Need to Develop New Nonsteroidal Anti-Inflammatory Drug Formulations

Clinical Therapeutics

Volumn 34, Issue 9, 2012, Pages 1954-1963

  McCarberg, Bill ^a,b   Gibofsky, Allan ^c  

^a Neighborhood Healthcare   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Lower dosage; NSAIDs; Pain management; Safety; Tolerability

Indexed keywords

ACECLOFENAC; CELECOXIB; DEXKETOPROFEN; DICLOFENAC; IBUPROFEN; INDOMETACIN; KETOPROFEN; NAPROXEN; NIMESULIDE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PIROXICAM; ROFECOXIB; VALDECOXIB;

ANALGESIA; ARTHRITIS; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; DOSE RESPONSE; DRUG EFFICACY; DRUG FORMULATION; DRUG INFORMATION; DRUG SAFETY; DRUG TOLERABILITY; GASTROINTESTINAL DISEASE; GASTROINTESTINAL HEMORRHAGE; HEALTH CARE NEED; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART DEATH; HEART INFARCTION; HUMAN; INFLAMMATION; KIDNEY DISEASE; LIVER DISEASE; OUTCOME ASSESSMENT; PEPTIC ULCER; REVIEW; RISK FACTOR;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DESIGN; DRUG LABELING; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; INFLAMMATION; PAIN; PHYSICIAN'S PRACTICE PATTERNS; PRIMARY HEALTH CARE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84866166538     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.08.005     Document Type: Review

References (72)

