Prophylactic aspirin and risk of peptic ulcer bleeding

Weil, J.; Colin‐Jones, D G; Langman, M. J. S.; Lawson, David H.; Logan, Richard F.; Murphy, Michael S.; Rawlins, M. D.; Vessey, Martin; Wainwright, Paul

doi:10.1136/bmj.310.6983.827

Cited by 507 publications

(371 citation statements)

References 24 publications

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“…Previous studies have consistently reported that no dose-response relationship exists for aspirin-related risk of GI ulcer or bleeding. 8,15,30 In clinical practice, all patients treated with clopidogrel receive 75 mg daily, and the figure thus also reflects the importance of treatment duration. Moreover, the groups continue to separate, thus supporting the importance of ischaemic heart disease as a risk factor for adverse GI events.…”

Section: Discussionmentioning

confidence: 99%

Gastrointestinal Events with Clopidogrel: A Nationwide Population-Based Cohort Study

et al. 2012

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BACKGROUND: Clopidogrel prevents cardiovascular events, but has been linked with adverse gastrointestinal (GI) complications, particularly bleeding events. OBJECTIVE: We aimed to investigate the risk of adverse GI events in patients treated with clopidogrel. DESIGN: A nationwide population-based cohort study based on linkage of three administrative registries in Denmark. PARTICIPANTS: All individuals who redeemed at least one prescription of clopidogrel from 1996 to 2008 were included as exposed subjects (n = 77,503). For each exposed subject, three matched controls were randomly selected from the background population (n = 232,510). ANALYSES: Follow-up began on January 1, 1996, and was censored on December 31, 2007, or if patients emigrated or died. The study endpoint was the occurrence of any gastritis, GI ulcer or bleeding. Analyses were adjusted for comorbidity and medication. RESULTS: Regardless of dose, adjusted odds ratios associating clopidogrel use with the study endpoint were statistically significant and followed a doseresponse pattern. The crude absolute risk of GI events were: never users: 2.2 %; <0.1 defined daily dose (DDD) of clopidogrel per day: 7.1 %; 0.1-0.39 DDD: 6.0 %; 0.4-0.79 DDD: 5.7 %; ≥0.80 DDD: 4.4 %. Adjusted odds ratios were: <0.1 DDD: 1.34, 95 % CI: 1.26-1.42; 0.1-0.39 DDD: 1.58, 95 % CI: 1.48-1.68; 0.4-0.79 DDD: 1.91, 95 % CI: 1.77-2.06; ≥0.80 DDD: 1.77, 95 % CI: 1.66-1.89, all p-values<0.01. Depending on the dose, numbers needed to harm ranged from 58 to 33 patients receiving 12 months of clopidogrel treatment. CONCLUSIONS: The well-known cardioprotective effect of clopidogrel must be carefully weighed against an increased risk of GI events.

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Section: Discussionmentioning

confidence: 99%

Gastrointestinal Events with Clopidogrel: A Nationwide Population-Based Cohort Study

et al. 2012

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“…Studies often had the following exclusion criteria: cancer (n=10), oesophageal varices (n=10), Mallory-Weiss disease (n=10), alcoholism (n=7), chronic liver disease (n=7) or/and coagulopathies (n=6). Aspirin exposure was de®ned as use during the last week in nine studies, use in the last month in three studies, and use reaching the index date or prescriptions that would cover the index date in the other 1 2 De Abajo [58] 3 4 5 6 7 8 9 10 11 12 Sorensen [57] García Rodríguez [55] Pérez Gutthan [54] McMahon [52] Hallas [49] Cohorts Lanas [56] Wilcox [53] Matikainen [52] Kelly [51] Weil [48] Savage [47] Henry [46] Keating [45] Nobili [38] Holvoet [44] Laporte [43] Case/control 0 1 3 14 15 2.2 3.1 Figure 1 Relative risks and 95% con®dence interval reported in original publications on aspirin use and UGIC during 1990 ±2001, strati®ed by study design. ®ve studies.…”

Section: Methodological Factorsmentioning

confidence: 99%

“…However, the risk was still elevated for doses up to 300 mg day x1 . Studies reported a signi®cantly increased risk of UGIC with daily doses below 300 mg, [47,56] 150 mg [46,57], and even as low as 75 mg [48,58] (Table 3).…”

Section: Aspirin Use Factorsmentioning

confidence: 99%

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Association between aspirin and upper gastrointestinal complications: Systematic review of epidemiologic studies

