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Research Article

Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies

  • Patricia McGettigan,

    Affiliation: Hull York Medical School, Hull, United Kingdom

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  • David Henry mail

    david.henry@ices.on.ca

    Affiliations: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada, Department of Medicine, University of Toronto, Toronto, Ontario, Canada, Discipline of Clinical Pharmacology, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia

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  • Published: September 27, 2011
  • DOI: 10.1371/journal.pmed.1001098

Reader Comments (4)

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Relevant data was not included in the systematic review

Posted by mangoni on 13 Oct 2011 at 14:32 GMT

The authors excluded the following paper on the basis that it had 'no data on individual NSAIDs':

4. Mangoni AA, Woodman RJ, Gaganis P, Gilbert AL, Knight KM. Use of non-steroidal anti-inflammatory drugs and risk of incident myocardial infarction and heart failure, and all-cause mortality in the Australian veteran community. Br J Clin Pharmacol 2010; 69:689-700.

This is incorrect as we presented individual data for risk of myocardial infarction with the following NSAIDs: diclofenac, naproxen, ibuprofen, and meloxicam (Table 2).

Moreover, another study published in 2010 from our group on the association between NSAIDs and stroke was not considered in the review:

Use of non-steroidal anti-inflammatory drugs and risk of ischemic and hemorrhagic stroke in the Australian veteran community. Mangoni AA, Woodman RJ, Gilbert AL, Knights KM. Pharmacoepidemiol Drug Saf. 2010 May;19(5):490-8.

In this study, too, we presented data on individual NSAIDs: diclofenac, naproxen, ibuprofen, and meloxicam (Table 2).

We feel that such studies have been inappropriately excluded from the analysis. This might have implications as a re-analysis might lead to different results.

Arduino Mangoni

No competing interests declared.

RE: Relevant data was not included in the systematic review

PatriciaMcGettigan replied to mangoni on 13 Oct 2011 at 22:35 GMT

Professor Mangonio is concerned at the exclusion of data reported by him and his colleagues. The exclusion is explained by information in the 'Study Exposures and Outcomes' section of our paper: 'For the studies included in this analysis, the NSAID prescription was regarded as being current if it covered a period that included the index day or continued to within 1 week or less of the index day (i.e., the day the adverse cardiac event occurred).' We considered this time window for exposure to be appropriate because of the presumed short onset and offset of the biological mechanisms of the adverse effects.
While Table 2 in Mangoni et al (Br J Clin Pharmacol 2010; 69:689-700) provides risk estimates for individual NSAIDs, the information related to 'NSAID supplies' over the preceding two years, (1-4 supplies, 5-10, 11-19, and 20+ versus none, ie. no supplies as the comparator in each case). The duration of treatment provided by a 'supply' was not defined.
Table 3 of Mangoni et al provides information on overall risk estimates associated with NSAIDs 'Used once or twice within the last 30 days' and 'Used more than twice within the last 30 days', but provided no information on individual NSAIDs.
So our reading of the data reported by Mangoni et al led us to exclude them on the grounds that they did not provide information on individual NSAIDs that met our exposure definition.

No competing interests declared.

RE: Relevant data was not included in the systematic review

PatriciaMcGettigan replied to mangoni on 13 Oct 2011 at 22:39 GMT

Professor Mangoni is concerned at the exclusion of data reported by him and his colleagues. The exclusion is explained by information in the 'Study Exposures and Outcomes' section of our paper: 'For the studies included in this analysis, the NSAID prescription was regarded as being current if it covered a period that included the index day or continued to within 1 week or less of the index day (i.e., the day the adverse cardiac event occurred).' We considered this time window for exposure to be appropriate because of the presumed short onset and offset of the biological mechanisms of the adverse effects. While Table 2 in Mangoni et al (Br J Clin Pharmacol 2010; 69:689-700) provides risk estimates for individual NSAIDs, the information related to 'NSAID supplies' over the preceding two years, (1-4 supplies, 5-10, 11-19, and 20+ versus none, ie. no supplies as the comparator in each case). The duration of treatment provided by a 'supply' was not defined. Table 3 of Mangoni et al provides information on overall risk estimates associated with NSAIDs 'Used once or twice within the last 30 days' and 'Used more than twice within the last 30 days', but provided no information on individual NSAIDs. So our reading of the data reported by Mangoni et al led us to exclude them on the grounds that they did not provide information on individual NSAIDs that met our exposure definition.

No competing interests declared.