1
Naproxen and OTC ibuprofen have the most favorable cardiovascular risk profile among widely used Rx and OTC NSAIDs 7 For patients already on, or for whom you are considering initiating a cardioprotective aspirin regimen: Taking ibuprofen at least ½ hour after the dosing of immediate-release low-dose aspirin is a practical method to minimize potential impairment of the antiplatelet effect of aspirin 8,9 Because the effect of aspirin taken daily on platelets is long lasting, the occasional use of ibuprofen poses a minimal risk of attenuating the antiplatelet effect of low-dose aspirin 9 To get a closer look at the clinical evidence and the Advil ® label, please visit us at www.AdvilAide.com. We invite you to explore the latest data on ibuprofen in regard to GI tolerability; cardiovascular, renal, and hepatic safety; as well as toxicity. What you find may surprise you. *Remind patients to use OTC analgesics as directed. Nothing is more effective than Advil ® for acute pain. †13-17 Rethink Relief. Think Advil ® . Among leading OTC pain relievers/fever reducers. © 2014 Pfizer Inc. 07/14 ADV051402 AdvilAide.com References: 1. Rainsford KD. Ibuprofen: pharmacology, efficacy, and safety. Inflammopharmacology. 2009;17(6):275-342. 2. Rainsford KD, Roberts C, Brown S. Ibuprofen and paracetamol: relative safety in non-prescription dosages. J Pharm Pharmacol. 1997;49:365-376. 3. Kellstein DE, Waksman JA, Furey SA, Binstok G, Cooper SA. The safety profile of nonprescription ibuprofen in multiple-dose use: a meta-analysis. J Clin Pharmacol. 1999;39:520-532. 4. Bjarnason I. Ibuprofen and gastrointestinal safety: a dose-duration-dependent phenomenon. J R Soc Med. 2007;100(suppl 48):11-14. 5. Moore N, Van Ganse E, Le Parc J-M, et al. The PAIN study: paracetamol, aspirin and ibuprofen new tolerability study. Clin Drug Invest. 1999;18(2):89-98. 6. Lewis SC, Langman MJS, Laporte J-R, Matthews JNS, Rawlins MD, Wiholm B-E. Dose-response relationships between individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol . 2002;54(3):320-326. 7. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med. 2011;8(9): 1-18. doi:10.1371/journal.pmed.1001098. 8. Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S. Double-blind, randomized, parallel, placebo-controlled study of ibuprofen effects on thromboxane B 2 concentrations in aspirin-treated healthy adult volunteers. Clin Ther. 2005;27(2):185-191. 9. Food and Drug Administration science paper: concomitant use of ibuprofen and aspirin: potential for attenuation of the anti-platelet effect of aspirin. Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM161282.pdf. Published September 8, 2006. Accessed June 6, 2012. 10. Whelton A. Renal effects of over- the-counter analgesics. J Clin Pharmacol. 1995;35:454-463. 11. Furey SA, Vargas R, McMahon FG. Renovascular effects of nonprescription ibuprofen in elderly hypertensive patients with mild renal impairment. Pharmacotherapy. 1993;13(2):143-148. 12. Kean WF, Rainsford KD, Kean IRL. Management of chronic musculoskeletal pain in the elderly: opinions on oral medication use. Inflammopharmacology. 2008;16:53-75. 13. Data on file. Pfizer Consumer Healthcare. 14. Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991;325:87-91. 15. Dalton JD Jr, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006;48:615-623. 16. Boureau F, Schneid H, Zeghari N, Wall R, Bourgeois P. The IPSO study: ibuprofen, paracetamol study in osteoarthritis: a randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip. Ann Rheum Dis. 2004;63:1028-1034. 17. Schiff M, Minic M. Comparison of the analgesic efficacy and safety of nonprescription doses of naproxen sodium and ibuprofen in the treatment of osteoarthritis of the knee. J Rheumatol. 2004;31:1373-1383. Take a closer look before your next OTC analgesic recommendation Data and messages around OTC analgesics continue to evolve, and, therefore, treatment paradigms must evolve as well. Take another look, and you may find that some communications are not telling the full story. When considering which OTC analgesic to recommend, it is important to periodically review all the evidence on risks and benefits as the data set continues to grow. A large-scale review article concluded that, when compared with all analgesics, OTC ibuprofen is less toxic in serious overdose situations and is rarely associated with deaths from either accidental or intentional overdose (or with serious adverse events) 1 OTC ibuprofen has a very low risk factor for developing liver injury, especially compared to the severe liver damage observed with acetaminophen overdose and the occasional liver reaction from aspirin 1,2 Overall, OTC ibuprofen has a low risk factor for developing acute or chronic renal conditions 1,10,11 NSAIDs, including ibuprofen, demonstrate an increased risk of causing renal impairment at high (Rx) doses, especially among elderly patients or patients with reduced renal function 12 Clinical studies have shown when OTC ibuprofen is taken as directed by the label for no longer than 10 days, there is a very low increased risk of stomach complaints or bleeding 1-4 In a study by Moore et al, only 4% of subjects taking OTC ibuprofen for 7 days reported a significant digestive system adverse event 5 Studies have demonstrated that higher doses of ibuprofen are associated with a greater risk of GI side effects (odds ratio 4.6) vs lower (OTC) doses (odds ratio 1.1) 1,6 OTC ibuprofen may be right for more patients than you think* Are safety considerations limiting your use of ibuprofen? It’s time to set the story straight

Are safety considerations limiting your use of ibuprofen? It’s time … · 2017-10-26 · ibuprofen is less toxic in serious overdose situations and is rarely associated with deaths

