inflammatory Drugs (NANSAIDs) and Risk of Myocardial Infarction (MI)." Pharmacoepidemiology and Drug Safety, vol. 14, no. 8, 2005, pp. 513-22.
Ilkhanoff L, Lewis JD, Hennessy S, et al. Potential limitations of electronic database studies of prescription non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and risk of myocardial infarction (MI). Pharmacoepidemiol Drug Saf. 2005;14(8):513-22.
Ilkhanoff, L., Lewis, J. D., Hennessy, S., Berlin, J. A., & Kimmel, S. E. (2005). Potential limitations of electronic database studies of prescription non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and risk of myocardial infarction (MI). Pharmacoepidemiology and Drug Safety, 14(8), pp. 513-22.
Ilkhanoff L, et al. Potential Limitations of Electronic Database Studies of Prescription Non-aspirin Non-steroidal Anti-inflammatory Drugs (NANSAIDs) and Risk of Myocardial Infarction (MI). Pharmacoepidemiol Drug Saf. 2005;14(8):513-22. PubMed PMID: 15959879.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Potential limitations of electronic database studies of prescription non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and risk of myocardial infarction (MI). AU - Ilkhanoff,Leonard, AU - Lewis,James D, AU - Hennessy,Sean, AU - Berlin,Jesse A, AU - Kimmel,Stephen E, PY - 2005/6/17/pubmed PY - 2005/11/16/medline PY - 2005/6/17/entrez SP - 513 EP - 22 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 14 IS - 8 N2 - PURPOSE: To determine whether specific limitations in electronic database studies may lead to biased estimates of the association between prescription, non-selective non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and myocardial infarction (MI) METHODS: Using our case-control study of NANSAIDs and first, non-fatal MI, we determined the odds ratio (OR) for prescription NANSAIDs and MI. In the 'Replicating Electronic Database Analysis,' we considered non-prescription NANSAID users to be 'non-users,' did not stratify by aspirin use, and did not adjust for confounders typically unavailable or incomplete in existing databases. In the 'Misclassification Assessment Analysis,' we removed non-prescription NANSAIDs from the 'non-user' category. In the 'Confounding Assessment Analysis #1,' we additionally adjusted for smoking, family history, and years of education. In the 'Confounding Assessment Analysis #2,' we also adjusted for body mass index (BMI) and physical activity. In the 'Interaction Assessment Analysis,' we stratified on aspirin use and repeated the latter analysis. RESULTS: The prevalence of current NANSAID and aspirin use was higher in our controls than in electronic database studies, consistent with the fact that non-prescription NANSAIDs accounted for 81% of all NANSAID use. Education, physical activity, and BMI also were associated with prescription NANSAID use. When each potential source of bias was removed, the OR for NANSAIDs moved further from 1.0 (i.e., toward a protective association with MI): 'Replicating Electronic Database' analysis (OR 1.00, 95% confidence interval [CI]: 0.78--1.28); 'Misclassification Assessment Analysis' (OR 0.89, 95%CI: 0.70--1.14); 'Confounding Assessment Analysis #1' (OR 0.85, 95%CI: 0.66--1.10); 'Confounding Assessment Analysis #2' (OR 0.78, 95%CI: 0.60--1.01); 'Interaction Assessment Analysis' (OR 0.69, 95%CI: 0.51--0.95). CONCLUSIONS: Limitations in electronic databases may be responsible for the lack of association of NANSAIDs on lower MI risk noted in these studies. Further studies-preferably randomized trials-are needed to address the risk-benefit ratio of NANSAID use. SN - 1053-8569 UR - https://www.unboundmedicine.com/medline/citation/15959879/Potential_limitations_of_electronic_database_studies_of_prescription_non_aspirin_non_steroidal_anti_inflammatory_drugs__NANSAIDs__and_risk_of_myocardial_infarction__MI__ L2 - https://doi.org/10.1002/pds.1129 DB - PRIME DP - Unbound Medicine ER -