1. Indomethacin [prescribing information] 2010, Heritage Pharmaceuticals, Inc, Edison, NJ.
2. Naproxen [prescribing information] 2010, Roxane Laboratories, Inc, Columbus, OH.
3. Voltaren [prescribing information] 2011, Novarttis Pharmaceuticals Corp, East Hanover, NJ.
4. Hart F.D., Boardman P.L. Indomethacin: a new non-steroid anti-inflammatory agent. Br Med J 1963, 2:965-970.
5. Ong C.K., Lirk P., Tan C.H., Seymour R.A. An evidence-based update on nonsteroidal anti-inflammatory drugs. Clin Med Res 2007, 5:19-34.
6. Wallace J.L., Granger D.N. The cellular and molecular basis of gastric mucosal defense. FASEB J 1996, 10:731-740.
7. Wallace J.L. Prostaglandins, NSAIDs, and gastric mucosal protection: why doesn't the stomach digest itself?. Physiol Rev 2008, 88:1547-1565.
8. NSAID Prescriptions in the United States 2011, IMS Institute for Healthcare Informatics, IMS, Parsippany, NJ.
9. Public Health Advisory: FDA announces important changes and additional warnings for COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs) US Food and Drug Administration, Accessed January 15, 2011. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm150314.htm.
10. Haanpaa M.L., Backonja M.M., Bennett M.I., et al. Assessment of neuropathic pain in primary care. Am J Med 2009, 122:S13-S21.
11. Mantyselka P., Kumpusalo E., Ahonen R., et al. Pain as a reason to visit the doctor: a study in Finnish primary health care. Pain 2001, 89:175-180.
12. McCarberg B. Treatment of mild-to-moderate acute pain: what can we do to improve the standard of care?. Am J Ther 2008, 15(Suppl 10):S5-S6.
13. Kuehn B.M. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA 2007, 297:249-251.
14. Walpole M.A. Massssachusetts Pain Initiative: Pain Survey Executive Summary 2011.
15. Governdale L. Outpatient prescription opioid utilization in the US, years 2000-2009 2010, US Food and Drug Administration, Department of Epidemiology, Office of Surveillance and Epidemiology, Silver Spring, MD.
16. Braden J.B., Fan M.Y., Edlund M.J. Trends in use of opioids by noncancer pain type 2000-2005 among Arkansas Medicaid and HealthCore enrollees: results from the TROUP study. J Pain 2008, 9:1026-1035.
17. Caudill-Slosberg M.A., Schwartz L.M., Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain 2004, 109:514-519.
18. Sullivan M.D., Edlund M.J., Fan M.Y., et al. Trends in use of opioids for non-cancer pain conditions 2000-2005 in commercial and Medicaid insurance plans: the TROUP study. Pain 2008, 138:440-449.
19. Fishbain D.A., Cole B., Lewis J., et al. What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-related behaviors?. a structured evidence-based review. Pain Med 2008, 9:444-459.
20. Larson A.M., Polson J., Fontana R.J., et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology 2005, 42:1364-1372.
21. Ostapowicz G., Fontana R.J., Schiodt F.V., et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002, 137:947-954.
22. A call to revolutionize chronic pain care in America an opportunity in health care reform [amended March 4, 2010] 2009, Mayday Fund, New York, NY.
23. McLean S.A., Clauw D.J., Abelson J.L., Liberzon I. The development of persistent pain and psychological morbidity after motor vehicle collision: integrating the potential role of stress response systems into a biopsychosocial model. Psychosom Med 2005, 67:783-790.
24. American Pain Society Clinical Practice Guidelines Accessed May 2, 2012. http://www.ampainsoc.org/library/cp_guidelines.htm.
25. American Academy of Pain Medicine, Accessed May 2, 2012. http://www.painmed.org/Library/Clinical_Guidelines.aspx.
26. García Rodríiguez L.A., Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994, 343:769-772.
27. Harris M.D., Siegel L.B., Alloway J.A. Gout and hyperuricemia. Am Fam Physician 1999, 59:925-934.
28. Singh G., Rosen Ramey D. NSAID induced gastrointestinal complications: the ARAMIS perspective, 1997: Arthritis, Rheumatism, and Aging Medical Information System. J Rheumatol Suppl 1998, 51:8-16.
29. Borer J.S., Simon L.S. Cardiovascular and gastrointestinal effects of COX-2 inhibitors and NSAIDs: achieving a balance. Arthritis Res Ther 2005, 7(Suppl 4):S14-S22.
30. Boardman P.L., Hart F.D. Side-effects of indomethacin. Ann Rheum Dis 1967, 26:127-132.
31. Lewis S.C., Langman M.J., Laporte J.R., et al. 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, 54:320-326.
32. García Rodríguez L.A., Hernandez-Diaz S. Risk of uncomplicated peptic ulcer among users of aspirin and nonaspirin nonsteroidal antiinflammatory drugs. Am J Epidemiol 2004, 159:23-31.
33. Laporte J.R., Ibanez L., Vidal X., et al. Upper gastrointestinal bleeding associated with the use of NSAIDs: newer versus older agents. Drug Safety 2004, 27:411-420.
34. García Rodríguez L.A., Cattaruzzi C., Troncon M.G., Agostinis L. Risk of hospitalization for upper gastrointestinal tract bleeding associated with ketorolac, other nonsteroidal anti-inflammatory drugs, calcium antagonists, and other antihypertensive drugs. Arch Intern Med 1998, 158:33-39.
35. García Rodríguez L.A., Barreales Tolosa L. Risk of upper gastrointestinal complications among users of traditional NSAIDs and COXIBs in the general population. Gastroenterology 2007, 132:498-506.
36. Lanas A., García-Rodríguez L.A., Arroyo M.T., et al. Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-steroidal anti-inflammatory drugs, aspirin and combinations. Gut 2006, 55:1731-1738. Associón Española de Gastroenterología.
37. Langman M.J., Weil J., Wainwright P., et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994, 343:1075-1078.
38. Bueno H., Bardaji A., Patrignani P., et al. Use of non-steroidal antiinflammatory drugs and type-specific risk of acute coronary syndrome. Am J Cardiol 2010, 105:1102-1106.