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Page 1: Are safety considerations limiting your use of ibuprofen? It’s time … · 2017-10-26 · ibuprofen is less toxic in serious overdose situations and is rarely associated with deaths

• Naproxen and OTC ibuprofen have the most favorable cardiovascular risk profile among widely used Rx and OTC NSAIDs7

• For patients already on, or for whom you are considering initiating a cardioprotective aspirin regimen:– Taking ibuprofen at least ½ hour after the

dosing of immediate-release low-dose aspirin is a practical method to minimize potential impairment of the antiplatelet effect of aspirin8,9

– Because the effect of aspirin taken daily on platelets is long lasting, the occasional use of ibuprofen poses a minimal risk of attenuating the antiplatelet effect of low-dose aspirin9

To get a closer look at the clinical evidence and the Advil® label, please visit us at www.AdvilAide.com. We invite you to explore the latest data on ibuprofen in regard to GI tolerability; cardiovascular, renal, and hepatic safety; as well as toxicity. What you find may surprise you.

* Remind patients to use OTC analgesics as directed.

Nothing is more effective than Advil® for acute pain.†13-17 Rethink Relief. Think Advil®.† Among leading OTC pain relievers/fever reducers.

© 2014 Pfizer Inc. 07/14 ADV051402 AdvilAide.com

References: 1. Rainsford KD. Ibuprofen: pharmacology, efficacy, and safety. Inflammopharmacology. 2009;17(6):275-342. 2. Rainsford KD, Roberts C, Brown S. Ibuprofen and paracetamol: relative safety in non-prescription dosages. J Pharm Pharmacol. 1997;49:365-376. 3. Kellstein DE, Waksman JA, Furey SA, Binstok G, Cooper SA. The safety profile of nonprescription ibuprofen in multiple-dose use: a meta-analysis. J Clin Pharmacol. 1999;39:520-532. 4. Bjarnason I. Ibuprofen and gastrointestinal safety: a dose-duration-dependent phenomenon. J R Soc Med. 2007;100(suppl 48):11-14. 5. Moore N, Van Ganse E, Le Parc J-M, et al. The PAIN study: paracetamol, aspirin and ibuprofen new tolerability study. Clin Drug Invest. 1999;18(2):89-98. 6. Lewis SC, Langman MJS, Laporte J-R, Matthews JNS, Rawlins MD, Wiholm B-E. Dose-response relationships between individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol. 2002;54(3):320-326. 7. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med. 2011;8(9): 1-18. doi:10.1371/journal.pmed.1001098. 8. Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S. Double-blind, randomized, parallel, placebo-controlled study of ibuprofen effects on thromboxane B2 concentrations in aspirin-treated healthy adult volunteers. Clin Ther. 2005;27(2):185-191. 9. Food and Drug Administration science paper: concomitant use of ibuprofen and aspirin: potential for attenuation of the anti-platelet effect of aspirin. Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM161282.pdf. Published September 8, 2006. Accessed June 6, 2012. 10. Whelton A. Renal effects of over-the-counter analgesics. J Clin Pharmacol. 1995;35:454-463. 11. Furey SA, Vargas R, McMahon FG. Renovascular effects of nonprescription ibuprofen in elderly hypertensive patients with mild renal impairment. Pharmacotherapy. 1993;13(2):143-148. 12. Kean WF, Rainsford KD, Kean IRL. Management of chronic musculoskeletal pain in the elderly: opinions on oral medication use. Inflammopharmacology. 2008;16:53-75. 13. Data on file. Pfizer Consumer Healthcare. 14. Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991;325:87-91. 15. Dalton JD Jr, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006;48:615-623. 16. Boureau F, Schneid H, Zeghari N, Wall R, Bourgeois P. The IPSO study: ibuprofen, paracetamol study in osteoarthritis: a randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip. Ann Rheum Dis. 2004;63:1028-1034. 17. Schiff M, Minic M. Comparison of the analgesic efficacy and safety of nonprescription doses of naproxen sodium and ibuprofen in the treatment of osteoarthritis of the knee. J Rheumatol. 2004;31:1373-1383.

Take a closer look before your next OTC analgesic recommendationData and messages around OTC analgesics continue to evolve, and, therefore, treatment paradigms must evolve as well. Take another look, and you may find that some communications are not telling the full story. When considering which OTC analgesic to recommend, it is important to periodically review all the evidence on risks and benefits as the data set continues to grow.

• A large-scale review article concluded that, when compared with all analgesics, OTC ibuprofen is less toxic in serious overdose situations and is rarely associated with deaths from either accidental or intentional overdose (or with serious adverse events)1

• OTC ibuprofen has a very low risk factor for developing liver injury, especially compared to the severe liver damage observed with acetaminophen overdose and the occasional liver reaction from aspirin1,2

• Overall, OTC ibuprofen has a low risk factor for developing acute or chronic renal conditions1,10,11

• NSAIDs, including ibuprofen, demonstrate an increased risk of causing renal impairment at high (Rx) doses, especially among elderly patients or patients with reduced renal function12

• Clinical studies have shown when OTC ibuprofen is taken as directed by the label for no longer than 10 days, there is a very low increased risk of stomach complaints or bleeding1-4

• In a study by Moore et al, only 4% of subjects taking OTC ibuprofen for 7 days reported a significant digestive system adverse event5

• Studies have demonstrated that higher doses of ibuprofen are associated with a greater risk of GI side effects (odds ratio 4.6) vs lower (OTC) doses (odds ratio 1.1)1,6

OTC ibuprofen may be right for more patients than you think*

Are safety considerations limiting your use of ibuprofen?

It’s time to set the story straight