Rodrı́guez

Hernández–Dı́az

Abajo³

2001

Brit J Clinical Pharma

249

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Aims Because of the widespread use of aspirin for prevention of cardiovascular diseases, side-effects associated with thromboprophylactic doses are of interest. This study summarizes the relative risk (RR) for serious upper gastrointestinal complications (UGIC) associated with aspirin exposure in general and with speci®c aspirin doses and formulations in particular.Methods After a systematic review, 17 original epidemiologic studies published between 1990 and 2001 were selected according to prede®ned criteria. Heterogeneity of effects was explored. Pooled estimates were calculated according to different study characteristics and patterns of aspirin use. Results The overall relative risk of UGIC associated with aspirin use was 2.2 (95% con®dence interval (CI): 2.1, 2.4) for cohort studies and nested case-control studies and 3.1 (95% CI: 2.8, 3.3) for non-nested case-control studies. Original studies found a dose±response relationship between UGIC and aspirin, although the risk was still elevated for doses lower or up to 300 mg day x1 . The summary RR was 2.6 (95% CI: 2.3, 2.9) for plain, 5.3 (95% CI: 3.0, 9.2) for buffered, and 2.4 (95% CI: 1.9, 2.9) for enteric-coated aspirin formulations. Conclusions Aspirin was associated with UGIC even when used at low doses or in buffered or enteric-coated formulations. The latter ®ndings may be partially explained by channeling of susceptible patients to these formulations.

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“…The mean annualized rate of ulcer complications is 3.0% per year, and we adopted this as our base-case estimate for average-risk patients in the NSAID NS strategy. The addition of low-dose aspirin (ASA) to an NSAID NS increases the risk of GI complications by 2.5 times baseline, on average (9,(25)(26)(27)(28)(29). We therefore assumed that the annualized rate of ulcer complications was 7.5% in the subset of patients receiving an NSAID NS ϩ ASA combination (3.0% base-case rate ϫ 2.5), and we varied this estimate between 5% and 10% in our sensitivity analysis.…”

mentioning

confidence: 99%

Minimizing complications from nonsteroidal antiinflammatory drugs: Cost‐effectiveness of competing strategies in varying risk groups

Spiegel¹,

Chiou²,

Ofman³

2005

Arthritis & Rheumatism

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Objective. To appraise the cost-effectiveness of competing therapeutic strategies in patient cohorts eligible for aspirin prophylaxis with varying degrees of gastrointestinal (GI) and cardiovascular risk. Methods. Cost-effectiveness and cost-utility analyses were performed to evaluate 3 competing strategies for the management of chronic arthritis: 1) a generic nonselective nonsteroidal antiinflammatory drug (NSAID NS ) alone; 2) NSAID NS plus a proton pump inhibitor (PPI); and 3) a cyclooxygenase 2-selective inhibitor (coxib) alone. Cost estimates were from a third-party payer perspective. The outcomes were incremental cost per ulcer complication avoided and incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was performed to evaluate the impact of varying patient GI risks and aspirin use. Results. In average-risk patients, the NSAID NS ؉ PPI strategy costs an incremental $45,350 per additional ulcer complication avoided and $309,666 per QALY gained compared with the NSAID NS strategy. The coxib strategy was less effective and more expensive than the NSAID NS ؉ PPI strategy. Sensitivity analysis revealed that the NSAID NS ؉ PPI strategy became the dominant approach in patients at high risk for an NSAID adverse event (i.e., patients taking aspirin with >1 risk factor for a GI complication). Conclusion. Generic nonselective NSAIDs are most cost-effective in patients at low risk for an adverse event. However, the addition of a PPI to a nonselective NSAID may be the preferred strategy in patients taking aspirin or otherwise at high risk for a GI or cardiovascular adverse event.

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Prophylactic aspirin and risk of peptic ulcer bleeding

Abstract: Objective-To determine the risks of hospitalisation for bleeding peptic ulcer with -the current prophylactic aspirin regimens of 300 mg daily or less.

Cited by 507 publications

References 24 publications

Gastrointestinal Events with Clopidogrel: A Nationwide Population-Based Cohort Study

Gastrointestinal Events with Clopidogrel: A Nationwide Population-Based Cohort Study

Association between aspirin and upper gastrointestinal complications: Systematic review of epidemiologic studies

Minimizing complications from nonsteroidal antiinflammatory drugs: Cost‐effectiveness of competing strategies in varying risk groups

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