111
Views
19
CrossRef citations to date
0
Altmetric
Clinical Features

Lower-Dose Diclofenac Submicron Particle Capsules Provide Early and Sustained Acute Patient Pain Relief in a Phase 3 Study

, MD, FACR, JD, , MD, , MD, , DO, & , MD
Pages 130-138 | Published online: 13 Mar 2015

References

  • . Hunt RH, Choquette D, Craig BN, . Approach to managing musculoskeletal pain: acetaminophen, cyclooxygenase-2 inhibitors, or traditional NSAIDs? Can Fam Physician. 2007;53(7):1177–1184
  • . Rostom A, Goldkind L, Laine L. Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol. 2005;3(5):489–498
  • . Boardman PL, Hart FD. Side-effects of indomethacin. Ann Rheum Dis. 1967;26(2):127–132
  • . Kuo HW, Tsai SS, Tiao MM, Liu YC, Lee IM, Yang CY. Analgesic use and the risk for progression of chronic kidney disease. Pharmacoepidemiol Drug Saf. 2010;19(7):745–751
  • . Salvo F, Fourrier-Reglat A, Bazin F, . Cardiovascular and gastrointestinal safety of NSAIDs: a systematic review of meta-analyses of randomized clinical trials. Clin Pharm Ther. 2011;89(6):855–866
  • . Schjerning Olsen AM, Fosbøl EL, Lindhardsen J, . Duration of treatment with nonsteroidal anti-inflammatory drugs and impact on risk of death and recurrent myocardial infarction in patients with prior myocardial infarction/clinical perspective. Circulation. 2011;123(20):2226–2235
  • . Richy F, Bruyere O, Ethgen O, . Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach. Ann Rheum Dis. 2004;63(7):759–766
  • . Ulinski T, Guigonis V, Dunan O, Bensman A. Acute renal failure after treatment with non-steroidal anti-inflammatory drugs. Eur J Ped. 2004;163(3):148–150
  • . US Food and Drug Administration. Public Health Advisory—FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetylnformationforPatientsandProviders/ucm150314.htm. Published April 7, 2005. Accessed October 3, 2012
  • . Manvelian G, Daniels S, Gibofsky A. The pharmacokinetic parameters of a single dose of a novel nano-formulated, lower-dose oral diclofenac. Postgrad Med. 2012;124(1):117–123
  • . Manvelian G, Daniels S, Gibofsky A. A phase 2 study evaluating the efficacy and safety of a novel, proprietary, nano-formulated, lower dose oral diclofenac. Pain Med. 2012;13911:1491–1498
  • . World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000;284(23):3043–3045
  • . Silverstein FE, Faich G, Goldstein JL, . Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. JAMA. 2000;284(10):1247–1255
  • . Bombardier C, Laine L, Reicin A, ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000;343(21):1520–1528
  • . Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacyto celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011;27(6):1243–1253
  • . Gigante A, Tagarro I. Non-steroidal anti-inflammatory drugs and gastroprotection with proton pump inhibitors: a focus on ketoprofen/omeprazole. Clin Drug Investig. 2012;32(4):221–233
  • . Laine L, Kivitz AJ, Bello AE, Grahn AY, Schiff MH, Taha AS. Double-blind randomized trials of single-tablet ibuprofen/high-dose famotidine vs. ibuprofen alone for reduction of gastric and duodenal ulcers. Am J Gastroenterol. 2012;107(3):379–386
  • . Lin J, Zhang W, Jones A, Doherty M. Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials. BMJ. 2004;329(7461):324
  • . Derry S, Moore RA, Rabbie R. Topical NSAIDs for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 2012;9: CD007400
  • . Arnstein PM. Evolution of topical NSAIDs in the guidelines for treatment of osteoarthritis in elderly patients. Drugs Aging. 2012;29(7):523–531
  • . Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy Adv Ther. 2011;28(9):776–788
  • . Pollak R, Raymond GA, Jay RM, . Analgesic efficacy of valdecoxib for acute postoperative pain after bunionectomy. J Am Podiatr Med Assoc. 2006;96(5):393–407
  • . Desjardins PJ, Traylor L, Hubbard RC. Analgesic efficacy of preoperative parecoxib sodium in an orthopedic pain model. J Am Podiatr Med Assoc. 2004;94(3):305–314
  • . Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012;28(6):953–961
  • . Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010;26(10):2375–2384
  • . Daniels S, Casson E, Stegmann JU, . A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin. 2009;25(6):1551–1561
  • . Manvelian G, Daniels S, Gibofsky A. A phase 2 study evaluating the efficacy and safety of a novel, proprietary, nano-formulated, lower dose oral diclofenac. Pain Med. 2012;13(11):1491–1498
  • . Lewis SC, Langman MJ, Laporte JR, Matthews JN, Rawlins MD, Wiholm BE. 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
  • . Graham DJ, Campen D, Hui R, . Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclooxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet. 2005;365(9458):475–481
  • . Johnsen SP, Larsson H, Tarone RE, . Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch Intern Med. 2005;165(9):978–984
  • . Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006;332(7553):1302–1308
  • . Helin-Salmivaara A, Virtanen A, Vesalainen R, . NSAID use and the risk of hospitalization for first myocardial infarction in the general population: a nationwide case-control study from Finland. Eur Heart J. 2006;27(14):1657–1663
  • . Huerta C, Castellsague J, Varas-Lorenzo C, Garcia Rodriguez LA. Nonsteroidal anti-inflammatory drugs and risk of ARF in the general population. Am J Kidney Dis. 2005;45(3):531–539
  • . Chan AT, Manson JE, Albert CM, . Nonsteroidal antiinflammatory drugs, acetaminophen, and the risk of cardiovascular events. Circulation. 2006;113(12):1578–1587
  • . Henry D, Lim LL, Garcia Rodriguez LA, . Variability in risk of gastrointestinal complications with individual non-steroidal antiinflammatory drugs: results of a collaborative meta-analysis. BMJ. 1996;312(7046):1563–1566
  • . Brater DC. Anti-inflammatory agents and renal function. Semin Arthritis Rheum. 2002;32(3 Suppl 1):33–42

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.