Reactions 1337 - 5 Feb 2011 Safety concerns about opioid use appear warranted Two studies by Dr Daniel Solomon and colleagues, published simultaneously in Archives of Internal Medicine, investigate the comparative safety of opioid analgesics in older adults. 1,2 The studies suggest that the risks associated with opioid analgesics are "substantial", 2 and "recent concerns raised about opioid use in nonmalignant pain syndromes appear warranted". 1 Small numbers needed to harm with opioids In a study conducted among older adults with arthritis, the research team, who were from the Brigham and Women’s Hospital in Boston, showed that – of analgesics – opioids are associated with the highest risks of most specific and severe safety events, while nonselective NSAIDS (nsNSAIDS) are associated with the lowest risk. 1 The team investigated the incidence of adverse events between propensity-matched cohorts of Medicare beneficiaries (mean age 80 years) treated with either an nsNSAID, a coxib [cyclo-oxygenase 2 inhibitor] or an opioid analgesic, in a comparison that they suggest, "would likely never be made in the setting of a randomized controlled trial." While the analgesics’ comparative safety depended on the particular event studied; coxibs and opioids were both associated with a higher relative risk of cardiovascular events than nsNSAIDS, and opioids were associated with a higher risk of fracture. 1 The use of coxibs was associated with a similar level of fracture risk as the use of nsNSAIDS and a reduced risk of GI bleeding. Compared with NSAIDS, opioids, but not coxibs, were associated with an increased risk of safety events requiring hospitalisation and an increased risk of all-cause mortality. The authors say that, "by 1 year, the numbers needed to harm for opioid users were small and thus clinically relevant." Meanwhile, "although nsNSAIDS pose certain risks, these analyses support the safety of these agents compared with other analgesics." Elevated CV risk with codeine "surprising" In a similar cohort study, Solomon and colleagues investigated the incidence of adverse events among older adults initiating therapy with various types of opioid analgesic for the treatment of nonmalignant pain. 2 They explain that it is "a commonly held belief that all opioids are associated with similar risk"; however, their findings showed that, while the risk of GI adverse events appeared to be similar across groups, tramadol and dextropropoxyphene [propoxyphene] were both associated with significantly lower risks of fracture compared with hydrocodone. What’s more, in a finding which the researchers exclaim is "surprising" and requiring "further validation in other data sets", codeine was associated with a significantly elevated cardiovascular risk after 180 days of treatment. Overall, the researchers conclude that, "causal inference requires experimental designs, but these results should prompt caution and further study." 2 1. Solomon DH, et al. The comparative safety of analgesics in older adults with arthritis. Archives of Internal Medicine 170: 1968-78, No. 22, 13 Dec 2010. Available from: URL: http://dx.doi.org/10.1001/archinternmed.2010.391. 2. Solomon DH, et al. The comparative safety of opioids for nonmalignant pain in older adults. Annals of Internal Medicine 170: 1979-1986, No. 22, 27 Dec 2010. 801161008 1 Reactions 5 Feb 2011 No. 1337 0114-9954/10/1337-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

Safety concerns about opioid use appear warranted

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Reactions 1337 - 5 Feb 2011

Safety concerns about opioid useappear warranted

Two studies by Dr Daniel Solomon and colleagues,published simultaneously in Archives of InternalMedicine, investigate the comparative safety of opioidanalgesics in older adults.1,2 The studies suggest that therisks associated with opioid analgesics are "substantial",2and "recent concerns raised about opioid use innonmalignant pain syndromes appear warranted".1

Small numbers needed to harm with opioidsIn a study conducted among older adults with

arthritis, the research team, who were from the Brighamand Women’s Hospital in Boston, showed that – ofanalgesics – opioids are associated with the highest risksof most specific and severe safety events, whilenonselective NSAIDS (nsNSAIDS) are associated withthe lowest risk.1

The team investigated the incidence of adverse eventsbetween propensity-matched cohorts of Medicarebeneficiaries (mean age 80 years) treated with either annsNSAID, a coxib [cyclo-oxygenase 2 inhibitor] or anopioid analgesic, in a comparison that they suggest,"would likely never be made in the setting of arandomized controlled trial."

While the analgesics’ comparative safety dependedon the particular event studied; coxibs and opioids wereboth associated with a higher relative risk ofcardiovascular events than nsNSAIDS, and opioids wereassociated with a higher risk of fracture.1 The use ofcoxibs was associated with a similar level of fracture riskas the use of nsNSAIDS and a reduced risk of GIbleeding. Compared with NSAIDS, opioids, but notcoxibs, were associated with an increased risk of safetyevents requiring hospitalisation and an increased risk ofall-cause mortality. The authors say that, "by 1 year, thenumbers needed to harm for opioid users were smalland thus clinically relevant." Meanwhile, "althoughnsNSAIDS pose certain risks, these analyses support thesafety of these agents compared with other analgesics."

Elevated CV risk with codeine "surprising"In a similar cohort study, Solomon and colleagues

investigated the incidence of adverse events amongolder adults initiating therapy with various types ofopioid analgesic for the treatment of nonmalignantpain.2 They explain that it is "a commonly held belief thatall opioids are associated with similar risk"; however,their findings showed that, while the risk of GI adverseevents appeared to be similar across groups, tramadoland dextropropoxyphene [propoxyphene] were bothassociated with significantly lower risks of fracturecompared with hydrocodone. What’s more, in a findingwhich the researchers exclaim is "surprising" andrequiring "further validation in other data sets", codeinewas associated with a significantly elevatedcardiovascular risk after 180 days of treatment.

Overall, the researchers conclude that, "causalinference requires experimental designs, but theseresults should prompt caution and further study."2

1. Solomon DH, et al. The comparative safety of analgesics in older adults witharthritis. Archives of Internal Medicine 170: 1968-78, No. 22, 13 Dec 2010.Available from: URL: http://dx.doi.org/10.1001/archinternmed.2010.391.

2. Solomon DH, et al. The comparative safety of opioids for nonmalignant pain inolder adults. Annals of Internal Medicine 170: 1979-1986, No. 22, 27 Dec 2010.

801161008