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<a href="http://doi.org/10.1016/s0304-3959(99)00267-5" target="_blank" rel="noreferrer">http://doi.org/10.1016/s0304-3959(99)00267-5</a>
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Title
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Quantitative estimation of rare adverse events which follow a biological progression: a new model applied to chronic NSAID use
Publisher
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Pain
Date
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2000
Subject
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Humans; Cohort Studies; Death; Disease Progression; Risk Assessment; Non-U.S. Gov't; Research Support; Models; Statistical; Anti-Inflammatory Agents; Databases; Factual; Digestive System; Endoscopy; Gastrointestinal Hemorrhage/chemically induced/mortality; Non-Steroidal/adverse effects; Peptic Ulcer Perforation/chemically induced/mortality
Creator
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Tramer MR; Moore RA; Reynolds DJ; McQuay HJ
Description
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Randomised controlled trials (RCTs) alone are unlikely to provide reliable estimates of the incidence of rare events because of their limited size. Cohort, case control, and other observational studies have large numbers but are vulnerable to various kinds of bias. Wanting to estimate the risk of death from bleeding or perforated gastroduodenal ulcers with chronic usage of non-steroidal anti-inflammatory drugs (NSAIDs) with greater precision, we developed a model to quantify the frequency of rare adverse events which follow a biological progression. The model combined data from both RCTs and observational studies. We searched systematically for any report of chronic (>/=2 months) use of NSAIDs which gave information on gastroduodenal ulcer, bleed or perforation, death due to these complications, or progression from one level of harm to the next. Fifteen RCTs (19364 patients exposed to NSAIDs for 2-60 months), three cohort studies (215076 patients redeeming a NSAID prescription over a 3-12 month period), six case-control studies (2957 cases) and 20 case series (7406), and case reports (4447) were analysed. In RCTs the incidence of bleeding or perforation in 6822 patients exposed to NSAIDs was 0.69%; two deaths occurred. Of 11040 patients with bleeding or perforation with or without NSAID exposure across all reports, 6-16% (average 12%) died; the risk was lowest in RCTs and highest in case reports. Death from bleeding or perforation in all controls not exposed to NSAIDs occurred in 18 out of 849489 (0.002%). From these numbers we calculated the number-needed-to-treat for one patient to die due to gastroduodenal complications with chronic (>/=2 months) NSAIDs as 1/((0.69x inverted question mark6-16%, average 12% inverted question mark)-0.002%))=909-2500 (average 1220). On average 1 in 1200 patients taking NSAIDs for at least 2 months will die from gastroduodenal complications who would not have died had they not taken NSAIDs. This extrapolates to about 2000 deaths each year in the UK.
2000
Identifier
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<a href="http://doi.org/10.1016/s0304-3959(99)00267-5" target="_blank" rel="noreferrer">10.1016/s0304-3959(99)00267-5</a>
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Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Type
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Journal Article
2000
Anti-Inflammatory Agents
Backlog
Cohort Studies
Databases
Death
Digestive System
Disease Progression
Endoscopy
Factual
Gastrointestinal Hemorrhage/chemically induced/mortality
Humans
Journal Article
McQuay HJ
Models
Moore RA
Non-Steroidal/adverse effects
Non-U.S. Gov't
Pain
Peptic Ulcer Perforation/chemically induced/mortality
Research Support
Reynolds DJ
Risk Assessment
statistical
Tramer MR