39. Fosbol E.L., Folke F., Jacobsen S., et al. Cause-specific cardiovascular risk associated with nonsteroidal antiinflammatory drugs among healthy individuals. Circ Cardiovasc Quality Outcomes 2010, 3:395-405.
40. Fosbol E.L., Gislason G.H., Jacobsen S., et al. Risk of myocardial infarction and death associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) among healthy individuals: a nationwide cohort study. Clin Pharmacol Ther 2009, 85:190-197.
41. García Rodríguez L.A., Tacconelli S., Patrignani P. Role of dose potency in the prediction of risk of myocardial infarction associated with nonsteroidal anti-inflammatory drugs in the general population. J Am Coll Cardiol 2008, 52:1628-1636.
42. Gislason G.H., Jacobsen S., Rasmussen J.N., et al. Risk of death or reinfarction associated with the use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs after acute myocardial infarction. Circulation 2006, 113:2906-2913.
43. Biskupiak J.E., Brixner D.I., Howard K., Oderda G.M. Gastrointestinal complications of over-the-counter nonsteroidal antiinflammatory drugs. J Pain Palliat Care Pharmacother 2006, 20:7-14.
44. Blot W.J., McLaughlin J.K. Over the counter non-steroidal anti-inflammatory drugs and risk of gastrointestinal bleeding. J Epidemiol Biostat 2000, 5:137-142.
45. Griffin M.R., Piper J.M., Daugherty J.R., et al. Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons. Ann Intern Med 1991, 114:257-263.
46. Mellemkjaer L., Blot W.J., Sorensen H.T., et al. Upper gastrointestinal bleeding among users of NSAIDs: a population-based cohort study in Denmark. Br J Clin Pharmacol 2002, 53:173-181.
47. Wang J., Donnan P.T., MacDonald T.M. An approximate Bayesian risk-analysis for the gastro-intestinal safety of ibuprofen. Pharmacoepidemiol Drug Safety 2002, 11:695-701.
48. Bombardier C., Laine L., Reicin A., et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000, 343:1520-1528. VIGOR Study Group, 2 p following 1528.
49. Ott E., Nussmeier N.A., Duke P.C., et al. Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg 2003, 125:1481-1492.
50. Bresalier R.S., Sandler R.S., Quan H., et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005, 352:1092-1102.
51. Nussmeier N.A., Whelton A.A., Brown M.T., et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 2005, 352:1081-1091.
52. Solomon S.D., McMurray J.J., Pfeffer M.A., et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005, 352:1071-1080.
53. Schmidt M., Christiansen C.F., Mehnert F., et al. Non-steroidal anti-inflammatory drug use and risk of atrial fibrillation or flutter: population based case-control study. BMJ 2011, 343:d3450.
54. Graham D.J., Campen D., Hui R., et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005, 365:475-481.
55. McGettigan P., Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 2011, 8.
56. Whelton A. Nephrotoxicity of nonsteroidal anti-inflammatory drugs: physiologic foundations and clinical implications. Am J Med 1999, 106:13S-24S.
57. Gooch K., Culleton B.F., Manns B.J., et al. NSAID use and progression of chronic kidney disease. Am J Med 2007, 120:280.e281-280.e287.
58. Griffin M.R., Yared A., Ray W.A. Nonsteroidal antiinflammatory drugs and acute renal failure in elderly persons. Am J Epidemiol 2000, 151:488-496.
59. Henry D., Page J., Whyte I., et al. Consumption of non-steroidal anti-inflammatory drugs and the development of functional renal impairment in elderly subjects: results of a case-control study. Br J Clin Pharmacol 1997, 44:85-90.
60. Huerta C., Castellsague J., Varas-Lorenzo C., Garcia Rodriguez L.A. Nonsteroidal anti-inflammatory drugs and risk of ARF in the general population. Am J Kidney Dis 2005, 45:531-539.
61. Kuo H.W., Tsai S.S., Tiao M.M., et al. Analgesic use and the risk for progression of chronic kidney disease. Pharmacoepidemiol Drug Safety 2010, 19:745-751.
62. Perez Gutthann S., Garcia Rodriguez L., Raiford D., et al. Nonsteroidal anti-inflammatory drugs and the risk of hospitalization for acute renal failure. Arch Intern Med 1996, 156:2433-2439.
63. Schneider V., Levesque L.E., Zhang B., Hutchinson T., Brophy J.M. Association of selective and conventional nonsteroidal antiinflammatory drugs with acute renal failure: a population-based, nested case-control analysis. Am J Epidemiol 2006, 164:881-889.
64. Giagoudakis G., Markantonis S.L. Relationships between the concentrations of prostaglandins and the nonsteroidal antiinflammatory drugs indomethacin, diclofenac, and ibuprofen. Pharmacotherapy 2005, 25:18-25.
65. Rane A., Oelz O., Frolich J.C., et al. Relation between plasma concentration of indomethacin and its effect on prostaglandin synthesis and platelet aggregation in man. Clin Pharmacol Ther 1978, 23:658-668.
66. Ekstrand R., Alván G., L'e Orme M., et al. Double-blind dose-response study of indomethacin in rheumatoid arthritis. Eur J Clin Pharmacol 1980, 17:437-442.
67. Dunagan F.M., McGill P.E., Kelman A.W., Whiting B. Naproxen dose and concentration: response relationship in rheumatoid arthritis. Br J Rheumatol 1988, 27:48-53.
68. Derry C., Derry S., Moore R.A., McQuay H.J. Single dose oral naproxen and naproxen sodium for acute postoperative pain in adults. Cochrane Database Syst Rev 2009, CD004234.
69. Kubitzek F., Ziegler G., Gold M.S., et al. Low-dose diclofenac potassium in the treatment of episodic tension-type headache. Eur J Pain 2003, 7:155-162.
70. Gehanno P., Dreiser R.L., Ionescu E., et al. Lowest effective single dose of diclofenac for antipyretic and analgesic effects in acute febrile sore throat. Clin Drug Invest 2003, 23:263-271.
71. Schachtel B.P., McCabe D., Berger M., et al. Efficacy of low-dose celecoxib in patients with acute pain. J Pain 2011, 12:756-763.
72. Zhang W., Nuki G., Moskowitz R.W., et al. OARSI recommendations for the management of hip and knee osteoarthritis. Part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010, 18:476-499.